CN1259968C - Medication for preventing and curing AIDS and preparation method - Google Patents

Abstract

The present invention discloses a medicine for preventing and treating AIDS, which is mainly prepared from stemona root, zedoray rhizome, dandelion, honeysuckle flower, glabrous greenbrier rhizome, cyrtomium rhizome and glycyrrhiza according to a certain weight proportion. The medicine has the functions of removing pestilence, strengthening bodies, dissipating blood stasis, dispelling toxin, dispersing wetness and nourishing yin and has good curative effect on treating AIDS; the present invention can be prepared into any commonly used preparation. The present invention also provides a capsule and a preparation method thereof of the medicine, the capsule is convenient to take, and effective components are concentrated; the present invention is particularly suitable for prevention and treatment of HIV carriers and AIDS patients.

Description

Medicine of a kind of prevention and treatment acquired immune deficiency syndrome (AIDS) and preparation method thereof

Technical field

The present invention relates to medicine of a kind of prevention and treatment acquired immune deficiency syndrome (AIDS) and preparation method thereof, belong to the field of Chinese medicines.Especially, the present invention relates to a kind of can inactivating AIDS poison, can protect the Chinese medicine with immune cell activated again, be applicable to prevention and treatment patients infected hiv and HIV sufferers.

Background technology

Acquired immune deficiency syndrome (AIDS) is a kind of disease of the acquired immune deficiency syndrome that caused by AIDS viral infection.Currently worldwide spread rapidly and widely, become the high-risk infectious disease that is threatening hundreds of millions people's health with popular.

Since finding the first routine HIV sufferers in 1981, by in December, 2002, whole world accumulative total is found HIV patient and aids patient (HIV/AIDS) 6,980 ten thousand, wherein dead 2,780 ten thousand.Only 2002,5,000,000 new the infecteds are just arranged, dead 3,100,000.

With regard to China, carried out the seroepidemiology inspection of acquired immune deficiency syndrome (AIDS) since 1984, prove that HIV (human immunodeficiency virus) imports China in nineteen eighty-two.2002 annual reports accumulative total AIDSinfected patient and aids patient 40563 examples, than calendar year 2001 rising 36.5%, death is 2639 examples, this numeral is well below real figure.Estimate that AIDSinfected patient in 2002 and aids patient surpass 1,000,000.In the numeral of announcing not long ago, AIDSinfected patient and aids patient have reached 840,000, and actual capabilities have reached 2,000,000.As developing into 2010, may reach 1,000 ten thousand by this speed.

According to the message of the United Nations, acquired immune deficiency syndrome (AIDS) had the trend that continues development, and the whole world is 6,480 ten thousand by calendar year 2001, also will have 4,600 ten thousand infectedly to the whole world in 2010, promptly will have 100,000,000 to whole world accumulative total AIDSinfected patient in 2010 and acquired immune deficiency syndrome (AIDS) patient.

Above-mentioned data are drawn certainly: Yang Piaoyu, " acquired immune deficiency syndrome (AIDS): China has not had the safety area ", " China's Healthy ", 2003 the 12nd phases, total the 200th phase, 025-026 page or leaf.

But up to the present, effective synthetic drug is the 5-6 kind only, is Western medicine.For example, zidovudine (AZT), dideoxycytidine (DDC), stavudine (D4T), DDF, lamivudine (3TC) etc., its compound preparation, be HAART, not only curative effect is limited, and drug toxicity is too big and be easy to generate drug resistance, the medicine high price is expensive simultaneously, is difficult to bear for the patient.Simultaneously,, still shoulder heavy responsibilities, can finish in non-five, seven years because the variability (having found 11 types at present) of HIV (human immunodeficiency virus) (Human Immunodeficiency Virus) makes the development of vaccine.Therefore, in the treatment and prevention of acquired immune deficiency syndrome (AIDS), press for exploitation new medicine or reagent.

After acquired immune deficiency syndrome (AIDS) occurred, a lot of doctors and research worker were also constantly from the cause of disease, symptom and the Therapeutic Method of the angle research acquired immune deficiency syndrome (AIDS) of Chinese medicine.According to the property of medicine and the clinical practice of single medicinal material, the Chinese medicine prescription of many treatment acquired immune deficiency syndrome (AIDS) has been proposed, also there are some Chinese medicine preparation to enter clinical experimental stage.But acquired immune deficiency syndrome (AIDS) is a kind of emerging disease, does not have ready-made treatment experience available in the Chinese medicine, and different doctor is to the explanation difference of the Chinese medicine cause of disease of acquired immune deficiency syndrome (AIDS), and therefore, these prescriptions and preparation have certain limitation.

In treatment by Chinese herbs and the research that prevents AIDS, general, general viewpoint is to set upright to relieve internal heat, generally to set upright compound recipe.At present, select flavour of a drug, compositing formula based on the literature of ancient book of Chinese medicine and doctor's personal experience basically.Because the Chinese medicine flavour of a drug are numerous, for example the Chinese medicine that states clearly in " Chinese medicine dictionary " (the new medical college in Jiangsu, Shanghai science tech publishing house, in May, 1986) has 5767 flavors, and the doctor is different to the understanding of acquired immune deficiency syndrome (AIDS) and single medicinal material, and these mutual difference of filling a prescription are bigger.At present, also there has been the Chinese medicine of some treatment acquired immune deficiency syndrome (AIDS) open with the form of patent documentation.Such as, Chinese patent application number is 02112873.1, and denomination of invention is " a kind of Chinese medicine for the treatment of acquired immune deficiency syndrome (AIDS) ", open day is 2002 on Decembers 4; Chinese patent application number is 01138133.7, and denomination of invention is " a kind of medicine and compound method thereof for the treatment of acquired immune deficiency syndrome (AIDS) ", open day is 2002 on JIUYUE 18; Chinese patent application number is 02109950.2, and denomination of invention is " medicine of treatment acquired immune deficiency syndrome (AIDS) ", open day is JIUYUE in 2002 4 days; Chinese patent application number is 02100242.8, and denomination of invention is " mieailing oral liquid and a compound method thereof ", and open day is on August 14th, 2002; Chinese patent application number is 02100252.5, and denomination of invention is " a kind of multifunctional bio-active agent that is exclusively used in aids prevention and treatment ", and open day is on August 14th, 2002; Chinese patent application number is 00117586.6, and denomination of invention is " Chinese medicine for oral administration---acquired immune deficiency syndrome (AIDS) dust composition and application thereof ", and open day is on June 12nd, 2002; Chinese patent application number is 00130131.4, and denomination of invention is " pure Chinese medicinal preparation of treatment acquired immune deficiency syndrome (AIDS), cancer, hepatitis, diabetes, angiopathy ", and open day is on May 15th, 2002; Chinese patent application number is 01120511.3, and denomination of invention is " medicine of treatment acquired immune deficiency syndrome (AIDS) ", and open day is on April 3rd, 2002; Chinese patent application number is 00121157.9, and denomination of invention is " acquired immune deficiency syndrome (AIDS) Chinese medicine and a preparation method ", and open day is on February 20th, 2002; Chinese patent application number is 01114153.0, and denomination of invention is " the Chinese medicine electuary and the method for making thereof of treatment acquired immune deficiency syndrome (AIDS) ", open day is calendar year 2001 December 26 days; Chinese patent application number is 01104273.7, and denomination of invention is " medicine of treatment acquired immune deficiency syndrome (AIDS) and acquired immunodeficiency syndrome and preparation method thereof ", open day is calendar year 2001 JIUYUE 5 days; Chinese patent application number is 00132658.9, and denomination of invention is " medicine of treatment immunodeficiency diseases ", and open day is June 13 calendar year 2001; Chinese patent application number is 99111378.0, and denomination of invention is " a kind of medicine for the treatment of acquired immune deficiency syndrome (AIDS) and cancer ", and open day is on March 1st, 2000; Chinese patent application number is 98119872.4, and denomination of invention is " compound polynary curing liquid ", and open day is on June 9th, 1999; Chinese patent application number is 97119177.8, and denomination of invention is " Chinese herbal medicine and the method for making of the treatment acquired immune deficiency syndrome (AIDS) that a kind of employing method of ruminating is refined ", and open day is on May 5th, 1999; Chinese patent application number is 98117141.9, and denomination of invention is " a kind of medicine for the treatment of acquired immune deficiency syndrome (AIDS) and preparation method thereof ", and open day is on February 10th, 1999; Chinese patent application number is 98113568.4, and denomination of invention is " A, the B prescription of treatment acquired immune deficiency syndrome (AIDS) ", and open day is on November 11st, 1998; Chinese patent application number is 97100881.7, and denomination of invention is " Chinese medicine of treatment acquired immune deficiency syndrome (AIDS) ", open day is JIUYUE in 1998 23 days; Chinese patent application number is 96119564.9, and denomination of invention is " a kind of injection that is used for the treatment of acquired immune deficiency syndrome (AIDS) and preparation method thereof ", and open day is on May 27th, 1998; Chinese patent application number is 96114715.6, and denomination of invention is " a kind of capsule of anti-AIDS ", and open day is on May 6th, 1998; Chinese patent application number is 96118770.0, and denomination of invention is " a kind of Chinese medicine oral liquid for the treatment of sexually transmitted disease (STD) ", and open day is on May 14th, 1997; Chinese patent application number is 95104152.5, and denomination of invention is " Zhonghuaaizikeduling-medicine for AIDS ", and open day is on October 30th, 1996; Chinese patent application number is 95105654.9, and denomination of invention is " medicine of treatment acquired immune deficiency syndrome (AIDS) and preparation method thereof ", and open day is on May 15th, 1996; Chinese patent application number is 94106018.7, and denomination of invention is " a kind of Chinese medicine for the treatment of sexually transmitted disease (STD) ", and open day is November 8 nineteen ninety-five; Chinese patent application number is 89109597.7, and denomination of invention is " manufacture method of the compositions of treatment immunologic function deficiency disease ", and open day is on January 16th, 1991; Chinese patent application number is 97121020.9, and denomination of invention is " a kind of Chinese medicine and processing technique thereof for the treatment of acquired immune deficiency syndrome (AIDS) ", and open day is on June 2nd, 1999; Chinese patent application number is 97119122.0, and denomination of invention is " a kind of oral liquid for the treatment of acquired immune deficiency syndrome (AIDS) and preparation method thereof ", and open day is on April 15th, 1998; Chinese patent application number is 97119121.2, and denomination of invention is " a kind of injection for the treatment of acquired immune deficiency syndrome (AIDS) and preparation method thereof ", and open day is on April 8th, 1998; Chinese patent application number is 00117586.6, and denomination of invention is " Chinese medicine for oral administration---acquired immune deficiency syndrome (AIDS) dust composition and application thereof ", and open day is on June 12nd, 2002; Chinese patent application number is 99113185.1, and denomination of invention is " a kind of steeping in wine Chinese medicine of preventing and treating acquired immune deficiency syndrome (AIDS) ", and open day is on March 15th, 2000; Chinese patent application number is 98117141.9, and denomination of invention is " a kind of medicine for the treatment of acquired immune deficiency syndrome (AIDS) and preparation method thereof ", and open day is on February 10th, 1999; Chinese patent application number is 89104831.6, and denomination of invention is " compound method of control AIDS medicine ", and open day is on January 23rd, 1991; Chinese patent application number is 89104226.1, and denomination of invention is " preventing and treating the preparation method of acquired immune deficiency syndrome (AIDS), sexually transmitted disease (STD) washing liquid ", and open day is on January 9th, 1991.

The flavour of a drug that the Chinese medicine preparation of existing treatment acquired immune deficiency syndrome (AIDS) generally uses are more, and disclosed Chinese medicine is made up of principal agent and accessory drugs in for example above-cited Chinese patent application 02112873.1, totally 22 flavor Chinese medicines; Chinese patent application 01138133.7 disclosed medicine is formulated by 17 kinds of medical materials.According to the principles of formulating prescriptions of monarch, the many product of the principal agent of these Chinese medicine preparations (monarch drug) with heat-clearing and toxic substances removing, referring to Chinese patent application 97121020.9, wherein used principal agent has Flos Lonicerae, Fructus Forsythiae, the Radix Pulsatillae, Herba Taraxaci, Herba Violae etc.Also have and regard acquired immune deficiency syndrome (AIDS) as deficient syndrome, principal agent is used qi-restoratives medicine more, and for example Chinese patent application 02112873.1, wherein use the Radix Astragali, Radix Codonopsis, Fructus Jujubae, Fructus Lycii, Fructus Ligustri Lucidi etc.In addition, the Chinese medicine preparation for the treatment of acquired immune deficiency syndrome (AIDS) at present is mostly based on doctor's clinical practice, and is less by pharmacology and toxicology test, is difficult to have general applicability.For example disclosed compound recipe YUQUAN WAN is made up of Radix Trichosanthis, Radix Puerariae, Radix Rehmanniae, Fructus Schisandrae Chinensis, Radix Glycyrrhizae, Herba Hyperici Monogyni, Ganoderma, Rhizoma Smilacis Glabrae in following document, be used to show in the pyretic toxicity accumulate, acquired immune deficiency syndrome (AIDS) that body fluid is impaired, for losing empty HIV sufferers, then should not use separately with healthy energy.Referring to Liu Gongwang, the pharmacology of Chinese medical formulae, Huaxia Press, 2002.1, the 635-636 pages or leaves.

Above-mentioned situation shows the cause of disease and the Therapeutic Method that is necessary further from the angle further investigation acquired immune deficiency syndrome (AIDS) of Chinese medicine, provide cost less, side effect is little, effective Chinese medicine product really, is used for the prevention and the treatment of acquired immune deficiency syndrome (AIDS).For the ease of industrial enforcement, Chinese medicine preparation and processing method should simple possible.

The present invention has satisfied above-mentioned needs.Studied the cause of disease of acquired immune deficiency syndrome (AIDS), proposed to form the Chinese medicine preparation simple, that curative effect is conclusive, the Chinese medicine that uses this Chinese medicine preparation preparation also is provided simultaneously.

Summary of the invention

An object of the present invention is provides a kind of Chinese medicine composition for the treatment acquired immune deficiency syndrome (AIDS).

The medicament selection Radix Stemonae of the present invention and Rhizoma Curcumae make up, the sweet profit tonify deficiency of the Radix Stemonae wherein, bitter degraded poison, can be effectively at the disease of acquired immune deficiency syndrome (AIDS); The hot temperature of loosing of Rhizoma Curcumae is logical, but dissipating blood stasisization is stagnant, and the mediation blood vessels strengthen Radix Stemonae antidotal function.

In order to reach better therapeutic, medicine of the present invention can also make up with Herba Taraxaci, Flos Lonicerae, Rhizoma Smilacis Glabrae, Rhizoma Osmundae.This is that Rhizoma Osmundae is bitter cool because Flos Lonicerae, Herba Taraxaci are sweet cold, and the sweet light property of Rhizoma Smilacis Glabrae is flat, and common assistant helps the monarch and his subjects' product heat-clearing and toxic substances removing.

In order to obtain better therapeutic, medicine of the present invention can also add Radix Glycyrrhizae on the basis of said medicine.This is because the Radix Glycyrrhizae nature and flavor are sweet flat, and replenishing QI to invigorate the spleen, eliminate the phlegm only expectorant, relieving spasm to stop pain, heat-clearing and toxic substances removing can coordinating the actions of various ingredients in a prescription.This 7 flavor medicine is used in combination, and plays altogether that the epidemic disease of dispelling is set upright, the merit of dissipating blood stasis detoxifcation, dehumidifying yin nourishing, thereby obtains the preferable curative effect of treatment acquired immune deficiency syndrome (AIDS).

The consumption of drug component of the present invention also is that the inventor gropes to draw with Test Summary in a large number, and the consumption of each component is for having curative effect preferably in the following weight parts scope: Radix Stemonae 12-20 part and Rhizoma Curcumae 8-13 part.

The consumption of drug component of the present invention can also be Radix Stemonae 12-20 part, Rhizoma Curcumae 8-13 part, Herba Taraxaci 1.5-4.0 part, Flos Lonicerae 1.5-4.0 part, Rhizoma Smilacis Glabrae 1.5-4.5 part and Rhizoma Osmundae 3.0-7.0 part.

The consumption of drug component of the present invention also can be Radix Stemonae 12-20 part, Rhizoma Curcumae 8-13 part, Herba Taraxaci 1.5-4.0 part, Flos Lonicerae 1.5-4.0 part, Rhizoma Smilacis Glabrae 1.5-4.5 part, Rhizoma Osmundae 3.0-7.0 part and Radix Glycyrrhizae 0.2-0.6 part.

Preferably, in one embodiment, medicine of the present invention can comprise: Radix Stemonae 30g, Rhizoma Curcumae 15g, Flos Lonicerae 15g, Herba Taraxaci 15g, Rhizoma Osmundae 15g, Rhizoma Smilacis Glabrae 15g and Radix Glycyrrhizae 6g.

Another purpose of the present invention has provided the preparation method of this Chinese medicine composition.

Medicine of the present invention can adopt the conventional method of Chinese medicine preparation to be prepared into any conventional formulation.For example these crude drug pulverizes can be mixed and made into powder and take after mixing it with water, also crude drug can be processed into pill and take.In order to make each crude drug in this medicine better bring into play drug effect, preferably the effective ingredient in the crude drug is extracted.Such as, Rhizoma Curcumae can be extracted, obtain volatile oil; Effective ingredient with medicines such as the ethanol extraction Radixs Stemonae.The effective ingredient that use extracts is made tablet, capsule, electuary, various pharmaceutical dosage forms such as injection.Adopt traditional decocting method can prepare the decoction of medicine of the present invention, be prepared into drink form and take.

In a preferred embodiment of the invention, take by weighing the crude drug of above-mentioned formula ratio.Extract volatile oil from Rhizoma Curcumae earlier.Reuse ethanol extracts from the Rhizoma Curcumae medicinal residues that extracted volatile oil and the Radix Stemonae, Flos Lonicerae, Herba Taraxaci, Rhizoma Osmundae, Rhizoma Smilacis Glabrae and obtains extract.With the two mixing, concentrate, be dried to solid, as the ingredient of preparation medicament capsule of the present invention.The ingredient of employing said extracted prepares the method for capsule, can carry out with reference to the professional technique handbook of this area.

Chinese medicine provided by the invention all shows the obvious treatment effect in the pathology pharmacological evaluation.

Chinese medicine provided by the invention can be used for the disease of accumulateing in the positive QI-insufficiency, noxious dampness of the traditional Chinese medical science that acquired immune deficiency syndrome (AIDS) chemicals acquired immune deficiency syndrome (AIDS) chemotherapy process occurred; Accumulate in eqpidemic disease heating, the noxious dampness, the heating due to thermal burn battalion the moon, weak, headache, systemic pain, pharyngalgia, the few expectorant of dry cough, diarrhoea, liver spleen and lymphadenectasis etc. are because of the virogenetic related symptoms of aids infection.Function cures mainly to timid epidemic disease is set upright, dissipating blood stasis detoxifies, the dehumidifying yin nourishing.

Detailed Description Of The Invention

In the present invention, term " prescription ", " compound recipe " has the identical connotation of essence with " prescription ", is equivalent to term " compositions ".

In the present invention, according to custom, term " Chinese medicine " is meant that with the Chinese traditional medicine theory be guidance, and by collection, the process of preparing Chinese medicine, preparation process, illustration mechanism instructs the medicine of clinical practice.That is to say that in the present invention, Chinese medicine just is meant under instruction of Chinese Medicine theory, be used to prevent, treat, diagnose the illness and have the material of rehabilitation and health-care effect.Chinese medicine is mainly derived from crude drug and processed goods thereof, comprises plant amedica, animal drugs, mineral drug and part chemistry, biological drug.Because plant amedica is in the majority in the Chinese medicine, so also have term " Chinese herbal medicine " and " medical herbs "; The medicine of commonly using in Chinese minority area is called as " ethnic drug " in addition.In the present invention, connotation the most widely taken in " Chinese medicine " speech, comprises " ethnic drug ", and it can replace use with " Chinese herbal medicine " and " medical herbs " simultaneously.

In the present invention, the principles of formulating prescriptions of " monarch " have been followed.Monarch drug (principal agent) is the medicine for the treatment of at main disease, is indispensable medicine in the prescription.Ministerial drug (accessory drugs) is to assist monarch drug to treat main disease, strengthens therapeutical effect, perhaps treats the medicine of accompanied symptoms.Adjuvant drug generally has three kinds of effects: 1. assist the monarch and his subjects' medicine to strengthen therapeutical effect, perhaps treat less important accompanied symptoms.2. be used for eliminating or alleviating the monarch and his subjects' medicine high strong property or toxicity.3. as corrigent.Messenger drug has two kinds of effects: 1. coordinating the actions of various ingredients in a prescription or play flavored action.2. guiding drug guides all medicines to arrive the medicine of sick position.Monarch drug is requisite in every prescription, minister, helps, makes and can accept or reject according to the state of an illness, needn't possess one by one sometimes.

In the present invention, described consumption metering " umber " all refers to weight.

In the present invention, " Chinese medicine composition " is meant the mixture of being made up of according to certain ratio the raw material of Chinese medicine medicine, also refer to the various dosage forms that above-mentioned " mixture " obtains through processing, also refer to the combination of effective ingredient that above-mentioned " mixture " obtained through purifying, and the various pharmaceutical preparations made from this combination of active principles.In the present invention, can in inventive compositions, add various adjuvants, comprise through the invention compositions of processing, purification and add adjuvant, be used to make various dosage forms.

In the present invention, " Chinese medicine of invention " comprises the compositions of above-mentioned raw material of Chinese medicine, the pharmaceutical preparation of being processed into etc.Just, " Chinese medicine of invention " is meant the Chinese medicine composition that contains invention, and uses the various medical products after proper method is processed the Chinese medicine composition of this invention.

In the present invention, " active constituents of medicine " or " active component " be meant in the crude drug of the present invention to treatment disease useful material, also can refer to play in the Chinese medicine composition of the present invention the general name of the material of therapeutical effect, also being used in reference to crude drug of the present invention is that raw material extracts the material with same or better therapeutic effect that obtains.In narration, also use " effective ingredient " sometimes, have same connotation.

First aspect, the present inventor has studied the etiology and pathogenesis of acquired immune deficiency syndrome (AIDS).

Acquired immune deficiency syndrome (AIDS) was imported China into only 17 years, did not have the record of " acquired immune deficiency syndrome (AIDS) " in the Chinese medicine, but had from exteroreception and the characteristics that harm is big, the change of disease is fast according to acquired immune deficiency syndrome (AIDS), and the present inventor is under the jurisdiction of motherland's medical science " epidemic pathogenic factor ", " noxious dampness " category with it.Acquired immune deficiency syndrome (AIDS) gets to the bottom of sb.'s illness and is " accumulate in diseases caused by exogenous pathogenic factor epidemic disease poison, the noxious dampness, thermal burn battalion the moon due to "." poison " refers to virus, epidemic pathogenic factor, the attribute that " heat " is had for poison, the sense just of evil poison, evil quadrature is striven, advancing of disease follows the rule change of disease of defensive-qi-nutrient-blood more, but because of the epidemic disease poison cruel, so defensive-qi-nutrient-blood be overlapping phenomenon, often state of an illness complexity often can occur, symptom is changeable, many organ injuries the person see more, and it is cruel to show the epidemic disease poison, the pathological characteristic that healthy energy is deficient.Because of the epidemic disease poison has stronger aggressivity, so its change of disease is rapid, be easy to fire-transformation impairment of YIN, deficiency of YIN affecting YANG in the course of disease, vigour consume, positive QI-insufficiency or cave in changes, and various danger occur and waits.

The sense just of evil poison often in the evolution that evil quadrature is striven, heating occurs, the pathogenic heat tension and relaxation, cloudy Tianjin is heavily bright, and the Gu Jinkuiyin wound runs through the whole process of primary disease, the weak asthenia of patient, present one chronic consumptive disease symptom, the inevitable impairment of YIN of epidemic disease poison, body fluid deficiency is cloudy hinders, the muscle arteries and veins loses supports then systemic pain, hyperactivity of fire caused by deficiency of YIN is the few expectorant of pharyngalgia, dry cough then, whole then lung spleen kidney three dirty friendships thanks to, whole body poisoning symptom such as diarrhoea, loss of appetite can occur, lose weight." heresy of epidemic disease poison can fight blood be the stasis of blood " simultaneously, because of intimately decocting, cloudy body fluid deficiency is few, and hyperlipidemia then stagnates and is the stasis of blood; The epidemic disease poison wildness strongly fragrant mechanism of qi that is at a loss for words, the stagnation of QI is hematogenous blockage then, and so the existence of blood stasis is arranged in the course of disease, liver spleen and lymphadenectasis etc. can appear in late period more, in a word, and epidemic disease poison, blood stasis reciprocal causation, weakened body resistance, body fluid deficiency impels the state of an illness a series of danger times more seriously to occur.

Epidemic disease heresy, noxious dampness, weakened body resistance be the key link of primary disease morbidity, poison resides in the damp, poison is gone into heresy, is sickly given birth to by void, becomes and is risen by poison, follows the experience that the traditional Chinese medical science was prevented and treated pestilence in several thousand, strengthening vital QI to eliminate pathogenic factors is the two big approach of getting rid of evils.

With regard to the Chinese medicine opinion, strengthening the body resistance Chinese medicine is not only effective to kill virus, simultaneously, can improve the immunologic function of human body significantly.Therefore, kill virus class Chinese medicine can be eliminating evil, and improving immunity function class Chinese medicine can strengthening the body resistance, and makes compound Chinese medicinal preparation, to solve the variation of HIV (human immunodeficiency virus) (Human Immunodeficiency Virus).

Second aspect the present invention proposes the prescriptions of Chinese medicine for the treatment of acquired immune deficiency syndrome (AIDS).

The flavour of a drug of Chinese medicine are various, and the Chinese medicine that states clearly in " Chinese medicine dictionary " (the Shanghai science tech publishing house) that is write by the new medical college in Jiangsu has 5767 flavors.Simultaneously, the Chinese medicine naming method is rich and varied, the several different methods that the effect of with good grounds medicine, agents area, the place of production, form, abnormal smells from the patient, flavour etc. are named.For Chinese medicine various in style, that the source is complicated,, also there is multiple sorting technique for the ease of retrieval, research and utilization.In the present invention, for the purpose of clear, used Chinese materia medica term all adopts the common connotation in present technique field.Clear and definite if desired, then illustrate especially.

Pathogenetic understanding based on to acquired immune deficiency syndrome (AIDS) the invention provides following prescriptions of Chinese medicine:

The Radix Stemonae: 12-20 part Rhizoma Curcumae: 8-13 part

Herba Taraxaci: 1.5-4.0 part Flos Lonicerae: 1.5-4.0 part

Rhizoma Smilacis Glabrae: 1.5-4.5 part Rhizoma Osmundae: 3.0-7.0 part

Radix Glycyrrhizae: 0.2-0.6 part

Reuse the Radix Stemonae that Gan Run, hardship fall in the side, with sweet profit tonify deficiency, bitter degraded poison, lung moistening YIN nourishing and the origin of through disease, bitter in the mouth drop-down and non-impairment of YIN, tepor is sweet to embellish but not dry strongly, is we's principal agent (monarch drug).The hot temperature of loosing of Rhizoma Curcumae is logical, has both gone into blood system, go into edema caused by disorder of QI again, but dissipating blood stasisization is stagnant, and the mediation blood vessels to help the merit of Radix Stemonae detoxifcation, are the accessory drugs in the side (ministerial drug).Flos Lonicerae, Herba Taraxaci are sweet cold, but cold heat-clearing and toxic substances removing, the sweet Hu Yin Tianjin of then consolidating, in clear " Chongqing hall random notes ", comment Flos Lonicerae " to separate the dirty filthy heresy of pestilence ", more give prominence to Flos Lonicerae and prevented and treated the effect of infectious disease, Herba Taraxaci focuses on removing toxicity for eliminating carbuncles, and clear supplementary Amplifications of the Compendium of Materia Medica has saying of " treating all poisonous insect snakebites ", to the detoxifcation notion expansion to some extent again of Herba Taraxaci.Rhizoma Osmundae is bitter cool, and gas is also dense, but both heat-clearing and toxic substances removing, but removing heat from blood parasite killing again, first year Rhizoma Osmundae in Shennong's Herbal called it and can " be separated all poison, kill three worms " and can remove the fraud of epidemic disease poison.The sweet light property of Rhizoma Smilacis Glabrae is flat, and the epidemic disease of dispelling detoxifcation, dehumidifying are warded off dirty, but the dispersing swelling and dissipating binds of holding concurrently, can strengthening the spleen and stomach and dispel foul.Four medicines (Flos Lonicerae, Herba Taraxaci, Rhizoma Osmundae, Rhizoma Smilacis Glabrae) are adjuvant drug altogether, dissipating blood stasis detoxifcation, the epidemic disease of dispelling dehumidifying, and heat clearing away and non-impairment of YIN, it is foul to dispel to detoxify.The Radix Glycyrrhizae nature and flavor are sweet flat, replenishing QI to invigorate the spleen, eliminate the phlegm only expectorant, relieving spasm to stop pain, heat-clearing and toxic substances removing, and coordinating the actions of various ingredients in a prescription, the Compendium of Material Medica cloud: " removing pathogenic heat, slow healthy energy, yin nourishing blood, tonifying the spleen and stomach, lung moistening ", strengthening vital QI to eliminate pathogenic factors is the messenger drug in the side.All medicines share, and play altogether that the epidemic disease of dispelling is set upright, the merit of dissipating blood stasis detoxifcation, dehumidifying yin nourishing.

The Radix Stemonae is the tuber of Stemonaceae plant Radix Stemonae Stemona sessilifolia (Miq.) Miq. Radix stemonae japonicae Stemona japonica (B1.) Miq. or radix stemonae tuberosae Stemona tuberose Lour..Mainly originate in ground such as Anhui, Jiangsu, Hubei, Zhejiang, Shandong.Spring, Qiu Erji excavate, and remove root hair, and be clean, places the boiling water part omitted to scald or steam to there not being the white heart, takes out, and dries, and cuts sheet and give birth to usefulness.The particulars of the relevant Radix Stemonae can be with reference to the books of the field of Chinese medicines, " Chinese medicine dictionary " (Shanghai science tech publishing house) of writing of the new medical college in Jiangsu for example, " Chinese materia medica " (China Traditional Chinese Medicine Publishing House, in JIUYUE, 2002) of Gao Xuemin chief editor.

Put down in writing the Radix Stemonae " main profit lung benefiting " in the ancient books.Therefore be used for cough-relieving clinically more.The in vitro tests proof is inhibited to antibacterials such as Bacillus tuberculosis, streptococcus pneumoniae, and certain calmness and analgesic activity are also arranged.

The different name of Rhizoma Curcumae is more, such as Rhizoma Curcumae, fluffy art, Rhizoma Curcumae etc. are arranged, is the tuber of zingiberaceous plant Rhizoma Curcumae Curcuma zedaaria (Berg.) Rosc..Rhizoma Curcumae has another name called radix zedoariae, green Rhizoma Zingiberis Recens.Main function is circulation of qi promoting, removing blood stasis, removing food stagnancy, pain relieving.

The different name of Flos Lonicerae has Flos Lonicerae, Flos Lonicerae, JINHUA, Flos Lonicerae etc., is the alabastrum of caprifoliaceae plant Radix Ophiopogonis Lonicera japonica Thunb., has heat clearing away, antidotal effect.

Herba Taraxaci is the whole herb with root of feverfew Herba Taraxaci Taraxacum mongolicum Hand.-Mazz.In addition, multiple congener also can be used as medicine on an equal basis, such as alkali ground Herba Taraxaci Taraxacum sinicum Kitag., different luxuriant Herba Taraxaci Taraxacum heterolepis Nakai et H.Koidz. etc.

The different name of Rhizoma Osmundae is passed through joint, pass through clock etc., be mainly Dryopteridaceae plant dryopteris crassirhizoma Dryopteris crassirhizoma Nakai, Athyriaceae plant lunathyrium acrostichoidesChing Lunathyriumacrostichoides (Sw.) Ching, ball Pteridiaceae plant Matteuccia strthiopteris Matteucciastruthiopteris (L.) Todaro, Osmundaceae plant osmund Osmunda japonica Thunb., Blechnaceae plant Blechnum orientale Linn. Blechnum orientale L., Brainea insignis Brainia insignis (Hook.) J.Sm, rhizome such as Rhizoma Osmundae Woodwardia japonica (L.f.) Sm..Preferred Rhizoma Dryopteris Crassirhizomatis, i.e. the Dryopteridaceae plant dryopteris crassirhizoma Dryopteris crassirhizomaNakai of using.

Rhizoma Smilacis Glabrae is a liliaceous plant Rhizoma Smilacis Glabrae Smilax glabra Roxb rhizome.Has detoxifcation, dehumidifying, the function in sharp joint.

Radix Glycyrrhizae is root and the root stock of glycyrrhizic legume Glycyrrhiza uralensis Fisch..The main function of Radix Glycyrrhizae is and middle emergency lung moistening, detoxifcation, coordinating the actions of various ingredients in a prescription.

Description about above-mentioned medical material, also can be with reference to Chinese Pharmacopoeia first one of version the 230th page " Rhizoma Curcumae " in 2000, the 100th page " Radix Stemonae ", the 289th page " Herba Taraxaci ", the 117th page " Flos Lonicerae ", the 271st page " Rhizoma Dryopteris Crassirhizomatis ", the 15th page " Rhizoma Smilacis Glabrae ", the regulation under the 65th page " Radix Glycyrrhizae " item.

Crude drug prescription of the present invention is based on pathogenetic understanding and the research of inventor to acquired immune deficiency syndrome (AIDS), and the principles of formulating prescriptions have been followed the monarch principle in the drug matching.Therefore, the effect of the every herbal medicine in the above-mentioned prescription and importance also meet the overview of Chinese medicine, according to the viewpoint of Chinese medicine above-mentioned prescription are carried out variation to a certain degree or replace also belonging within the scope of the present invention.Various being equal to of being done according to those skilled in the art of the present technique's ordinary skill level, substitute also within the scope of the invention.

The 3rd aspect the invention provides the compositions that comprises the Chinese medicine in the above-mentioned prescription, and this Chinese medicine composition comprises:

The Radix Stemonae: 12-20 part Rhizoma Curcumae: 8-13 part

Herba Taraxaci: 1.5-4.0 part Flos Lonicerae: 1.5-4.0 part

Rhizoma Smilacis Glabrae: 1.5-4.5 part Rhizoma Osmundae: 3.0-7.0 part

Radix Glycyrrhizae: 0.2-0.6 part

Above-mentioned umber is for crude drug according to weight portion, the consumption of the commercially available medical material of just above-mentioned 7 flavor medicines.Particularly in the process of preparation pill and powder, can make effective pharmaceutical dosage form according to above-mentioned weight portion.If preparation concentrates capsule, because may be variant to the extraction efficiency of said medicine, above-mentioned part by weight may change, but under the situation that does not deviate from spirit of the present invention and aim, still thinks within the scope of the present invention.

Similarly, according to of the present invention noted earlier, and the principle of Chinese medicine, said composition can comprise the Radix Stemonae and Rhizoma Curcumae, the Radix Stemonae, Rhizoma Curcumae, Herba Taraxaci, Flos Lonicerae, Rhizoma Smilacis Glabrae and Rhizoma Osmundae can be comprised, also the Radix Stemonae, Rhizoma Curcumae, Herba Taraxaci, Flos Lonicerae, Rhizoma Smilacis Glabrae, Rhizoma Osmundae and Radix Glycyrrhizae can be comprised.According to the viewpoint of Chinese materia medica, on the basis of the combination of having used the Radix Stemonae and Rhizoma Curcumae, comprise the combination of other materials, also should belong to scope of the present invention.

Said composition can be that said medicine is combined direct formation, also can obtain extract after again according to corresponding purification way every kind of medicine that row combines, and perhaps the compositions that contains above-mentioned Chinese medicine is carried out the medicine that processing and preparing obtains.

According to the record of existing document, can tentatively learn the principal component of the medical material of respectively distinguishing the flavor of, existing main known composition list of categories with above-mentioned medical material related in the invention process is in table 1:

The known composition classification of medicine of respectively distinguishing the flavor of in table 1 prescription

Flavour of a drug	The composition classification
		The Radix Stemonae	Alkaloid ((-)-Stemoninine, Stemonidine) etc.
Rhizoma Curcumae	Volatile oil (terpenoid and sesquiterpene derivative, eucalyptus globulus quintessence oil) etc.
		Rhizoma Smilacis Glabrae Rhizoma Dryopteris Crassirhizomatis Herba Taraxaci Flos Lonicerae Radix Glycyrrhizae	Saponin, tannin, bracken acids such as resin, the flavaspidic acid class, the bracken triterpene, tannin, volatile oil, carotenoids such as resin, triterpenes, phytosterol, the sesquiterpene lactones class, flavonoid, phenolic acids volatile oil, luteolin, chlorogenic acid, isochlorogenic acid, saponin, tannin, triterpeness such as caffeic acid, glycyrrhizic acid, enoxolone, flavonoid etc.

Details can be with reference to following document:

1, Miao Mingsan, Li Zhenguo etc. modern practical Chinese medicine quality control technology. Beijing: People's Health Publisher, 2000.281,397,678,814,985,1048

2, the new medical college in Jiangsu. the Chinese medicine voluminous dictionary. Shanghai: Shanghai science tech publishing house, 1977:858,1484,2459,1403,91,567

3, Zhou Xin etc. the research of different places of production Rhizoma Curcumae volatile oil. West China pharmaceutical journal, 2002,17 (3): 201-203

4, Li Aiqun etc. the composition of warm Rhizoma Curcumae volatile oil. Chinese herbal medicine, 2001,32 (9): 782-783

5, the king bathes life, Deng Wenlong etc. herbal pharmacology and application, the 2nd edition [M]. and Beijing: People's Health Publisher .1998:895

6, Cong Xiaodong, Xu state equalization. Radix Stemonae pharmacognostical study. Acta Pharmaceutica Sinica, 1992,27 (7): 556-560

7, Cong Xiaodong, Xu Guojun. Radix Stemonae pharmacognostical study III. China Medicine University journal, 1991,22 (4): 197-199

8, Wu Shoujin, Yang Xiuxian. the Rhizoma Dryopteris Crassirhizomatis The Chemical Constituents. Chinese herbal medicine, 1997,28 (12): 712-715

9, Li Dehua, Hao Xiaoge etc. Rhizoma Osmundae live part moral antitumor action. Chinese herbal medicine, 1986,17 (6): 14-15

10, Zhang Lijun, Tian Shaoku etc. the progress of Rhizoma Osmundae. the Shaanxi traditional Chinese medical science, 2002,23 (8): 748-749

11, Jiang Yasheng, Yang Ning. the pharmacological research progress of Rhizoma Osmundae. pharmacy practice magazine, 2000,18 (1): 17-18

12, Zhao Shouxun, Hang Bingqian. the chemical constituent of Herba Taraxaci and pharmacological action. Chinese wild plant resource, the 20th volume, the 3rd phase, 1-3

13、Burrows，S et J Chen Soc 1938：2042

14、CA：1959；51；11495

15、Takasaki M，Konoshima T，Tokada H，et al，Anti-carcinogenicactivity of Taraxacum Plant II.Biol Pharm Bull 1999；22(6)：606

16, Li Yiqing, Yi Yanghua etc. the Rhizoma Smilacis Glabrae chemical constitution study. Chinese herbal medicine, 1996,27 (12): 712-714

17, easy Israeli troops, Cao is just medium. Rhizoma Smilacis Glabrae The Chemical Constituents (I). and Chinese herbal medicine, 1993,24:234

18, easy Israeli troops, Cao is just medium. Rhizoma Smilacis Glabrae The Chemical Constituents (II). and research and development of natural products, 1994,3:33

19, easy Israeli troops, Cao is just medium. Rhizoma Smilacis Glabrae The Chemical Constituents (III). and Acta Pharmaceutica Sinica, 1995,30 (9): 718-720

20, Ji Yubin opens wide class. Chinese medicine antitumor effective ingredient pharmacology and application. and Heilungkiang: Heilungkiang science and technology publishing house, 1998.153-154

The 4th aspect the invention provides a kind of Chinese medicine compound agent that prevents and treats acquired immune deficiency syndrome (AIDS).It can go out and control HIV (human immunodeficiency virus) (Human Immunodeficiency Virus), and protection and improve to activate the T4 cell strengthens patient's immunologic function, reaching the therapeutical effect to patients infected hiv and HIV sufferers, and experimental results show that effect is remarkable.

The effective site of this preparation is micromolecular compound, can see through blood brain barrier, reaches the effect of preventing and treating acquired immune deficiency syndrome (AIDS).

According to the composition of each medicine, drafting the main framework of technology is to add ethanol extraction after Rhizoma Curcumae extracts volatile oil, concentrates, and all the other Six-element medical materials add ethanol or water extraction, concentrate, and merge with curcumenol extracted extract and supercritical extract, granulate, and are encapsulated, get final product.

The record of " the Chinese medicine dictionary " write according to the new medical college in Jiangsu contains 1～1.5% volatile oil in the Rhizoma Curcumae rhizome.Main constituent is a sesquiterpene in the oil.The sesquiterpene of getting from rhizome has zederone, zedoarone, Furanodiene., curzerene, furanodienone, isofuranodienone, Rhizoma Curcumae ketenes, Epicurzerenone, curdiono, curcolone, Rhizoma Curcumae Longae epoxy azulene enol, former Rhizoma Curcumae Longae epoxy azulene enol, different Rhizoma Curcumae Longae epoxy azulene enol, Rhizoma Curcumae Longae epoxy azulene alcohol, Rhizoma Curcumae Longae two azulene enols.Also contain curcumin, dehydrogenation curcumin.

In preparation, at first adopt supercritical extraction to obtain volatile oil from Rhizoma Curcumae.Supercritical extraction technique is a kind of new separation technology.Operable supercritical fluid material is a lot, for example carbon dioxide, nitric oxide, water, ethane etc.Wherein the carbon dioxide critical temperature is near room temperature, and critical pressure is not high yet, and colourless, tasteless, nontoxic, chemical inertness, nonflammable, low price, easily makes high-pure gas, so preferably use supercritical CO ₂Extraction.According to supercritical CO ₂Abstraction technique obtains the volatile oil of Rhizoma Curcumae, and is standby.Preferably, supercritical extraction is under temperature 40-60 ℃ and pressure 15-25MPa, prepares volatile oil.Keep medicinal residues simultaneously.

Rhizoma Curcumae medicinal residues in the previous step and all the other raw material of Chinese medicine medicines are merged, use ethanol extraction.

With zedoary oil with cyclodextrin embedding or absorption.

The effective ingredient of refining ethanol extraction.In ethanol extraction, add an amount of water, obtain precipitate.If use water extraction at first, then in water extract, add adequate amount of ethanol, obtain precipitate.Concentrate with the concentrating under reduced pressure method subsequently, with appropriate method dryings such as spray dryinges.

The solid-state drug effective ingredient that mixes the said process preparation is as the major ingredient of preparation.In another embodiment of the present invention, also can extract its effective ingredient and make liquid injection.

In preparation, adjuvant can be starch, dextrin, little smart silica gel, and consumption is the 20%-100% of major ingredient, and wetting agent can adopt ethanol.Every of the capsule of making contains the drug substance contents of 0.3g-0.5g.From in appearance, the content of capsule is faint yellow or yellow particle.

Particularly, the present invention is achieved through the following technical solutions, and is the capsule made from the following weight proportion raw material.

The Radix Stemonae: 12--20 part Rhizoma Curcumae: 8--13 part

Herba Taraxaci: 1.5-4.0 part Flos Lonicerae: 1.5-4.0 part

Rhizoma Smilacis Glabrae: 1.5-4.5 part Rhizoma Osmundae: 3.0-7.0 part

Radix Glycyrrhizae: 0.2-0.6 part

Get Rhizoma Curcumae, use supercritical extraction, at temperature 40-60 ℃, pressure is at 15-25MPa, and the time was extracted volatile oil at 2-4 hour.Medicinal residues after the extraction merge other 6 flavor Chinese medicine, use ethanol extraction, and concentration of alcohol is 60%-80%, and consumption is 6-10 times, and return time is 0.5-2 hour, and extracting number is 2-4 time.Oleum Curcumae is with cyclodextrin embedding or absorption.Process for purification is water extraction alcohol precipitation, alcohol extraction water precipitation method, concentrates with decompression, method for concentration, carries out drying with spray drying method.Adjuvant adopts starch, dextrin, microcrystalline silicon, and consumption is the 20%-100% of major ingredient, and wetting agent is made the capsule of 0.3g-0.5g/ grain with the ethanol of 60%-90% concentration, and content is faint yellow or yellow particle.

Preferably, a kind of Chinese medicine as described below provided by the invention:

1. medicine is formed: Radix Stemonae 30g Rhizoma Curcumae 15g Flos Lonicerae 15g Herba Taraxaci 15g Rhizoma Osmundae 15g Rhizoma Smilacis Glabrae 15g Radix Glycyrrhizae 6g

2. function: the epidemic disease of dispelling is set upright, dissipating blood stasis detoxifcation, dehumidifying yin nourishing

3. cure mainly: accumulate in eqpidemic disease heating, the noxious dampness, the heating due to thermal burn battalion the moon, weak, headache, systemic pain, pharyngalgia, the few expectorant of dry cough, diarrhoea, liver spleen and lymphadenectasis etc. are because of the virogenetic related symptoms of aids infection.

More preferably, the preparation method of medicine activity component of the present invention is as follows:

Get a certain amount of Rhizoma Curcumae, at temperature 40-60 ℃, pressure extracted Rhizoma Curcumae volatile oil 2-4 hour at 15-25MPa.Be Rhizoma Curcumae medicinal residues, the Radix Stemonae, Flos Lonicerae, Herba Taraxaci, Rhizoma Osmundae, Rhizoma Smilacis Glabrae after the 60%-80% ethanol extraction extraction with concentration, and Radix Glycyrrhizae, the ethanol consumption be 6-10 doubly, return time is 0.5-2 hour, extracting number is 2-4 time, obtains ethanol extraction.The ethanol extraction that mixes Rhizoma Curcumae volatile oil, Rhizoma Curcumae ethanol extraction and other drug obtains the effective ingredient of medicine of the present invention.

The active component of medicine of the present invention can add various conventional adjuvant required when preparing different dosage form, as excipient, and wetting agent, disintegrating agent, the method of Chinese medicinal of binding agent routine is prepared into any peroral dosage form commonly used, as pill, and powder, tablet, capsule, oral liquid etc.Also can extract the effective ingredient of medicine of the present invention and make liquid injection.Used adjuvant preferably uses starch when preparation patent medicine preparation, dextrin, and microcrystalline silicon, its consumption are the 20%-100% of major ingredient, and wetting agent preferably uses ethanol, and concentration is preferably 60%-90%, the preferred capsule of peroral dosage form.The weight of capsule is the 0.3g-0.5g/ grain.Content is faint yellow or yellow particle.

Chinese medicinal capsule preparation of the present invention has the following advantages: effective site is micromolecular compound; can see through blood brain barrier, go out and control HIV (human immunodeficiency virus) (Human Immunodeficiency Virus), protection and raising T4 cell; strengthen the patient immune function, to reach therapeutical effect to patients infected hiv and HIV sufferers.

Prescription of the present invention is to make determined curative effect on the basis of clinical practice.Consider that in the treating AIDS, needs of patients is taken medicine for a long time, and patient's psychological factors such as resistance, can prepare pill, tablet, capsule etc. based on prescriptions of Chinese medicine of the present invention.

The experimental data that below provides further illustrates the effect of medicine of the present invention.In experiment, used the capsule content that is described to by in the extractum of the Radix Stemonae, Rhizoma Curcumae, Flos Lonicerae, Herba Taraxaci, Rhizoma Osmundae, Rhizoma Smilacis Glabrae, Radix Glycyrrhizae preparation and the above-mentioned fourth aspect.Experiment shows: active ingredient of drugs of the present invention has the effect of following three aspects at least:

1. antivirus action

Experimental technique is with reference to Pauwels R., Balzarini J., Baba M., Deng, Rapid andautomated tetrazolium-based colorimetric assay for the detection ofanti-HIV compound, J.Virol.Methods, 1988,20:309-321; Viscidi R, Farzadegan H, Leister F, Deng, Enzyme immunoassay for detection of humanimmunodeficiency virus antigens in cell cultures, J.Clin.Micro., 1988,26:371-374 carries out.Experiment shows, is using Strain HIV-I _SF33Attack in the system of MT-4 cell, the therapeutic index that the extractum of medicine of the present invention shows is 2.35; Using Strain HIV-1 _SHXDC0591Attack in the system of PBMC cell (monokaryon lymphocyte), the therapeutic index that the extractum of medicine of the present invention shows is 15.7.

2. antiinflammatory action

1) to the effect of the rat paw edema due to the Ovum Gallus domesticus album

By measuring the administration front and back, the swelling degree that causes by giving the fresh Ovum Gallus domesticus album of rat foot plantar subcutaneous injection (but the release of injecting inflammatory mediators such as fresh Ovum Gallus domesticus album induce tissue amine, 5-HT, thereby cause that local capillary permeability is hyperfunction, liquid oozes out) change the antiinflammatory action of investigating active constituents of medicine of the present invention.Adopt A Si to taste with discrimination the forest tract agent as positive control drug.

Get 50 of SD (Sprague-Dawley) rats, male and female half and half, body weight 180-230 gram.By sex, body weight random packet, 10 every group (male and female half and half).Gastric infusion, volume are the 1ml/100g body weight, and dosage and grouping see Table 2.Fasting is 12 hours before the experiment, freely drinks water.Shank-feathering bottom, every Mus left back claw ankle joint upper end is located to the greatest extent with the standardized clear horizontal line of ball pen, and it is long-pending to survey the Mus corpus unguis with special glass container drainage.One people catches rat head and neck skin of back to fix, and a people vertically stretches into left back Mus pawl in the measuring device, and measuring device mark line and Mus pawl horizontal line are harmonious.The Mus corpus unguis that effusive liquid bulk product is under the normal condition from measuring device is long-pending.Gavage for the reagent thing, get one piece of new fresh hen egg after 45 minutes, pour out Ovum Gallus domesticus album, stir, draw Ovum Gallus domesticus album 0.05ml/ pawl with the 0.25ml syringe, subcutaneous with No. 5 left back foot sole of the foots of syringe needle injection rat.Respectively surveyed the Mus corpus unguis then in 0.5,1,2 hour long-pending 1 time, calculating Mus pawl swelling percentage rate compares between organizing.

Mus pawl swelling percentage rate (%)=(cause scorching back Mus corpus unguis amass-cause scorching before the Mus corpus unguis long-pending)/cause scorching before the Mus corpus unguis amass * 100%

Experimental result also sees Table 2.

Table 2

Medicine of the present invention is to the antagonism of rat paw edema due to the Ovum Gallus domesticus album (x ± s)

Group	Cause scorching preceding Mus corpus unguis long-pending (ml)	Cause scorching back Mus corpus unguis long-pending (ml) and swelling degree (%)
					0.5 hour	1 hour	2 hours
		1	1.30±0.23	2.15±0.22 68.92±25.43				2.45±0.26 93.59±36.77	2.48±0.20 96.19±37.53
2	1.45±0.19				2.07±0.33 42.74±13.61	2.26±0.21 56.94±10.61 *	2.10±0.20 46.32±16.43 **
		3	1.27±0.22	1.93±0.18 55.31±23.73				2.03±0.11 63.57±25.55	2.01±0.11 63.94±38.89
4	1.25±0.17				2.04±0.20 64.75±16.92	2.09±0.16 69.98±25.25	2.03±0.14 64.84±21.67
		5	1.34±0.12	1.83±0.17 37.52±18.06 *				2.08±0.11 55.69±6.93 *	1.99±0.17 49.39±16.69 **

Explain:

1 group: the solvent contrast;

2 groups: use the aspirin group, 0.2g/Kg;

3 groups: use active constituents of medicine of the present invention, low dose group, 0.45g/Kg;

4 groups: use active constituents of medicine of the present invention, low dose group, 0.9g/Kg;

5 groups: use active constituents of medicine of the present invention, low dose group, 1.8g/Kg;

Compare with the solvent group, ^*: p＜0.05; ^*: p＜0.01

G/Kg represents the medication amount that every kg body weight is used.

As can be seen from Table 2, cause scorching back 1h, compare with matched group, aspirin, active constituents of medicine of the present invention can obviously alleviate the laboratory animal paw swelling, and both compare, and there is significant difference p＜0.05～0.01; Cause scorching back 2h its, the effect that suppresses foot swelling is still continuing, and illustrates that active constituents of medicine of the present invention has antagonism preferably to rat paw edema due to the Ovum Gallus domesticus album.

2) the rat chronic granulation tissue increases good inhibitory effect

The positive control drug that experiment is adopted is that A Si tastes with discrimination the forest tract agent.Get 60 rats, male and female half and half are divided 5 groups at random by body weight, sex, and dosage setting and grouping see Table 3.Rat fasting 12h before the experiment freely drinks water.Behind the etherization, in rat back heeling-in one aseptic filter paper sheet (diameter 8mm, thick 0.28mm, weight 6.5mg, sterilization 30min under 8 pounds of pressure, drying), sew up wound, at room temperature 20-24 ℃, humidity 55% ± 5% environment is raised down.Implant the scraps of paper and played the beginning gastric infusion on the 6th, the administration volume is 1ml/100g, and matched group gives the isometric(al) distilled water, successive administration 3 days.Implant the scraps of paper and put to death animal on 9th, the scraps of paper and granulation tissue are extracted in the lump, weigh after 8 hours, deduct original scraps of paper weight, be the weight of granulation tissue in 80 ℃ of dryings.Experimental result sees Table 3.

Table 3 medicine of the present invention is to the granulomatous effect of rat chronic (x ± s)

Group	Dosage (g/kg)	Mus number (n)	Granulation tissue heavy (mg)
				The solvent contrast	-	12	63.24±23.25
The aspirin group	0.2	12	23.71±10.44 **
				Active constituents of medicine of the present invention, low dose group	0.45	10	30.11±9.40 **
Active constituents of medicine of the present invention, middle dosage group	0.9	12	26.31±8.05 **
				Active constituents of medicine of the present invention, high dose group	1.8	12	20.99±6.68 **

Annotate: compare with the solvent group, ^*: p＜0.01

As can be seen from Table 3, compare with matched group, basic, normal, high dose of group of aspirin, active constituents of medicine of the present invention, its granulation tissue weight obviously alleviates, and both compare, and there is significant difference p＜0.01.Illustrate that growth has good inhibitory effect to active constituents of medicine of the present invention to the rat chronic granulation tissue.

3) to allergic effect due to the dinitrochlorobenzene

With (DNCB) is hapten, it is applied in behind the skin it can combines with skin protein and form complete antigen.Stimulate the T lymphocyte to rise in value into primed lymphocyte thus.After 4-7 days, when again DNCB being applied in skin, but this position produces delayed allergy (swelling).Can observe the antiphlogistic effects that is tried thing thus.

With the male KM mice, by the body weight random packet, 12 every group, grouping and dosage see Table 3.Each treated animal is in back subcutaneous injection 7%2, after 4-dinitrochlorobenzene-acetone soln 0.02ml sensitization, and since the 6th day gastric infusion, administration volume 0.2ml/10g body weight, for three days on end.Be coated with 7%2 at mice left side ear in the last administration after 1 hour, 4-dinitrochlorobenzene-acetone soln 0.03ml was put to death animal after 16 hours, cut two ears along the auricle baseline, sweep away auricle in same position with the 8mm card punch and weigh, with the difference of two ear weight be between the swelling degree is organized relatively.The results are shown in Table 4.

Table 4 medicine of the present invention is to (the X ± S) of allergic influence due to the dinitrochlorobenzene

Group	Dosage (g/kg)	Number of animals (n)	Swelling degree (mg)	Ear swelling suppression ratio (%)
					The solvent group	0.2ml/10g body weight	12	4.47±1.45	-
Aspirin	0.5	12	8.75±1.91 **	90.11
					Low dose group	0.625	12	7.76±1.76 **	73.60
Middle dosage group	1.25	12	6.96±1.47 *	55.70
					High dose group	2.5	12	8.45±2.15 **	89.03

Annotate: compare with the solvent group, ^*: p＜0.05, ^*: p＜0.01.Wherein, used the active component of medicine of the present invention in low dose group, middle dosage group, the high dose group.

As can be seen from Table 4, in mice delayed allergy (auricle edema method), each dosage group auricle swelling degree all is higher than matched group, and tardy paraphilia reaction has potentiation (P＜0.05) to the DNCB inducing mouse, shows that this product has the enhancing cellular immune function.

4) the xylol induced mice capillary of skin permeability effect of drawing up of increasing

Dimethylbenzene is dripped in the mouse web portion skin of unhairing, because of its local irritant effect causes capillary permeability hyperfunction.After injecting the blue dyes azovan blue from intravenous, azovan blue can outwards ooze out from hyperfunction blood capillary, forms blue speckle in the not position of melted paraxylene.Therefore how much can be used as of dyestuff seepage discharge judges whether medicine can the hyperfunction index of the early stage capillary permeability of inflammation-inhibiting.

60 of NIH mices, body weight 20-22g, male and female half and half are divided into 5 groups at random by body weight, and 12 every group, grouping and dosage see Table 4.Every day gastric infusion once, continuous 4 days, after the last administration 1 hour, give each Mus through tail vein injection 0.5% azovan blue normal saline solution 0.1ml/10g body weight respectively, melted paraxylene 0.02ml/ is only on the skin of unhairing of position, mouse web portion center immediately.Take off cervical vertebra after 20 minutes and put to death, peel skin of abdomen, the blue speckle of every skin is shredded to drop into operating scissors to be had in the plug teat glass, pours acetone-sodium sulfate extracting solution 10ml into, opens in dark place, and shakes this test tube every day gently 2～3 times.2000rpm is centrifugal 10 minutes after 3 days, gets supernatant and carries out colorimetric determination optical density (with the acetone-metabisulfite solution school zero of not steeping skin) in the 590nm place with ultraviolet spectrophotometer.The results are shown in Table 5.

Table 5 active constituents of medicine xylol of the present invention

The influence that induced mice capillary of skin permeability increases (X ± SD)

Group	Dosage (g/kg)	Number of animals (n)	Dyestuff optical density value (OD)
				The solvent matched group	-	10	0.73±0.27
Aspirin group (positive controls)	0.3	12	0.41±0.14 **
				Low dose group	0.0625	12	0.24±0.20 **
Middle dosage group	1.25	12	0.27±0.14 **
				High dose group	2.5	12	0.45±0.16 **

Annotate: compare with the solvent matched group, ^*: p＜0.01.Wherein, used the active component of medicine of the present invention in low dose group, middle dosage group, the high dose group.

As can be seen from Table 5, the optical density value of three dosage groups of the active component of medicine of the present invention all is starkly lower than the solvent matched group, difference has extremely significantly meaning (p＜0.01), shows that active constituents of medicine of the present invention can obviously suppress the hyperfunction of dimethylbenzene induced mice skin of abdomen capillary permeability.

5) influence of the swollen mouse corrosion disease effect of xylol ear

As proinflammatory agent, observe the influence of active constituents of medicine xylol induced mice auricle edema of the present invention with dimethylbenzene, understand the antiinflammatory action of this medicine.Positive control drug adopts the aspirin enteric coatel tablets.

NIH mice male and female half and half, body weight 18-20g.Random packet, 13 every group, grouping and dosage see Table 6.Each organizes gastric infusion, administration volume 0.2ml/10g body weight.Behind the administration 1hr, each evenly is coated with and spreads dimethylbenzene 0.02ml in the positive and negative two sides of left side auricle, puts to death animal after 2 hours, cuts two ears along the auricle baseline, sweeping away auricle in same position with the 8mm card punch and weigh, is that the swelling degree carries out data statistic analysis with the difference of two ears.Experimental result sees Table 6.

Table 6 medicine of the present invention is to the influence of mouse corrosion disease effect (X ± S)

Group	Dosage (g/kg)	Number of animals (n)	Swelling degree (mg)	Ear swelling rate (%)
					The solvent group	0.2ml/10g body weight	12	60.25±11.48	103.15±17.51
Aspirin	0.3	13	29.31±14.21 **	50.13±23.62 **
					Low dose group	0.625	12	51.38±20.67	87.51±34.72
Middle dosage group	1.25	12	48.17±22.14	81.07±34.51
					High dose group	2.5	13	39.23±16.23 **	64.28±24.25 **

Annotate: compare with the solvent group, ^*: p＜0.01.Wherein, used the active component of medicine of the present invention in low dose group, middle dosage group, the high dose group.

As can be seen from Table 6, compare with the solvent group, the high agent group of aspirin group, active constituents of medicine of the present invention can significantly suppress the mice ear due to the dimethylbenzene, shows that it has better action to the acute exudative inflammation model.

6) to the influence of blood coagulation system function

SD50 rat, male and female half and half are divided into 5 groups at random by body weight, sex, and 10 every group, grouping and dosage see Table 6.Every day gastric infusion once, continuous 5 days, after the last administration 1 hour, the Mus broken end is got blood, measure thrombin time (TT), prothrombin time (PT), activated partial thromboplastin time (APTT) and Fibrinogen (Fib) concentration respectively with ST art 4 type coaglation analyzers.Experimental result sees Table 7.

Table 7 medicine of the present invention is to the influence of blood coagulation system function (X ± SD)

Group	Dosage (g/kg)	TT (Sec.)	PT (Sec.)	APTT (Sec.)	FIB (g/L)
						The solvent matched group	-	32.37±8.63	14.68±1.01	14.94±0.63	3.56±0.36
The aspirin group	0.2	37.21±4.96	14.02±3.40	18.56±4.20	3.18±0.23
						Low dose group	0.0625	30.49±8.68	13.52±3.79	16.21±3.09	3.10±0.44
Middle dosage group	1.25	31.48±7.13	12.80±2.58	15.32±2.37	2.64±0.56
						High dose group	2.5	33.24±10.76	19.23±4.54 **	19.02±2.39 **	2.83±0.44

Annotate: compare with the solvent matched group, ^*: p＜0.01.Wherein, used the active component of medicine of the present invention in low dose group, middle dosage group, the high dose group.

The result as can be seen from table 7, the high dose group of the active component of medicine of the present invention has the prolongation effect to prothrombin time (PT), activated partial thromboplastin time (APTT), difference has extremely significantly meaning (p＜0.01), shows that medicine of the present invention has certain anticoagulation.

3. to the influence of immunity of organism effect

1) to the influence of carbon clearance function in the mice body

When microgranular foreign body such as india ink enter in the mice body blood circulation, can engulf for mononuclear phagocyte rapidly and remove, its main position is the liver spleen.So can understand and be tried the influence of thing by measuring the removing speed of carbon granules in the mice blood to the mononuclear cell phagocytic function.Positive control drug adopts dexamethasone tablet.

60 mices are divided into 5 groups at random by body weight, 12 every group, every day gastric infusion once, continuous 5 days, the grouping and dosage see Table 6.After the last administration 1 hour, from mouse tail vein injection india ink 0.1ml/10g body weight, 1min behind the injection prepared Chinese ink, 10min joins the 2ml 0.1%Na2CO3 solution after the mouse orbit rear vein beard is got blood 20 μ l with blood capillary (use in advance heparin solution moistening) with blood sampling respectively and shakes up, colorimetric under ultraviolet spectrophotometer wavelength 680nm is measured optical density (OD) then.With the mice sacrificed by decapitation, take by weighing respectively that Mouse Liver is heavy, spleen heavy, be calculated as follows and engulf (cleaning up) index (K) and activate the phagocytic capacity (index is cleaned up in correction) α, with the solvent matched group relatively, organize a t check, the significance of comparing difference.

K＝(logOD1-logOD2)/(t2-t1)

α=K ¹/ ₃* body weight/(liver weight+spleen is heavy)

(OD1, OD2: be the optical density of blood sample that different time is taked; T2-t1: for getting the time difference of two blood samples)

Experimental result sees Table 8.

Table 8 medicine of the present invention is to the influence of carbon clearance function in the mice body

Group	Dosage (g/kg)	Number of animals (n)	Phagocytic index (K)	Activate the phagocytic capacity α
					The solvent matched group	-	9	0.0604±0.0175	6.392±0.627
Dexamethasone group	0.075	10	0.0325±0.0128 *	6.021±0.951
					Low dose group	0.0625	10	0.1017±0.0302 *	8.800±1.349 ***
Middle dosage group	1.25	10	0.1066±0.0302 ***	9.113±1.773 ***
					High dose group	2.5	10	0.1012±0.0301 *	8.156±0.769 *

Annotate: compare with the solvent matched group, ^*: p＜0.05, ^{* *}: p＜0.001, wherein, used the active component of medicine of the present invention in low dose group, middle dosage group, the high dose group.

As can be seen from Table 8, the phagocytic index K value of Dexamethasone group reduces, and compares with the solvent matched group, and there was a significant difference (p＜0.05), shows that dexamethasone has the obvious suppression effect to the phagocytic function of mononuclear phagocyte.Basic, normal, high three the dosage groups of medicine of the present invention all can obviously improve mice phagocytic index K value and activate the phagocytic capacity α value (p＜0.05, p＜0.001), illustrate that the phagocytic function to mononuclear phagocyte has tangible activation, potentiation.

2) to the influence of humoral immunization (serum hemolysin)

When microgranular foreign body such as india ink enter in the mice body blood circulation, can engulf for mononuclear phagocyte rapidly and remove, its main position is the liver spleen.So can understand and be tried the influence of thing by measuring the removing speed of carbon granules in the mice blood to the mononuclear cell phagocytic function.Adopt positive control drug: the aspirin enteric coatel tablets experimentize.

With the KM mice, the 18-22 gram, random packet, 12 every group, each organizes gastric infusion, administration volume 0.2ml/10g body weight, grouping and dosage see Table 8.Successive administration carries out immunity after three days: get aseptic sheep red blood cell (SRBC) SRBC (being stored in 4 ℃ of A Shi liquid), wash 3 times with normal saline, each 2000r/min * 10min is centrifugal, supernatant discarded, get precipitation and be made into the 5%SRBC suspension, every ip in mice 0.5ml with normal saline.Be subjected to the reagent thing in back 2 hours in immunity, after the administration the 4th day, extract eyeball of mouse, drop of blood is gone in the 1.5ml plastic centrifuge tube, place 2h for 4 ℃.8000r/min * 2min centrifugalize serum gets serum and carries out hemolytic experiment.The serum 1ml that takes 200 times of normal saline dilutions is to reaction tube, add 0.5ml 5%SRBC, add the complement (complement: extract 3 guinea pig heart blood, separation of serum of 1ml again with normal saline dilution in 1: 10, mix-20 ℃ of preservations in back), place in 37 ℃ of waters bath with thermostatic control and keep 10min.Reaction finishes, and reaction tube is moved in the ice bath immediately with cessation reaction.Preparation blank: with 1ml physiologic saline for substitute blood serum sample, the same reaction tube of the addition of SRBC and complement.Reaction tube and the centrifugal 2min of blank pipe 5000r/min get supernatant 0.5ml adding and are added with in advance in the test tube of 1.5ml normal saline, add 1 of hemolysin again and shake up, and sentence control tube with ultraviolet spectrometer in 540nm and make blank, measure the absorbance of each test tube respectively.Get 100ul 5%SRBC simultaneously, add in the 1.9ml normal saline, add 1 of quick hemolysin again, shake up, survey SRBC half hemolysis value (do 3 times and ask its average).Calculate the half hemolysis value (HC50) of every mice sample by following formula.

Sample HC50=(the absorbance average during sample absorbance/SRBC HD50) * 200 (serum diluting multiples)

Experimental result sees Table 9.

The influence that table 9 pair mice hemolytic antibody generates (X ± s)

Group	Dosage (g/kg)	Number of animals	HC50
				Matched group	0.2ml/10g body weight	12	3.82±1.87
Aspirin	0.5	11	19.41±13.51 *
				Low dose group	0.625	10	11.57±10.83
Middle dosage group	1.25	11	12.12±11.88
				High dose group	2.5	10	12.57±7.02 *

Annotate: compare with matched group, ^*: p＜0.05..Used the active component of medicine of the present invention in low dose group, middle dosage group, the high dose group.

Table 9 is the result show: aspirin can obviously improve the ability that mice produces hemolysin, and medicine high dose group of the present invention also has this effect, the humoral immunization of medicine energy enhancing body of the present invention is described, the antibody horizontal of rising body.

The present invention has also studied the toxicity situation of invention Chinese medicine, tests from acute toxicity and long-term two aspects of toxicity.

1. acute toxicity data

With the tolerant Cmax 3.363g/ml of mice (pressing crude drug calculates) and 40ml/kg/ gastric infusion of maximum volume, do not see any toxic reaction; And given for behind the examination thing with maximal dose 134.53g/kg (calculating by crude drug) oral administration to trying mice, do not see any toxic reaction yet.Therefore the oral median lethal dose(LD 50) of mice (LD50) of Chinese medical concrete of the present invention is greater than the maximum tolerated dose of 134.53g/kg (pressing crude drug calculates).

(3.363g crude drug/ml) and maximum volume (40ml/kg/ time) are irritated stomach and are given mice and be subjected to not see animal dead behind the test product, therefore can't measure its median lethal dose(LD 50) (LD50), so measured the maximum tolerated dose that is subjected to test product with Cmax.The maximum tolerated dose of Chinese medical concrete of the present invention is 134.53g/kg (pressing crude drug calculates).In seven days viewing durations behind this dosed administration, the animal mental status is good, and behavior is normal, weight increase, no abnormality seen phenomenon.Show that Chinese medical concrete of the present invention under the situation of the oral maximum dosage-feeding 134.53g/kg of mice (pressing crude drug calculates), does not have any toxic reaction.With reference to " study of tcm new drug guide ", bureau of drug policy ﹠ administration of Ministry of Health of the People's Republic of China compiles, and 1994 experimentize, and the results are shown in Table 10.

The acute toxicity test in mice of the active component of table 10 medicine of the present invention (gastric infusion)

Dosage	Number of animals (n)		Dead animal number (n)	Mortality rate (%)	Maximum tolerated dose (MTD) (g crude drug amount/kg)
						♀	♂
	134.53g crude drug amount/kg	5						5	0	0	MTD＝134.53
134.53g crude drug amount/kg			5	5	0	0
	134.53g crude drug amount/kg	5					5	0	0

2, long term toxicity data

Give the rat oral gastric infusions with continuous 23 weeks of 3g crude drug/kg (being equivalent to clinical 10 times of using dosage of people) of Chinese medicine of the present invention, show no obvious abnormalities change in behavior, body weight, urine, hematology and blood biochemical of animal subject are checked, also not seeing has the histopathology relevant with being subjected to the reagent thing to change.Therefore, can think that this dosage is the non-toxic reaction dosage under this experimental condition.

Along with dosage increases to 15g crude drug/kg, 30g crude drug/kg (be equivalent to clinical with dosage 50,100 times), can occur that lactic acid dehydrogenase increases, the liver organ coefficient increases, slight hepatocyte has a liking for that acid changes etc.Can think thus has slight toxicity to liver when this test sample dosage increases, and is recoverable but the result of observation period shows this toxicity.

The testing result of clinical chemistry (routine urinalysis, routine blood test, blood clotting and the serum biochemistry) aspect when administration phase and observation period finish, fluctuation is often arranged and cause between group and administration phase and the observation period result when finishing relatively, demonstrated significant difference (p＜0.05), as the Fibrinogen and the LDH rising (p＜0.05) of administration phase high dose group; The blood sugar increasing of middle dosage group etc.According to operator's experience, this situation is the reason (all within the fluctuation range of instrument) of instrument mostly.

After 23 weeks of administration, the liver organ coefficient of middle and high dosage group rat increases (p＜0.05), but after 3 weeks of drug withdrawal, this species diversity becomes no significance (p＞0.05), shows that test sample has restorability to the influence of liver.

After 23 weeks of administration, in the hepatocyte volume that as seen is dispersed in of dosage group (7/11) and high dose group (7/13) diminish slightly, become justify, endochylema is red dyes, is the homogenizing shape, this has a liking for acid for slight hepatocyte and becomes, show when this test sample dosage increases liver is had slight toxicity, and after the end of the convalescent period in 3 weeks, above-mentioned pathological changes greatly alleviates.

As seen basic, normal, high each dosage group and solvent matched group when administration phase and observation period finish have in various degree pneumonia, pulmonary venous pleonaemia, slight pulmonary abscess and slight nephremia variation etc.These change and are subjected to the dosage size of reagent thing and animal sex not to have positive correlation, may be the spontaneous pathological changes of animal, or due to the tissue automatic soup-dissolving.

Medicine of the present invention has carried out some clinical experiments with Capsule form, shows good curative effect.In crude drug, drug use dosage of the present invention is each 0.3 gram, can change according to the state of an illness in a big way; Every day, application times was 2-6 time, was advisable with 3 times.

Be the experimental result that HIV sufferers is taken the capsule of medicine of the present invention below, shown in table 11, table 12 and table 13.9 routine patients (male 6 examples, women 3 examples) confirm by the HIV antibody positive, take medicament capsule of the present invention totally 150 days with oral 3 times/day, 6/time application method.In table 11 and table 13, represent these patients with alphabetical A-I respectively.These patients' of table 11 expression clinical symptoms change situation, table 13 expression is carried out CD to these patients ⁴, CD ⁸The result that cell counting and HIV virus load detect.

In table 11,9 routine patients' sex, age, the take medicine preceding clinical symptoms and the back 150 days clinical symptoms of taking medicine have been listed.Table 12 is concluded this.

In table 13, listed these patients and taken (being designated as " preceding " in the table 13) before the medicine of the present invention, take back 90 days (being designated as " back 1 " in the table 13) and take some testing results of the last 150 days (be designated as in the table 13 " afterwards 2 ").Gathering the blood samples of patients sample respectively detects.CD wherein ⁴, CD ⁸The instrument that cell counting adopts is COULTER ELITE ESP flow cytometer and full-automatic blood counting instrument, agents useful for same is the IMMUNOTECH reagent of being produced by U.S. Beckman Coulter company, fluorescent antibody CD3-FITC, CD4-PE, CD45-PC5, rabbit is washed hemolysin (1ysing Solution C).It is NuclisensRcader that virus load is measured used instrument, reagent Nuclisens HIV-I QT (NASBA) 50test/kit that French BioMerieux company produces that serves as reasons, product batch number is 02121301 (Amplication kit), 02121302 (Detection kit).Said determination, all the description that provides according to test kit and instrument is operated.

Clinical symptoms change before and after table 11 patient takes medicine

Numbering	Sex	Age	Cardinal symptom and variation before and after taking medicine
					Before	After
			A	The man			45	Headache, cough, diarrhoea, weak	Appetite increases, headache is not coughed again, diarrhoea disappears, weak alleviating
B	The woman	42			Easy catching a cold, normal headache, weak, facial rash	Appetite rising, physical enhancing, weight increase, weakly alleviate, facial rash disappears substantially
			C	The man			36	Easy catching a cold, heating, cough, weak	Do not catch a cold again, heating, weak improvement
D	The man	42			Easy catching a cold, headache, cough with blood-flecked phlegm silk, weak, the back of the hand erythra, sural spasm	Appetite rises, sleeps, weakly alleviate, the back of the hand erythra disappears, gastrocnemius spasm no longer
			E	The man			38	Discontinuity is suffered from abdominal pain, was suffered from diarrhoea	The disappearance of not catching a cold again, sleep, suffer from diarrhoea
F	The man	39			Easy catching a cold, appetite poor, weak, oral cavity (white fur), Candida albicans disease	Times of common cold reduces, the oral cavity white fur disappears, sleep, weakly alleviate, physical enhancing, weight increase
			G	The woman			44	Health is general	Sleep, muscle power strengthens, body weight increases

				Add
					H	The man	42	Repeated cold, hyperpyrexia, headache, cough, weak	Times of common cold reduces, weakly alleviate, still headache (waiting to look into)
I	The woman	40	Easy catching a cold, heating, headache, cough, abdominal distention, stool is rare, appetite is poor, weak, whole body is dispersed in little pimple	Appetite rises, abdominal distention disappears, stool is normal, times of common cold reduces, weakly alleviate, weight increase

The brief summary of table 12 clinical symptoms

	Often flu companion cough	Sleep difference companioned with headache	Diarrhoea	Malaise	Oral cavity monilial infection	Erythra	Appetite improvement weight increase
								Before the treatment	8	6	4	8	1	3
After the treatment	1	1				1	6

Table 13 blood examination result

Numbering	CD 4Counting			CD 8Counting			CD 4/CD 8			Virus load
													Before	Back 1	Back 2	Before	Back 1	Back 2	Before	Back 1	Back 2	Before	Back 1	Back 2
	A	67	66	67	457	257	344	0.15	0.26	0.19	290000(290×10 3)	6000													11500
B													182	156	242	823	705	1326	0.22	0.22	0.18	1050000(105×10 4)	100000	75000
	C	224	150	365	1324	505	1478	0.17	0.3	0.25	950000(950×10 3)	165000													275000
D													397	307	198	503	1113	640	0.79	0.28	0.31	160000(160×10 2)	17000	31500
	E	335	256	379	889	837	1321	0.38	0.31	0.29	20000	13000													7500
F													375	242	472	436	430	858	0.86	0.56	0.55	18000	700	850
	G	421	431	553	987	523	656	0.43	0.82	0.84	22000	14000													9500
H													169	94	201	731	303	530	0.23	0.31	0.37	47500	24000	11000
	I	224	80	48	1705	889	939	0.14	0.09	0.05	300000	650000													250000

Above-mentioned clinical experiment shows that medicine of the present invention is improving clinical symptoms, improving quality of life and CD ₄There are tangible clinical meaning and effect in the rising aspect, and the controller opportunistic infections has no adverse reaction in clinical practice effectively, does not see toxic and side effects.

Preferred implementation of the present invention

The capsule preparation of embodiment 1 medicine of the present invention

1) takes by weighing the raw material Chinese medicine of following weight portion, 0.5 part in 17 parts of the Radixs Stemonae, 10 parts of Rhizoma Curcumae, 2.5 parts of Herba Taraxacis, 2.5 parts of Flos Loniceraes, 3.0 parts of Rhizoma Smilacis Glabraes, 5.0 parts of Rhizoma Dryopteris Crassirhizomatiss and Radix Glycyrrhizae.

2) get Rhizoma Curcumae, use supercritical extraction, under 40 ℃ of temperature and pressure 15MPa, extract and obtained volatile oil in 2 hours, obtain active component 1.And with it with cyclodextrin embedding or absorption.

3) with step 2) the Rhizoma Curcumae medicinal residues, merge other 6 the flavor Chinese medicine, use ethanol extraction, concentration of alcohol is 60%, consumption is 6 times, return time is 0.5 hour, extracts 2 times.Obtain active component 2.

4) merge active component 1 and active component 2 and obtain active constituents of medicine of the present invention, obtain pressed powder through concentrate drying, as major ingredient.

5) add supplementary product starch according to 20% of major ingredient weight, be prepared into capsule 's content, the snap fit capsule of packing into.

The capsule preparation of embodiment 2 medicines of the present invention

1) takes by weighing the raw material Chinese medicine of following weight portion, 0.5 part in 17 parts of the Radixs Stemonae, 10 parts of Rhizoma Curcumae, 2.5 parts of Herba Taraxacis, 2.5 parts of Flos Loniceraes, 3.0 parts of Rhizoma Smilacis Glabraes, 5.0 parts of Rhizoma Dryopteris Crassirhizomatiss and Radix Glycyrrhizae.

2) get Rhizoma Curcumae, use supercritical extraction, under 60 ℃ of temperature and pressure 25MPa, extract and obtained volatile oil in 4 hours, obtain active component 1.And with it with cyclodextrin embedding or absorption.

3) with step 2) the Rhizoma Curcumae medicinal residues, merge other 6 the flavor Chinese medicine, use ethanol extraction, concentration of alcohol is 80%, consumption is 10 times, return time is 2 hours, extracts 4 times.Obtain active component 2.

4) merge active component 1 and active component 2 and obtain active constituents of medicine of the present invention, obtain pressed powder through concentrate drying, as major ingredient.

5) add supplementary product starch according to 100% of major ingredient weight, be prepared into capsule 's content, the snap fit capsule of packing into.

The injection preparation of embodiment 3 medicines of the present invention

1) takes by weighing the raw material Chinese medicine of following weight portion, 0.5 part in 17 parts of the Radixs Stemonae, 10 parts of Rhizoma Curcumae, 2.5 parts of Herba Taraxacis, 2.5 parts of Flos Loniceraes, 3.0 parts of Rhizoma Smilacis Glabraes, 5.0 parts of Rhizoma Dryopteris Crassirhizomatiss and Radix Glycyrrhizae.

2) get Rhizoma Curcumae, use supercritical extraction, under 40 ℃ of temperature and pressure 15MPa, extract and obtained volatile oil in 2 hours, obtain active component 1.

3) with step 2) the Rhizoma Curcumae medicinal residues, merge other 6 the flavor Chinese medicine, use ethanol extraction, concentration of alcohol is 60%, consumption is 6 times, return time is 0.5 hour, extracts 2 times.Obtain active component 2.

4) merge active component 1 and active component 2 and obtain active constituents of medicine of the present invention.

5) filter through microporous filter membrane room temperature, canned, be heated to 100 ℃ at last, 30 minutes, the flowing steam sterilization obtained injection.

Claims (12)

1. the medicine of prevention and treatment acquired immune deficiency syndrome (AIDS) is characterized in that it is made by following raw materials by weight proportions: Radix Stemonae 12-20 part, Rhizoma Curcumae 8-13 part, Herba Taraxaci 1.5-4.0 part, Flos Lonicerae 1.5-4.0 part, Rhizoma Smilacis Glabrae 1.5-4.5 part, Rhizoma Osmundae 3.0-7.0 part and Radix Glycyrrhizae 0.2-0.6 part.

2. according to the medicine of claim 1, wherein the consumption of each crude drug is: 17 parts of the Radixs Stemonae, 10 parts of Rhizoma Curcumae, 2.5 parts of Herba Taraxacis, 2.5 parts of Flos Loniceraes, 3.0 parts of Rhizoma Smilacis Glabraes, 5.0 parts of Rhizoma Osmundae, 0.5 part in Radix Glycyrrhizae.

3. according to the medicine of claim 1 or 2, wherein said Rhizoma Osmundae is a Rhizoma Dryopteris Crassirhizomatis.

4. according to the medicine of claim 1 or 2, be prepared as capsule, pill, powder, oral liquid and injection.

5. according to the preparation method of the capsule of claim 1 or 2 described medicines, this method comprises the following steps:

1) volatile oil of extraction Rhizoma Curcumae;

2) ethanol extraction in Rhizoma Curcumae medicinal residues preparation 1);

3) effective ingredient of the usefulness ethanol extraction Radix Stemonae, Herba Taraxaci, Flos Lonicerae, Rhizoma Smilacis Glabrae, Rhizoma Osmundae and Radix Glycyrrhizae;

4) merge above-mentioned steps 1), 2) and 3) the gained material, incapsulate, obtain capsule.

6. according to the method for claim 5, it is characterized in that: adopt supercritical extraction in the step 1), wherein said supercritical extraction is under the condition of temperature 40-60 ℃ and pressure 15-25MPa, with obtaining volatile oil in carbon dioxide extraction 2-4 hour.

7. according to the method for claim 5, step 2 wherein) and 3) merge and carry out.

8. according to the method for claim 5, step 2 wherein) and 3) in, used concentration of alcohol is 60%-80%, consumption be injection volume 6-10 doubly, return time is 0.5-2 hour, extracting number is 2-4 time.

9. according to the method for claim 5, the volatile oil of wherein said Rhizoma Curcumae is with cyclodextrin embedding or absorption.

10. according to the method for claim 5, wherein step 4) further uses adjuvant to mix with the gained material.

11. according to the preparation method of the injection of claim 1 or 2 described medicines, this method comprises the following steps:

1) volatile oil of extraction Rhizoma Curcumae;

2) ethanol extraction in Rhizoma Curcumae medicinal residues preparation 1);

3) effective ingredient of the usefulness ethanol extraction Radix Stemonae, Herba Taraxaci, Flos Lonicerae, Rhizoma Smilacis Glabrae, Rhizoma Osmundae and Radix Glycyrrhizae;

4) merge above-mentioned steps 1), 2) and 3) the gained material, remove by filter thermal source, canning and sterilizing obtains injection.

12., adopt decocting method to be prepared into oral liquid according to the medicine of claim 1 or 2.