CN102805810B - Chinese medicinal preparation for treating acquired immune deficiency syndrome (AIDS) and preparation method thereof - Google Patents

Abstract

The invention discloses a Chinese medicinal preparation for treating acquired immune deficiency syndrome (AIDS) and a preparation method thereof. The Chinese medicinal preparation is prepared from the following raw materials of baical skullcap root, sophora flower, astragalus, Chinese angelica, siberian solomonseal rhizome, prepared rehmannia root, liquoric root, weeping forsythia, Chinese caterpillar fungus and citric acid in a weight ratio. The Chinese medicinal preparation has the effects of clearing heat and removing toxicity, strengthening body resistance to eliminate pathogenic factors,activating blood circulation and tonifying qi, is used for human immunodeficiency virus (HIV) infected persons and AIDS patients, has an effect of improving cluster of differentiation 4 (CD4) lymphocyte count, can reduce the HIV viral load of peripheral blood gradually, improve the symptoms of the patients obviously and improve liver functions of the patients, and does not have toxic or side effects of antiviral medicines in western medicines.

Description

A kind of Chinese medicine preparation and corresponding preparation method for the treatment of acquired immune deficiency syndrome (AIDS)

Technical field

The present invention relates to technical field of Chinese medicines, particularly relate to a kind of Chinese medicine preparation and corresponding preparation method for the treatment of acquired immune deficiency syndrome (AIDS).

Background technology

The World Health Organization (WHO) report whole world survival HIV carriers in 2010 and HIV sufferers totally 3,400 ten thousand newly infects 2,700,000, annual dead 1,800,000 people.Have every day to surpass 7000 people's New Developments and infect, district from all parts of the world all has popular, but more than 97% in, low income country, attach most importance to Africa especially.The expert estimates that the Asia may be shifted to from Africa in global popular severely afflicated area.Estimate according to CDC, end to the end of the year 2011, China survival HIV carriers and about 780,000 people of HIV sufferers, annual New Development the infected 4.8 ten thousand people, dead 2.8 ten thousand people.Epidemic situation has covered all provinces, autonomous regions and municipalities of the whole nation, and China faces acquired immune deficiency syndrome (AIDS) morbidity and dead peak period at present, and has begun the group diffusion to common people by high-risk crowds such as drug abuse, unlicensed prostitutes.

Along with popularizing of global anti-reverse transcription medicine, HIV (human immunodeficiency virus) (Human Immunodeficiency Virus) is also more and more outstanding to the drug resistance problem of Western medicine.The director of acquired immune deficiency syndrome (AIDS) department of World Health Organization (WHO) Gottfried Skien Sha Er said: by the end of the year in 2011, middle and low income country has 8,000,000 patients infected hivs to accept the anti-reverse transcription Drug therapy, increased more than 20 times than 2003, one of consequence that the medicine coverage enlarges is that virus begins to occur drug resistance, and expensive, many patients are unable to be born.

And result of study shows: the symptom and sign determined curative effect (as weak, diarrhoea, heating, erythra etc.) of Chinese medicine to improving acquired immune deficiency syndrome (AIDS); Can obviously improve patient's life quality; Immunologic function tool to raising and stable patient has certain effect.Therefore seeking efficiently from little, the cheap Chinese medicine of wide material sources, toxic and side effects, inverase has become one of important subject of relevant acquired immune deficiency syndrome (AIDS) research.

Summary of the invention

Technical problem to be solved by this invention is, a kind of Chinese medicine preparation for the treatment of acquired immune deficiency syndrome (AIDS) is provided, effective, the safe and reliable and low price aspect the treatment acquired immune deficiency syndrome (AIDS) of this Chinese medicine preparation, and the present invention simultaneously also provides the corresponding preparation method of this Chinese medicine preparation.

In order to solve the problems of the technologies described above, on the one hand, embodiments of the invention provide a kind of Chinese medicine preparation for the treatment of acquired immune deficiency syndrome (AIDS), are the preparations of being made by the following weight proportion raw material:

60～90 parts of Radix Scutellariaes, 60～90 parts in Flos Sophorae, 120～250 parts of the Radixs Astragali, 120 parts-250 parts of Radix Angelicae Sinensis, 120～250 parts of Rhizoma Polygonatis, 90～150 parts of Radix Rehmanniae Preparata, 20～55 parts in Radix Glycyrrhizae, 120～250 parts of Fructus Forsythiaes, 25～60 parts of Cordyceps, 60～90 parts of citric acids.

On the other hand, the invention provides a kind of preparation method for the treatment of the Chinese medicine preparation of acquired immune deficiency syndrome (AIDS), comprising:

Get Cordyceps, Flos Sophorae, Fructus Forsythiae, citric acid four Chinese medicine material respectively by the composition weight proportioning, mistake 80 mesh sieves after being crushed to 80 orders carry out sterilization treatment to the medicated powder behind mistake 80 mesh sieves, and are standby;

Get the Radix Astragali, Rhizoma Polygonati, Radix Glycyrrhizae, Radix Scutellariae, Radix Angelicae Sinensis and Radix Rehmanniae Preparata respectively by the component weight proportion, decoct with water secondary: 10 times of weight by crude drug decoct with water 2 hours for the first time, 8 times of amounts by crude drug decoct with water 2 hours for the second time, filter and merging filtrate, the filtrate drying is condensed into the extractum of relative density 1.2～1.25, after being crushed to 80 orders, cross 80 mesh sieves and obtain the extractum powder body, standby;

After medicated powder after the above-mentioned sterilization, extractum powder body and pharmaceutic adjuvant adopted groove to mix machine to mix 50 minutes, again it is carried out granulate and cross 80 mesh sieves, to the capable sterilization treatment of mixed medicated powder of sieving, used pharmaceutic adjuvant is at least a in maltodextrin, pregelatinized Starch and the lactose;

Medicated powder after above-mentioned mixing and the sterilization is prepared in capsule, soft capsule, tablet, syrup, oral liquid or the granule powder any.

Preferably, after getting the Radix Astragali, Radix Angelicae Sinensis, Rhizoma Polygonati, Radix Glycyrrhizae, Radix Scutellariae, Radix Rehmanniae Preparata, Flos Sophorae, Fructus Forsythiae, Cordyceps by weight ratio, further comprise:

Described medical material is carried out the step that dust removal is handled, comprising:

Vibrate 10 minutes with the electronic sieve that shakes, the dust that will be mingled in the medical material after vibration is removed, perhaps

Clean secondary at least with drinking circulating water.

Preferably, Cordyceps, Flos Sophorae, Fructus Forsythiae, citric acid four Chinese medicine material are further comprised before pulverizing:

After Flos Sophorae, Fructus Forsythiae, Cordyceps medical material dewatered with centrifuge, the control temperature was carried out drying at 60 ± 5 ℃, is dried to moisture content 3～8%.

Preferably, described sterilization treatment is specially:

With at least a sterilization treatment of carrying out in cobalt 60 sterilizing methods, ultraviolet disinfection method, the ozone sterilization method.

Preferably, the described step that the filtrate drying is condensed into the extractum of relative density 1.2～1.25 is specially:

The employing baking temperature is that 30～50 ℃ vacuum spray drying mode is carried out dried to filtrate; Perhaps

The employing baking temperature is that 90 ± 5 ℃ steam drying mode is carried out dried to filtrate.

Preferably, the step that the medicated powder after above-mentioned mixing and the sterilization is prepared into tablet is specially:

Hydroxypropyl emthylcellulose HPMC1400 part and Polyethylene Glycol PEG400 part are successively joined in 20000 parts of 60 ℃ of purified water, the limit edged stirs, the ethanol that fully adds 20000 part 95% after the swelling is again prepared the tunica albuginea slurry that obtains wrapping film-coat, this process is in coating preparation in preceding 24 hours, add 2 000 parts of titanium dioxides and 1000 parts of Pulvis Talci before the coating, colloid mill is crossed in the back that stirs;

Take by weighing 10500 parts of purified water, agitator is stretched into 2/3 place under the liquid level, start agitator, make liquid level form whirlpool, 2 000 parts of the coating materials GMI of red powder constantly are sprinkling upon on the whirlpool liquid level with speed stably, continue again to stir 45 minutes to coating materials molten fully diffusing prepare the color film slurry of bag film-coat;

Medicated powder after described mixing and the sterilization is pressed into substrate, described substrate is put into high-efficiency coating machine, adopt conventional preparation process, the tunica albuginea slurry for preparing is sprayed to the sheet bed, after 2～3 hours, again the color film slurry for preparing is sprayed to the sheet bed, after 2～3 hours, unilateral smooth exquisiteness namely.

It is a kind of that the enforcement embodiment of the invention provides, and has following beneficial effect:

1, the present invention is under the guidance of theory of Chinese medical science, it is by heat-clearing and toxic substances removing (antimicrobial pathogen), sets upright the principle that damp eliminating (strengthen human immunologic function) combines and treat acquired immune deficiency syndrome (AIDS), used for reference the achievement of modern pharmacology research simultaneously, filter out the Chinese medicine that meets the rule for the treatment of of the present invention, make the traditional Chinese medicine preparation product with obvious therapeutic effect.

2, the present invention's curative effect in clinical practice is obvious, the application and popularization value height, and for improving the aids patient clinical symptoms, the existence quality of life effect that improves patient is remarkable.

3, raw material of the present invention is obtained easily, and cost is low, does not see significant side effects, and is safe.

The specific embodiment

Below with reference to the preferred embodiments of the present invention are described.

In following embodiment one to embodiment six, the Chinese medicine preparation for the treatment of acquired immune deficiency syndrome (AIDS) of the present invention is prepared from by its weight ratio by following raw material:

?	Embodiment one	Embodiment two	Embodiment three	Embodiment four	Embodiment five	Embodiment six
							Radix Scutellariae	60	60	80	70	85	90
Flos Sophorae	60	60	80	70	85	90
							The Radix Astragali	120	120	190	220	150	250
Radix Angelicae Sinensis part	120	120	190	220	150	250
							Rhizoma Polygonati	120	220	190	170	150	250
Radix Rehmanniae Preparata	90	130	120	140	100	150
							Radix Glycyrrhizae	20	40	38	50	30	55
Fructus Forsythiae	120	220	190	150	230	250
							Cordyceps	25	55	43	30	40	60
Citric acid	60	70	75	80	85	90

Wherein, described Chinese medicine preparation component is at least a in all chemical compounds, bioactive ingredients and all kinds of molecular cluster that extract in each proportioning raw material and derivant, the full synthetics.

The invention also discloses the preparation method of above-mentioned Chinese medicine preparation, comprising:

One, technique for producing raw material step

Step 1, get Cordyceps, Flos Sophorae, Fructus Forsythiae, citric acid four Chinese medicine material respectively by each composition weight proportioning in above-described embodiment one to embodiment six, after being crushed to 80 orders, cross 80 mesh sieves, the medicated powder of crossing behind 80 mesh sieves is carried out sterilization treatment, standby;

Wherein, before pulverizing, after Flos Sophorae, Fructus Forsythiae, Cordyceps medical material can being dewatered with centrifuge, the control temperature is carried out drying at 60 ± 5 ℃, is dried to moisture content 3～8%.

Wherein, sterilization treatment can be with at least a sterilization treatment of carrying out in cobalt 60 sterilizing methods, ultraviolet disinfection method, the ozone sterilization method.

Step 2, press the weight ratio of each component in above-described embodiment one to embodiment six, get the Radix Astragali, Rhizoma Polygonati, Radix Glycyrrhizae, Radix Scutellariae, Radix Rehmanniae Preparata and Radix Angelicae Sinensis respectively, in this step, further can comprise these six kinds of medical materials are chosen, remove impurity and non-medicinal part and polishing proportional quantity in the medical material;

Step 3. the medical material in the step 2 is carried out dust removal process; Be specifically as follows:

The medical material qualified to selection in the step 2 vibrates 10 minutes with the electronic sieve that shakes, and the dust that will be mingled in the medical material after vibration is removed; Perhaps

With drinking circulating water above-mentioned medical material is cleaned secondary at least.

Step 4 with the Radix Astragali after dust removal process, Rhizoma Polygonati, Radix Glycyrrhizae, Radix Scutellariae, Radix Angelicae Sinensis and Radix Rehmanniae Preparata, directly decocts with water secondary, for the first time, decoct with water 2 hours by 10 times of amounts of crude drug, for the second time, 8 times of amounts by crude drug decoct with water 2 hours, filter merging filtrate;

Step 5, the filtrate drying is condensed into the extractum of relative density 1.2～1.25, particularly:

The employing baking temperature is that 30～50 ℃ vacuum spray drying mode is carried out dried to filtrate; Perhaps

Adopting baking temperature is that 90 ± 5 ℃ steam drying mode is carried out dried to filtrate to obtain relative density be 1.2 ~ 1.25 extractum;

And above-mentioned extractum is pulverized the back cross 80 mesh sieves acquisition extractum powder body, standby;

Step 6, the extractum powder body that the medicated powder that above-mentioned steps one is obtained and step 5 obtain, and after pharmaceutic adjuvant adopts groove to mix machine to mix 50 minutes, again it is carried out granulate and cross 80 mesh sieves, the mixed medicated powder that sieves carries out sterilization treatment.Wherein, described pharmaceutic adjuvant is at least a in maltodextrin, pregelatinized Starch and the lactose.

Wherein, sterilization treatment is with at least a sterilization treatment of carrying out in cobalt 60 sterilizing methods, ultraviolet disinfection method, the ozone sterilization method.

Step 7 is prepared in capsule, soft capsule, tablet, syrup, oral liquid or the granule powder any with the medicated powder after above-mentioned mixing and the sterilization.

Two, capsule production craft step

Further, it is as follows wherein to make the step of capsule in the step 7:

With mix and sterilization after medicated powder, adopt groove mix machine mix fully stirred in 50 minutes, mix even all after, make capsule at dust proof workshop by the capsule filling production lines, the clean loading amount of every capsules content is 400mg, and keeps moisture content 4～8%.

Three, tablet manufacturing processing step

The step of wherein making tablet in the step 7 is as follows:

1, step 6 is mixed and sterilization after medicated powder, the molding of last tablet manufacturing line pressure sheet wherein, is produced the said adjuvant of tablet and is by weight 27 parts of 25 parts of maltodextrins, 25 parts of pregelatinized Starch and lactose.Wherein, described medicated powder and pharmaceutic adjuvant are taped against and carry out drying in the stainless steel disc after mixing 50 minutes with the mixed machine of groove, and baking temperature is 90 ℃, and dry back is crushed to 80 orders with pulverizer, and sieves by 80 order granulate.

2, wrap the preparation that film-coat is starched with tunica albuginea: 1400 parts of hydroxypropyl emthylcelluloses (HPMC) and 400 parts of priorities of Polyethylene Glycol (PEG) are joined in 20000 parts of 60 ℃ of purified water, the limit edged stirs, the ethanol that fully adds 20000 part 95% after the swelling is again prepared the tunica albuginea slurry that obtains wrapping film-coat, this process is in coating preparation in preceding 24 hours, add 2 parts of titanium dioxides and 1 000 parts of Pulvis Talci before the coating, colloid mill is crossed in the back that stirs;

3, wrap the preparation that film-coat is starched with the color film: take by weighing 10500 parts of purified water, agitator is stretched into 2/3 place under the liquid level, start agitator, make liquid level form whirlpool, 2000 parts of the coating materials (GMI) of red powder constantly are sprinkling upon on the whirlpool liquid level with speed stably, continue again to stir 45 minutes to coating materials molten fully diffusing prepare the color film slurry of bag film-coat;

4, the substrate after will suppressing is put into high-efficiency coating machine, preparation process starts each system of coating equipment routinely, adjusts parameters such as spray speed, intake, inlet temperature, pot speed, exhaust air rate, and the tunica albuginea slurry for preparing is sprayed to the sheet bed, after 2～3 hours, make unilateral smooth exquisiteness; Again the color film slurry for preparing is sprayed to the sheet bed, after 2～3 hours, make unilateral exquisiteness, color and luster is even.

More than amount to ten kinds of materials and three kinds of adjuvants, according to medicine and the active characteristics of adjuvant, through powder process, water is carried and pharmaceutical technology such as mixing is handled, 500 milligrams of every tablet net weight, and keep moisture content 4～8%.

Chinese crude drug, the record of pharmaceutic adjuvant Quality Identification standard that each the component raw material medicine that adopts among the present invention all can be formulated referring to relevant departments such as the Pharmacopoeia of the People's Republic of China (version in 2010) and domestic each province, city, district's health, drug and food supervision and management.

The record of the pharmacopeia of ten kinds of medicinal raw materials and pharmacological research are as follows in the prescription of the present invention:

(1) Radix Scutellariae:

1, the Chinese medicine ancient books and records are described:

Record in " Bencao Jingshu ": Radix Scutellariae, its property is respectful clearly, so except evil: so bitter in the mouth dampness; So YIN-cold wins heat, so main all heat.

2, the modern pharmacology of Radix Scutellariae is studied:

In the 10th international AIDS conference, Japanese scholar reports Chinese medicine ingredients Baiicalien(Radix Scutellariae glycoside unit) to suppressing HIV good action is arranged.Radix Scutellariae glycoside unit is the main active of Radix Scutellariae.(source of data: 07 phase of " Shandong journal of Chinese medicine " nineteen ninety-five)

(2) Flos Sophorae:

1, the Chinese medicine ancient books and records are described:

Record in " book on Chinese herbal medicine just ": Flos Sophorae, cool large intestine kills the infantile malnutrition worm.Control skin sore, erosion of vulva pruritus due to damp pathogen, anal fistula is separated the Fructus Myricae rubrae malignant boil, primary sore volt poison.

2, the modern pharmacology of Flos Sophorae is studied:

The research Flos Sophorae extracts the external anti-HIV-1 activity of compound K 3, and its anti-HIV-1 mechanism is tentatively inquired into.

Method: adopt MTT colorimetry detection compound to the toxicity of various cells.Form counting method with syncytium, the external anti-HIV-1 activity of several different methods research chemical compound such as p24 antigen capture ELISA method and RT-PCR.

Conclusion: Flos Sophorae extracts that compound K 3 is external an anti-HIV-1 activity preferably, can suppress copying of virus experiment strain (HIV-1 III B), persister (HIV-1 74v) and clinical separation strain multiple Strain such as (HIV-1KM018), and its mechanism of action is many target spots, not only can suppress entering of virus, can also suppress the HIV-1 reverse transcriptase activity.(source of data: " Flos Sophorae extracts the research of compound K 3 external anti-HIV-1 activity " Kunming Institute of Zoology, Chinese Academy of Sciences molecular immune pharmacological experiment chamber, Kunming, Yunnan 650223 Postgraduate School, Chinese Academy of Sciences, Beijing 100039)

(3) Radix Astragali:

1, the Chinese medicine ancient books and records are described:

Record in " book on Chinese herbal medicine converges and says ": the Radix Astragali, real arresting sweating is defended in the tonifying the lung spleen invigorating, and the medicine of wind dispelling fortune poison is also.

2, the modern pharmacology of the Radix Astragali is studied

62 routine HIV sufferers are divided into Radix Astragali associating HAART treatment group 30 examples and 32 examples are organized in conventional H AART treatment through collecting, and each treated for 24 weeks, observes two groups of patients and reach the lymphocytic dynamic change of CD4+T in the peripheral blood in the time of the 1st, 3,6 month for the treatment of back before treatment.

The result: all have in various degree through the two groups of CD+4T lymphocytes in 1,3,6 month treatment back and to improve, and compare before the treatment, difference has statistical significance (P＜0.05).Relatively, treat the CD4+T lymphocyte apparently higher than conventional H AART treatment group through 3,6 months treatment back Radix Astragali associating HAART between two groups, difference has statistical significance (P＜0.05).

Conclusion: simple HARRT treatment, Radix Astragali associating HAART treatment can more effective raisings CD4+T lymphocyte quantities, enhancing HIV sufferers immunity.(source of data: " Chinese tropical source of data medical science " 2011 the 11st volumes o. 11th 1393-1393 page or leaf).

(4), Rhizoma Polygonati

1, the Chinese medicine ancient books and records are described:

Record in " herbal classic is met former ": Rhizoma Polygonati, the alleviating distention in middle-JIAO QI invigorating makes five to hide mediation, and muscle sufficiency, bone marrow are hard by force, all are the merits of nourishing YIN.

2, the modern pharmacology of Rhizoma Polygonati is studied

Positive Rhizoma Polygonati agglutinin (Polygonatum cyrtonema Hua.Lectin) is a kind of multi-functional mannose/sialic acid binding lectin of purification from China's tradition Chinese herbal medicine liliaceous plant Rhizoma Polygonati, except hemagglutination activity, short lymphocyte mitogen activation, anti-human simple herpesvirus activity and the anti-hepatitis B virus activity of Rhizoma Polygonati agglutinin show the biologic activity that it is special; Research finds that also the Rhizoma Polygonati agglutinin can prevent effectively that HIV (human immunodeficiency virus) (HIV-1/2) is to Normocellular infection.(source of data: " the tenth the academic conference thesis summary set of Chinese biological physics " 2006)

(5), Radix Rehmanniae Preparata

1, the Chinese medicine ancient books and records are described:

Put down in writing in the Compendium of Material Medica: Radix Rehmanniae Preparata, can fill out bone marrow, longue meat, promoting generation of vital essence and blood, tonifying five ZANG-organs, internal injury deficiency, promoting blood circulation, sharp knowledge, black beard and hair, man's five kinds of strain and seven kinds of impairment, woman's damaging the spleen and stomach threatened abortion, irregular menorrhea, tire produces all kinds of diseases and ailments.2, the modern pharmacology of Radix Rehmanniae Preparata is studied:

Employing cyclophosphamide molding method is made the immunosuppressed mice model, and then observes the bosom Dihuang polysaccharide to its peritoneal macrophage phagocytic function, hemolysin formation, hemolysis plaque formation, LT influence.

The result: Dihuang polysaccharide big low dose in bosom all can make phagocytic percentage, phagocytic index significantly raise; Can significantly promote hemolysin and hemolysis plaque to form, promote lymphocytic conversion.

Conclusion: the bosom Dihuang polysaccharide has significant excitation to low immunologic function.(source of data: " Chinese Chinese medicine science and technology " 03 phase in 2002 " experimentation of bosom Dihuang polysaccharide immunological stimulation ")

(6), Radix Glycyrrhizae

1, the Chinese medicine ancient books and records are described:

Record in " book on Chinese herbal medicine converges and says ": Radix Glycyrrhizae and middle QI invigorating, the medicine of tonify deficiency detoxifcation also.Strengthening the spleen and stomach, Gu the weakness with emaciation of middle gas, association's negative and positive and uncomfortable battalion defend.So control the strain internal injury, deficiency-weakness of spleen-QI, first YANG deficiency, the lung qi void that declines, its Gan Wenping mends, and effect and ginseng, stilbene are also also.

2, the modern pharmacology of Radix Glycyrrhizae is studied:

14 researcheres of research institutions such as Japan tohoku university are found a kind of Main Ingredients and Appearance glycyrrhizin (glycyrrhizine) of Radix Glycyrrhizae, can prevent the development of acquired immune deficiency syndrome (AIDS).They begin the clinical research glycyrrhizin to the drug effect of 11 HIV sufferers in August, 86, and Radix Glycyrrhizae is anti AIDS virus effectively.(source of data: " Heilungkiang Chinese medicine " 01 phase " Radix Glycyrrhizae is anti AIDS virus effectively " in 1988)

(7), Fructus Forsythiae

1, the Chinese medicine ancient books and records are described:

Put down in writing in the Shennong's Herbal: main cold and heat, Mus flaccidity, scrofula, carbuncle malignant boil, goiter, stagnation of pathogenic heat.

2, the modern pharmacology of Fructus Forsythiae is studied:

Fructus Forsythiae is a kind of heat clearing Chinese medicine commonly used, and is inhibited to multiple viruses such as syncytial virus, herpes simplex virus, influenza virus.(source of data: " Chinese Medicine Leader " 02 phase in 2010 " the antiviral progress of Fructus Forsythiae ")

(8), Cordyceps

1, the Chinese medicine ancient books and records are described:

Record in " book on Chinese herbal medicine justice ": Cordyceps, the beginning sees Wu Shi " Bencao Congxin ", claims it sweet flat, protects lung, kidney tonifying, benefit marrow, hemostasis and phlegm, chronic cough.

2, the modern pharmacology of Cordyceps is studied:

Cordyceps not only has expansion bronchus, regulates heart beating, tranquilizing soporific, androgen-like action, and has anticancer, blood sugar lowering, anti inflammatory immunity regulating action etc.Particularly in recent years, the anti inflammatory immunity regulating action of Cordyceps becomes the focus of people's research, many experts and scholars further investigate the anti inflammatory immunity regulating action of Cordyceps, find that Cordyceps has enhancing monokaryon-macrophage phagocytic function, stimulate T, bone-marrow-derived lymphocyte propagation, strengthen the lymphopoiesis effect that ConA, PHA induce, the effect of immunosuppressant such as antagonism prednisone etc., and can exert an influence to many cytokines.(source of data: " Anhui medicine " the 3rd phase in 2004 4 pages of 163-166 pages or leaves " progress of Cordyceps anti inflammatory immunity regulating action ")

(9), Radix Angelicae Sinensis

1, the Chinese medicine ancient books and records are described:

Record in " book on Chinese herbal medicine is just ": Radix Angelicae Sinensis, its sweet in the mouth and weigh, so specially can enrich blood, its gas is light and hot, thus again can promoting the circulation of blood, invigorating middle warmer has, in the row benefit is arranged, the gas medicine in the sincere blood, also the panacea in the blood is also.About mending to mend then of assistant, thus can support nutrition blood, the QI invigorating spermatogenesis, settling five organs, body by force, beneficial mind, all tangible deficient diseases, nothing is unsuitable.

2, the modern pharmacology of Radix Angelicae Sinensis is studied:

Radix Angelicae Sinensis polysaccharide (AP) is one of main component in the Radix Angelicae Sinensis, and domestic and international composition Study and pharmaceutical research to Radix Angelicae Sinensis polysaccharide had new progress in recent years, finds that it has obvious effect to body immune system, hemopoietic system.It has important defense function to macrophage (M Φ), and it has the chemotaxis directed movement, engulfs and remove the function of foreign body and aging death cell, secretes multiple bioactive substance and participation and regulates immune response.Radix Angelicae Sinensis can promote the macrophage secrete cytokines, strengthens immunologic function.According to Wang Jin etc.: Radix Angelicae Sinensis polysaccharide (AP) and tumor vaccine coupling can significantly strengthen the macrophage-mediated cytotoxicity of mice with tumor, have improved the anti-tumor effect of tumor vaccine.AP can increase the content of mouse blood calcium, thereby replenishes body to the needs of calcium, protection immunocyte, the phagocytic function of enhancing macrophage.AP can strengthen the expression of interleukin-2 (IL-2), interleukin-4 (IL-4), interleukin-6 (IL-6) and IFN-(INF-γ), its process is at first to activate macrophage and the NK cell that relates to the nonspecific immunity effect, be t helper cell then, increase antibody quantity, and then the collaborative immunologic function that strengthens.(source of data: " Sichuan animal and veterinary " the 03rd phase in 2005 " Radix Angelicae Sinensis polysaccharide is to the research of immune system effect ").

(10), citric acid

The pharmacological action of citric acid:

Citric acid claims citric acid to receive again, citric acid radical can with calcium ion in the blood form be difficult to resolve from complex, calcium ion is one of material required in the coagulation process, because the minimizing of calcium ion, and blood coagulation is obstructed in the blood.Because citric acid is alkalescence, scalable human internal environment acid-base value when appropriateness is used can to a certain degree suppress the plasmodial formation of hemocyte in the scope simultaneously theoretically.

The write out a prescription monarch combination principle of preparation of the present invention is as follows:

Monarch drug: Radix Scutellariae, the Radix Astragali (with heat-clearing and toxic substances removing and set upright QI invigorating and drive together and drive).

Ministerial drug: Flos Sophorae, Fructus Forsythiae, Rhizoma Polygonati (assisting a ruler in governing a country monarch drug).

Adjuvant drug: Radix Rehmanniae Preparata, Cordyceps, Radix Glycyrrhizae (double fill blood and be in harmonious proportion the property of medicine).

Make medicine: Radix Angelicae Sinensis (infecting the hemocyte of expressing CD4 albumen because acquired immune deficiency syndrome (AIDS) is HIV-1, so the efficacy of a drug is introduced blood system).

Citric acid is not Chinese medicine and using as the auxiliary adjustment agent, can cooperate Radix Angelicae Sinensis invigorate blood circulation (anticoagulant is poly-, suppress infected hemocyte syncytium forms and reduce the cd4 cell apoptosis).The consumption of each medical material of distinguishing the flavor of also is to carry out compatibility according to the monarch principle.

According to the analysis result of modern pharmacology to said medicine, according to the Therapeutic Principle to acquired immune deficiency syndrome (AIDS), focus on exactly with the principle of medication of all kinds of preparations of the present invention preparation and to suppress HIV-1 and to promote patient's cd4 cell.

Beneficial effect of the present invention is:

1, the present invention is under the guidance of theory of Chinese medical science, it is to treat acquired immune deficiency syndrome (AIDS) by the principle that heat-clearing and toxic substances removing (antimicrobial pathogen), strengthening vital QI to eliminate pathogenic factors (strengthening the human immunologic function) combine, used for reference the achievement of modern pharmacology research simultaneously, filter out the Chinese medicine that meets the rule for the treatment of of the present invention, make the traditional Chinese medicine preparation product with obvious therapeutic effect.Its principles of formulating prescriptions are: the antipyretic and antidotal type medical material: Radix Scutellariae, Fructus Forsythiae, Flos Sophorae; Set upright the class medical material: the Radix Astragali, Rhizoma Polygonati, Radix Rehmanniae Preparata, Radix Angelicae Sinensis, Cordyceps, Radix Glycyrrhizae.

2, raw material of the present invention is obtained easily, and taking convenience, cost are low, do not see obvious toxic-side effects, and be safe.Curative effect is obvious in clinical practice, the application and popularization value height, and for improving the aids patient clinical symptoms, the existence quality of life effect that improves patient is remarkable.

Capsule with the present invention's preparation is observed the clinical efficacy for the treatment of acquired immune deficiency syndrome (AIDS)

According to the made preparation of the present invention, to understand through following the tracks of repeatedly, said preparation at HIV sufferers volunteer human bodies that is widely used among the people such as Yunnan, Henan, has shown many positive drug effects with tcm prescription medicine form since 2002.Use capsule instead after improving: HIV sufferers and patients infected hiv patient take 12 every day, can obviously improve symptom, improve liver function, the toxicity of no Western medicine antiviral drugs.After taking, quality of life makes moderate progress, and spiritual appetite takes a turn for the better, and life quality obviously improves, and prolong life cycle, and recover normal live and work ability gradually.

The present invention adopts capsule preparations treatment acquired immune deficiency syndrome (AIDS) and HIV patient's preliminary clinical trial data:

Since 2004, with the present invention's capsule form of medication of writing out a prescription, to the rural area in counties such as Zhumadian City, Henan Province south, Shangcai that Zhoukou City's acquired immune deficiency syndrome (AIDS) epidemic situation is more serious, Xihua, successively 238 HIV sufferers and viral infection persons because of the infected by HIV of donating blood-1 are treated.

The primary condition that patient is selected in:

The first, confirmed as the HIV sufferers (the infected) of HIV antibody positive by local disease prevention and control center; The second, the peripheral blood cd4 cell is equal to or less than 400/ml, the 3rd, stops anti-reverse transcription enzyme western medicine and other antiviral treatment at period in a medicine, improves the immune function Drug therapy.

Mode and judgment criteria are treated in smelting:

Every patient's treatment time is 12 months, takes 12 of capsules of the present invention every day, and treating and adopting CD4 and patient's doing well,improving situation of patient treatment front and back after 1 year is curative effect index for the own control data.And by State Administration of Traditional Chinese Medicine's " five province's Chinese medicine acquired immune deficiency syndrome (AIDS) project clinical technology schemes " be the curative effect judgment criteria; Virus load to anti-HIV-1 excludes this treatment observation category temporarily because fund and condition are limit.

Safety conditions: 238 routine patients (the infected):

A, took medicine when finishing in 12 months, because of 231 term and general principle patients (the infected) after dead 7 of the opportunistic infection complication, the hepatic and renal function index does not all have the deterioration situation, wherein has 156 patients (the infected) glutamate pyruvate transaminase to also have in various degree and descends except midway.The glutamate pyruvate transaminase meansigma methods dropped to 36.8 by 57.6 before 231 routine patients (the infected) took medicine; Uric acid, creatinine, blood urea nitrogen average index also have to a certain degree decline.

B, took medicine 1 year after treatment effectiveness statistics: 238 routine patients (the infected) have 196 patients' (the infected) CD4 lymphocyte obviously to rise before the treatment by before and after after 12 months the treatment, and average rising value is 36.28%; Dead 7, stable or invalid (CD4 descend or rising value be lower than 30% all be considered as invalid) 35; The medicostatistics result of 238 patients (the infected) CD4 self cross-reference is P＜0.01; 175 of hyperpyrexia, the doing well,improving rates of suffering from diarrhoea and becoming thin.Overall effective percentage 82.3%.Most of patient has recovered life, labor capacity.

C, due to acquired immune deficiency syndrome (AIDS) is infected by HIV-1, because the destruction of HIV (human immunodeficiency virus), the CD4T lymphocyte is destroyed or bring out cd4 cell colony apoptosis, patient's cd4 cell is descended gradually, therefore have only and suppressed virus, cd4 cell just may obtain preserving and ging up, but because listing the antiviral index in, this treatment do not observe system, therefore the write out a prescription anti-HIV drug effect of capsule of the present invention also there is not positive evidence, for this reason, prescription drugs of the present invention has been sent the relevant viral laboratory of Germany to suppress the HIV-1 activity at present, well afoot is tested in the multinomial tests relevant with antiviral such as film fusion at present.

Above disclosed is preferred embodiment of the present invention only, can not limit the present invention's interest field certainly with this, so equivalent variations, still belongs to the scope that the present invention is contained.

Claims (7)

1. a Chinese medicine preparation for the treatment of acquired immune deficiency syndrome (AIDS) is characterized in that, is the preparation of being made by the following weight proportion raw material:

60～90 parts of Radix Scutellariaes, 60～90 parts in Flos Sophorae, 120～250 parts of the Radixs Astragali, 120 parts-250 parts of Radix Angelicae Sinensis, 120～250 parts of Rhizoma Polygonatis, 90～150 parts of Radix Rehmanniae Preparata, 20～55 parts in Radix Glycyrrhizae, 120～250 parts of Fructus Forsythiaes, 25～60 parts of Cordyceps, 60～90 parts of citric acids.

2. a kind of preparation method for the treatment of the Chinese medicine preparation of acquired immune deficiency syndrome (AIDS) as claimed in claim 1, its feature exists, and comprising:

Get Cordyceps, Flos Sophorae, Fructus Forsythiae, citric acid four Chinese medicine material respectively by the composition weight proportioning, mistake 80 mesh sieves after being crushed to 80 orders carry out sterilization treatment to the medicated powder behind mistake 80 mesh sieves, and are standby;

Get the Radix Astragali, Rhizoma Polygonati, Radix Glycyrrhizae, Radix Scutellariae, Radix Angelicae Sinensis and Radix Rehmanniae Preparata respectively by the component weight proportion, decoct with water secondary: 10 times of weight by crude drug decoct with water 2 hours for the first time, 8 times of amounts by crude drug decoct with water 2 hours for the second time, filter and merging filtrate, the filtrate drying is condensed into the extractum of relative density 1.2～1.25, after being crushed to 80 orders, cross 80 mesh sieves and obtain the extractum powder body, standby;

After medicated powder after the above-mentioned sterilization, extractum powder body and pharmaceutic adjuvant adopted groove to mix machine to mix 50 minutes, again it is carried out granulate and cross 80 mesh sieves, to the capable sterilization treatment of mixed medicated powder of sieving, used pharmaceutic adjuvant is at least a in maltodextrin, pregelatinized Starch and the lactose;

Medicated powder after above-mentioned mixing and the sterilization is prepared in capsule, tablet, syrup, oral liquid or the granule powder any.

3. preparation method as claimed in claim 2 is characterized in that, after getting the Radix Astragali, Radix Angelicae Sinensis, Rhizoma Polygonati, Radix Glycyrrhizae, Radix Scutellariae, Radix Rehmanniae Preparata, Flos Sophorae, Fructus Forsythiae, Cordyceps by weight ratio, further comprises:

Described medical material is carried out the step that dust removal is handled, comprising:

Vibrate 10 minutes with the electronic sieve that shakes, the dust that will be mingled in the medical material after vibration is removed, perhaps

Clean secondary at least with drinking circulating water.

4. a kind of preparation method for the treatment of the Chinese medicine preparation of acquired immune deficiency syndrome (AIDS) as claimed in claim 2 is characterized in that, Cordyceps, Flos Sophorae, Fructus Forsythiae, citric acid four Chinese medicine material are further comprised before pulverizing:

After Flos Sophorae, Fructus Forsythiae, Cordyceps medical material dewatered with centrifuge, the control temperature was carried out drying at 60 ± 5 ℃, is dried to moisture content 3～8%.

5. preparation method as claimed in claim 3 is characterized in that, described sterilization treatment is specially:

With at least a sterilization treatment of carrying out in cobalt 60 sterilizing methods, ultraviolet disinfection method, the ozone sterilization method.

6. preparation method as claimed in claim 5 is characterized in that, the described step that the filtrate drying is condensed into the extractum of relative density 1.2～1.25 is specially:

The employing baking temperature is that 30～50 ℃ vacuum spray drying mode is carried out dried to filtrate; Perhaps

The employing baking temperature is that 90 ± 5 ℃ steam drying mode is carried out dried to filtrate.

7. as each described preparation method of claim 2-6, it is characterized in that the step that the medicated powder after above-mentioned mixing and the sterilization is prepared into tablet is specially:

Hydroxypropyl emthylcellulose HPMC1400 part and Polyethylene Glycol PEG400 part are successively joined in 20000 parts of 60 ℃ of purified water, the limit edged stirs, the ethanol that fully adds 20000 part 95% after the swelling is again prepared the tunica albuginea slurry that obtains wrapping film-coat, this process is in coating preparation in preceding 24 hours, add 2 000 parts of titanium dioxides and 1000 parts of Pulvis Talci before the coating, colloid mill is crossed in the back that stirs;

Take by weighing 10500 parts of purified water, agitator is stretched into 2/3 place under the liquid level, start agitator, make liquid level form whirlpool, 2 000 parts of the coating materials GMI of red powder constantly are sprinkling upon on the whirlpool liquid level with speed stably, continue again to stir 45 minutes to coating materials molten fully diffusing prepare the color film slurry of bag film-coat;

Medicated powder after described mixing and the sterilization is pressed into substrate, described substrate is put into high-efficiency coating machine, adopt conventional preparation process, the tunica albuginea slurry for preparing is sprayed to the sheet bed, after 2～3 hours, again the color film slurry for preparing is sprayed to the sheet bed, after 2～3 hours, unilateral smooth exquisiteness namely.