CN1255144C - Health care medicinal composition for regulating blood fat and its preparation - Google Patents
Health care medicinal composition for regulating blood fat and its preparation Download PDFInfo
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- CN1255144C CN1255144C CN 200410046082 CN200410046082A CN1255144C CN 1255144 C CN1255144 C CN 1255144C CN 200410046082 CN200410046082 CN 200410046082 CN 200410046082 A CN200410046082 A CN 200410046082A CN 1255144 C CN1255144 C CN 1255144C
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Abstract
The present invention discloses a health care medicinal composition for regulating blood fat, particularly a capsule for regulating blood fat and a preparation method thereof. The medicine contains the components of the following proportioning by weight: 2000 to 3000 parts (preferably 2300 to 2700 parts and most preferably 2590 parts) of red rice, 1500 to 2000 parts (preferably 1650 to 1800 parts and most preferably 1727 parts) of chitosan and 150 to 200 parts (preferably 170 to 190 parts and most preferably 183 parts) of grape seed extractive. The medicine has the advantages of nontoxicity, stabilization and obvious function for regulating blood fat.
Description
Technical field
The present invention relates to a kind of health medicine compositions of blood lipid regulation, relate in particular to capsule of a kind of blood lipid regulation and preparation method thereof.
Background technology
Blood fat is the general name of contained lipid material in the blood.Lipid in the blood mainly comprises triglyceride, phospholipid, cholesterol and free fatty etc., they in blood be with different protein bound together, exist with the form of " lipoprotein ".Lipid content is compared with whole body lipid total amount and is only accounted for a littlely in the blood, but it transports between each tissue, often can reflect lipid metabolism situation in the body.Normal adult plasma lipid content is relatively stable, and certain fluctuation range is arranged.Blood fat is a kind of important material in the human body, and many very important functions are arranged, but can not surpass certain scope.Hyperlipidemia is meant blood cholesterol (TC) and/or triglyceride (TG) is too high or HDL-C (HDL-C) is low excessively, and modern medicine is referred to as dyslipidemia.If hyperlipoidemia causes " blood is thick " easily, on blood vessel wall, deposit, form little speckle (being exactly " atherosclerosis " that we often say) these " specklees " gradually and increase, increase, artery-clogging makes blood flow slack-off gradually, and blood flow is interrupted when serious.Low-density lipoprotein cholesterol (LDL-C) accounts for the 40-50% of plasma lipoprotein total amount.Its major physiological function is the intravital cholesterol of transhipment.Cholesterol in the liver is transported to each tissue through blood to be utilized.It is arteriosclerotic important detection index, and it is arteriosclerotic risk factor that LDL-C raises, and assists the diagnosis hyperlipoproteinemia.If this situation occurs in heart, just cause coronary heart disease; Occur in brain, apoplexy will occur; If the obstruction optical fundus blood vessel will cause visual deterioration, blind; If occur in kidney, will cause renal arteriosclerosis, renal failure; Occur in lower limb, limb necrosis can occur, fester etc.In addition, hyperlipidemia can cause hypertension, brings out cholelithiasis, pancreatitis, increases the weight of hepatitis, causes male sexual disorder, disease such as senile dementia.Current research prompting hyperlipidemia may be relevant with the morbidity of cancer.It is normal to regulate the human body lipids contents, has been a worldwide problem.
Monas cuspurpureus Went is traditional simply medical material, forms for the monascus fungus Mauve aspergillar Monascuspurpureus Went of Monas cuspurpureus Went section is inoculated in the rice top fermentation.Lovastatin (lovastatin) is that monacolin K is the new anti-cholesterol agent that produces in the monascus Pseudomonas metabolic process, it is specific 3-hydroxy-3-methyl glutaryl (HMG-COA) reductase inhibitor, suppress the synthetic of cholesterol, it is remarkable to serum cholesterol reduction effect, and the effect of energy triglyceride reducing and low density lipoprotein, LDL.Medicine with other blood fat reducing is compared, and the lipid-lowering effect of monacolin K is better than clofibrate, examines rare amine, probucol and nicotinic acid etc.1999 the 17th volumes of " Chinese herbal medicine " 1999 the 30th volume the 10th phase 792-attached 2 " Monas cuspurpureus Went metabolite and medicinal function thereof " (author Dai Chunhua etc.) and " pharmacy practice magazine " the 3rd phase 172-174 " progress of Chinese medicine Monas cuspurpureus Went " (author's Song Hongtao etc.) has the complete description of knowing to the effect for reducing fat of the metabolite lovastatin of Monas cuspurpureus Went.
Chitin (chitin) is a kind of natural polysaccharose substance, extensively is present in the shell of Crustaceans such as shrimp Eriocheir sinensis, and its chemical name is poly-(1,4)-2-acetylglucosamine, indissoluble, and utilization can not be absorbed by the body.The chitin deacetylase base is obtained chitosan (chitosan), and chemical name is for poly-(1,4)-2-glucosamine, and is solvable, is easily absorbed by the body.Preparing chitosan from the chitin deacetylase base has been very sophisticated technology." Chinese marine drug " the 6th phase in the 2000th (total the 78th phase) 37-41 " chitosan is transferred blood fat activity research overview " (author Tian Defeng etc.) has described the blood lipid regulation effect of chitosan.It can suppress the increase that HDL-C reduces, plasma cholesterol rises and liver is heavy.
Procyanidin (Procyanidins, PC) belong to condensed tannin (Condensed tannin), extensively be present in occurring in nature, as Fructus Vitis viniferae, Cortex Pini, blue berry, Fructus Pruni pseudocerasi, Fructus Pruni salicinae, Fructus Crataegi, cacao bean and Semen arachidis hypogaeae etc., wherein Semen Vitis viniferae is the best source of procyanidin.Procyanidin has extremely strong antioxidant activity, is a kind of good oxygen-cent red radical scavenger and lipid peroxidation inhibitor." the pharmacological action that Chinese Pharmacological Bulletin 2002 Feb:18 (1): 9-12 " the pharmaceutical research progress of procyanidin " (author Ling Zhiqun etc.) has specifically disclosed procyanidin.Discover that procyanidin can reduce plasma cholesterol hydrogen peroxide fat, serum TC, serum TG and serum LDL, suppress serum hdl and reduce that blood fat is had regulating action.
Monas cuspurpureus Went, chitosan and procyanidin have been used for health care medicine now, as: publication number is that the patent application of CN 1383819A discloses a kind of procyanidin slow-releasing microcapsule, this microcapsule wall is made up of complexation layer and three layers of material of chitosan sedimentary deposit of calcium alginate coacervate, chitosan and alginate, this microcapsule capsule-core material is procyanidin or the mixture that contains procyanidin, cyst wall has delayed the release time of procyanidin, thereby has postponed its metabolism time.In this application, active medicine is a procyanidin, and chitosan is an adjuvant, and its effect is an intensity of utilizing self structure characteristics enhancing cyst wall, improves the stability of cyst wall.Publication number is the pharmaceutical composition that the patent application of CN1398632 A discloses a kind of blood lipid regulation, and this medicine is made up of Herb Gynostemmae Pentaphylli total glycosides powder, monascus mycopowder and Fructus Gardeniae.Publication number is that the patent application of CN 1318317 A discloses a kind of the fat-reducing and the health food of blood fat reducing, and it contains chitosan, L-carnitine stone hydrochlorate and the edible adjuvant of different molecular weight.Existing product all is to be active medicine with a kind of in Monas cuspurpureus Went, chitosan and the procyanidin, with other composition combination, obtains different health medicines again.
Summary of the invention
Technical problem to be solved by this invention is to propose a kind of health medicine compositions of blood lipid regulation of brand-new combination based on prior art, capsule of especially a kind of blood lipid regulation and preparation method thereof.
Of the present inventionly be contemplated that mainly the inventor utilizes China's Chinese medicine rarity in conjunction with modern science and technology,, proposed a kind of pharmaceutical composition of new blood lipid regulation with thousand, ten thousand kind of raw material from number by extensive work.
The health medicine compositions of the blood lipid regulation that the present invention proposes comprises following materials of weight proportions composition: Monas cuspurpureus Went 2000-3000 part, chitosan (chitosan) 1500-2000 part, Semen Vitis viniferae extract 150-200 part; Preferred Monas cuspurpureus Went 2300-2700 part, chitosan 1650-1800 part, Semen Vitis viniferae extract 170-190 part; Most preferably Monas cuspurpureus Went is 2590 parts, 1727 parts of chitosans, 183 parts of Semen Vitis viniferae extracts.
The invention allows for the preparation method of aforementioned pharmaceutical compositions, this method may further comprise the steps:
A. Semen Vitis viniferae is removed impurity, is cleaned, and oven dry is pulverized, and uses ethanol extraction three times;
B. merge extractive liquid, filters, and gets filtrate, reclaims ethanol, and it is 1.12 that debris is evaporated to relative density, adds deionized water in the gained concentrated solution, removes by filter insoluble matter;
C. get supernatant, regulating pH value with hydrochloric acid is 3-5, preferred 3.5, and precipitation separation is got filtrate;
D. add ethanol in gained filtrate, placed 12-24 hour, filter, add deionized water, being concentrated into does not have the ethanol abnormal smells from the patient, 150-250 order, preferred 200 order net filtrations;
E. with gained filtrate spray drying, the spray dryer inlet temperature is that 170 ℃, outlet temperature are 90 ℃, and moisture is lower than 5%, and the gained material is the extract of Semen Vitis viniferae, and is standby; Also the gained Semen Vitis viniferae extract can be carried out behind the irradiation sterilization standby;
F. according to weight proportion, take by weighing Monas cuspurpureus Went 2000-3000 part, chitosan 1500-2000 part and above-mentioned Semen Vitis viniferae extract 150-200 part, preferred Monas cuspurpureus Went 2300-2700 part, chitosan 1650-1800 part and above-mentioned Semen Vitis viniferae extract 170-190 part, more preferably 2590 parts in Monas cuspurpureus Went, 1727 parts of chitosans and Semen Vitis viniferae extract are 183 parts, with its mix homogeneously, can use the conventional method of this area to make conventional peroral dosage form, as capsule, pill, tablet etc., preferred capsule.
Can also be with gained capsule irradiation sterilization, packing, warehouse-in.
Wherein, among the step a, the preferred 79-85 of the temperature of ethanol extraction ℃, more preferably 80 ℃; Extract the preferred 65-75% of used concentration of alcohol, more preferably 70%;
Among the step b, reclaim the preferred 79-85 of alcoholic acid temperature ℃, more preferably 80 ℃; Add deionized water volume be preferably the concentrated solution volume 2-6 doubly, more preferably 4 times;
In the steps d, to add concentration of alcohol preferred 95%, the 5-7 that its volume is preferably the concentrated solution volume doubly, more preferably 6 times.
Among the present invention, biological limited technology company buys used Monas cuspurpureus Went from east, Zhuozhou, Hebei, and strain be called Monascupurpureus Went, and strain number is the Monascus anka Nakazawa et sato A S3.991 that distinguishes the flavor of, lovastatin content 0.6%, and its quality standard is as follows:
| Project | Index |
| Outward appearance | Peony is Powdered |
| Abnormal smells from the patient | Little have an acid gas |
| Lovastatin content, | 0.6％ |
| Moisture content | ≤7.0％ |
| Ash | ≤3.0％ |
| Arsenic | ≤2ppm |
| Plumbous | ≤1ppm |
| Hydrargyrum | ≤0.1ppm |
| Copper | ≤10ppm |
| Total plate count | ≤1000cfu/g |
| Coliform, MPN/100 | Must not detect |
| Mycete | ≤100cfu/g |
| Yeast | ≤25cfu/g |
| Pathogenic bacterium (Salmonella, shigella, staphylococcus aureus are congratulated Hemolytic streptococcus) | Must not detect |
Chitosan is the chitosan that comes out from the crustacean shell extraction, and through the material that the hydrolysis deacetylate forms, deacetylation is not less than 90%, and is as follows available from its quality standard of Jinhu County, Huantai County carapace Products Co., Ltd:
| Project | Index |
| Deacetylation | ≥90％ |
| Color | Faint yellow |
| Viscosity | 100mps |
| Moisture content | ≤8.0％ |
| Ash | ≤1.0％ |
| Arsenic | ≤0.5ppm |
| Plumbous | ≤0.3ppm |
| Hydrargyrum | ≤0.005ppm |
| Copper | ≤30.0ppm |
| Total plate count | ≤1000cfu/g |
| Coliform, MPN/100 | Must not detect |
| Mycete | ≤25cfu/g |
| Yeast | ≤25cfu/g |
| Pathogenic bacterium (Salmonella, shigella, staphylococcus aureus are congratulated Hemolytic streptococcus) | Must not detect |
Semen Vitis viniferae, cleaning, fresh does not have and goes mouldy, damages by worms, and the Semen Vitis viniferae extract quality standard is as follows:
| Project | Index |
| Outward appearance | Rufous is Powdered |
| Taste | Astringent taste |
| Procyanidin content | ≥95.0％ |
| Solubility in acid | Dissolving |
| Insoluble matter in the water | ≤5.0％ |
| Insoluble matter in the acid | ≤5.0％ |
| Ash | ≤2.0％ |
| Moisture content | ≤5.0％ |
| PH (4% is water-soluble) | 2.5-4.5 |
| Heavy metal | ≤10％ |
| Ferrum | ≤10％ |
| Arsenic | ≤2％ |
Ethanol is food grade, meets the regulation of GB 10343-1989.
Monas cuspurpureus Went contains abundant metabolite lovastatin, can significantly reduce serum cholesterol, can also triglyceride reducing and low density lipoprotein, LDL, and effective blood fat reducing, Monas cuspurpureus Went also has blood pressure lowering, falls the blood ammonia effect; Chitosan molecule and human body have good affinity and intermiscibility, can reduce cholesterol in blood and the liver, reduce ldl concn in the serum, improve high-density lipoprotein concentration, have good blood lipid regulation function; Be rich in procyanidin in the Semen Vitis viniferae extract, it can significantly reduce plasma cholesterol serum cholesterol, triglyceride and low density lipoprotein, LDL, and increase serum high-density LP, has tangible blood lipid regulation effect, but also have antioxidation, defying age, resisting hypertension, effects such as atherosclerosis.After three kinds of material medicines make up with rational weight proportion, have excellent blood lipid regulation effect,, also have excellent prevention, health protection and therapeutic action as hypertension, arteriosclerosis etc. to other cardiovascular disease.
When taking health medicine capsule of the present invention, every day 2 times, each 3, every 450mg is equivalent to the every kg body weight 45mg of adult (in 60 kilograms).When taking other peroral dosage forms of health medicine of the present invention, it is identical with capsule that dose is converted into raw medicinal material.
Health medicine of the present invention has passed through the specified entity check through Ministry of Public Health: the animal safety toxicological evaluation is the avirulence material, confirm no mutagenicity through Salmonella reversion test, micronucleus test and spermatic aberration test, stability, hygiene inspection is qualified, functional component procyanidin, lovastatin equal size are qualified, and the animal experiment proof has the blood lipid regulation effect.
One, safety evaluatio
Check unit: Chinese Academy of Medical Sciences Ins of Nutrition ﹠ Food Hygiene
Test basis: " toxicological evaluation of food safety procedure and method " GB15193-94
Sample survey is a capsule of the present invention
Experimental animal and feedstuff: Kunming mouse (secondary) is available from Chinese Academy of Medical Sciences's Animal Experimental Study
Institute's breeding field (quality certification number: SCXK11-00-0006); SD rat (secondary) is available from Animal Experimental Study center, Beijing (quality certification SCXK11-00-0008), and feedstuff is available from Animal Experimental Study center, Beijing.
1. acute toxicity test
Rat acute toxicity test: press horn method.Choose 20 of SD healthy adult rats, each 10 of male and female.The average weight female rats is 191.7g (181-202), and male rat is 196.3 (182-208).Irritate stomach and tried thing, dosage is 10.0g/kg., every day 3 times, irritating the amount of emitting is 1.0ml/100g.Observe animal toxic reaction and death condition in 14 days.
Respectively organize the reaction of rat no abnormality seen in viewing duration, growing state is good, does not have dead the generation, and animal heavy male and female eventually is 213.8 (198-228) grams, and male is 243.7 (226-257) grams.Tried thing rat mouth LD through tabling look-up
50Male, female all greater than 10g/kg, actual no mould according to the acute toxicity grading criteria given the test agent.
Acute toxicity test in mice: press horn method.Choose 20 of Kunming kind healthy mices, each 10 of male and female.The average weight female mice is 19.4g (18.6-20.5), and male rat is 19.5 (18.3-20.5).Sample is mixed with solution with distilled water, irritates stomach and is tried thing, and dosage is 10.0g/kg.Every day 2 times, irritating the stomach amount is 0.2ml/10g.Observe animal toxic reaction and death condition in 14 days.
Respectively organize the reaction of rat no abnormality seen in viewing duration, growing state is good, does not have dead the generation, and animal heavy male and female eventually is 30.7 (28.5-33.2) grams, and male is 35.1 (32.9-36.7) grams.Tried thing mice mouth LD through tabling look-up
50Male, female all greater than 10g/kg, nontoxic according to acute toxicity grading criteria given the test agent reality.
2. mutagenicity test
Salmonella reversion test: adopt flat board to mix method, use TA97, TA99, TA100 and four bacterial strains of TA102 of this packing, S-9 also is that this institute makes by oneself, and is all normal through five evaluations of bacterial strain and S-9 determination of activity.Test dose adds sample 0,0.008,0.04,0.2,1.0 and 5.0mg/ ware respectively for each bacterial strain, 1g is tried thing be diluted to 20ml with sterilized water, mixing is crossed post (implant is activatory XADII resin), dry up moisture content, wash post 2 times with 10ml acetone, volatilization acetone, being settled to 10ml with the DMSO dissolution with solvents is high concentration (100 μ l/ ware).Positive thing is respectively 2-AF, and (2-aminofluorene, TA97, TA98 and TA100 add S-9 and use, and dosage is 10.0 μ g/ wares; NPD (4-nitro-O-time phenylenediamine, TA97, TA98 do not add S-9,20.0 μ g/ wares); Sodium azide (TA100 uses, and does not add S-9,1.5 μ g/ wares); MMC) mitomycin, TA102 uses, and does not add S-9,2.5 μ g/ wares) and 1,8-dihydroxyanthraquinone (TA102 adds S-9,50 μ g/ wares).
Given the test agent Salmonella reversion test result (S9)
| Title | Dosage | Clump count (X ± SD) | |||
| TA97 | TA98 | TA100 | TA102 | ||
| Organized by examination | 0.008 | 139.0±14.2 | 39.3±3.1 | 123.7±15.0 | 306.3±10.1 |
| 0.04 | 128.3±11.0 | 37.0±7.8 | 122.0±11.5 | 308.3±1.5 | |
| 0.2 | 137.7±7.6 | 43.0±4.6 | 139.0±7.5 | 320.7±15.0 | |
| 1.0 | 128.3±17.6 | 37.0±10.8 | 140.7±19.8 | 311.7±11.2 | |
| 5.0 | 132.3±4.7 | 30.7±2.5 | 127.0±16.5 | 304.0±17.5 | |
| Blank | 162.7±12.5 | 26.3±2.1 | 128.7±8.1 | 291.3±15.9 | |
| The reagent contrast | 160.3±8.5 | 26.7±3.1 | 130.7±11.2 | 276.7±19.9 | |
| Positive control | 1729±219 | 1747±131 | 2183±159 | 2031±70 | |
Given the test agent Salmonella reversion test result (+S9)
| Title | Dosage | Clump count (X ± SD) | |||
| TA97 | TA98 | TA100 | TA102 | ||
| Organized by examination | 0.008 | 124.0±5.3 | 45.3±2.5 | 138.7±13.9 | 299.7±11.6 |
| 0.04 | 134.7±6.1 | 50.3±12.0 | 122.3±14.8 | 302.7±11.6 | |
| 0.2 | 123.0±20.5 | 42.7±4.9 | 137.7±14.8 | 306.0±24.5 | |
| 1.0 | 131.7±10.1 | 38.8±3.2 | 135.0±7.0 | 307.0±23.1 | |
| 5.0 | 112.7±14.5 | 28.0±4.6 | 113.7±16.4 | 288.7±23.2 | |
| Blank | 173.7±7.2 | 29.0±1.0 | 129.3±7.6 | 281.0±15.9 | |
| The reagent contrast | 162.7±22.0 | 27.7±3.5 | 136.7±12.1 | 282.0±8.5 | |
| Positive control | 1721±110 | 2966±141 | 1903±140 | 828±131 | |
Wherein, numerical value shown in each ware is that returning of three plates becomes the clump count average.
In institute's amount of reagent scope (0.008-5.0mg/ ware), each bacterial strain is not seen the obvious rising of sudden change clump count, and positive control ware oil significant reaction shows and tried thing and do not have the effect that causes gene mutation in being subjected to the amount of reagent scope under normal experiment condition.
The PCEMNR micronucleus test: choose 50 of healthy kunming mices, body weight is 25-30g, is divided into 5 groups immediately by the body weight nuclear sex, 10 every group, and male and female half and half.The 1st group of negative matched group given distilled water; 2-4 group is experimental group, and basic, normal, high dosage is respectively 0.56,1.67,5.0g/kg; The 5th group of positive matched group intraperitoneal injection of cyclophosphamide 40mg/kg.Irritate stomach for 2 times and give to be tried thing, irritating the stomach amount is 0.4ml/20g, 24 hours at interval, irritate stomach for the second time after 6 hours cervical vertebra dislocation methods put to death mice, get the bone marrow of sternum smear, Giemsa staining and oily mirror microscopy, the micronucleus cell number of 1000 polychromatic erythrocytes of every Mus counting.
Given the test agent is to the influence of PCEMNR microkernel incidence
| Sex | Dosage (g/kg.bw) | Number of animals (only) | Observation of cell number (individual) | Micronucleus number (individual) | Incidence rate (‰) |
| Female | Negative control group a0.56g/kg group 1.67g, kg group 5.0g/kg group positive controls b | 5 5 5 5 5 | 5×10 3 5×10 3 5×10 3 5×10 3 5×10 3 | 11 8 8 9 169 | 2.2 1.6 1.6 1.8 33.8 |
| Female | Negative control group a0.56g/kg group 1.67g/kg group 5.0g/kg group positive controls b | 5 5 5 5 5 | 5×10 3 5×10 3 5×10 3 5×10 3 5×10 3 | 9 7 8 9 154 | 1.8 1.4 1.8 1.8 30.8 |
Annotate:
a: show and respectively tried the thing processed group relatively, Poisson distribution statistics P＞0.05
b: show with negative control group and respectively tried the thing processed group relatively, Poisson distribution statistics P＜0.01
No matter female still male mice cyclophosphamide positive controls microkernel incidence all apparently higher than negative control group with respectively tried processed group, and each given the test agent and negative control group relatively do not have significant difference, illustrate that this is tried thing the mice somatic chromosome is not had mutagenic action.
Mouse sperm distortion test: choose 25 of healthy adult male mice in kunming, body weight is the 25-30 gram, is divided into 5 groups immediately, and 5 every group, the 1st group is matched group, gives distilled water; 2-4 group is experimental group, and basic, normal, high dosage is respectively 0.56,1.67,5.0g/kg; The 5th group of positive matched group, lumbar injection is given cyclophosphamide 40mg/kg.Each group was tried thing 5 days continuously, irritated stomach amount 0.4ml/20g, in the 35th day, the cervical vertebra dislocation is put to death mice and is got two flank testis, degrease, and normal saline shreds, centrifugal, 1000 rev/mins centrifugal 7 minutes, remove supernatant, stay a little mixed drop in smear, methanol fix, 1.5% Yihong dyeing and microscopy.1000 sperms of every Mus counting, counting is respectively organized sperm distortion number and aberration rate, and the sperm distortion rate is represented with percentage rate.
Being tried thing influences mouse sperm is distored
| Dosage | Number of animals (only) | Observe sperm count (individual) | Sperm deformity number (individual) | Rate of teratosperm (%) |
| Negative control group a0.56g/kg group 1.67g/kg group 5.0g/kg group positive controls b | 5 5 5 5 5 | 5×10 3 5×10 3 5×10 3 5×10 3 5×10 3 | 123 136 133 125 291 | 2.46 2.72 2.66 2.50 5.82 |
Annotate:
a: show and respectively tried the thing processed group relatively, X
2Check P＞0.05
b: show with negative control group and respectively tried the thing processed group relatively, X
2Check P＜0.01
Positive group distortion incidence rate is apparently higher than negative control group and respectively tried the thing processed group, and each dosage is tried the thing group and the negative control group aberration rate does not relatively have significant difference, illustrates that this is tried thing and does not have the mouse propagation cell of causing distortion effect.
3. 30 days feeding trials of rat: select 80 of health, ablactation SD rats for use, body weight 43-65 gram, animal is divided into 4 groups immediately by body weight, and 20 every group, male and female half and half.The 1st group is matched group, and the 2-4 group is experimental group, and basic, normal, high dosage is respectively per kilogram of body weight 1.12g, 2.25g and 4.5g (high dose group is with respect to 100 times of people's the highest recommended amounts 2.7g/ day of clothes).Feedstuff is standing feedstuff (singly adding fish flour), calculates to add by 10% food-intake and is tried thing, and mixing is standby.The animal sub-cage rearing, ad lib, observe following index:
The weight of animals and food utilization: write down food-intake weekly, weigh weekly once, calculate food utilization (the body weight gain gram numbers of every absorption 100 gram feedstuffs);
Hematological examination: comprise hemoglobin, red blood cell count(RBC), platelet count, numeration of leukocyte and classification thereof.The tail vein is got blood, measures once in experiment is final;
Blood parameters: the tail vein is got blood, measures once in experiment is final.Get behind the blood (3000 rev/mins of centrifugalize serum, 15 minutes), the test kit that adopts Beijing Chinese biological engineering High-tech company to provide carries out glutamate pyruvate transaminase, glutamic oxaloacetic transaminase, GOT, blood glucose, creatinine, blood urea nitrogen, triglyceride, T-CHOL, total protein, albuminous mensuration with automatic biochemical analyzer (Hitachi, Ltd produces 7060 types);
Organ coefficient: before experiment finishes to put to death animal, weigh, it is fixing that the sacrificed by decapitation animal is got liver, kidney, stomach and duodenum, testis (or ovary) is put into 10% formalin solution, paraffin section, H.E dyeing, tissues observed morphological change under optical microscope.
Tried thing to the influence of rat body weight (mean ± SD)
| Sex | Dosage (g/kg) | Number of animals (only) | Starting weight (g) | First week (g) | Second week (g) | The 3rd week (g) | Around (g) |
| Male | Contrast 1.12 2.25 4.50 | 10 10 10 10 | 63.1±5.5 63.5±3.6 63.6±3.6 63.2±3.6 | 104.9±7.3 101.3±7.7 105.2±7.4 114.6±9.6 | 160.3±7.8 162.0±7.2 163.0±7.2 164.8±13.5 | 212.9±4.8 212.4±8.4 215.4±6.7 220.1±18.5 | 260.8±10.1 256.0±12.4 258.0±12.0 262.8±19.8 |
| Female | Contrast 1.12 2.25 4.50 | 10 10 10 10 | 57.4±4.7 57.9±5.8 57.6±3.4 57.0±3.4 | 99.7±9.0 97.4±8.2 96.1±8.2 103.1±7.1 | 141.2±5.5 135.2±6.4 131.9±9.6 144.0±12.4 | 170.2±8.7 164.5±8.7 167.9±12.3 166.3±10.9 | 193.3±10.1 191.5±9.7 195.7±9.7 190.3±16.8 |
Male, female each dosage treated animal body weight and matched group do not have significant difference (P＞0.05).
Tried thing to rat total foodstuff utilization rate shadow noon (mean ± SD)
| Sex | Dosage (g/kg) | Number of animals (only) | Body weight increment (g) | Food-intake (g) | Food utilization % | Statistical value F | The P value |
| Male | Contrast 1.12 2.25 4.50 | 10 10 10 10 | 197.7±11.8 192.5±13.6 194.4±12.5 199.6±21.1 | 568.4±51.0 561.8±26.6 569.6±34.3 571.6±42.4 | 35.1±4.5 34.3±3.1 34.3±3.7 35.3±5.8 | 0.1433 | 0.9333 |
| Female | Contrast 1.12 2.25 4.50 | 10 10 10 10 | 135.9±12.8 133.6±10.3 138.1±9.6 133.3±16.8 | 508.4±26.6 510.2±37.1 518.4±24.4 512.1±37.4 | 26.8±2.8 26.3±2.5 26.7±2.0 26.1±3.0 | 0.1611 | 0.9218 |
Food utilization unit: gram/100 grams
Tried that each dosage group of thing is female, the total augment weight of male rat, total food-intake and the food utilization difference of comparing with matched group that there are no significant (compare with matched group, and the statistics value is respectively F=0.3118, P=0.8167 by total augment weight, total food-intake; F=0.1860, P=0.9052; Male F=0.4415, P=0.7247; F=0.1148, P=0.9509).
Safe health board ZHIQING JIAONANG rat blood check result (mean ± SD)
| Sex | Dosage (g/kg) | Number of animals (only) | Numeration of leukocyte (10 9/L) | Red blood cell count(RBC) (10 12/L) | Platelet (10 9/L) | Hemoglobin (g/L) |
| Male | Contrast 1.12 2.25 4.50 | 10 10 10 10 | 18.1±2.88 17.6±2.76 17.1±2.47 17.6±1.99 | 6.75±0.33 6.59±0.35 6.77±0.33 6.57±0.38 | 1109.9±15.5 1143.8±61.9 1113.8±40.0 1115.0±57.9 | 134.6±9.02 135.5±6.89 135.2±5.22 133.5±7.91 |
| Male | Contrast 1.12 2.25 4.50 | 10 10 10 10 | 15.9±3.26 16.8±2.57 16.0±3.13 16.2±2.53 | 6.27±0.41 6.24±0.41 6.25±0.44 6.22±0.35 | 1133.8±35.5 1167.4±87.3 1106.0±61.0 1167.4±87.3 | 131.8±6.46 129.1±8.32 132.6±7.64 131.5±9.22 |
Tried the influence (mean ± SD) of thing rat WBC
| Sex | Dosage (g/kg) | Number of animals (only) | Lymph % | Neutral % | Acidophilia % | Monokaryon % |
| Male | Contrast 1.12 2.25 4.50 | 10 10 10 10 | 77.7±4.22 76.7±5.08 79.2±2.90 78.6±5.64 | 20.3±4.45 21.3±4.78 18.6±2.55 19.7±4.72 | 0.9±0.88 0.8±0.79 0.9±0.74 0.5±0.53 | 1.1±0.99 1.2±0.92 1.3±0.95 1.2±0.92 |
| Female | Contrast 1.12 2.25 4.50 | 10 10 10 10 | 79.5±7.18 78.4±5.12 78.2±5.51 78.0±4.94 | 18.4±6.00 19.3±5.08 19.3±5.58 19.7+5.42 | 0.8±0.92 0.8±0.79 0.7±0.67 0.9±0.88 | 1.3±1.06 1.5±1.08 1.8±1.03 1.4±1.12 |
Content of hemoglobin, platelet count, leukocyte count, leukocyte differential count and the matched group of female, male each dosage treated animal more all do not have significant difference (P＞0.05).
Tried thing rat blood serum biochemical indicator measured value (mean ± SD)
| Sex | Dosage (g/kg) | Number of animals (only) | Glutamate pyruvate transaminase (U/L) | Glutamic oxaloacetic transaminase, GOT (U/L) | Blood urea nitrogen (mmol/L) | Creatinine (μ mol/L) | Cholesterol (mmol/L) |
| Female | Contrast 1.12 2.25 4.50 | 10 10 10 10 | 43.3±9.4 43.5±8.6 45.2±7.8 44.1±4.2 | 159.4±34.8 169.4±30.9 157.7±22.2 159.7±36.7 | 6.13±0.80 6.66±0.73 6.78±1.25 6.63±0.94 | 58.62±3.41 60.58±4.90 62.80±5.14 63.08±4.45 | 1.74±0.33 1.81±0.20 1.89±0.23 1.80±0.23 |
| Male | Contrast 1.12 2.25 4.50 | 10 10 10 10 | 47.3±10.3 44.9±6.1 53.6±12.4 54.0±15.7 | 162.9±30.5 160.0±29.2 182.6±35.3 185.2±37.2 | 6.15±0.73 6.17±1.18 6.09±0.54 5.89±0.81 | 60.91±3.90 62.50±3.60 61.48±5.15 61.06±2.73 | 1.74 ± 0.15 1.91 ± 0.28 1.65 ± 0.43 1.61 scholar 0.31 |
Tried thing rat blood serum biochemical indicator measured value (mean ± SD)
| Sex | Dosage (g/kg) | Number of animals (only) | Triglyceride (mmol/L) | Blood glucose (mmol/L) | Total protein (g/L) | Albumin (g/L) |
| Female | Contrast 1.12 2.25 4.50 | 10 10 10 10 | 1.44±0.39 1.54±0.53 1.27±0.47 1.41±0.30 | 6.83±0.62 6.87±0.76 7.20±0.79 7.31±0.71 | 66.5±3.61 68.6±3.50 68.3±4.14 69.1±3.48 | 40.3±1.42 41.2±1.71 41.2±1.64 41.2±1.10 |
| Male | Contrast 1.12 2.25 4.50 | 10 10 10 10 | 1.78±0.48 1.58±0.72 1.67±0.74 1.82±0.91 | 6.66±0.72 6.42±0.39 6.60±0.53 6.80±0.56 | 68.4±5.41 69.9±3.79 71.6±2.50 69.1±3.29 | 40.6±1.53 40.6±1.35 41.2±1.29 40.0±1.25 |
Difference that female, male each dosage group rat blood serum glutamate pyruvate transaminase, glutamic oxaloacetic transaminase, GOT, blood urea nitrogen, creatinine, blood glucose, triglyceride, T-CHOL, total protein and albumin compare with matched group that there are no significant.Female Mus: serum glutamic pyruvic transminase F=0.1068, P=0.9556; Glutamic oxaloacetic transaminase, GOT F=0.2812, P=0.8386; Blood urea nitrogen F=0.9083; P=0.4466; Creatinine F=2.1365, P=0.1127; T-CHOL F=0.6234, P=0.6045; Triglyceride F=0.6662, P=0.5783; Blood glucose F=1.0899, P=0.3658; Total protein F=0.9213, P=0.4403; Albumin F=0.9180, P=0.4419.
Male Mus: serum glutamic pyruvic transminase F=1.5272, P=0.2241; Glutamic oxaloacetic transaminase, GOT F=1.5473, P=0.2190; Blood urea nitrogen F=0.2279; P=0.8764; Creatinine F=0.3309, P=0.8030; T-CHOL Hc=4.2434, P=0.2362; Triglyceride F=0.2226, P=0.8800; Blood glucose F=0.7843, P=0.5105; Total protein F=1.2330, P=0.3119; Albumin F=1.2461, p=0.3074., tried thing to the influence of the dirty body ratio of rat (mean ± SD)
| Sex | Dosage (g/kg) | Number of animals (only) | Liver/body % | Kidney/body % | Spleen/body % | Testis (ovary)/body % |
| Female | Contrast 1.12 2.25 4.50 | 10 10 10 10 | 2.51±0.27 2.73±0.28 2.66±0.25 2.57±0.21 | 0.70±0.40 0.68±0.07 0.67±0.06 0.68±0.05 | 0.23±0.03 0.26±0.05 0.25±0.04 0.25±0.04 | 1.05±0.02 1.03±0.07 1.08±0.07 1.05±0.06 |
| Male | Contrast 1.12 2.25 4.50 | 10 10 10 10 | 3.48±0.58 3.57±0.56 3.59±0.48 3.58±0.33 | 0.84±0.05 0.87±0.04 0.86±0.04 0.87±0.06 | 0.32±0.06 0.31±0.03 0.32±0.05 0.33±0.04 | 0.057±0.012 0.053±0.005 0.052±0.006 0.055±0.009 |
Unit: dirty body ratio: gram/100 grams
Female, male each dosage group rat liver,kidney,spleen is compared there was no significant difference (P＞0.05) with the dirty body of gonad than with matched group.
Histopathologic examination: gross anatomy is respectively organized each internal organs of rat and is shown no obvious abnormalities.Degeneration, necrosis or scorching reaction do not appear in histological examination rats'liver, kidney, stomach and duodenum, testis internal organs such as (or ovaries), renal tubules,convoluted epithelial cell; Gastric mucosa is complete, does not see epithelial cell shedding and scorching reaction; Testis (or ovary) is grown no abnormal; Lobules of liver is complete, does not see that pathological changes such as necrosis appear in hepatocyte, and loose in various degree and indivedual mononuclear cell kitchen range infiltrations appear in part animal liver cell slurry, but compare there was no significant difference with matched group.So think and do not see and tried the toxicity pathological change that thing causes.
4. add up: data are calculated mean box standard deviation through EXCEL, carry out variance analysis through the PEMS statistical package, and the heterogeneity of variance person adopts the nonparametric analysis.
5, result:
In sum, through large and small Mus acute toxicity, mutagenicity test and 30 days feeding trials, this is tried thing does not have overt toxicity.
Two, health care evaluation
Check unit: health food functional check center, Chinese Academy of Medical Sciences Ins of Nutrition ﹠ Food Hygiene
Test basis: " the health food function assessment assessment process and the method for inspection "
1. material and method
1.1 sample survey is a capsule of the present invention.Recommended amounts is that each 3, every 450mg is equivalent to adult's per kilogram of body weight 45mg (in 60 kilograms) 2 times for each person every day.The product content thing is the kermesinus powder.
1.2 laboratory animal: secondary SD male rat, 48, weight range: 160-200 gram; Available from Beijing Vital River Experimental Animals Technology Co., Ltd..Licence numbering: SCXK11-00-0008.
1.3 dosage is selected:
It is formulated that the normal feedstuff that high lipid food is bred factory and provided by Chinese Academy of Medical Sciences's laboratory animal adds cholesterol, Adeps Sus domestica, cholate.Wherein normal feedstuff 93.3%, cholesterol 1.5%, Adeps Sus domestica 5%, cholate 0.2%.
Tried thing to irritate the stomach mode, each organizes concrete dosage is that low dose group 225mg/kg.bw, middle dosage group 450mg/kg.bw, high dose group 1350mg/kg.bw, matched group give distilled water, and the dosage that each dosage group is tried thing is equivalent to 5,10,30 times of people's recommended amounts (45mg/kg.bw) respectively.28 days observation cycles; Get the preceding fasting of blood 12 hours at every turn.
1.4 key instrument and reagent
Scale, 722 grating spectrophotometers, Shanghai the 3rd analytical tool factory produces.
Main agents and assay method:
During adopting, the mensuration of serum total cholesterol (TC), triglyceride (TG) gives birth to the enzyme reagent kit that high-tech bio-engineering corporation produces, colorimetric determination under the 500nm wavelength.
During adopting, the mensuration of HDL-C (HDL-C) gives birth to the enzyme reagent kit that high-tech bio-engineering corporation produces, through the colorimetric determination under the 500nm wavelength of phosphorus ursolic acid-magnesium (PTA-MG2+) post precipitation.
After recording light absorption value, respectively according to the concentration of T-CHOL (TC), triglyceride (TG), HDL-C (HDL-C) in the following formula calculation sample:
(in the formula: 2-is an extension rate)
1.5 experimental technique:
After 5 days, fasting is weighed with normal feedstuff feed rat, gets tail blood, enzymatic assays serum total cholesterol (TC), triglyceride (TG), HDL-C (HDL-C).According to body weight, TC level animal is divided into 4 groups at random: matched group, 3 are subjected to examination group (225mg/kg.bw; 450mg/kg.bw; 1350mg/kg.bw).Begin from formal test, each treated animal is used high lipid food instead, is tried thing and is assigned to desired concn with vegetable oil.Tried thing to irritate the stomach mode, matched group gives distilled water respectively.In the time of the 14th, 28 day, weigh respectively, get the every blood lipids index of tail hematometry.
1.6 experimental data statistics: carry out statistical analysis with SPSS software.
2 results
2.1 tried the influence of thing to rat body weight
Respectively organize body weight (g, the M ± SD) of rat in experiment initial stage, mid-term, latter stage
| Group | Number of animals (only) | Dosage (mg/kg.bw) | The initial stage body weight | Mid-term body weight | Latter stage body weight |
| Dosage group high dose group in the matched group low dose group | 12 12 12 12 | 0 225 450 1350 | 204.2±28.4 192.6±12.5 195.6±12.7 196.4±14.2 | 261.8±15.4 271.2±15.7 264.8±21.8 260.6±22.0 | 320.2±32.9 332.5±19.2 334.5±28.8 325.2±24.7 |
It is normal that whole experimental session is respectively organized the rat growth.Each experimental group rat body weight and control rats body weight zero difference (P＞0.05).
2.2 tried the influence of thing to serum total cholesterol (TC) concentration
Respectively organize serum TC concentration (mmol/L, M ± SD) in experiment initial stage, mid-term, latter stage
| Group | Number of animals (only) | The experiment initial stage | Test mid-term | Test latter stage |
| Dosage group high dose group in the matched group low dose group | 12 12 12 12 | 1.95±0.21 1.95±0.22 1.96±0.22 1.92±0.21 | 2.28±0.30 2.12±0.28 2.04±0.30 2.03±0.29 * | 2.47±0.34 2.19±0.26 * 2.17±0.31 * 2.16±0.34 * |
*Compare P＜0.05 with matched group
Compare with matched group latter stage in experiment, basic, normal, high each dosage group rat blood serum T-CHOL (TC) concentration significantly reduces (P＜0.05).
2.3 tried the influence of thing to rat blood serum triglyceride (TG) concentration
Respectively organize serum TC concentration (mmol/L, M ± SD) in experiment initial stage, mid-term, latter stage
| Group | Number of animals (only) | The experiment initial stage | Test mid-term | Test latter stage |
| Dosage group high dose group in the matched group low dose group | 12 12 12 12 | 1.58±0.25 1.57±0.20 1.60±0.23 1.53±0.19 | 1.73±0.21 1.59±0.23 1.56±0.22 1.56±0.18 | 1.95±0.35 1.74±0.24 1.71±0.22 * 1.70±0.28 * |
Compare with matched group:
*P＜0.05
Serum triglycerides (TG) level of middle and high dosage group rat is compared remarkable reduction with matched group, and the difference (P＜0.05) on the statistics is arranged.
2.4 tried the influence of thing to rat blood serum HDL-C (HDL-C) concentration
Respectively organize Serum HDL-C concentration (mmol/L, M ± SD) in test initial stage, mid-term, latter stage
| Group | Number of animals (only) | The experiment initial stage | Test mid-term | Test latter stage |
| Dosage group high dose group in the matched group low dose group | 12 12 12 12 | 1.17±0.17 1.21±0.23 1.18±0.26 1.27±0.31 | 1.02±0.12 1.02±0.12 0.98±0.11 0.97±0.17 | 0.95±0.17 0.90±0.17 0.85±0.11 0.84±0.12 |
Each experimental group rat blood serum HDL-C (HDL-C) concentration is compared the difference (P＞0.05) on the no statistics with matched group.
2.5 tried the influence of thing to rat blood serum HDL-C/T-CHOL (HDL-C/TC) ratio
Respectively organize Serum HDL-C/TC ratio (M ± SD) in experiment initial stage, mid-term, latter stage
| Group | Number of animals | The experiment initial stage | Test mid-term | Test latter stage |
| Dosage group high dose group in the matched group low dose group | 12 12 12 12 | 0.60±0.08 0.62±0.09 0.61±0.15 0.67±0.18 | 0.45±0.08 0.49±0.07 0.49±0.09 0.49±0.10 | 0.39±0.09 0.42±0.08 0.40±0.05 0.40±0.07 |
HDL-C/T-CHOL (HDL-C/TC) ratio has reflected the ratio of cardiovascular " the protection factor " HDL-C in TC, the HDL-C/TC ratio there was no significant difference (P＞0.05) of each group.
2.6 tried the influence of thing to the rat fat level
Tried the influence of thing to the rat fat level
| Group | TC (％) | TG (％) | HDL-C (％) |
| Low dose group | -11.3 | -10.8 | -5.3 |
| Middle dosage group | -12.1 | -12.3 | -10.5 |
| High dose group | -12.6 | -12.8 | -11.6 |
With 225,450, the medicament capsule of the present invention of 1350mg/kg.bw dosage irritates stomach, after the 28th day, serum TC is respectively 11.3,12.1,12.6 than matched group decline percentage rate; With 225,450, the medicament capsule of the present invention of 1350mg/kg.bw dosage irritates stomach, serum TG is than matched group decline percentage rate respectively 10.8,12.3,12.8.
3. conclusion
This experimental result shows, compares with the control rats of the high lipid food of feeding, and gives being tried thing and can making rat blood serum T-CHOL (TC) concentration significantly descend (P＜0.05) of basic, normal, high dosage; In giving and being tried thing rat blood serum triglyceride (TG) concentration is significantly descended of high dose (P＜0.05).According to the criterion in " the health food function assessment assessment process and the method for inspection ", can think that this sample survey has the blood lipid regulation effect.
The specific embodiment
Below in conjunction with embodiment embodiments of the present invention are described, but these embodiment and unrestricted embodiments of the present invention.The present invention has multiple different embodiment, has more than to be limited to content described in this description.Those skilled in the art is under the present application mental condition, the scheme Ying Zaiben that is finished
In the scope of invention.
Embodiment 1
A. Semen Vitis viniferae is removed impurity, is cleaned, and oven dry is pulverized, and with 70% ethanol extraction three times, each used ethanol weight is respectively 3 times, 2 times and 2 times of Semen Vitis viniferae weight when temperature is 80 ℃, and extraction time is 1 hour at every turn;
B. merge extractive liquid, filters, and gets filtrate, reclaims ethanol in the time of 80 ℃, and it is 1.12 that debris is evaporated to relative density, and adding volume in the gained concentrated solution is its deionized water of 4 times, removes by filter insoluble matter;
C. get supernatant, regulating pH value with hydrochloric acid is 3.5, and precipitation separation is got filtrate;
D. adding volume in gained filtrate is its 95% ethanol of 6 times, places 20 hours, filters, and adds deionized water, and being concentrated into does not have the ethanol taste, 200 order net filtrations;
E. with gained filtrate spray drying, the spray dryer inlet temperature is that 170 ℃, outlet temperature are 90 ℃, and moisture is lower than 5%, and the gained material is the extract of Semen Vitis viniferae;
F. the gained Semen Vitis viniferae extract is carried out behind the irradiation sterilization standby;
G. take by weighing Monas cuspurpureus Went 2590g, chitosan 1727g and Semen Vitis viniferae extract 183g,, incapsulate by 450mg/ grain standard with its mix homogeneously, altogether 10000 capsules.
Embodiment 2
A. Semen Vitis viniferae is removed impurity, is cleaned, and oven dry is pulverized, and is 83 ℃ in temperature, 68% ethanol extraction three times, and each used ethanol weight is respectively 4 times, 3 times and 2 times of Semen Vitis viniferae weight, and each extraction time is 1.5 hours;
B. merge extractive liquid, filters, and gets filtrate, reclaims ethanol in the time of 83 ℃, and it is 1.12 that debris is evaporated to relative density, and adding volume in the gained concentrated solution is its deionized water of 5 times, removes by filter insoluble matter;
C. get supernatant, regulating pH value with hydrochloric acid is 4, and precipitation separation is got filtrate;
D. adding volume in gained filtrate is its 95% ethanol of 5 times, places 14 hours, filters, and adds deionized water, and being concentrated into does not have the ethanol taste, 200 order net filtrations;
E. with gained filtrate spray drying, the spray dryer inlet temperature is that 170 ℃, outlet temperature are 90 ℃, and moisture is lower than 5%, and the gained material is the extract of Semen Vitis viniferae, and is standby;
F. take by weighing Monas cuspurpureus Went 2200g, chitosan 1900g and above-mentioned Semen Vitis viniferae extract 200g, use the conventional method of this area to make tablet by the standard of drug powder 450mg/ sheet.
Embodiment 3
A. Semen Vitis viniferae is removed impurity, is cleaned, and oven dry is pulverized, and with 73% ethanol extraction three times, each used ethanol weight is respectively 3,2 times and 2 times of Semen Vitis viniferae weight when temperature is 79 ℃, and extraction time is 0.5 hour at every turn;
B. merge extractive liquid, filters, and gets filtrate, reclaims ethanol in the time of 79 ℃, and it is 1.12 that debris is evaporated to relative density, and adding volume in the gained concentrated solution is its deionized water of 3 times, removes by filter insoluble matter;
C. get supernatant, regulating pH value with hydrochloric acid is 4.5, and precipitation separation is got filtrate;
D. adding volume in gained filtrate is its 95% ethanol of 7 times, places 16 hours, filters, and adds deionized water, and being concentrated into does not have the ethanol taste, 200 order net filtrations;
E. with gained filtrate spray drying, the spray dryer inlet temperature is that 170 ℃, outlet temperature are 90 ℃, and moisture is lower than 5%, and the gained material is the extract of Semen Vitis viniferae;
F. the gained Semen Vitis viniferae extract is carried out behind the irradiation sterilization standby;
G. take by weighing Monas cuspurpureus Went 2600g, chitosan 1700g and above-mentioned Semen Vitis viniferae extract 170g,, use the conventional method of this area to make pill by the standard of drug powder 450mg/ sheet with its mix homogeneously.
Claims (10)
1, a kind of health medicine compositions of blood lipid regulation, it is characterized in that, this health medicine compositions is made up of following components by weight ratio: Monas cuspurpureus Went 2000-3000 part, chitosan 1500-2000 part, extract 150-200 part of Semen Vitis viniferae, the extract of described Semen Vitis viniferae is the extract of following Semen Vitis viniferae: a. Semen Vitis viniferae is removed impurity, is cleaned, oven dry, pulverize, use ethanol extraction three times; B. merge extractive liquid, filters, and gets filtrate, reclaims ethanol, and it is 1.12 that debris is evaporated to relative density, adds deionized water in the gained concentrated solution, removes by filter insoluble matter; C. get supernatant, regulating pH value with hydrochloric acid is 3-5, and precipitation separation is got filtrate; D. add ethanol in gained filtrate, placed 12-24 hour, filter, add deionized water, being concentrated into does not have the ethanol abnormal smells from the patient, 150-250 order, preferred 200 order net filtrations; E. with gained filtrate spray drying, the spray dryer inlet temperature is that 170 ℃, outlet temperature are 90 ℃, and moisture is lower than 5%, and the gained material is the extract of Semen Vitis viniferae.
2, health medicine compositions as claimed in claim 1 is characterized in that, this health medicine compositions is made up of following components by weight ratio: Monas cuspurpureus Went 2300-2700 part, chitosan 1650-1800 part, extract 170-190 part of Semen Vitis viniferae.
3, health medicine compositions as claimed in claim 1 is characterized in that, this health medicine compositions is made up of following components by weight ratio: 2590 parts in Monas cuspurpureus Went, 1727 parts of chitosans, 183 parts of the extracts of Semen Vitis viniferae.
4, health medicine compositions as claimed in claim 1 is characterized in that, this health medicine combination dosage form is conventional peroral dosage form.
5, health medicine compositions as claimed in claim 4 is characterized in that, this health medicine combination dosage form is a capsule.
6, a kind of health medicine method for compositions for preparing blood lipid regulation as claimed in claim 1 is characterized in that this method may further comprise the steps:
A. Semen Vitis viniferae is removed impurity, is cleaned, and oven dry is pulverized, and uses ethanol extraction three times;
B. merge extractive liquid, filters, and gets filtrate, reclaims ethanol, and it is 1.12 that debris is evaporated to relative density, adds deionized water in the gained concentrated solution, removes by filter insoluble matter;
C. get supernatant, regulating pH value with hydrochloric acid is 3-5, and precipitation separation is got filtrate;
D. add ethanol in gained filtrate, placed 12-24 hour, filter, add deionized water, being concentrated into does not have the ethanol abnormal smells from the patient, 200 order net filtrations;
E. with gained filtrate spray drying, the spray dryer inlet temperature is that 170 ℃, outlet temperature are 90 ℃, and moisture is lower than 5%, and the gained material is the extract of Semen Vitis viniferae, and is standby;
F. according to weight proportion, take by weighing Monas cuspurpureus Went 2000-3000 part, chitosan 1500-2000 part and above-mentioned Semen Vitis viniferae extract 150-200 part,, use the conventional method of this area to make conventional peroral dosage form its mix homogeneously.
7, the health medicine method for compositions of preparation blood lipid regulation as claimed in claim 6 is characterized in that, among the step a, and the described ethanol extraction of using, its temperature is 79-85 ℃; Among the step b, described recovery ethanol, its temperature is 80 ℃, described deionized water volume is concentrated solution volume 2-6 times; Among the step c, described pH value is 3.5; In the steps d, described ethanol volume is filtrate volume 5-7 times.
8, the health medicine method for compositions of preparation blood lipid regulation as claimed in claim 6 is characterized in that, in step e, Semen Vitis viniferae extract can be carried out behind the irradiation sterilization standby.
9, the health medicine method for compositions of preparation blood lipid regulation as claimed in claim 6 is characterized in that, after the step f, the gained medicine can be carried out irradiation sterilization.
10, the application of the health medicine compositions of blood lipid regulation as claimed in claim 1 in the medicine of preparation treatment blood lipid regulation.
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