CN1211111C - Antilipemic Chinese medicine - Google Patents

Abstract

The present invention relates to a drug for treating hyperlipidemia, particularly to a traditional Chinese medicine compound drug which is used for nourishing yin, clearing the liver, promoting blood circulation and dredging channels and mainly treats the yin deficiencies of the liver and the kidney and blood stasis type hyperlipoidemia. A traditional Chinese medicine compound drug preparation of the present invention is prepared by extracting and processing five traditional Chinese medicines of Semen Cassiae, wolfberry fruit, mulberry, haw and safflower.

Description

A kind of blood fat reducing Chinese medicine

Technical field:

The present invention relates to a kind of medicine for the treatment of hyperlipemia, particularly YIN nourishing liver heat removing, promoting blood circulation to remove obstruction in the collateral cure mainly the traditional Chinese compound medicine that the hepatic and renal YIN deficiency is held concurrently the blood stasis type hyperlipemia.

Background technology:

Hyperlipemia belongs to commonly encountered diseases in clinical, its sickness rate also obviously increases with advancing age.Hyperlipemia plays an important role in the pathogenesis of arteriosclerosis, coronary heart disease, obesity, causes people's common concern, the control of cardiovascular and cerebrovascular disease is included in public health service in China, puts on an equal footing with the infectious disease control.

At present, doctor trained in Western medicine is all obtaining very big progress to hyperlipemia aspect theory research, the experimentation, the mechanism of metabolism disorder of blood lipid and the relation between blood fat and the cardiovascular and cerebrovascular disease have been done deep research, but it is desirable that clinical means is still owed, the side effect of particularly taking medicine for a long time, be still a great problem of treatment hyperlipemia, at the Chinese Economy Development situation, many patients accept to expensive blood fat reducing Western medicine also difficulty.

Recent two decades comes, and in use medicine is prevented and treated the hyperlipemia aspect and done number of research projects, for new prospect has been opened up in the research of hyperlipemia.In conjunction with modern means of science and technology such as doctors trained in Western medicine, aspect the Chinese medical discrimination basic research, theory of Chinese medical science has had new understanding to hyperlipemia, the traditional Chinese medical science thinks that hyperlipemia is the disease of deficiency in origin and excess in superficiality, need microcosmic syndrome differentiation to carry out typing with macroscopical dialectical combination to hyperlipemia, this provides the diagnosis basis of treatment hyperlipemia for the traditional Chinese medical science.Aspect the pharmacological research of high fat Chinese medicine, find that the effect of Chinese medicine accent fat mainly realizes by following four channels: 1. suppress the intestinal class and absorb; 2. it is synthetic to suppress endogenous TC, TG; 3. influence lipid metabolism in the body; 4. promote the body inner cholesterol to drain.Aspect clinical treatment research, treatment to hyperlipemia, constantly progressive from unilateral blood fat reducing to adjusting blood lipid level, only do not observe the variation of TC, TG, also carry out simultaneously the accent fat treatment of comprehensive consideration to different blood lipoproteins, lipoprotein influence, use the report of Chinese medicine prevention hyperlipemia at present, many-sides such as single medicinal material, compound recipe, acupuncture, the qigong have been related to, find that existing more than 60 kind of Chinese herbal medicine has therapeutical effect to hyperlipemia, with the basis of Chinese medicine and western medicine curative effect comparative study on filter out a collection of Cheng Fangyu folk prescription that the symptom of a trend is arranged.

Yet, even so, still can not satisfy the demand of medical market.According to investigations, at present, existing 80,000,000 people of China suffer from heart and brain pipe disease, and every day is with 10,000 patients' speed increase.Cardiovascular and cerebrovascular disease becomes the leading killer of health risk in China worthy of the namely, and hyperlipemia is the major incentive of cardiovascular and cerebrovascular disease.Thereby, the needing that (accent) fat medicine has become the control cardiovascular and cerebrovascular disease of falling of developing determined curative effect when affair.

At present, the Chinese patent medicine of treatment hyperlipemia is more, mainly contains following several:

1. Yunnan pollen tianqi oral liquid: form by pollen of Semen Fagopyri Esculenti, Typhonium flagelliforme (Lodd.) Blume, Mel.The syndrome of static blood blocking collaterals that is used for hyperlipemia.

2. xinqingning tablet: form by Radix Et Rhizoma Rhei.The pyretic toxicity inner product card that is used for hyperlipemia.

3. fat can be clear: be made up of Semen Lepidii, Radix Scutellariae, Fructus Crataegi, Rhizoma Alismatis, Radix Et Rhizoma Rhei, the Radix Aucklandiae.Be used for accumulateing card in the phlegm-damp of hyperlipemia.

4. Radix Polygoni Multiflori tablet: form by the Radix Polygoni Multiflori.The syndrome of yin deficiency of liver and kidney that is used for hyperlipemia.

5. SHANZHAJING JIANGZHI PIAN: form by Fructus Crataegi.The interior card that stagnates of the food stasis of blood that is used for hyperlipemia.

6. fat-reducing health sheet: form by Rhizoma Alismatis.The insufficiency of the spleen leading to overabundance of dampness card that is used for hyperlipemia.

7. xinmaitong tablet: form by Radix Angelicae Sinensis, Semen Cassiae, Ramulus Uncariae Cum Uncis, Radix Achyranthis Bidentatae, Radix Salviae Miltiorrhizae, Radix Puerariae, Flos Sophorae, Mao Keqing, Xia Jucao, Radix Notoginseng.The syndrome of static blood blocking collaterals that is used for hyperlipemia.

8. JIANGZHILINGPIAN: form by Radix Polygoni Multiflori Preparata, Semen Cassiae, Rhizoma Polygonati, the Radix Aucklandiae, Fructus Crataegi, Fructus Rosae Laevigatae, Herba Taxilli, Rhizoma Alismatis.The syndrome of yin deficiency of liver and kidney that is used for hyperlipemia.

9. hypogastric lipid-lowering pill: form by Radix Salviae Miltiorrhizae, the Radix Polygoni Multiflori, Radix Ginseng, Rhizoma Polygonati, Radix Notoginseng, Rhizoma Chuanxiong, Radix Angelicae Sinensis, Rhizoma Alismatis, Herba Epimedii, Cortex Acanthopancis, Cortex Cinnamomi.The deficiency of YIN stasis of blood resistance card that is used for hyperlipemia.

Above medicine belongs to a bit cures the symptoms, not the disease, and some uses expensive composition, and some is cut and interrupt using owing to uncertain therapeutic efficacy in application process.

The invention provides a kind of determined curative effect, safe ready, little, the cheap pure traditional Chinese compound medicine of side effect.

Summary of the invention:

The invention provides the pharmaceutical preparation of a kind of prevention and treatment hyperlipemia, particularly YIN nourishing liver heat removing, promoting blood circulation to remove obstruction in the collateral cure mainly the traditional Chinese compound medicine preparation that the hepatic and renal YIN deficiency is held concurrently the blood stasis type hyperlipemia.

Traditional Chinese compound medicine preparation of the present invention is processed into through extraction by Semen Cassiae, Fructus Lycii, Fructus Mori, Fructus Crataegi, Flos Carthami Chinese medicine of the five flavours.

During prescription of the present invention was formed, the characteristic of each component document record was as follows:

Semen Cassiae: 1.＜property of medicine opinion 〉: " sharp the five internal organs, remove liver man heat ".＜Japan hanako materia medica: help irritability, beneficial smart water ".＜Bencao Jingshu: " salty aqueous vapor, rusticly sweet, if can expel the heat-evil, the flat gastric qi of closing, cold can expelling the heat-evil by tonifying YIN, the positive medicine of liver channel of foot-Jueyin also ".4.＜book on Chinese herbal medicine justice 〉: " nourishing the liver and kidney, the tranquillizing and subduing nourishing YIN ".

Fructus Lycii; 1. TAO Hong-Jing: " nourishing the essence and strengthening QI, prosperous and powerful vagina ".2.＜property of medicine opinion 〉: " all insufficiency of essence of energy tonification ".3.＜Compendium of Materia Medica〉" nourishing kidney, lung moistening, make eye bright ".4.＜and book on Chinese herbal medicine〉state " it is dizzy to control apoplexy, asthenia ".

Fructus Mori: 1.＜Amplification on Materia Medica〉" it is thirsty to control heat, spermatogenesis god ".2.＜the southern regions of the Yunnan Province book on Chinese herbal medicine 〉: " the dirty and controlling nocturnal emission with astringent drugs of kidney tonifying, clothes stop the invention order for a long time ".3.＜book on Chinese herbal medicine looks for the truth 〉: " heat extraction yin nourishing ".4.＜occupy the diet spectrum with breath 〉: " wind-damp dispelling walks with vigorous strides to carry out for nourish liver and kidney, enrich blood, breath wind syndrome caused by deficiency, clear asthenic fire ".

Fructus Crataegi: 1.＜daily book on Chinese herbal medicine 〉: " stagnation of QI, the wide diaphragm that is good for the stomach, the blood mass at the hypochondrium that disappears piece are amassed, go in relieving dyspepsia ".2.＜food mirror book on Chinese herbal medicine〉" change clot, air parcel, invigorate blood circulation ".3.＜book on Chinese herbal medicine upgrades 〉: control insufficiency of the spleen damp and hotly, the mill that helps digestion is long-pending, sharp defecation ".

Flos Carthami: 1.＜the Amplification on Materia Medica benefit is deficient 〉: broken stagnant blood, nourish blood.Many with removing blood stasis then, few with then nourish blood ".2.＜and book on Chinese herbal medicine remittance speech 〉: Flos Carthami, the medicine of removing blood stasis, promoting the circulation of blood and blood, accent blood is also ... the card of disharmony between QI and blood, non-Flos Carthami can not be transferred.3.＜and medicine justice 〉: Flos Carthami is apt to the tonneau passages through which vital energy circulates.

Prescription foundation of the present invention is that hyperlipemia is a kind of micro index, though the name of disease of motherland's medical science ahyperlipoidemia.But relevant argumentation is arranged.As " Ling Shu Miraculous Pivot or Divine Axis. a disorder of defensive QI piece of writing " day: " gas is sliding few for fat person, its serum ".Illustrate expectorant turbid for sick, have viscous based on it to coagulate puckery characteristics, often can cause venation to be stopped up stagnating not smooth." element is asked. the logical deficiency and excess opinion of commenting " day: fertile high official, then disease due to addiction to eating greasy food also "; " a vital QI of the body connecting with natural QI opinion piece of writing " pointed out the cause of disease, pathology and the symptom of hyperlipemia, and day, " distinguishing the flavor of can be sweet, obstruction of heart-QI with dyspnea, channel black, imbalance of kidney-QI." and that the mechanism of the clinical symptoms of relevant hyperlipemia and control are discussed is a lot of, is dispersed in the relevant book more, as:

" Jing Yue's complete work. dizzy fortune 〉: " Dan Xi then day no expectorant can not do dizzy, when controlling expectorant, and his medicine of dual-purpose. Yu Zeri does not have void and can not do dizzyly, when controlling void, and drinks double its mark. "

＜Linzheng Zhinan Yi. dizzy door〉Hua Xiuyun presses, " the dificiency in lower-JIAO person must control from liver, the kidney invigorating liver nourishing, and nourishing YIN for attracting YANG, controlling that the town is taken the photograph is also.“

" Jing Yue's complete work. non-wind " " people has this card more after the middle age, it declines as can be known.Through cloud man-year 40 and half of YIN QI consumed, just be with the deficiency of YIN speech also.", " card such as non-wind apathy, unlikely because of its vim and vigour, so do not know sufferings, QI invigorating void is fiber crops then, and blood deficiency is wood then, and the endlessly then hemiplegia fistula of numbness is useless, gradually to month increasing.”

Above document description, more than 40 years old middle-aged and elderly people kidney qi, liver blood gradually void decline, along with improving constantly of social senilization's degree, the hyperlipemia sickness rate improves year by year.

At present, Chinese medicine is thought: the formation of hyperlipemia, nothing more than inside and outside two factors, exopathogenic factor is the product Excessive Intake of exogenous delicious food savoury, endogenous cause of ill be because of " void " to " stasis of blood "." void " comprises yang deficiency, the deficiency of YIN, the deficiency of vital energy, blood deficiency; " stasis of blood " has the accumulation of blood stasis, the expectorant stasis of blood and metabolite, thus sick position duty in spleen, liver, kidney, pathogenesis is nothing more than " void ", " stasis of blood ".

Find in the clinical practice that the blood stasis person that holds concurrently sees real the genus hepatic and renal YIN deficiency more.The cloudy insufficiency of essence of the plain body Liver and kidney of all patients, or angry because of being worried, the cloudy blood of liver is secretly consumed, decrease kidney essense down then, all can cause Liver and kidney two void.The cloudy liquid of Liver and kidney both lost, and the moon is not made sun, gave birth in the deficiency-heat, and can refine blood is fat, and hematozemia is the stasis of blood, or because of the hepatic and renal YIN deficiency, vital organs of the human body essence, gas, blood gradually empty, thereby cause the venation stasis of blood to stagnate, form the hold concurrently pathological characteristic of blood stasis of deficiency of the liver and kindey.The cloudy insufficiency of essence of Liver and kidney, the brain inanition, YANG-orifices failing to be nourished is so dizziness, tinnitus, order are colored; Waist is a house of kidney, deficiency of kidney yin, and the waist mansion is lost and is supported, then soreness of the waist and knees; The moon is not made sun, and liver-yang is high partially, so feeling of fullness in the head, headache; Disturbance of deficiency-heat inside the body is so see feverish sensation in the palms and soles, agitation; Deficiency of YIN Tianjin is few, and deficiency-heat consumption liquid decreases Tianjin in addition, thus xerostomia, constipation with dry stool; The limbs passages through which vital energy circulates loses and moistens, and the resistance of the channels stasis of blood is obstructed in addition, so see numb limbs and tense tendons; Arteries and veins is diseases such as being also shown in uncomfortable in chest, chest pain so the stasis of blood stagnates.Red tongue or dark red, or there is ecchymosis on the limit, tongue is few, and thready and hesitant pulse or count accurately also is the hepatic and renal YIN deficiency the resembling of blood stasis of holding concurrently.In a word, assertive evidence is this with the hepatic and renal YIN deficiency, and the interior-heat yang hyperactivity has the not smooth change of venation concurrently for mark.So control suitable nourish liver and kidney with clearind deficient heat, educate Kidney-Yin to make high sun, double invigorating blood circulation with unobstructed venation.

Semen Cassiae is gone into liver, kidney, large intestine channel in the prescription of the present invention, sweet-salty and hardship, and cold nature has kidney nourishing water, removing heat from the liver, relieving constipation to let out turbid effect.Be the key medicine of YIN nourishing liver heat removing, so monarch drug in the side of being.The Fructus Lycii sweet in the mouth is flat, goes into liver, kidney two warps, the special nourishing liver and replenishing blood of merit, and kidney-tonifying sperm-generating makes cloudy blood abundance, and water can be contained wood, and deficiency-heat is from disappearing.Fructus Mori " sweet cold beneficial blood and heat extraction are the enrich blood key medicine of tonifying YIN of removing heat from blood " so be minister with this two medicine, helps the merit of Semen Cassiae YIN nourishing liver heat removing, and is long with clear benefit.And the hepatic and renal YIN deficiency, the venation stasis of blood of often holding concurrently stagnates, thus be aided with the Flos Carthami blood circulation promoting and blood stasis dispelling with unobstructed venation, so adjuvant drug in the side of being; The cold and cool partially and flavor of Semen Cassiae, Fructus Lycii, Fructus Mori property grow greasy, probably hinder the fortuneization of the taste, so join the Fructus Crataegi invigorating the spleen and stomach, relieving dyspepsia, both, do not have the turbid trouble of the expectorant of growing again, and Fructus Crataegi there was the merit of promoting blood circulation to remove blood stasis can eliminate the fraud that its stagnant diaphragm hinders stomach, can help the unobstructed channels of Flos Carthami, so adjuvant drug in the side of being all.All medicines are assisted mutually, play the effect of YIN nourishing liver heat removing, promoting blood circulation to remove obstruction in the collateral altogether.YIN nourishing liver heat removing, blood circulation promoting and blood stasis dispelling, blood fat reducing collateral dredging can be prevented and treated the cardiovascular and cerebrovascular disease of middle-aged and elderly people effectively.

Prescription of the present invention has YIN nourishing liver heat removing, promoting blood circulation to remove obstruction in the collateral effect through experiment confirm, cures mainly the hepatic and renal YIN deficiency and holds stasis of blood type hyperlipemia under the arm.

Chinese medicine preparation of the present invention, the proportioning of its prescription composition and each component is as follows:

Semen Cassiae 231-924 part Fructus Lycii 231-924 part Fructus Mori 231-924 part

Flos Carthami 77-308 part Fructus Crataegi 231-924 part

Preferably

Semen Cassiae 346-616 part Fructus Lycii 346-616 part Fructus Mori 346-616 part

Flos Carthami 115-205 part Fructus Crataegi 346-616 part

Most preferably

462 parts in 462 portions of Fructus Moris of 462 parts of Fructus Lycii of Semen Cassiae

462 parts of 154 portions of Fructus Crataegis of Flos Carthami

In more than forming, weight is calculated with crude drug, if be unit with the gram, this composition can be made into 1000 doses of pharmaceutical preparatioies, described 1000 doses of fingers, the final drug preparation of making, as make 1000 of capsule preparations, 1000 in tablet, 1000 bags of granules, oral liquid 1000 peace bottles etc., also can make big packing as granule, as the 100-500 bag, specifically can be 100 bags, 125 bags, 200 bags, 250 bags, 500 bags etc., every bag can be used as taking dose 1 time.

More than form, as if being unit with the gram, can be made into the preparation of 50-1000 taking dose, as tablet, make 1000, each taking dose can be the 1-20 sheet, can take 50-1000 time altogether.As granule, make 125 bags, take the 1-2 bag at every turn, can take 62.5-125 time altogether.

More than form to be by weight as proportioning, when producing, can increase or reduce according to corresponding proportion, as large-scale production can be unit with the kilogram, or be unit with the ton, small-scale production can be unit with the milligram also, weight can increase or reduce, but the constant rate of the raw medicinal herbs weight proportion between each composition.

The ratio of above weight proportion obtains through science screening, and for especial patient, the proportioning of can corresponding adjustment forming increases or reduce being no more than 100%.

Single medicinal material, especially ministerial drug and adjuvant drug in more than forming also can be replaced by the suitable Chinese medicine with identical property of medicine, and its drug effect of the Chinese medicine preparation after the replacement is constant.

Chinese medicine preparation of the present invention, can add the medicine acceptable carrier when being prepared into medicament, described medicine acceptable carrier can be: starch, sucrose, lactose, mannitol, silicon derivative, cellulose and derivant thereof, alginate, gelatin, polyvinylpyrrolidone, glycerol, soil temperature 80, agar, calcium carbonate, calcium bicarbonate, surfactant, Polyethylene Glycol, cyclodextrin, beta-schardinger dextrin-, phospholipid material, Kaolin, Pulvis Talci, calcium stearate, magnesium stearate etc.

Chinese medicine preparation of the present invention can be any pharmaceutically useful dosage form, and these dosage forms comprise: tablet, sugar coated tablet, film coated tablet, enteric coated tablet, capsule, hard capsule, soft capsule, oral liquid, suck agent, granule, electuary, pill, powder, unguentum, sublimed preparation, suspensoid, powder, solution, injection, suppository, ointment, plaster, cream, spray, drop, patch.Preparation of the present invention, peroral dosage form preferably, as: capsule, tablet, oral liquid, granule, pill, powder, sublimed preparation, unguentum etc., preferably granule.

Preparation of the present invention is determined usage and dosage according to patient's situation in use, but obeys every day three times, each 1-20 agent, as: 1-20 bag or grain or sheet.

Preparation of the present invention can prepare by the following method:

Prescription:

Semen Cassiae Fructus Lycii Fructus Mori Fructus Crataegi Flos Carthami

Method for making:

5 flavor medical materials are soaked in the side of getting, and boil, and filter; Medicinal residues add water again, boil, and filter; Merge 2 times extracting solution, be concentrated into certain density, obtain extractum, this extractum is the active component of Chinese medicine preparation of the present invention.

This active component can be made into the various form of Chinese drug of taking by the ordinary preparation process technology.

As be granule, in concentrated solution, add adjuvant as lactose, sucrose etc., stir and make dissolving, spray drying then, dry extract; Get dried cream powder,, must do granule, pack with the aluminum-plastic composite membrane bag, promptly with dry granulation mechanism granule.

As be capsule, in the gelatine capsule of above-mentioned granule can being packed into.

As be tablet, tabletting is promptly on tablet machine above-mentioned granule can be added lubricant.

Chinese medicine preparation of the present invention has YIN nourishing liver heat removing, promoting blood circulation to remove obstruction in the collateral effect.Cure mainly the hepatic and renal YIN deficiency hyperlipemia of blood stasis of holding concurrently.Disease is seen dizziness or is expanded or pain, tinnitus order flower, and soreness of the waist and knees, feverish sensation in the palms and soles or agitation, numb limbs and tense tendons or chest pain, xerostomia, constipation with dry stool, tongue is dark red, or there is the petechia ecchymosis on the limit, and tongue is few, thready and hesitant pulse or count accurately.

Below be clinical experiment data of the present invention:

The treatment group: fat recovering particles group (what this group used is medicinal granule with the method preparation of embodiment 1, at this called after fat recovering particles, and each 1 bag during use, every day 2 times)

Matched group: the fenofibrate group (fenofibrate is a kind of Western medicine of blood fat reducing, during use each 2, and every day 3 times)

Transfer the total curative effect of fat relatively to see Table 1 for two groups;

Treatment is organized in 102 examples, produce effects 41 examples, and effective 47 examples, invalid 13 examples worsen 1 routine obvious effective rate 40.2%, total effective rate 86.27%; In matched group 61 examples, produce effects 27 examples, effective 27 examples, invalid 7 examples, worsen 0 example, obvious effective rate 44.26%, 88.52%, two group of curative effect of total effective rate is relatively, learn by statistics and handle (Ridit analytic process), difference does not have significance meaning (P＞0.05), illustrates that the effect of accent fat and the matched group of treatment group is suitable.

Two groups to the curative effects of the every index of dyslipidemia relatively: see Table 2, table 3

As can be seen from Table 2, it is suitable with matched group with rising HDL-C curative effect that the treatment group reduces TG, LDL-C, but with the curative effect that reduces TC, AI owing to matched group.

As can be seen from Table 3: after two groups of treatments, TC, TG, LDL-C, AI all obviously descend.HDL-C obviously rises, and relatively preceding with treatment: difference has the significance meaning.(P＜0.05 or P＜0.01).Two groups of therapeutic equivalences that reduce TG, LDL-C and rising HDL-C, comparing difference does not have significance meaning (P＞0.05) between group, is lower than matched group but the treatment group reduces the curative effect of TC, AI, and relatively, difference has significance meaning (P＜0.05) between group.

Curative effect to slight obesity:

In the treatment group with patient's 41 examples of slight obesity (being above standard body weight more than 20%), treat patient's 11 examples of weight loss 2Kg after two courses of treatment, patient's 23 examples of weight loss 2.1-4kg, patient's 7 examples of weight loss 4.1-6kg, matched group is with patient's 19 examples of obesity, and body weight does not have significant change before and after the treatment.Illustrate that the agent of fat recovering particles has certain antiobesity action.

To the hypertension curative effect:

Companion I phase hypertension 49 examples in 102 examples are organized in treatment, and through treating a course of treatment (the different depressor of using), back produce effects (more than the diastolic pressure decline 10mmHg, and reaches normal range; Though or diastolic pressure do not fall normally, descended 20mmHg or more than) 17 examples, effectively (diastolic pressure descends not as good as 10mmHg, but has reached normal range, or diastolic pressure decline 10-19mmHg before the treatment, but does not reach normal range; Or systolic pressure is more than the preceding decline 30mmHg of treatment) 28 examples, invalid (not reaching art standard person) 4 examples, total effective rate reaches 91.83%, and matched group accompanied with hypertension patient 17 examples, blood pressure no change before and after the treatment maybe need add with other depressor treatments.

To the hepatic and renal YIN deficiency syndrome of blood stasis of holding concurrently:

Two groups of therapeutic effect of syndrome relatively see Table 4, table 5.

Treat the variation of front and back disease primary symptom integrations and relatively see Table 6 for two groups

As can be seen from Table 6, two groups are all improved symptoms such as feeling of fullness in the head, limb fiber crops significantly, but the curative effect of primary symptoms such as treatment group improvement dizziness, headache, the soreness of waist, limb fiber crops obviously is better than matched group.

Untoward reaction:

All do not find tangible untoward reaction for two groups in the observation process, 35 examples are organized in treatment, matched group 20 examples.Detect before and after the treatment that routine blood test, urine are conventional, stool routine examination and liver function, renal function be all in normal range, illustrates that the agent of fat recovering particles do not have influence to blood and hepatic and renal function.

Conclusion:

Clinical observation result shows: the agent of fat recovering particles is used for the hepatic and renal YIN deficiency syndrome of blood stasis of holding concurrently, the Primary hyperlipemia determined curative effect, and the curative effect of its cholesterol reducing and atherogenic index is better than matched group, and effectively good accent fat and the antiatherogenic effect of this medicine is described.

The have clear improvement effect of hepatic and renal YIN deficiency blood stasis syndrome of fat recovering particles, the curative effect of its syndrome and the curative effect of improving primary symptoms such as dizziness, soreness of the waist and knees, limb fiber crops obviously are better than matched group.

The agent of fat recovering particles has certain blood pressure lowering and antiobesity action, and it is particularly suitable that dyslipidemia companion I phase hypertension and slight the obesity patients card are belonged to the hepatic and renal YIN deficiency blood stasis person that holds concurrently.

Fat recovering particles agent drug safety is not seen the poison reaction in the clinical observation, be a kind of new drug of blood fat reducing safely and effectively.

The specific embodiment:

Further specify the present invention by the following examples.

Embodiment 1

Prescription:

Semen Cassiae 462g

Fructus Lycii 462g

Fructus Mori 462g

Fructus Crataegi 462g

Flos Carthami 154g

Lactose 500g

Make the about 1000g of dried granule altogether

Method for making:

5 flavor medical materials add 12 times of water gagings and soaked 1 hour in the side of getting, and boil 1.5 hours, filter; Medicinal residues add 10 times of water gagings again, boil 1 hour, filter; Merge 2 times extracting solution, being concentrated into relative density is 1.05-1.10 (60 ℃), adds lactose in concentrated solution; stirring makes dissolving; spray drying gets dry extract (yield must not do 25% less behind the lactose that the dried cream powder deduction adds) then, gets dried cream powder; with dry granulation mechanism granule; cross 8-10 mesh sieve sieve then and remove coarse powder, cross the 60-65 mesh sieve and remove fine powder, get the dried granule of 1000g approximately; pack (every loading amount 8g) with the aluminum-plastic composite membrane bag, promptly.

Embodiment 2

Prescription:

Semen Cassiae 462g

Fructus Lycii 462g

Fructus Mori 462g

Fructus Crataegi 462g

Flos Carthami 154g

Lactose 500g

Make 1000 of capsules altogether

Method for making:

5 flavor medical materials add 12 times of water gagings and soaked 1 hour in the side of getting, and boil 1.5 hours, filter; Medicinal residues add 10 times of water gagings again, boil 1 hour, filter; Merge 2 times extracting solution, being concentrated into relative density is 1.05-1.10 (60 ℃), adds lactose in concentrated solution; stirring makes dissolving; spray drying gets dry extract (yield must not do 25% less behind the lactose that the dried cream powder deduction adds) then, gets dried cream powder; with dry granulation mechanism granule; cross 8-10 mesh sieve sieve then and remove coarse powder, cross the 60-65 mesh sieve and remove fine powder, get the dried granule of 1000g approximately; with dried granule 1000 No. 1 hard gelatin capsules of packing into, every capsules contains the 1g medicine.

Embodiment 3

Prescription:

Semen Cassiae 462g

Fructus Lycii 462g

Fructus Mori 462g

Fructus Crataegi 462g

Flos Carthami 154g

Lactose 500g

Magnesium stearate 10g

Method for making:

5 flavor medical materials add 12 times of water gagings and soaked 1 hour in the side of getting, and boil 1.5 hours, filter; Medicinal residues add 10 times of water gagings again, boil 1 hour, filter; Merge 2 times extracting solution, being concentrated into relative density is 1.05-1.10 (60 ℃), adds lactose in concentrated solution; stirring makes dissolving, and spray drying gets dry extract (yield must not do 25% less behind the lactose that the dried cream powder deduction adds) then; get dried cream powder,, cross 8-10 mesh sieve sieve then and remove coarse powder with dry granulation mechanism granule; cross the 60-65 mesh sieve and remove fine powder, get the dried granule of 1000g approximately, add magnesium stearate; mixing; be pressed into 1000 tablets of tablets, every 1g, coating are promptly.

Embodiment 4

Prescription:

Semen Cassiae 462g

Fructus Lycii 462g

Fructus Mori 462g

Fructus Crataegi 462g

Flos Carthami 154g

Sucrose 500g

Method for making:

5 flavor medical materials add 12 times of water gagings and soaked 1 hour in the side of getting, and boil 1.5 hours, filter; Medicinal residues add 10 times of water gagings again, boil 1 hour, filter; Merge 2 times extracting solution, add sucrose, stir and make dissolving, add entry to 10000ml, mixing filters, and is filled in 1000 bottles of 10ml peace bottles promptly.

Table 1 a liang group transfers the fat total effects relatively

Group example digital display is imitated enabledisable and is worsened obvious effective rate % total effective rate %

Treatment organizes 102 41 47 13 1 40.2 86.27

Matched group 61 27 27 70 44.26 88.52

Annotate: compare △ P＞0.05 between group

The curative effect of the table 2 liang every index of group treatment dyslipidemia relatively

Blood fat project group example digital display is imitated enabledisable and is worsened obvious effective rate (%) normalization rate (%) total effective rate (%) P

Treatment organizes 69 30 31 71 40.48 39.13 88.40

TC ＜0.05

Matched group 35 10 18 70 28.57 25.71 80.00

Treatment organizes 94 40 43 11 0 42.55 39.36 88.29

TG ＞0.05

Matched group 57 25 26 60 43.86 38.59 89.47

Treatment organizes 56 24 24 80 42.86 37.5 86.84

HDL-C ＞0.05

Matched group 38 16 17 50 42.10 36.84 84.21

Treatment organizes 67 30 28 81 44.78 40.29 86.57

LDL-C ＞0.05

Matched group 41 17 18 51 41.46 36.58 87.80

Treatment organizes 102 42 48 10 1 41.18 38.24 89.22

AI ＜0.05

Matched group 61 19 29 11 2 31.14 21.86 78.68

As can be seen from Table 2: it is suitable with matched group with rising HDL-C curative effect that the treatment group reduces TG LDL-C, but be better than matched group with the curative effect that reduces IC AI.

The variation of blood fat before and after the table 3 liang group treatment (mmol/L X ± S)

Front and back difference after the medication before the medication of blood fat project group example number

The TC treatment organizes 69 7.32 ± 0.731 5.19 ± 0.615 ^{* *}-2.13 ± 0.573

△△

Matched group 35 7.21 ± 0.974 6.01 ± 0.673 ^*-1.20 ± 0.613

Treatment organizes 94 2.35 ± 1.362 1.25 ± 0.723 ^{* *}-1.10 ± 1.217

TG △

Matched group 57 2.32 ± 0.923 1.11 ± 0.627 ^{* *}-1.21 ± 0.705

Treatment organizes 56 1.01 ± 0.374 1.71 ± 0.417 ^{* *}0.70 ± 0.397

HDL-C △

Matched group 38 1.09 ± 0.416 1.74 ± 0.431 ^*0.65 ± 0.379

Treatment organizes 102 6.36 ± 0.713 4.47 ± 0.415 ^{* *}-1.89 ± 0.475

LDL-C △

Matched group 61 6.31 ± 0.695 4.67 ± 0.529 ^{* *}-1.04 ± 0.546

Treatment organizes 102 6.25 ± 1.374 4.89 ± 0.783 ^{* *}-1.36 ± 0.792

AI △△

Matched group 61 6.21 ± 1.415 5.17 ± 0.717 ^*-0.74 ± 0.517

Annotate: relatively preceding with treatment: ^*P＞0.05, ^*P＜0.05 ^{* *}Between P＜0.01 group relatively: △ P＞0.05, △ △ P

The table 4 treatment group and the treatment of control group hepatic and renal YIN deficiency the hold concurrently curative effect and the comparison thereof of syndrome of blood stasis

Group example number clinic control produce effects enabledisable obvious effective rate % total effective rate %

Treatment organizes 102 28 42 28 4 68.62 96.08

△△△ △△△

Matched group 61 07 39 15 11.48 75.4

Annotate: compare between group: △ △ △ P＜0.01

The variation of syndrome integrated value before and after the table 5 liang group treatment

Syndrome integrated value (X ± S branch)

Group example number

Difference (α ± S. branch)

After treating before the treatment

Treatment organizes 102 20.35 ± 4.173 6.97 ± 2.714 ^{* *}13.38 ± 3.675

△△△

Matched group 61 21.17 ± 4.267 16.24 ± 3.259 ^*4.83 ± 3.243

Annotate: own control (with ratio before the treatment): ^*P＜0.05 ^{* *}Between P＜0.01 group relatively: △ △ △ P＜0.01

The variation and the comparison of disease primary symptom integration before and after the table 6 liang group treatment

The treatment foreset is divided integration front and back, treatment back difference

Primary symptom group example number (X ± S branch) (X ± S branch) (α ± S. branch)

Treatment organizes 101 2.15 ± 0.941 0.43 ± 1.353 ^{* *}1.72 ± 0.713

Dizzy △ △

Matched group 59 2.23 ± 0.317 2.07 ± 0.278 ^*0.16 ± 0.217

Treatment organizes 91 2.17 ± 0.861 0.59 ± 0.473 ^{* *}1.58 ± 0.713

Feeling of fullness in the head △ △

Matched group 49 2.21 ± 0.792 1.19 ± 0.517 ^*1.02 ± 0.471

Treatment organizes 96 2.31 ± 0.631 0.49 ± 0.417 ^{* *}1.82 ± 0.379

Headache △ △

Matched group 51 2.29 ± 0.693 1.67 ± 0.617 ^*0.62 ± 0.417

Treatment organizes 78 2.03 ± 0.734 0.59 ± 0.273 ^{* *}1.44 ± 0.374

Soreness of the waist and knees △ △

Matched group 42 2.13 ± 0.617 2.01 ± 0.537 ^*0.12 ± 0.431

Treatment organizes 75 2.75 ± 0.713 0.47 ± 0.617 ^{* *}2.28 ± 0.531

Numb limbs and tense tendons △ △

Matched group 37 2.81 ± 0.671 1.79 ± 0.516 ^*1.02 ± 0.437

Annotate: relatively preceding with treatment: ^*P＞0.05, ^*P＜0.05, ^{* *}Between P＜0.01 group relatively: △ P＞0.05, △ △ P＜0.05

Claims (5)

1. a Chinese medicine preparation that prevents and/or treats hyperlipemia is characterized in that, is made by following Chinese medicine raw materials by weight proportion

462 parts in 462 portions of Fructus Moris of 462 parts of structure Fructus Lyciis of Semen Cassiae

462 parts of 154 portions of Fructus Crataegis of Flos Carthami.

2. the Chinese medicine preparation of claim 1 is tablet, capsule, oral liquid, buccal tablet, granule, electuary, pill, powder, suspensoid, powder, solution, drop or drop pill.

3. the Chinese medicine preparation of claim 2 is granules.

4. the Chinese medicine preparation of claim 1 prevents and/or treats application in the medicine of hyperlipemia in preparation.

5. the preparation method of the Chinese medicine preparation of claim 1 is characterized in that, may further comprise the steps:

A. Semen Cassiae, Fructus Lycii, Fructus Mori, Fructus Crataegi, Flos Carthami 5 flavor medical materials add water, boil, and filter, and filtrate concentrates, and obtains extractum;

B. this extractum and medicine acceptable carrier are mixed.