CN108926595A

CN108926595A - A kind of health care product with protection liver and hypolipemic function

Info

Publication number: CN108926595A
Application number: CN201810842137.XA
Authority: CN
Inventors: 李金星; 刘莉
Original assignee: Step Yuantang Biotechnology Co Ltd
Current assignee: Step Yuantang Biotechnology Co Ltd
Priority date: 2018-07-27
Filing date: 2018-07-27
Publication date: 2018-12-04

Abstract

The invention discloses a kind of health care product with protection liver and hypolipemic function, the raw material of following weight: kudzu root extract 100g is contained in 400g health care product；Notogineng Extract 56g；Ginkgo biloba p.e 54g；Herb Gynostemmae Pentaphylli extract 45g；Ganodenna Lucidum P.E 40g；Microcrystalline cellulose 101 g；Magnesium stearate 4g；It is to be mixed, softwood processed, granulation, drying, whole grain, total mix, be prepared after tabletting by following raw material.It is health food made of primary raw material that the present invention, which is kudzu root extract, Notogineng Extract, ginkgo biloba p.e, Herb Gynostemmae Pentaphylli extract, Ganodenna Lucidum P.E, microcrystalline cellulose, magnesium stearate,；Prove that there is the healthcare function for having assistant protection function to chemical damage through animal experiment；Prove that there is the healthcare function of auxiliary reducing blood lipid through animal experiment and human feeding trial.

Description

A kind of health care product with protection liver and hypolipemic function

Technical field

The present invention relates to a kind of health care products, and in particular to a kind of health care product with protection liver and hypolipemic function belongs to In field of health care products.

Background technique

With social development and the aging of world population and drinking problem is serious is widely present, the abuse of drug, So that chemical damage has become a kind of common disease, frequently-occurring disease, the health of the people is seriously affected.So-called chemically liver damage Wound, is the hepatic injury as caused by chemically Hepatoxic substance, these chemical substances include alcohol, the chemical toxicant in environment and Its some drugs.The liver of important removing toxic substances organ as human body has arteria hepatica and vena hepatica double blood supply, chemicals Matter can enter liver by gastrointestinal tract portal vein or body circulation and be converted, therefore liver is easy by the toxic substance in chemicals Matter damage.There are some pairs of virose substances of liver in the Nature and human industry's production process, referred to as " hepatotropic poison ", These poisonous substances are universal susceptible in crowd, and incubation period is short, and the process of lesion and the dosage of infection are directly related, can cause liver not With the necrosis of liver cells of degree, fat deformation, cirrhosis and liver cancer.

Long-term alcohol be also to the damage of liver it is very serious, ethyl alcohol enter into the human body, 60-80% is in liver by oxygen Change, oxidative pathway has two: one is ADH oxidation of ethanol system；Intracorporal ethyl alcohol be ingested by the alcohol dehydrogenase in liver cell Catalysis, dehydrogenation generate acetaldehyde, and for acetaldehyde by acetaldehyde-dehydrogenase enzymatic, dehydrogenation generates acetic acid, and the rear acetyl coenzyme A that formed enters tricarboxylic acids Circulation ultimately produces carbon dioxide and water, discharges ATP.The second is the microsomal oxidation of alcohol induced liver cell smooth surfaced endoplasmic reticulum System (MEOS) participates in oxidation of ethanol, and ethyl alcohol is oxidized the process for generating acetaldehyde acetic acid in vivo, and a large amount of NAD are reduced into NADH causes NADH/NAD ratio to increase, and disposable a large amount of intake ethyl alcohol can cause depot fat by the effect of catecholamine It mobilizes, and simultaneously with the generation of hyperlipemia.

Hyperlipidemia is the Major Risk Factors for causing human atherosclerosis's property disease, easily causes cerebral apoplexy, coronary disease Disease, myocardial infarction, sudden death etc..For hyperlipidemia, Chinese medicine thinks that diet, feelings will, work and rest etc. are unbalance and causes function between body internal organs Energy disorder, human internal environment's whole machine balancing are destroyed, and qi and blood biochemistry operation function obstacle, it is its generation that blood quality, which changes, Basic reason.Pathological change is related with the heart, liver,spleen,kidney, gas, blood, and the pathogenic characteristic of hyperlipemia is with deficiency of spleen and stomach, liver Spleen is not adjusted at all, and wetness hyperactivity, phlegm, the stasis of blood are marked for it.

Understanding of the Chinese medicine to dyslipidemia: dyslipidemia is made a kind of or several in blood plasma since lipid-metabolism operates exception Kind lipid is higher than normal metabolic disease, shows as the mixed type that high cholesterol card, hypertriglyceridemia card or both have concurrently Dyslipidemia.The main reason for being atherosclerosis, cardiovascular and cerebrovascular disease and pathogenesis of fatty liver.Western medicine thinks lipid in blood Not exist in slurry with free state, the biggish lipoprotein complexes of solubility will be formed in conjunction with protein to be followed in blood It is operated in ring.The raising of high-density lipoprotein (HDL) level may advantageously facilitate peripheral tissues and remove cholesterol, to prevent artery Atherosis occurs, it is considered to be the anti arteriosclerosis factor.It for some reason generates lipid excessive, or because of its degradation, or turns Obstacle occurs for fortune, or when because of hereditary metabolic deficiency, the content or quality for different plasma lipoprotein of classifying will change, and lead Disorders of lipid metabolism is caused, the blood lipid time is lengthened, just forms hyperlipemia.

Hyperlipidemia, usually as caused by following factor: 1. excessively nourishing, for example eat excessive high protein, high-fat, high Calorie foodstuffs；2. the whirl of society is more, undesirable living habit, such as long-term alcohol；3. lacking movement；4. thought is off one's guard, Especially young man is swamped with and but lacks the consciousness of physical examination；And these reasons also result in huge burden to liver, hold very much Easily cause the damage of liver；As it can be seen that liver contacts with hyperlipidemia there are huge.Liver is the important metabolic organ of body and machine Body Chinese medicine barrier organ, removing toxic substances and phagocytic function have important protective effect for body, still, China's liver diseases disease incidence Height, influences wide, endangers people's health and national economy serious.Therefore for chemical damage have assistant protection function and The health-product market demand of auxiliary lipid-lowering function is huge.

Currently, in the market to assist reducing blood lipid and have the Double-function health care product product of assistant protection function to chemical damage Kind is various.Wherein, western medicine result is significant, but the pairs such as hepatorenal damage caused by long-term administration, rhabdomyolysis, drug withdrawal knock-on Effect is still the problem of this disease treatment.And the toxic side effect of Chinese medicine treatment is small, but existing market, which is the absence of, has auxiliary drop Blood fat function, while can reduce to hepar damnification, to the traditional Chinese medicine health care product of its auxiliary protection function of chemical damage.

Summary of the invention

The technical problem to be solved by the present invention is to be directed to the deficiencies in the prior art, and provide a kind of with protection The health care product (being named as step source hall board fat eliminating liver-protecting tablet) of liver and hypolipemic function, using the refrigerant lower fire of pueraria lobata, whetting the appetite, Liver-protecting and blood fat-reducing and Radix Notoginseng taste micro-sweet and hardship, quite like the taste of ginseng, and bright, negative blood system of fainting the medicine of sun, therefore all blood disease can be controlled；Ginkgo Leaf invigorating heart astringing lung-QI, dampness elimination antidiarrheal；There is strengthening by means of tonics, brain tonic to pacify for gynostemma pentaphylla strengthening spleen, tonifying kidney, preventing phlegm from forming and stopping coughing, clearing heat and detoxicating and ganoderma lucidum The characteristics of mind, strengthening the essence gas, the above five tastes reach protection liver jointly, have assistant protection function and auxiliary to chemical damage The dual function of reducing blood lipid.

To achieve the goals above, the present invention adopts the following technical scheme:

It is a kind of with protection liver and hypolipemic function health care product, be mixed by the raw material of following weight, softwood processed, It is prepared after granulation, drying, whole grain, total mix, tabletting；Contain the raw material of following weight in 400g health care product: pueraria lobata extracts Object 100g；Notogineng Extract 56g；Ginkgo biloba p.e 54g；Herb Gynostemmae Pentaphylli extract 45g；Ganodenna Lucidum P.E 40g；Microcrystalline cellulose 101g；Magnesium stearate 4g.

In above-mentioned technical proposal, the kudzu root extract, Notogineng Extract, ginkgo biloba p.e, Herb Gynostemmae Pentaphylli extract, Ganodenna Lucidum P.E, microcrystalline cellulose and magnesium stearate are product that is commercially available, existing, meeting respectively inspection specification.

In above-mentioned technical proposal, the preparation method of the health care product, comprising the following steps:

(1) mix: will examine qualified kudzu root extract, Notogineng Extract, ginkgo biloba p.e, Herb Gynostemmae Pentaphylli extract, Ganodenna Lucidum P.E, microcrystalline cellulose cross 80 meshes respectively, carry out being mixed to get mixing after then weighing respectively according to the ratio Powder；

(2) softwood processed: the mixed powder that step (1) obtains is uniformly mixed with ethyl alcohol, it is spare to obtain softwood；

(3) it pelletizes: the softwood that step (2) obtains is prepared into wet granular with 16 meshes；It is spare to obtain wet granular；

(4) dry: the wet granular that step (3) obtains to be dried, moisture controls within 5.0%, obtains dry particl It is spare；

(5) whole grain: the dry particl that step (4) obtains is crossed into 18 meshes and carries out whole grain, obtained particle is spare；

(6) total mix: the magnesium stearate of particle and the ratio that step (5) obtains is mixed, obtained total mix Grain is spare；

(7) tabletting: the total mix particle that step (6) obtains is placed in tabletting in tablet press machine, piece amount is 0.4g/ piece, stringent to control Tablet weight variation processed is made within ± 5%, tablet is health care product.In being polished to tablet, being carried out again after fastidious relic, sliver It can be sold after packaging, outer packing, inspection and storage.

(8) inner packing: using oral stable medicinal polythene bottle with high density for inner packaging material, is wrapped inside dress, and 180 Piece/bottle；

(9) outer packing: labelling, vanning；

(10) it examines, be put in storage: testing according to the method and requirement of enterprise-quality standard, qualified warehousing finished products.

Preferably, in step (1), incorporation time 30min, stirring rate when mixing is 40 revs/min.

Preferably, in step (2), ethyl alcohol is the ethyl alcohol that mass concentration is 95%.

Preferably, in step (4), dry temperature is 50-60 DEG C, and moisture controls within 5.0%.

Preferably, in step (6), incorporation time 20min, stirring rate when mixing is 40 revs/min.

Illustrate: present invention production ethyl alcohol used meets GB10343 edible alcohol；It is multiple to take orally medicinal high-density polyethylene bottle Close YBB00122002；All supplementary materials meet company standard prescribed requirement, and production process strictly presses that " health food is well given birth to Produce specification " it executes.The step of production (1)-step (8) is completed in 300,000 clean areas, and product matter can be preferably controlled Amount, all indexs such as product microorganism of production meet company standard (formulating according to GB16740-1997) and require.

Health care product of the invention, sexual element Puerarin 2.4g, total saposins 3.5g containing mark in every 100g；It is oral, daily 2 Secondary, 3 tablets once (children, pregnant woman and wet nurse avoid use).

Pueraria lobata in the present invention, micro-pungent sweet in flavor, gas faint scent is cool in nature, and master enters taste warp, there is relieving muscles diaphoresis, invigorating vital function and promoting eruption, solution The effect of heat is promoted the production of body fluid.Puerarin is the active material extracted from the root of Chinese medicament kudzu-vine root, has coronary artery dilator, is depressured the anti-heart The effects of myocardial ischemia improves microcirculation, adjusts blood lipid metabolism；Puerarin with to chemical damage have assistant protection function And auxiliary lipid-lowering function.

Notogineng Extract in the present invention, warm-natured, sweet in flavor, slight bitter；Enter liver, stomach meridian；Energy activating microcirculation and removing stasis medicinal, disappears at rich in nutrition Swollen analgesic.Radix Notoginseng can stop blooding becomes silted up without staying, and has the effect of dissipating stasis and stanching bleeding, can treat caused by stagnation of blood stasis, traumatic injury Pain, and can be used for various haemorrhages.Notoginseng total saponin not only has strengthening by means of tonics, resist oxygen lack, anti-aging, fatigue-resisting function, Also there is hemostasis, analgesia, anti-inflammatory, inhibit platelet aggregation；Especially can coronary dilatation arteries and veins, increase the resistance to of myocardial blood supply and anoxic By property, and has the function of reducing blood lipid simultaneously, expands blood vessel.Become the ideal medicine of prevention and cure of cardiovascular disease and health care for the middle and old aged Object.In addition, Notogineng Extract also has raising immune function, liver-protective effect, notoginseng total saponin has protection liver cell Effect, hepatodynia a variety of for hepatitis, liver fibrosis and cirrhosis etc. all have having a better effect.Therefore Notogineng Extract has protection Liver has assistant protection function to chemical damage and assists the double action of reducing blood lipid.

Ginkgo biloba p.e in the present invention, it is mild-natured, sweet in flavor, bitter, puckery, there is activating microcirculation and removing stasis medicinal, inducing meastruation to relieve menalgia, astringing lung-QI to put down Breathe heavily, change turbid lipid-loweringing and other effects, it is used for obstruction of collaterals by blood stasis, chest impediment and cardialgia, hemiplegia, deficiency syndrome of the lung cough and asthma and hyperlipemia.Furthermore ginkgo Leaf extract also has the function of the ability removed free radical or free radical is inhibited to be formed, and has anti-liver injury and liver-protective Effect.Therefore ginkgo biloba p.e has protection liver, has assistant protection function to chemical damage and assists reducing blood lipid Double action.

Herb Gynostemmae Pentaphylli extract in the present invention, main component are gypenoside, polysaccharide and flavonoids, gynostemma pentaphyllum total soap Glycosides can inhibit hepatomicrosome spontaneous and lipid peroxidation caused by a variety of radical generating systems, and energy antagonism is by lipid Membrane fluidity caused by peroxidating reduces, and has the function of protecting liver cell；Also there is reducing blood lipid, Adjust-blood lipid, drop enzyme protect liver, subtract Light fatty liver promotes the pharmacological actions such as liver cell regeneration, antitumor, hypoglycemic, anti-aging.Therefore Herb Gynostemmae Pentaphylli extract has protection Liver has assistant protection function to chemical damage and assists the double action of reducing blood lipid.

Ganodenna Lucidum P.E of the invention has protect liver, anti-oxidant and remove a variety of effects such as free radical, to a variety of physical and chemical and Hepatic injury caused by biological factor has protective effect；No matter before liver damage occurs or after occurring, Ganodenna Lucidum P.E is all Have the function of protecting liver, mitigate hepatic injury, anti peroxidation of lipid.It adjusts blood lipid in addition, Ganodenna Lucidum P.E also has, reduce Blood lipid, regulating lipid metabolism and the effect for enhancing anti peroxidation of lipid.Therefore Ganodenna Lucidum P.E has protection liver, to chemically liver Damage the double action that there is assistant protection function and assist reducing blood lipid.

The present invention uses ethyl alcohol for wetting agent.50% ethyl alcohol, softwood easily agglomerate, are not easy that particle is made；75% ethyl alcohol, Softwood holding is agglomerating, and light pressure dissipates, and dry particl feel is harder；And 95% ethyl alcohol, softwood is held agglomerating, and light pressure dissipates, and does Grain can be at coarse fine powder with hand twirl；Therefore the present invention using 95% ethyl alcohol as wetting agent.

The present invention is using microcrystalline cellulose as filler.Microcrystalline cellulose is the hydrolysate of native cellulose, and property is stablized, It is not chemically reacted with primary raw material；It is uniformly tiny as filler for particle can be made loosely in tablet, in conjunction with Performance is good；Tablet can be made to expand rapidly and be disintegrated after absorbing water simultaneously, therefore it also serves as disintegrating agent.Therefore the present invention selects crystallite fine Dimension element.

The present invention selects magnesium stearate as lubricant.Magnesium stearate is generally 0.1%-1% as the dosage of lubricant, The mobility of material often indicates that angle of repose is smaller with angle of repose, shows that the mobility of powder is better, it is considered that angle of repose≤ 10 °, mobility can meet production needs.Present invention applicant has investigated 1% magnesium stearate particles of addition using angle of repose as index Mobility, by taking embodiment 1 as an example, when the dosage of magnesium stearate be 1% or so when, angle of repose≤10 °, mobility can meet life It produces and needs.

When the present invention is prepared into tablet, incorporation time 30min；Mixing is one of basic program of preparation process, mesh Be guarantee each component content uniformly, homogeneity it is consistent with appearance luster.Present invention applicant has investigated (15 points of incorporation time Clock, 30 minutes and 45 minutes) influence to the uniformity of mixed powder, by taking embodiment 1 as an example, when incorporation time is 15 minutes, When mixing unevenly, and mixing 30 minutes, 45 minutes, mixing is all relatively uniform, it is contemplated that production effect and cost, preferably Mix 30min；And the mixed powder after 30min is mixed, the significant ingredient total saposins of mixed powder different parts and containing for Puerarin Amount one is consistent, therefore provable mixed powder is uniformly mixed.

Tablet is made in the present invention, and technique is simpler, while transporting, store and carrying, using all more convenient, this is exactly piece One of feature of protrusion of agent, and the dimensionally stable of product, dosage is accurate, machinery production yield is big, at low cost and price just Preferably, it is easy to the advantages that being received by consumer.

As shown in the above, the present invention is mentioned by kudzu root extract, Notogineng Extract, ginkgo biloba p.e, gynostemma pentaphylla Taking object, Ganodenna Lucidum P.E, microcrystalline cellulose, magnesium stearate is health food made of primary raw material；Prove have through animal experiment There is the healthcare function for having assistant protection function to chemical damage；Proved through animal experiment and human feeding trial, have pair The healthcare function of chemical damage defencive function and auxiliary reducing blood lipid.

Detailed description of the invention

Fig. 1 is the process flow chart of health care product preparation method of the present invention；

Wherein:Represent 300,000 clean areas, that is to say, that the dashed rectangle in bright book attached drawing represents 300,000 cleanings Area.

The effect of Fig. 2 is examining report six composition detection result (figure contains page 2).

Fig. 3 is the Hygienic determination result of examining report seven (figure contains page 2).

Fig. 4 is that stablizing for examining report eight learns testing result (figure contains page 5).

Fig. 5 is the results of animal for having assistant protection function to chemical damage (figure contains page 1).

Fig. 6 is the results of animal with auxiliary lipid-lowering function (figure contains page 1).

Fig. 7 is human experiment experimental result (figure contains page 1).

Specific embodiment

The specific embodiment of technical solution of the present invention is described in detail below, but the present invention is not limited in being described below Hold:

In the present invention, microcrystalline cellulose, magnesium stearate meet " Chinese name republic pharmacopeia " two 2010 editions " crystallite fibres Dimension element ", magnesium stearate " provide under item；The quality of kudzu root extract, Notogineng Extract, ginkgo biloba p.e, Herb Gynostemmae Pentaphylli extract 1-5 is shown in Table with the quality requirement of Ganodenna Lucidum P.E:

Table 1: the quality requirement of kudzu root extract

Table 2: the quality requirement of Notogineng Extract

Table 3: the quality requirement of ginkgo biloba p.e

Table 4: the quality requirement of Herb Gynostemmae Pentaphylli extract

Table 5: the quality requirement of Ganodenna Lucidum P.E

In following embodiment of the present invention, the main production equipments title and model used are shown in Table 6:

Table 6: main production equipments title and model

Title	Model	Equipment manufacturer
			Oscillating granulator	YK-160	Changzhou KeYu drying equipment Co., Ltd
Tablet press machine	ZP31D	Shanghai Tian He pharmaceutical machine Co., Ltd
			Highly effective drying case	GZ-2000	Shanghai Tian He pharmaceutical machine Co., Ltd

In following embodiment of the invention, Notogineng Extract, Ganodenna Lucidum P.E, Herb Gynostemmae Pentaphylli extract, kudzu root extract, silver Apricot leaf extract, purchase are in careless plant Trade Co., Ltd. of Xuancheng City hundred；Microcrystalline cellulose purchase is medicinal auxiliary in the Anhui mountains and rivers Expect limited liability company.

The present invention is specifically illustrated below with reference to specific embodiment:

Embodiment 1:

A kind of health care product (being named as step source hall board fat eliminating liver-protecting tablet) with protection liver and hypolipemic function, 400g is protected Contain the raw material of following weight: kudzu root extract 100g in strong product；Notogineng Extract 56g；Ginkgo biloba p.e 54g；Gynostemma pentaphylla Extract 45g；Ganodenna Lucidum P.E 40g；Microcrystalline cellulose 101 g；Magnesium stearate 4g；It is to be prepared by following methods:

(1) mix: will examine qualified kudzu root extract, Notogineng Extract, ginkgo biloba p.e, Herb Gynostemmae Pentaphylli extract, Ganodenna Lucidum P.E, microcrystalline cellulose cross 80 meshes respectively, carry out being mixed to get mixing after then weighing respectively according to the ratio Powder；Incorporation time is 30min, and stirring rate when mixing is 40 revs/min；

(2) softwood processed: the mixed powder that step (1) obtains is uniformly mixed with the ethyl alcohol that mass concentration is 95%, is obtained soft Material is spare；

(4) dry: the wet granular that step (3) obtains to be dried, dry temperature is 50-60 DEG C, and moisture control exists Within 5.0%, it is spare to obtain dry particl；

(6) total mix: the magnesium stearate of particle and the ratio that step (5) obtains is mixed, obtained total mix Grain is spare；Incorporation time is 20min, and stirring rate when mixing is 40 revs/min；

(7) tabletting: being placed in tabletting in tablet press machine for the total mix particle that step (6) obtains, and amounts to 1000, and piece amount is 0.4g/ piece, for strict control tablet weight variation within ± 5%, tablet is health care product.Tablet is polished, select it is residual It can be sold after dress, outer packing, inspection and storage is wrapped inside after piece, sliver again.

(9) outer packing: labelling, vanning；

In the present invention, Puerarin is twisted with having assistant protection function and auxiliary lipid-lowering function to chemical damage Stock is blue, saponin content is abundant in Radix Notoginseng, and have there is assistant protection function and auxiliary to drop blood chemical damage in human body The physiological activity of rouge, therefore by Puerarin and total saposins witness marker ingredient, 2.4g containing Puerarin, total saposins in every 100g 3.5g is detailed in examining report six.

It is red thin that acute toxicity test, Salmonella reversion test, the thermophilic polychromatophilia of marrow have been carried out to the health care product that the embodiment of the present invention 1 obtains The test such as born of the same parents' micronucleus test, sperm malformation test, 30d feeding trial, while having carried out functional component, hygiene, having stablized etc. Detection, has also carried out the animal experiment for having assistant protection function to chemical damage, the animal with auxiliary lipid-lowering function Test and auxiliary lipid-lowering function human feeding trial, concrete outcome are as follows:

Examining report one: acute toxicity test in mice

The health care product that the embodiment of the present invention 1 obtains is sent to Shandong Center for Disease Control & Prevention and is detected, acute poison Property test method, result it is as follows:

1 material and method

1.1 samples: being provided by Shanxi Bu Quan Biotechnology Co., Ltd, is brown color tablet, is protected at shady and cool ventilation drying It deposits.Human body recommended amounts are 2.4g/ people days, and adult weight is based on 60kg.Sample grind into powder is as tested material for experiment.

1.2 experimental animals: SPF grades of ICR mouse, totally 20, half male and half female, 18~22g of weight, by Beijing, dimension tonneau China is real The offer of zoo technical Co., Ltd, production licence number: SCXK (capital) 2012-0001 are provided.Feeding environment is barrier grade, using perhaps It can the number of card: SYXK (Shandong) 2008-0005,20~24 DEG C of room temperature, relative humidity 45~65%.Experimental animal standard feed is Beijing Magnificent Fukang biotech inc provides, production licence number: SCXK (capital) 2009-0008.

The selection of 1.3 dosage gives mode with tested material: 10.0g tested material weighed, 20ml is assigned to distilled water, it is final concentration of 0.5g/ml, experimental animal is given in stomach-filling in two times, is spaced 4h, and each stomach-filling amount is 0.2ml/10g.bw, accumulates poisoning dosage For 20.0g/kg.bw.

1.4 key instruments and reagent: electronic balance

1.5 test methods: it tests and carries out according to maximal tolerance dose (MTD) method.Animal empty stomach 16h is spare (unlimited before testing System drinking-water).After tested material is given in animal weighing, stomach-filling, the poisoning manifestations and death condition of animal are recorded, 14d is observed continuously.

1.6 test datas statistics: the weight of animals mean value and standard deviation, the death rate etc. are calculated.

1.7 result judgements: mouse oral acute toxicity MTD is acquired according to the test of MTD method, and determines tested material toxicity point Grade.

2 results: after tested material is given in stomach-filling, each experimental animal has no obvious poisoning symptom, in 14d animal without it is dead (see Table 1).Test result shows that the tested material is all larger than 20.0g/kg.bw to the MTD of two kinds of gender mouse.According to acute toxicity point Grade standard, the sample belong to nontoxic grade.

1. Mouse Acute Toxicity experimental result of table

3 brief summaries: mtd test is the results show that the tested material is all larger than 20.0g/ to the MTD of two kinds of gender mouse kg.bw.According to acute toxicity grading criteria, which belongs to nontoxic grade.

Examining report two: Salmonella reversion test

The health care product that the embodiment of the present invention 1 obtains is sent to Shandong Center for Disease Control & Prevention and is detected, Ames examination Method, the result tested are as follows:

1 material section and method

1.2 experimental animal test strains: for identified satisfactory salmonella typhimurium histidine deficient TA97, TA98, TA100, TA102, activation system are the S-9 mixed liquor of rat liver homogenate (S-9) preparation of Polychlorinated biphenyls induction.

1.3 dosage selection with tested material give mode: take tested material, respectively with distilled water, dimethyl sulfoxide (DMSO), 95% ethyl alcohol, acetone as solvent, by comparing, tested material solute effect in distilled water is best, therefore distillation is chosen in testing Water as solvent.According to toxicity test as a result, 8,40,200,1000,5,000 5 dosage of μ g/ ware are set up in test, while setting up certainly Send back to change group, solvent control group and positive controls.Tested material 5.00g is weighed, is placed in volumetric flask, to distill water as solvent, It is settled to 100ml, is handled with steam disinfecting apparatus 0.068Mpa, 20min, is taken out after cooling and places 4 DEG C of preservations, concentration 50000 μ g/ml takes distilled water successively to carry out 1: 4 dilution, show that concentration is respectively 10000,2000,400,80 μ g/ml.Every ware is added 0.1ml, tested material concentration are respectively equivalent to 5000,1000,200,40,8 μ g/ wares.Positive substance used in positive controls is enemy gram Pine, 2- aminofluorene, methyl methylsulfonate, 1,8- dihydroxy anthraquinone (being shown in Table 2), solvent for use is DMSO.

1.4 key instruments and reagent: Baker SG603AINT Biohazard Safety Equipment, BINDER KBW240 constant incubator, Julabo TW20 water bath with thermostatic control, HIRAYAMA HVE-50 steam pressure sterilizer, IUL Countermat flash are full-automatic Colonometer, YDS-50 liquid nitrogen container, electronic balance.Positive substance is 2- aminofluorene (Sigma-Aldich company), methane sulfonic acid Methyl esters (NERCK-Schuchand company), 1,8- dihydroxy anthraquinone (ACROS ORGANICS company), fenaminosulf (Chem Service company).

1.5 test methods: test according to plate incorporation methods adding S-9 to carry out under conditions of S-9 mixed liquor is not added, each Group sets 3 plates.Zengjing Granule melts top layer culture medium and is sub-packed in sterile cuvette.The top layer kept the temperature in 45 DEG C of water-baths In culture medium 2ml, the fresh enrichment liquid 0.1ml of test strain is sequentially added, (S-9 mixed liquor is added in tested material 0.1ml when activation 0.5ml), it mixes, is poured into rapidly on bottom culture medium, rotation plate is evenly distributed on top layer culture medium on bottom, lays flat solid Change, 37 DEG C of culture 48h observe result.Separately do positive control, solvent control and untreated control.The whole series test is under the same conditions It carries out twice.

1.6 test datas statistics: clump count mean value, the standard deviation in 3 plates are calculated.

1.7 result judgements: if returning for tested material becomes clump count as the 2 times or more of spontaneous backcrossing clump count, and there is dosage- Reaction relation is then determined as the positive.

2 results: by table 2-1, table 2-2 as it can be seen that each dosage group of tested material time change clump count is less than certainly in test twice 2 times for becoming clump count are sent back to, also without dose-response relationship, illustrate that the sample is to salmonella typhimurium when adding and S-9 being not added TA 97, TA 98, TA 100, the not shown genetoxic of 102 4 plants of test strains of TA.

Table 2-1 Salmonella reversion test result (first time)

Table 2-2 Salmonella reversion test result (for the second time)

Note: (1) fenaminosulf, 50 μ g/ ware (2) 2- aminofluorenes, 10 μ g/ wares

(3) methyl methylsulfonate, 0.5 μ l/ ware (4) 1,8- dihydroxy anthraquinone, 50 μ g/ wares

3 brief summaries: illustrate that the sample is to salmonella typhimurium TA 97, TA 98, TA 100, TA when adding and S-9 being not added The not shown genetoxic of 102 4 plants of test strains.

Examining report three: mice bone marrow micronucleus

The health care product that the embodiment of the present invention 1 obtains is sent to Shandong Center for Disease Control & Prevention and is detected, Mouse Bone Method, the result of marrow polychromatic erythrocyte micronucleus test are as follows:

1 material and method

1.2 experimental animals: SPF grades of ICR mouse, totally 50, half male and half female, 25~30g of weight, by Beijing China Fukang biology Science and Technology Co., Ltd. provides, production licence number: SCXK (capital) 2009-0004.Feeding environment is barrier grade, uses license Card number: SYXK (Shandong) 2008-0005,20~24 DEG C of room temperature, relative humidity 45~65%.Experimental animal standard feed is Beijing China Fukang biotech inc provides, production licence number: SCXK (capital) 2009-0008.

The selection of 1.3 dosage gives mode with tested material: mouse is randomly divided into 5 groups, and every group 10, half male and half female.Experiment is set 3 experimental groups are found, poisoning dosage is respectively 2.5,5.0,10.0g/kg.bw, separately sets distilled water negative control group and cyclophosphamide Positive controls (40mg/kg.bw).2.5,5.0,10.0g tested material are weighed respectively, and 20ml, final concentration point are assigned to distilled water Not Wei 0.125,0.25,0.50g/ml, stomach-filling gives experimental animal.Stomach-filling amount is 0.2ml/10g.bw, and altogether twice, interval is for 24 hours.

1.4 key instruments and reagent: electronic balance, OLYMPUS CX21 biomicroscope, calf serum (Hangzhou Chinese holly Biological engineering material Co., Ltd), methanol (analysis is pure), Giemsa dye liquor (SIGMA company), cyclophosphamide (the permanent auspicious doctor in Jiangsu Medicine joint stock company limited, 12021725).

1.5 test methods: 6h puts to death animal after last gives tested material, separates breastbone.Marrow is taken, through smear, fixation, dye The routine film-making such as color.1000 polychromatic erythrocytes (PCE) of every animal microscopy record micronucleus cell number, calculate micronuclear rates (i.e. Micronucleus cell number/polychromatic erythrocyte number, is indicated with permillage).200 PCE are observed simultaneously, and it is thin to count just incarnadining of observing Born of the same parents (NCE) number, and calculate PCE/NCE ratio.

1.6 test datas statistics: it is distributed according to Poisson for statistical analysis.

1.7 result judgements: compared with the control group, test result micronuclear rates experimental group has apparent dose-response to test group Relationship, and it is statistically significant when, be determined as positive findings.

2 results: seen from table 3, buck negative control group PCE/NCE ratio be 1.26, experimental group ratio between Between 1.24~1.32；Jenny negative control group PCE/NCE ratio be 1.31, experimental group ratio between 1.22~1.35 it Between.Each two gender mouse ratio of dosage group of tested material is not less than the 20% of negative control group, illustrates that tested material is not thin to marrow Born of the same parents generate cytotoxic effect.There was no significant difference compared with negative control group (P > 0.05) for each dosage group micronuclear rates of tested material, And cyclophosphamide positive controls have extremely significant sex differernce (P < 0.01) compared with negative control group, illustrate that the sample is small without causing The effect of mouse Micronucleus.

3 mice bone marrow micronucleus result of table

Note:^**P < 0.01 (compared with negative control group)

3 brief summaries: illustrate the sample without cause mouse bone marrow polychromatic erythrocytes micronucleus effect.

Examining report four: mouse inbred strain

The health care product that the embodiment of the present invention 1 obtains is sent to Shandong Center for Disease Control & Prevention and is detected, mouse essence Method, the result of sub- acute experiment are as follows:

1 material and method

1.2 experimental animals: SPF grades of ICR mouse, totally 25, male, 25~30g of weight, by Beijing China Fukang biotechnology Limited liability company provides, production licence number: SCXK (capital) 2009-0004.Feeding environment is barrier grade, uses licensing Number: SYXK (Shandong) 2008-0005,20~24 DEG C of room temperature, relative humidity 45~65%.Experimental animal standard feed is Beijing China Fukang biotech inc provides, production licence number: SCXK (capital) 2009-0008.

The selection of 1.3 dosage gives mode with tested material: mouse is randomly divided into 5 groups, every group 5.3 experiments are set up in experiment Group, poisoning dosage are respectively 2.5,5.0,10.0g/kg.bw, separately set distilled water negative control group and cyclophosphamide positive controls (40mg/kg.bw).2.5,5.0,10.0g tested material are weighed respectively, and 20ml is assigned to distilled water, final concentration is respectively 0.125, 0.25, experimental animal is given in 0.50g/ml, stomach-filling.Stomach-filling amount be 0.2ml/10g.bw, continuous 5d,

1.4 key instruments and reagent: electronic balance, OLYMPUS CX21 biomicroscope, methanol (analysis is pure), Yihong dye Liquid, cyclophosphamide (Hengrui Medicine Co., Ltd., Jiangsu Prov., 12021725).

1.5 test methods: 35d puts to death animal, conventional film-making after the few stomach-filling of head.It is complete that every animal counts 1000 structures Whole sperm records distortion type and quantity, calculates rate of teratosperm (expressed as a percentage).

1.6 test datas statistics: according to X²It examines for statistical analysis.

2 results: by table 4-1, table 4-2 as it can be seen that each dosage group mouse sperm deformity rate of tested material compared with negative control group First significant difference (P > 0.05), and cyclophosphamide positive controls have extremely significant sex differernce (P < compared with negative control group 0.01), illustrate the sample without cause mouse sperm deformity effect.

Table 4-1 mouse inbred strain result (one)

Note:^**P < 0.01 (compared with negative control group).

Table 4-2 mouse inbred strain result (two)

3 brief summaries: illustrate the sample without cause mouse sperm deformity effect.

Examining report five: rat 30d feeding trial

The health care product that the embodiment of the present invention 1 obtains is sent to Shandong Center for Disease Control & Prevention and is detected, rat 30 Method, the result of its feeding trial are as follows:

1 material and method

1.2 experimental animals: SPF grades of SD rats, totally 80, half male and half female, 61~86g of weight, by Beijing China Fukang biology Science and Technology Co., Ltd. provides, production licence number: SCXK (capital) 2009-0004.Feeding environment is barrier grade, uses license Card number: SYXK (Shandong) 2008-0005,20~24 DEG C of room temperature, relative humidity 45~65%.Experimental animal standard feed is Beijing China Fukang biotech inc provides, production licence number: SCXK (capital) 2009-0008.

The selection of 1.3 dosage gives mode with tested material: rat 80, it is randomly divided into 4 groups, every group 20, and half male and half female.Root Set up 3 experimental groups according to human body recommended amounts, poisoning dosage is respectively 1.0,2.0,4.0g/kg.bw (is respectively equivalent to human body to push away The 25 of the amount of recommending, 50,100 times).Tested material is calculated in food intake dose incorporation feed according to the 10% of the weight of animals, i.e., 1.0%, 2.0%, 4.0% (mass fraction) is fed with experimental animal.Control group gives basal feed.Single cage is fed, free diet, Continuously now examine 30d.

1.4 key instruments and reagent: ABBOTT CD3700 cellanalyzer, 7180 full-automatic biochemical of HITACHI point Analyzer, Heraeus Multifuge 3plus centrifuge, pathology equipment (LEICA ASP200S fully-automatic dewatering machine, EG1150 Embedding machine, RM2245 slicer, Sakura Tissue-Tek Prisma, Tissue-Tek Glasg2 tissue staining mounting one Body machine), electronic balance, OLYMPUS CX21 biomicroscope etc..

1.5 test methods: general performance, behavior, poisoning manifestations and the death of animal clinical examination: are observed and recorded daily Situation.Claim a weight and 2 food intake doses weekly, calculate weekly with total food utilization rate.

Test latter stage fasting 16h, weigh the weight of animals (for calculate liver,spleen,kidney, testis, etc. organ coefficients use) after, warp Abdominal aortic blood carries out blood biochemical and hematology measurement, dissects animal and draw materials.

Hematology measurement uses K₂EDTA- anticoagulation, index include hemoglobin, red blood cell count(RBC), total white blood cells and Its classification etc..Blood biochemical analysis measurement uses serum, and testing index includes glutamic-pyruvic transaminase, glutamic-oxalacetic transaminease, urea nitrogen, flesh Acid anhydride, cholesterol, triglycerides, blood glucose, total protein and albumin, and calculate albumin, globulin ratio etc..

Gross examination is carried out to all animals and internal organs at the end of experiment, weighs the organ weights such as liver,spleen,kidney, testis, root According to the weight of animals after organ weights and fasting, its organ coefficient is calculated.By internal organs such as liver,spleen,kidney, stomach, intestines, testis, ovaries It is fixed to save, carry out histopathological examination.

1.6 test datas statistics: measurement data carries out mean, standard deviation using Microsoft Excel and SPSS software Calculating and variance analysis (or rank sum test), data are with mean ± standard deviationForm indicates.Data variance Qi Shicai With variance analysis, F value is calculated.Conclusion no significant difference between each group mean when F value < F0.05；F value >=F0.05, i.e. P≤ 0.05, it is counted with the comparative approach two-by-two of mean between multiple experimental groups and control group.To the number of abnormal or heterogeneity of variance According to variable conversion appropriate is carried out, counted after meeting normal state or variance and requiring together.If after variable conversion still not up to just State or the neat purpose of variance, use rank sum test instead and are counted.Enumeration data uses X²It examines.

1.7 result judgements: by clinical examination, growth and development situation, hematology, blood biochemistry, gross anatomy, organ weights and Dirty body ratio, connection statistical result carry out comprehensive analysis, tentatively judge toxic action feature, degree, target organ, cause to have according to a preliminary estimate The dosage and target organ of evil effect, obtain NOAEL.

2 results:

The general performance of 2.1 animals: in order, weight increases each test group of animals overall growth by week in the test period It is long, have no poisoning sign and death.

2.2 weight, food utilization measurement result: by table 5, table 6, table 7, table 8 and table 9 as it can be seen that each experimental group body weekly That there are no significant compared with the control group is poor for weight, food-intake, food utilization and weight gain, total food-intake, total food utilization rate Different (P > 0.05), and in this laboratory range of normal value.

5 30d of table feeds the influence to rat body weight

6 30d of table feeds the influence to rat food-intake weekly

7 30d of table feeds the influence increased weight weekly to rat body weight

8 30d of table feeds the influence to rat food utilization weekly

Note: * P < 0.05 (compared with the control group)

9 30d of table feeds the influence to rat total food utilization rate

2.3 hematology measurement results: by table 10 and table 11 as it can be seen that male experimental animal low dose group red blood cell count(RBC), low, High dose group monocyte percentage；There is conspicuousness compared with the control group in jenny middle dose group basicyte percentage Difference (P < 0.05 or P < 0.01), but still in this laboratory range of normal value.Remaining each each hematological indices of experimental group with Difference (P > 0.05) that control group compares that there are no significant, and its value is in this laboratory range of normal value.

10 rat 30d feeding trial latter stage hematological examination result of table

Note:^**P < 0.01 (compared with the control group).

11 30d of table feeds the influence to rat leukocyte

Note:^*P < 0.05,^**P < 0.01 (compared with the control group).

2.4 blood biochemical analysis measurement results: by table 12-1 and table 12-2 as it can be seen that buck high dose group creatinine and female Animal low dose group blood glucose statistically exists significant difference (P < 0.05 or P < 0.01) compared with the control group, but its Value is not considered as that there are biological significances still in this laboratory range of normal value.Remaining each each index of test group of animals blood biochemistry Difference that there are no significant compared with the control group (P > 0.05), and its value is in this laboratory range of normal value.

Table 12-1 rat 30d feeding trial latter stage blood biochemical result

Wang:^**P < 0.01 (compared with the control group).

Table 12-2 rat 30d feeding trial latter stage blood biochemical result

Note:^*P < 0.05 (compared with the control group).

2.5 pathological anatomy

2.5.1 gross anatomy: carrying out gross examination to all animals at the end of experiment, liver size is normal, color is fresh, Surface is smooth, soft, clear-cut margin, without tubercle mass etc..Two sides kidney and adrenal gland are taken out, is directed at the hilus renalis for kidney with maximum Section is splitted, and exposure renal plevis checks that cortex and the thickness of medullary substance, color are normal, distinct.It has no bleeding of gastrointestinal mucosa, burst Ulcer thickens, the lesions such as lymph foilicie hyperplasia.It is clear and legible to observe spleen section malpighian corpuscle.Testis/ovarian morphology, normal in size. In the liver of each test group of animals, kidney, stomach, intestines, spleen and ovary/testis tissue, show no obvious abnormalities.

2.5.2 organ coefficient measurement result: by table 13, table 14 as it can be seen that the weight and internal organs of the internal organs such as liver,spleen,kidney, testis Coefficient there are no significant compared with the control group difference (P > 0.05).

13 rat 30d of table feeds organ weights

14 rat 30d of table feeds dirty body and compares result

2.5.3 histopathological examination result: take high dose group and control group is female, liver,spleen,kidney of tom, stomach, intestines, The internal organs such as testis, ovary carry out histopathological examination.

2.5.3.1 liver normal configuration understands, lobuli hepatis marshalling, it is seen that regular radial arrangement hepatic cell cords, just Normal blood sinus, central vein, portal area.Liver cell is in polygon, and endochylema is slight, and acidophilia colours, nucleolus, central position.It is right Slight pathological change (the results are shown in Table 15-1) can be observed according to group and high dose group minority animal.

(1) that liver dotted in lobuli hepatis can be observed in 1/10 sample of male control group 1/10 and female control group is thin Born of the same parents' necrosis region: single or several necrosiss of liver cells, cytoplasm pyknosis, dense dye or nuclear fragmentation, dissolution disappear, eucaryotic cell structure It destroys even not multiple visible.

(2) visible in male control group 1/10 and 1/10 female high dose group 1/10, control group sample lobuli hepatis Dotted cell infiltration stove.

Table 15-1 pathology of hepar inspection result

2.5.3.2 kidney normal configuration understands.Cortex, medullary substance boundary clear, the nephron are uniformly distributed in cortex, and kidney is small The thin glomus of chaeta, capsula glomeruli semilune lacuna are high-visible.Renal tubule proximal convoluted tubule is coated simple columnar epithelium, core circle, base Bottom position, iuntercellular boundary are unclear.Concetrated pipe endochylema is transparent, core circle, central position, and cell boundary is clear.Mucous membrane of renal pelvis is coating to be migrated Epithelium.Slight pathological change (the results are shown in Table 15-2) can be observed in control group and high dose group minority animal.

(1) visible glomerular capillary ball is swollen in 1/10 sample of male high dose group 1/10 and female control group Swollen, blister cavities narrows or even capillary ball and blister cavities adhesion.

(2) tamm-Horsfall protein cast, the intracavitary red dye of cast homogeneous can be observed in 1/10 sample of male control group.

It (3) can in male high dose group 1/10 and 1/10 female high dose group 1/10, control group sample renal interstitial Observe dotted inflammatory cell infiltration stove.

Table 15-2 renal histopathology inspection result

2.5.3.3 stomach glandular stomach part mucous epithelium is stratified squamous epithelium, and there is angling on surface, and tunica propria is thin, muscular layer of mucosa Prosperity, submucosa are loose connective tissue, are rich in blood vessel.Glandular stomach galandular epithelium is simple columnar epithelium, thin by chief cell, wall Born of the same parents, mucilage cell form, and have a large amount of compact arranged bodies of gland in tunica propria, there is a small amount of connective tissue between body of gland, muscle layer is flourishing.It is right Pathological change (the results are shown in Table 15-3) is not observed according to group and high dose group animal.

Table 15-3 gastric tissue pathological examination result

2.5.3.4 small intestine can clearly recognize mucous membrane, submucosa, muscle layer, placenta percreta.Mucomembranous surface is digitation Villus, coated with simple columnar epithelium, a large amount of enteraden of distribution in mucous membrane.Control group and high dose group animal do not observe that pathology changes Become (the results are shown in Table 15-4).

Table 15-4 small intestine pathological examination result

2.3.5.3.5 the girder that the visible envelope connective tissue of spleen and smooth muscle deeply essentially form, lumps white pulp, and Wide red pulp.White pulp centrum germinativum is clear, one layer of lymphoblast band of surrounding.Control group and high dose group animal are not observed To pathological change (the results are shown in Table 15-5).

Table 15-5 spleen histopathological examination result

2.3.5.3.6 testis outermost layer is the tunica albuginea of dense connective tissue composition, is below a large amount of convoluted seminiferous tubules, by Outer and interior visible each phase cell: sperm mother cell, spermatogonium, spermatoblast and sperm.It can be seen that form is irregular, boundary is unclear Sertoli cell.Control group and high dose group animal do not observe pathological change (the results are shown in Table 15-6).

Table 15-6 testis tissue pathological examination result

2.3.5.3.7 ovary is made of cortex and medullary substance.The ovarian follicle of visible different developmental phases in the cortex of envelope lower section, That is primordial follicle, primary follicle, secondary follicle and graaffian follicle are also shown corpus luteum, lean type etc..Control group and high dose group animal Pathological change (the results are shown in Table 15-7) is not observed.

Table 15-7 ovary tissue pathological examination result

In conclusion having no bright in the liver of each test group of animals of gross examination of skeletal muscle, kidney, stomach, intestines spleen and ovary/testis tissue It is aobvious abnormal.In histological examination, there are pathological change, but these pathological changes in the sample of control group and high dose group minority animal Lesser extent and without distribution of specific between group, considers related with animal quality, compared with the control group, is not considered as that experimental group has The pathological change of meaning.

2.3.6 rat 30d feeding trial brief summary: each test group of animals growth and development is good within experimental period, weight gain, The indices such as food utilization, organ weights and organ coefficient are in this laboratory range of normal value.Experimental group blood routine And each index of blood biochemistry is in this laboratory range of normal value.Histopathologic examination's experimental group is detected internal organs and has no significant Pathological change.

Examining report six: functional component examining report

The health care product that the embodiment of the present invention 1 obtains is sent to Shandong Center for Disease Control & Prevention and is detected, main function It is as shown in Figure 2 to imitate composition detection result:

Examining report seven: Hygienic determination report

The health care product that the embodiment of the present invention 1 obtains is sent to Shandong Center for Disease Control & Prevention and is detected, hygiene Testing result is as shown in Figure 3:

Examining report eight: stablize and learn examining report

The health care product that the embodiment of the present invention 1 obtains is sent to Shandong Center for Disease Control & Prevention and is detected, stablizes and learns Testing result is as shown in Figure 4:

Zoopery one: there is the animal experiment of assistant protection function to chemical damage

The health care product that the embodiment of the present invention 1 obtains is sent to Shandong Center for Disease Control & Prevention, is carried out to chemically liver Damage has the zoopery of assistant protection function, and animal experiment method is as described below, and results of animal is as shown in Figure 5:

1 material and method

1.1 samples: being provided by Shanxi Bu Quan Biotechnology Co., Ltd, is brown color tablet, and human body recommended dose is 2.4g/ people days (adult weight is in terms of 60kg).

1.2 experimental animals:

Select Beijing HFK Bio-Technology Co., Ltd. (production licence number: SCXK (capital) 2009-0004) numerous The SPF grade ICR male mice grown, 18.0~22.0g of weight, are randomly divided into 5 groups by totally 60, respectively sample low dose group, in Dosage group, high dose group, blank control group, model control group.

Experimental situation: barrier environment, experimental animal are SYXK (Shandong) 2008-0005 using credit number.Room temperature 20~22 DEG C, relative humidity 45~65%.

Feed: for Beijing HFK Bio-Technology Co., Ltd.'s experimental animal standard feed, production licence number is SCXK (capital) 2009-0008.

The selection of 1.3 dosage gives mode with tested material:

Sample human body recommended amounts are 2.4g/60kg.bw, and experiment sets three dosage groups, it may be assumed that 0.20g/kg.bw group, The dosage of 0.40g/kg.bw group, 1.20g/kg.bw group, basic, normal, high three groups is respectively equivalent to the 5 of human body recommended intake Again, 10 times, 30 times.Blank control group and model control group are set up simultaneously.Needed for being assigned to sample respectively using distilled water as solvent Concentration, that is, take 0.40g (low), 0.80g (in), 2.40g (height) sample with distilled water be assigned to 40ml, blank control group and mould respectively Type control group stomach-filling distilled water starts to measure indices after daily 0.2ml/10g.bw continuously oral stomach-filling 30d.

1.4 key instruments and reagent:

SPECTRAMAX plus microplate reader, CPA2202S type electronic balance, PL203 type electronic balance, 2000GenoGrinderTM high-flux tissue grinder, centrifuge, eddy blending machine, SW shaking bath slot, Leica CM1800 Freezing microtome, surgical instrument, glacial acetic acid (analysis is pure).

Malonaldehyde (MDA) kit: Bioengineering Research Institute, lot number 20130610 are built up in Nanjing.

Reduced glutathione (GSH) kit: Bioengineering Research Institute, lot number 20130610 are built up in Nanjing.

Triglycerides (TG) kit (GPO-PAD method): the safe clinical reagent company of Beijing Northization, lot number are 20130112。

1.5 test methods:

It tests 30d and gives model group and each dosage group of sample to 50% ethyl alcohol (by nothing by stomach-filling of 12ml/kg.bw Water-ethanol is diluted with distilled water), blank control group gives distilled water.Fasting overnight put to death animal after 16 hours, and liver is taken to weigh, Calculate liver coefficient.MDA, GSH, TG assay in hepatic tissue are carried out again, and make histopathologic examination.

1.5.1 Indexs measure: taking liver that 1% homogenate is made, and measures MDA, GSH and TG content using RNA isolation kit.

1.5.2 histopathologic examination: taking mouse liver lobus sinister, from left lobe of liver in the middle part of do cross section materials, frozen section, Oil red 0 dyes.When microscopy, from the pathological change of one end visual field start recording cell of liver, it is observed continuously with 40 times of object lens whole A histotomy.Main detection fat drips are in the distribution of liver, range and area.

Standards of grading:

1.6 test datas statistics: establishing database with Excel software, for statistical analysis with SPSS software.Using variance Analysis, first carries out homogeneity test of variance, and variance is neat, calculates F value, F value < F_0.05, p > 0.05, conclusion: difference between each group mean Without significant；F value >=F_0.05, P≤0.05, with the comparative approach two-by-two of mean between multiple experimental groups and a control group (Dunnett method of inspection) is for statistical analysis；Variable conversion appropriate is carried out to the data of abnormal or heterogeneity of variance, wait meet After normal state or homogeneity of variance require, counted with the data after conversion；If being still not up to normal state after variable conversion or variance being neat Purpose, use rank sum test instead and counted.

1.7 result judgements:

There is assistant protection function (alcoholic hepatic injury model) to chemical damage: 1. tri- liver MDA, GSH, TG indexs As a result positive, it can determine whether that the given the test agent has auxiliary protection function to hepatic injury caused by ethyl alcohol, 2. liver MDA, GSH, TG tri- Appoint binomial index positive in item index, and hepatic pathology result is positive, can determine whether the given the test agent to hepatic injury caused by ethyl alcohol There is auxiliary protection function.

2 results:

Influence of 2.1 samples to mouse weight

Influence of 1 sample of table to mouse weight

Note: P value is compared with blank control group.

Seen from table 1, weight and weight gain value and blank control before the modeling of model control group and each experimental mice Difference (P > 0.05) that group compares that there are no significant.

The testing result of indices in 2.2 liver homogenates

2.2.1 in liver homogenate lipid peroxide catabolite MDA measurement result:

The measurement result of MDA in 2 liver homogenate of table

Note: P₁Value: compared with blank control group；P₂Value: compared with model control group；

As can be seen from Table 2, the MDA content of model control group is apparently higher than blank control group, statistically significant (the P < of difference 0.01), show that damage model is set up.The MDA content of low, middle and high dose groups is significantly lower than model control group, and there are extremely significant property Difference (P < 0.01).

GSH measurement result in 2.2 2 liver homogenates:

The measurement result of GSH in 3 liver homogenate of table

Seen from table 3, the GSH content of model control group is significantly lower than blank control group, statistically significant (the P < of difference 0.05), show that damage model is set up.Low, high dose group GSH content is apparently higher than model control group, and there are significant differences (P < 0.05).

2.2.3 in liver homogenate TG measurement result:

The measurement result of TG in 4 liver homogenate of table

By table 4 as it can be seen that the TG content of model control group is apparently higher than blank control group, there is extremely significant sex differernce (P < 0.01), show that damage model is set up.The obvious low submodel control group of the TG content of low, middle and high dose groups, it is poor that there are conspicuousnesses Different (P < 0.05 or P < 0.01).

2.3 pathological examination results:

2.3.1 to the influence of mouse liver weight, liver coefficient and pathological index

Influence of the table 5 to mouse liver weight, liver coefficient

By table 5 as it can be seen that the liver coefficient of model control group is apparently higher than blank control group, difference has extremely significant property (P < 0.01), show that damage model is set up.The organ coefficient of low dose group is significantly lower than model control group, and there are extremely significant sex differernces (P < 0.01).

Influence of the table 6 to mouse pathological index

By table 6 as it can be seen that the hepatic pathology scoring of model control group is apparently higher than blank control group, difference has extremely significant property (P < 0.01), show that damage model is set up, the hepatic pathology scoring of low dose group is significantly lower than model control group, and there are extremely significant Sex differernce (P < 0.01).

2.3.2 histological indications:

Blank control group normal configuration understands, lobuli hepatis marshalling, structural integrity, it is seen that regular radial arrangement liver is thin Born of the same parents' rope, normal blood sinus, central vein, portal area.Liver cell is in polygon, acidophilia coloring that endochylema is slight, nucleolus, in Position is entreated, cell is without denaturation, necrosis and cell infiltration.

There is diffusivity pathological change centered on central vein in model control group, and liver cell is disorganized, swelling and gas Ball sample becomes, it is seen that hepatic cell fattydegeneration distinct, round fat drips vacuole not of uniform size, rouge occurs in liver cell endochylema Fat lesion total score obviously increases.

For each dosage group compared with model control group, lobuli hepatis structure is more visible, and liver cell cloudy swelling, steatosis obviously subtract Gently.

3 brief summaries

The experimental results showed that the malonaldehyde (MDA) of model control group, triglycerides (TG) and the obvious liter of hepatic pathology scoring Height, glutathione (GSH) are substantially reduced, and are had significant difference (P < 0.05 or P < 0.01) compared with blank control group, are shown Liver injury model is set up.The MDA of low, middle and high dose groups is significantly lower than model control group, and difference has extremely significant property (P < 0.01)； Low, high dose group GSH content is apparently higher than model control group, and there are significant difference (P < 0.05)；Low, middle and high dose groups TG content be significantly lower than model control group, there are significant difference (P < 0.05 or P < 0.01)；The hepatopathy of low dose group Reason scoring is significantly lower than model control group, and there are extremely significant sex differernce (P < 0.01).According to " health food is examined and evaluation skill Art specification " criterion, which has auxiliary protection function to chemical damage.

Zoopery two: the animal experiment with auxiliary lipid-lowering function

The health care product that the embodiment of the present invention 1 obtains is sent to Shandong Center for Disease Control & Prevention, carries out that there is auxiliary drop The animal experiment of blood fat function, experimental method is as follows, and experimental result is as shown in Figure 6:

1 material and method

1.1 samples: for brown color tablet, human body recommended amounts are 2.4g/ people days, and adult weight is based on 60kg.

1.2 experimental animals:

It is provided by Beijing Vital River Experimental Animals Technology Co., Ltd., SPF grades healthy SD male rat 40, weight 150~180g.Production licence number is SCXK (capital) 2012-0001.Barrier environment is SYXK (Shandong) using credit number 2008-0005,20~24 DEG C of room temperature, relative humidity 45~65%.Experimental animal standard feed is by Beijing China Fukang biotechnology Limited liability company provides, production licence number: SCXK (capital) 2009-0008.

High lipid food: basal feed 78.8%, cholesterol 1%, lard 10%, yolk powder 10%, cholate 0.2%.

The selection of 1.3 dosage gives mode with tested material:

Experiment sets three dosage groups, it may be assumed that 0.2g/kg.bw, 0.4g/kg.bw, 1.2g/kg.bw are respectively equivalent to human body and push away 5 times, 10 times, 30 times for recommending intake.Sample is assigned to required concentration respectively by solvent of distilled water, that is, weigh 0.8g, 1.6g, 4.8g sample is assigned to 40ml with distilled water respectively, and to sample, the distilled water of same volume, stomach-filling amount are given in model control group stomach-filling for stomach-filling It is 1mL/100g.bw, once a day, continuous 30 days, and weigh in weekly, it is each to adopt tail hematometry for fasting at the end of experiment Item blood lipid refers to border.

1.4 key instruments and reagent:

PL2002 type electronic balance, HITACHI7180 automatic clinical chemistry analyzer, serum total cholesterol determination kit, Triglyceride determination kit, high-density lipoprotein cholesterol assay kit

1.5 test methods:

After being observed 11 days with basal feed feeding rat, tail blood is taken, is measured serum total cholesterol (TC), triglycerides (TG), animal is randomly divided into 4 groups according to TC level by high-density lipoprotein cholesterol (HDL-C): control group high in fat, 3 it is tested Object group (0.2g/kg.bw, 0.4g/kg.bw, 1.2g/kg.bw) is respectively equivalent to 5 times, 10 times, 30 times of human body recommended amounts), Since formal test, groups of animals uses high lipid food instead.Tested material is assigned to required concentration with distilled water respectively, stomach-filling to sample, The distilled water of same volume is given in control group stomach-filling high in fat, and stomach-filling amount is 1mL/100g.bw, once a day, continuous gavage 30 days Afterwards, tail hematometry items blood lipids index is taken

1.6 test datas statistics:

Database is established with Excel software, it is for statistical analysis with SPSS software, first carry out homogeneity test of variance, variance Variance analysis is used when neat, calculates F value, F value < F_0.05, P > 0.05, conclusion: no significant difference between each group mean；F Value >=F_0.05, P≤0.05, with the comparative approach two-by-two (Dunnett method of inspection) of mean between multiple experimental groups and a control group It is for statistical analysis；Variable conversion appropriate, normal state or homogeneity of variance to be met are carried out to the data of abnormal or heterogeneity of variance After it is required that, counted with the data after conversion；If being still not up to normal state or the neat purpose of variance after variable conversion, sum of ranks is used instead Inspection is counted.

1.7 result judgements:

1.7.1 blood-fat-decreasing functional result determine: in serum total cholesterol, triglycerides, high-density lipoprotein gallbladder Serum total cholesterol and triglycerides binomial index are positive in three Indexs measures of sterol, can determine that given the test agent auxiliary drop blood Rouge function results of animal is positive.

1.7.2 auxiliary reduces triglycerides result judgement: 1. two dosage group results of triglycerides are positive；2. triglycerides One dosage group result is positive, while the significantly high sub- control group of high-density lipoprotein cholesterol, can determine that the given the test agent assists It is positive to reduce triglycerides results of animal.

1.7.3 auxiliary reduces serum total cholesterol result judgement: 1. two dosage group results of serum total cholesterol are positive；② One dosage group result of serum total cholesterol is positive, while high-density lipoprotein cholesterol is significantly higher than control group, can determine that this It is positive that given the test agent auxiliary reduces serum total cholesterol results of animal.

2 results:

Influence of 2.1 samples to rat body weight

Influence of 1 sample of table to rat body weight

Seen from table 1, in the entire experiment process, groups of animals vegetative activity is normal, each dosage group animal of tested material Weight is compared with control group high in fat, and there was no significant difference (P > 0.05).

Influence of 2.2 samples to hyperlipemia rat blood lipid

Influence of 2 sample of table to hyperlipemia rat TC, TG, HDL-C

Note:^*The P < 0.05 compared with control group high in fat；^**The P < 0.01 compared with control group high in fat

As can be seen from Table 2, after giving high lipid food, after control group experiment high in fat compared with before experiment, the serum TC of rat, TG is significantly raised, shows that high blood lipid model is set up.Compared with control group high in fat, 0.4g/kg.bw group and 1.2g/kg.bw group Serum TC and the TG that High fat diet rats can be substantially reduced are horizontal (P < 0.05 or P < 0.01).

Influence of 2.2 samples to hyperlipemia rat blood lipid level

Influence of 3 sample of table to hyperlipemia rat blood lipid level

Seen from table 3, after giving high lipid food, compared with control group high in fat, the blood of sample low, middle and high dose groups rat Clear TC decline percentage is respectively 13.33%, 15.24%, 22.22%, serum TG decline percentage be respectively 21.62 %, 32.09%, 34.12%, Serum HDL-C rising respectively -0.02mmol/L, 0.02mmol/L, 0.04mmol/L.

3 brief summaries:

The results showed that the sample 30d of orally administration rat various dose, compared with control group high in fat, 0.4g/ Kg.bw group and 1.2g/kg.bw group can be substantially reduced the serum TC and TG level (P < 0.05 or P < 0.01) of High fat diet rats. According to " health food is examined and assessment technique specification " criterion, sample has auxiliary lipid-lowering function.

Clinical trial: auxiliary lipid-lowering function human feeding trial

The health care product that the embodiment of the present invention 1 obtains is sent to university of TCM of Shandong Province of Shandong Center for Disease Control & Prevention Second affiliated hospital carries out clinical trial, and test method is as follows, and human experiment experimental result is as shown in Figure 7:

1 materials and methods

1.1 samples walk source hall board fat eliminating liver-protecting tablet, are provided by Shanxi Bu Quan Biotechnology Co., Ltd, 0.4g/ piece * 180 Piece/bottle, human body recommended amounts are 2 times a day that 3 tablets once.

1.2 subjects selection

1.2.1 be included in standard: subject's male or female is simple dyslipidemia crowd, keeps normal diet.It is adopted in half a year Blood twice, twice serum total cholesterol (TC) >=5.2mmol/L or serum triglyceride (TG) >=1.65mmol/L, as standby Select object.Subject is the non-hyperlipemia being hospitalized.

1.2.2 exclusion criteria:

1.2.2.1 the age is in under-18s or over-65s person.

1.2.2.2 the gestational period or breast feeding women, to health food allergy sufferers.

1.2.2.3 merge intentionally, liver, the serious diseases patient such as kidney and hemopoietic system.

1.2.2.4 article related with tested function is taken in a short time, is influenced to result judgement person.

1.2.2.5 the standard of being included in is not met, not by edible given the test agent is provided, can not determining effect or data, umbra is not rung Effect or safe sex determination person.

1.3 packet design

Using itself between group two kinds of control designs.106 subjects are randomly divided into test-meal group and right by blood lipid level According to group, test-meal group 53, control group 53, grouping considers to influence the principal element such as age, gender etc. of result as far as possible, carries out Harmony is examined, with the comparativity between guarantee group.

1.4 test method

Test-meal group takes test-meal sample, and control group uses blank control, and instructions of taking is 2 times a day that 3 tablets once, continuously It takes 30-45 days, does not change original life and eating habit, normal diet during test.

1.5 test apparatuses and reagent

Automatic blood analyzer XT-1800i (Japanese Sysmex)；Full-automatic dirt analyzer 7600-110 (day It is vertical)；Urine Analyzer Uritest-500B (Guilin Uritest)；X-ray machine XR/D (U.S. GE)；Electrocardiograph ECG-1350P (day This photoelectricity)；B ultrasound diagnostic equipment PREIRUS (Er-Lang god, Hitachi).

Blood cell analysis dilution: Japanese Sysmex (lot number: G3182)；Urine test paper item: Uritest (lot number: G56130393)；Total protein kit: Beijing Li Deman (lot number: 305232E)；Albumin reagent box: Beijing Li Deman (batch Number: 304273D)；Glutamic-pyruvic transaminase kit: Japan and light (lot number: AP933)；Glutamic-oxalacetic transaminease kit: Japan and light (lot number: AP931)；Triglyceride reagent box: German Ou Taike (lot number: 935820)；Total cholesterol kit: German Ou Taike (lot number: 865273)；Creatinine reagent box: Sichuan is newly at (lot number: 0713041)；Blood sugar kit: Shanghai fine horse reality (lot number: 13100919)；Urea nitrogen kit: German Ou Taike (lot number: 865273)；Uric acid reagent box: German Ou Taike (lot number: 935820)。

2 observation index

2.1 ordinary circumstances observation: detailed medical history-taking, understand patient diet's situation, spirit, sleep, stool and urine, blood pressure, Heart rate etc..

2.2 safety observations:

2.2.1 blood urine just routine inspection: white blood cell count(WBC), red blood cell count(RBC), platelet count, hemoglobin, routine urinalysis, Stool routine examination.

2.2.2 Biochemical Indexes: seralbumin (ALB), total protein (TP), glutamic-pyruvic transaminase (ALT), millet straw turn ammonia Enzyme (AST), urea ammonia (Urea), creatinine (Cr), glucose (GLU).

2.2.3 abdominal B-scan ultrasonography, electrocardiogram, x-ray fluoroscopy of chest (are only done before on-test primary).

2.3 efficiency observations:

2.3.1 efficacy measures: serum total cholesterol (TC) is horizontal and to reduce percentage, triglycerides (TG) horizontal and reduce Percentage, high-density lipoprotein cholesterol (HDL-C) level and ascensional range.

2.3.2 effect criterion:

Effective: TC reduces > 10%；TG reduces > 15%；HDL-C rises > 0.104mmol/L.

It is invalid: not up to effective standard person.

Serum total cholesterol (TC) effective percentage is observed, triglycerides (TG) is efficient, high-density lipoprotein cholesterol (HDL- C) efficient and total effective rate.

3 statistical methods

It is for statistical analysis using SPSS17.0 statistical software, all own control data can use paired t-test, two groups Mean compares using independent samples t-test, and the latter need to carry out homogeneity test of variance, carries out to the data of Non-Gaussian Distribution or heterogeneity of variance Variable appropriate conversion, wait meet normal state variance it is neat after, t inspection is carried out to the data of conversion；If change data is not able to satisfy still Normal state variance requires together, uses t ' inspection or rank sum test instead；Variance is together but the data of the coefficient of variation too big (such as CV > 50%) is answered Use rank sum test.Efficient and total effective rate uses X²It examines.Four fold table total number of cases are less than 40 or total number of cases are equal to or more than 40 But when there is theoretical value equal to or less than 1, exact propability should be used instead.

4 result judgements

Compare serum total cholesterol (TC) after test-meal, triglycerides (TG), high-density lipoprotein cholesterol (HDL-C) variation Situation, itself compare before and after test-meal group test-meal and test-meal after test-meal group and control group comparison among groups, difference has conspicuousness, and reaches Effective criterion can determine that serum total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C) knot Fruit is positive.

Human feeding trial result judgement: 1. serum total cholesterol (TC), triglycerides (TG) binomial index are positive, highly dense Degree lipoprotein cholesterol (HDL-C) is not significantly lower than control group, can determine that the given the test agent has auxiliary lipid-lowering function effect； 2. an index positive in serum total cholesterol (TC), triglycerides (TG) binomial index, high-density lipoprotein cholesterol (HDL- C it) is not significantly lower than control group, can determine that there is auxiliary to reduce serum total cholesterol (TC) or auxiliary and reduce glycerol for the given the test agent The effect of three esters (TG).

5 results

The observation of 5.1 ordinary circumstances

5.1.1 case depigmentation rate explanation

Be included in 106 people of subject, test-meal group 53, control group 53, after test after, test-meal group has 1 subject It is screened out because lost to follow-up, control group has 1 subject to be screened out because lost to follow-up, and depigmentation rate is 1.9%.Finally actually active number of cases is 104, test-meal group 52, control group 52.

5.1.2 test-meal group is compared with control group harmony

104 subjects, test-meal group 52, control group 52.Test-meal group: male/female 19/33, the age be 52.37 ± 11.54 years old；Control group: male/female 23/29, age are 50.94 ± 10.43 years old.Test-meal group serum TC, TG, HDL-C before test-meal Compared with the control group, no significant difference (P > 0.05) prompts to be comparable between two groups for horizontal and age, gender.(see Table 1)

Table 1 is tested preceding two groups of serum TCs, TG, HDL-C level and age, gender harmony and is compared

5.1.3 test-meal group is compared with control group ordinary circumstance

Interrogation is carried out to spirit, sleep, diet situation before and after examination trencherman's test-meal, ordinary circumstance is good before and after two groups of test-meals, Spirit, sleep, diet situation are showed no obvious abnormalities.Blood pressure, heart rate are substantially at normal model before and after the test of two groups of subjects It encloses, and itself compares before and after test-meal, no significant difference (P > 0.05), show test-meal step source hall board fat eliminating liver-protecting tablet to human body Ordinary circumstance has no adverse effects.(being shown in Table 2)

The two groups of ordinary circumstances in the test of table 2 front and back compare

5.1.4 the comparison of test-meal front and back two groups of blood routines, routine urinalysis, stool routine examination

Leucocyte, red blood cell, hemoglobin, blood platelet are substantially in normal range (NR) before and after the test of two groups of subjects, And test front and back itself compares nothing and significantly changes (P > 0.05).Two groups of subjects test front and back routine urinalysis, stool routine examination is located substantially In in normal range (NR).(being shown in Table 3)

The comparison of two groups of blood routines, routine urinalysis, stool routine examination before and after 3 test-meal of table

5.1.5 the comparison of the two groups of blood biochemistry index in test-meal front and back

Total serum protein, albumin, glutamic-pyruvic transaminase, glutamic-oxalacetic transaminease, urea nitrogen, flesh before and after the test of two groups of subjects Acid anhydride, glucose are substantially in normal range (NR), and itself are compared nothing before and after testing and significantly changed (P > 0.05).(being shown in Table 4)

The comparison of two groups of blood biochemistry index before and after 4 test-meal of table

5.1.6 abdominal B-scan ultrasonography, electrocardiogram, x-ray fluoroscopy of chest detection: normal.

5.1.7 other adverse reactions are had no during test-meal.

5.2 functional observation

Test front and back serum TC, the horizontal situation of change of TG, HDL-C: compare before serum TC, TG and test-meal after test-meal group test-meal Compared with difference has conspicuousness (P < 0.05), and Serum HDL-C is compared with before test-meal after test-meal group test-meal, no significant difference (P > 0.05)；Compared with the control group, difference has conspicuousness (P < 0.05), test-meal group test-meal by serum TC, TG after test-meal group test-meal Afterwards Serum HDL-C compared with the control group, no significant difference (P > 0.05).(being shown in Table 5,6,7,8)

Two groups of serum total cholesterol variations before and after 5 test-meal of table

Note:^**The P < 0.05 compared with before test-meal:^##P < 0.05 compared with the control group.

Two groups of serum triglyceride variations before and after 6 test-meal of table

Note:^**The P < 0.05 compared with before test-meal；^##P < 0.05 compared with the control group.

Two groups of serum High Density Lipoprotein Cholesterol variations before and after 7 test-meal of table

Efficient situation compares before and after 8 test-meal of table

6 brief summaries

6.1 subjects continuously take step source hall board fat eliminating liver-protecting tablet during, spirit, sleep, diet, stool and urine, blood pressure, Every clinical indices etc. are showed no significant change, have no other adverse reactions.Illustrate this product to examination trencherman's health without bad It influences.

6.2 step sources hall board fat eliminating liver-protecting tablet test-meal group serum TC rate of descent 19.44%, TG rate of descent 19.66%, HDL-C Reduce 0.03mmol/L, TC effective percentage 55.8%, TG effective percentage 59.6%, HDL-C effective percentage 34.6%, total effective rate 15.4%；Control group serum TC rate of descent 3.53%, TG rate of descent -5.96%, HDL-C reduce 0.12mmol/L, and TC is efficient 28.8%, TG effective percentage 13.5%, HDL-C effective percentage 15.4%, total effective rate 0.Serum TC, TG and examination after test-meal group test-meal Before food relatively, there is significant difference (P < 0.05), Serum HDL-C is compared with before test-meal after test-meal group test-meal, and there was no significant difference (P > 0.05)；Test-meal group serum TC, TG compared with the control group, there is significant difference (P < 0.05), test-meal after test-meal after test-meal Compared with the control group, there was no significant difference (P > 0.05) for group Serum HDL-C.Obvious adverse reaction is showed no before and after test-meal.Root According to " health food is examined and assessment technique specification " (version in 2003) evaluation criterion, it can determine that the given the test agent has auxiliary drop blood Rouge function.

Examples detailed above is technical conception and technical characteristics to illustrate the invention, can not be limited with this of the invention Protection scope.The equivalent transformation or modification that all essence according to the present invention is done, should all cover in protection scope of the present invention Within.

Claims

1. a kind of health care product with protection liver and hypolipemic function, it is characterised in that: be the raw material by following weight through mixed It closes, softwood processed, granulation, drying, whole grain, total mix, be prepared after tabletting；Contain the original of following weight in 400g health care product Material: kudzu root extract 100g；Notogineng Extract 56g；Ginkgo biloba p.e 54g；Herb Gynostemmae Pentaphylli extract 45g；Ganodenna Lucidum P.E 40g；Microcrystalline cellulose 101 g；Magnesium stearate 4g.

2. the preparation method of health care product described in claim 1, it is characterised in that: the following steps are included:

(1) it mixes: by kudzu root extract, Notogineng Extract, ginkgo biloba p.e, Herb Gynostemmae Pentaphylli extract, Ganodenna Lucidum P.E, crystallite Cellulose crosses 80 meshes respectively, carries out being mixed to get mixed powder after then weighing respectively according to the ratio；

(4) dry: the wet granular that step (3) obtains to be dried, moisture controls within 5.0%, and it is spare to obtain dry particl；

(6) total mix: the magnesium stearate of particle and the ratio that step (5) obtains is mixed, obtained total mix particle is standby With；

(7) tabletting: the total mix particle that step (6) obtains is placed in tabletting in tablet press machine, piece amount is 0.4g/ piece, strict control system For tablet weight variation within ± 5%, tablet is health care product.

3. preparation method according to claim 2, it is characterised in that: in step (1), incorporation time 30min, when mixing Stirring rate be 40 revs/min.

4. preparation method according to claim 2, it is characterised in that: in step (2), ethyl alcohol is that mass concentration is 95% Ethyl alcohol.

5. preparation method according to claim 2, it is characterised in that: in step (4), dry temperature is 50-60 DEG C, water Sub-control system is within 5.0%.

6. preparation method according to claim 2, it is characterised in that: in step (6), incorporation time 20min, when mixing Stirring rate be 40 revs/min.