CN108114083A - A kind of Chinese medicine composition for preventing hepatic injury - Google Patents

A kind of Chinese medicine composition for preventing hepatic injury Download PDF

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CN108114083A
CN108114083A CN201711347613.2A CN201711347613A CN108114083A CN 108114083 A CN108114083 A CN 108114083A CN 201711347613 A CN201711347613 A CN 201711347613A CN 108114083 A CN108114083 A CN 108114083A
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extract
parts
liver
chinese medicine
dry
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佘宜寰
隋岩
宋华先
韩风雨
于秀玲
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Inner Mongolia Boao Mongolia Medicine Engineering Research Institute Co Ltd
INNER MONGOLIA TIANQI ZHONGMENG PHARMACEUTICAL Co Ltd
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Inner Mongolia Boao Mongolia Medicine Engineering Research Institute Co Ltd
INNER MONGOLIA TIANQI ZHONGMENG PHARMACEUTICAL Co Ltd
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    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/63—Oleaceae (Olive family), e.g. jasmine, lilac or ash tree
    • A61K36/638—Ligustrum, e.g. Chinese privet
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    • A61K2236/30—Extraction of the material
    • A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
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Abstract

The present invention relates to a kind of Chinese medicine compositions for preventing hepatic injury, it is prepared using kudzu root extract, glossy privet fruit extract, raisin tree seed extract, Schisandra chinens P.E, Fructus lycii P.E, capejasmine extract as raw material, its weight proportion is 80 120 parts of kudzu root extract, 40 60 parts of glossy privet fruit extract, 40 60 parts of raisin tree seed extract, 24 36 parts of Schisandra chinens P.E, 24 36 parts of Fructus lycii P.E, 24 36 parts of capejasmine extract.

Description

A kind of Chinese medicine composition for preventing hepatic injury
Technical field
The present invention relates to pharmaceutical technology field, more particularly to a kind of Chinese medicine composition for being used to prevent hepatic injury.
Background technology
Liver diseases caused by hepatic injury have become a major issue in puzzlement global medical field.Hepatic injury includes The types such as chemical damage, drug induced hepatic injury, immunological liver injury and alcoholic liver injury.One of the most common is alcohol Property hepatic injury, alcoholic liver injury (ALD) is the liver diseases caused by long-term heavy drinking, and initial stage is usually expressed as fat Liver, and then alcoholic hepatitis, alcoholic fibrosis and alcoholic cirrhosis can be developed into, seriously extensive liver can be induced during excessive drinking Even meronecrosis liver failure.
The pathogenesis of ALD is not fully aware of at present, and the lipid peroxidation of free radical and its mediation is considered most main The pathogenic factor wanted.Ethyl alcohol can generate a large amount of free radicals in liver metabolism：O2-, H2O2, OH-, C2H5O- and C2H5OH-, mistake The free radical of amount can cause liver plasma membrane that peroxidatic reaction of lipid occurs, and destroy cell membrane and organelle structure, membrane fluidity It is not normal；Enzyme (ALT, AST) is released into blood in a large amount of liver cells, and can exhaust removing free radical enzyme (SOD, GPx), liver cell damage Wound further aggravates, dysfunction of liver, fat metabolic disturbance, ultimately results in liver cell extensive necrosis, and cellular swelling is dead.Cause This, removes free radical anti-lipid peroxidation and reacts, protect liver cell, recover liver normal function, is that prevention ALD occurs and sends out The key of exhibition.So far clinically there are no the ideal medicament of effective prevention alcoholic liver injury, therefore there is an urgent need for have safely in the market Effect, the specific resisting alcoholic liver injury medicament of mechanism of action.
The content of the invention
The technical problems to be solved by the invention are to overcome the defect of the prior art, provide a kind of Chinese medicine for treating hepatic injury Composition.
The present invention is stagnated with relieving alcoholism, clearing away damp-heat, soothing the liver courage, row, resolving sputum knot, by enhancing liver detoxification and enzymolysis, with The decomposition and excretion of ethyl alcohol in diuresis acceleration bodies prevent alimentary canal to the absorption of ethyl alcohol and the effect of central nervous system, Damage of the ethyl alcohol to liver is reduced, stimulated hepatic cell regeneration increases brain and coronal vascular flow, carrys out group for the purpose of alleviation poisoning symptom Side.
Pueraria lobata, which is used to relieve the effect of alcohol, long-term clinical accumulation, golden ZHANG Cong-zheng《Confucian's Duties to Their Parents》In i.e. recorded recipe of relieving the effect of alcohol " pueraria lobata dissipates ".Modern pharmacological studies have shown that it has an impact the absorption and metabolism of alcohol, it can be via anti-oxidant, liver protection, protection The approach such as central nervous system play antialcoholism action.
Liver-protecting activity ingredient there are many containing in the fruit of glossy privet：Triterpenes components such as oleanolic acid, acetyloleanolic acid, ursolic acid Deng；Iridoid such as Ligustrum lucidum Ait, Specnuezhenide, 10- hydroxyls Ligustrum lucidum Ait, new nuzhenide etc.；Benzyl carbinol-glycoside Close object such as p-hydroxyphenylethanol-β-D glucosides (rhodioside)；Fructus Ligustri Lucidi polysaccharide etc..These active principles are by removing oxygen Free radical and anti-hepatic fibrosis protect liver.
Hoveniae semoveniae semen has the effect of reducing fever and causing diuresis, relieving alcoholism, cures mainly the diseases such as wine poison, dysphoria with smothery sensation, thirsty, vomiting, difficulty in urination and defecation.The people Between be known as the saying of " thousand glasss of not liquor-saturated hoveniae semoveniae semens ", ancient medical book《Hospital examines》In it is also on the books " hoveniae semoveniae semen (cockspur), relieves the effect of alcohol, Excessively flower of kudzuvine.Hoveniae semoveniae semen can accelerating alcohol metabolism, reduce blood alcohol concentration after drinking, enhancing L-AD activity reduces liver Dirty lipid peroxidation risk, hepatic injury caused by reducing ethyl alcohol etc..
Schisandra chinensis contains the lignan components such as schizandrin, Schisantherin C, schizandrin A and deoxyschizandrin, These ingredients are the main matter bases of its hepatoprotective effect, and having improves liver function, mitigates liver cell lipid peroxidation injury, from And prevent the effect of liver fibrosis.Wherein deoxyschizandrin can mitigate H2O2Caused human liver cell oxidative damage.
The fruit of Chinese wolfberry, name come from《Sheng Nong's herbal classic》, it is sweet in flavor, mild-natured, available for treatment because of kidney deficiency and liver, lung deficiency of the kidney void institute Cause all diseases.Its polysaccharides has good protective effect for liver.
It is cape jasmine bitter, cold in nature, there is apocatharsis to be tired of, clearing heat and promoting diuresis, removing pattogenic heat from the blood and toxic material from the body the effect of, be clinically used hepatic cholagogic Medicine.
Technical scheme is as follows：
A kind of Chinese medicine composition for preventing hepatic injury, with kudzu root extract, glossy privet fruit extract, raisin tree seed extract, five Taste seed extract, Fructus lycii P.E, capejasmine extract are prepared for raw material, and weight proportion is kudzu root extract 80-120 Part, 40-60 parts of glossy privet fruit extract, 40-60 parts of raisin tree seed extract, 24-36 parts of Schisandra chinens P.E, Fructus lycii P.E 24-36 parts, 24-36 parts of capejasmine extract；Further preferably 100 parts of kudzu root extract, 50 parts of glossy privet fruit extract, hoveniae semoveniae semen 50 parts of extract, 30 parts of Schisandra chinens P.E, 30 parts of Fructus lycii P.E, 30 parts of capejasmine extract.
Kudzu root extract：Take pueraria lobata, add water to cook twice, collecting decoction, filter, filtrate concentration, it is dry to get.
Glossy privet fruit extract：Take the fruit of glossy privet, add water to cook twice, collecting decoction, filter, filtrate concentration, it is dry to get.
Raisin tree seed extract：Take hoveniae semoveniae semen, add water to cook twice, collecting decoction, filter, filtrate concentration, it is dry to get.
Schisandra chinens P.E：Schisandra chinensis is taken, adds 75~85% ethyl alcohol heating and refluxing extractions twice, merges extracting solution, is filtered, Concentration, it is dry to get.
Fructus lycii P.E：Take the fruit of Chinese wolfberry, add water to cook twice, collecting decoction, filter, filtrate concentration, it is dry to get.
Capejasmine extract：Take cape jasmine, add water to cook twice, collecting decoction, filter, filtrate concentration, it is dry to get.
Present invention additionally comprises solid pharmaceutical preparation made of suitable pharmaceutic adjuvant is added with above-mentioned Chinese medicine composition, dosage form is piece Agent, capsule or granule.
Present invention additionally comprises above-mentioned Chinese medicine compositions and its preparation to prepare the application in preventing liver injury medicament.
Above-mentioned Chinese medicine composition is after continuous 30 days oral gavages give female sd inbred rats, it is seen that animal growth is just Often.On the basis of the establishment of alcoholic liver injury model, middle and high dosage group can significantly reduce the lipid peroxidation in rat liver homogenate Matter catabolite mda content (P ＜ 0.01, P ＜ 0.05)；Reduced glutathione in middle and high dosage group rat liver homogenate Content rise has significant difference (P ＜ 0.05, P ＜ 0.01)；Each dosage group content of triglyceride nothing compared with model control group Significant difference (P ＞ 0.05).The fat stains scoring of middle and high dosage group, which reduces, significant difference (P ＜ 0.01, P ＜ 0.01), Histopathological examination result is the positive.Above-mentioned composition has female sd inbred rats the auxiliary protection work(of alcoholic liver injury Energy.
Specific embodiment
Protective effect of the embodiment 1 to alcoholic liver injury
1. experimental method
1.1 sample：The extract in table is removed, is uniformly mixed, it is spare.It is tested with distillation water as solvent preparation during experiment Object, it is stored refrigerated.
Formula Formulation weight (Kg)
Kudzu root extract 10
Glossy privet fruit extract 5
Raisin tree seed extract 5
Schisandra chinens P.E 3
Capejasmine extract 3
Fructus lycii P.E 3
The preparation method of each extract is as follows：
Kudzu root extract：Take pueraria lobata, the water of 8 times of weight added to decoct twice, every time 1.5 it is small when, collecting decoction filters, filter Liquid concentrates, it is dry to get.
Glossy privet fruit extract：Take the fruit of glossy privet, the water of 8 times of weight added to decoct twice, every time 1.5 it is small when, collecting decoction, filter Cross, filtrate concentration, it is dry to get.
Raisin tree seed extract：Take hoveniae semoveniae semen, the water of 8 times of weight added to decoct twice, every time 1.5 it is small when, collecting decoction, filter Cross, filtrate concentration, it is dry to get.
Schisandra chinens P.E：Take Schisandra chinensis, add 8 times of 80% ethyl alcohol heating and refluxing extractions of weight twice, every time 1.5 it is small when, Merge extracting solution, filter, concentration, it is dry to get.
Fructus lycii P.E：Take the fruit of Chinese wolfberry, the water of 8 times of weight added to decoct twice, every time 1.5 it is small when, collecting decoction, filter Cross, filtrate concentration, it is dry to get.
Capejasmine extract：Take cape jasmine, the water of 8 times of weight added to decoct twice, every time 1.5 it is small when, collecting decoction filters, filter Liquid concentrates, it is dry to get.
1.2 experimental animal：The female sd inbred rats 50 provided by Sichuan Provincial Academy of Traditional Chinese Medicine Experimental Animal Center, weight 181-220g, production licence number are 2013-19.SPF grades of SCXK (river).Animal feed is by Sichuan Academy of Medical Sciences Sichuan Institute of lab animals of the People's Hospital of province provides, production licence number：SCXK (river) 2015-01.Experimental animal room uses license Card number is SYXK (river) 2016-043. barrier systems, and temperature is 20-25 DEG C, relative humidity 40-70%.
1.3 dosage select and tested material gives mode：Female sd inbred rats are randomly divided into five groups, every group 10, experiment is set Tri- dosage groups of 267mg/kg.BW, 800mg/kg.BW, 1600mg/kg.BW (be respectively equivalent to the daily recommended amounts of human body 5, 15th, 30 times), 6.68g, 20.00g, 40.00g tested material are weighed respectively, and successively plus distilled water is spare to 250ml mixings, is finished again Match somebody with somebody.Separately set distilled water control group and 50% ethanol model control group.Liver injury model, concentration of alcohol are caused with ethyl alcohol (analysis is pure) For 50% (being diluted with distilled water), gavage amount 14ml/kg.BW (dosage of equivalent ethyl alcohol is 7000mg/kg.BW).By 10ml/ Kg.BW daily once, continuously give 30 days, claim weight twice weekly, dosage is adjusted with this by oral gavage.1.4 test method： Using alcoholic liver injury modelling, three dosage groups give the tested material of various dose, negative control group and model control group Give distilled water.By model control group and three dosage groups, once oral gavage gives 50% ethanol solution, agent during off-test It measures as 14ml/kg.BW, negative control group gives the distilled water of same volume, and putting to death animal after fasting 16h takes liver to weigh, and calculates Dirty body ratio, and carry out biochemical indicator detection and histopathological examination with liver.
2. Testing index
Lipid peroxide catabolite malonaldehyde (MDA), reduced glutathione (GSH) and glycerine three in 2.1 liver homogenates The measure of ester (TG)：MDA and GSH assay kits are built up Bioengineering Research Institute by Nanjing and are provided, with the U.S. science instrument in Shanghai day The UV1100 spectrophotometric determinations of device Co., Ltd production；TG assay kits are diagnosed limited by German Olympus (Europe) Company provides, and the AU-400 automatic clinical chemistry analyzers produced with Japanese Olympus Optical Co., Ltd are measured.
2.2 livers are weighed and the calculating of organ coefficient
2.3 pathology of hepar diagnostic criteria
2.3.1 pathological observation material：Cross section materials, section, dyeing, Microscopic observation fat drips are done in the middle part of from animal left lobe of liver Distribution, scope and area in liver.
2.3.2 pathological observation method：Histotomy is observed continuously with 40 times of object lens in every animal liver tissue, according to positive thin The how many scopes with distribution of born of the same parents, score by 0,1,2,3,4 point.Using the average value of obatained score as the fat of this hepatic tissue Fat dyeing scoring.
2.3.3 pathological diagnosis standard：Pathologic examination is dyed using liver cell fat drips as observation index, and according to disease Change degree " 0 ", " 1 ", " 2 ", " 3 ", " 4 " quantization are managed, carries out the evaluation of hepatic injury degree.
2.3.4 liver cell fat stains is divided into Pyatyi：
2.4 test datas count：Test data statistics is handled using SPSS11.0for windows software packages.Control group For data with each dosage group through homogeneity test of variance, variance is neat, carries out variance analysis, if P values are less than 0.05, then uses Dunnett Method is compared two-by-two；If heterogeneity of variance, data conversion is carried out, it is still uneven, use rank sum test instead, if P values are less than 0.05, then With Dunnett, s T3 methods are compared two-by-two.Negative control group is then examined with model control group data using T.
2.5 result judgement：Liver MDA, tri- Testing index results positives of reduced form GSH and TG or liver MDA, reduced form Wantonly two indexs are positive in tri- indexs of GSH and TG and histopathologic examination's result is positive.Meet any of the above condition, can sentence The fixed given the test agent has and has auxiliary protection function to alcoholic liver injury.
3. result of the test
3.1 pairs of rat body weights, liver weight, liver body than influence
By table 1 as it can be seen that the original body mass of each dosage group rat is compared with negative control group and model control group, the neat (P of variance ＞ 0.05), the results of analysis of variance (P ＞ 0.05) illustrates that each group animal original body mass is balanced.The mid-term body of model control group Weight, eventually weight, liver weight, liver body ratio are compared with negative control group, except liver weight, liver body than significantly rise (P ＜ 0.01, P ＜ 0.01) outside, There was no significant difference for remaining index (P ＞ 0.05).The mid-term weight of each dosage group animal, eventually weight, liver weight and liver body ratio and model Control group compares, and there was no significant difference (P ＞ 0.05).
Table 1 to rat body weight, liver weight, liver body than influence
Note：Δ Δ represents the P ＜ 0.01 compared with negative control group.
The influence of MDA, GSH, TG content in 3.2 pairs of rat liver homogenates
By table 2 as it can be seen that MDA, GSH, TG content in model control group rat liver homogenate are compared with negative control group, through t It examines, MDA, TG content significantly raise (P ＜ 0.01, P ＜ 0.01), and GSH contents significantly reduce (P ＜ 0.01), show the model It is successful, experimental system is reliable.MDA, GSH, TG content of three dosage groups are compared with model control group, it is seen that middle and high dose The MDA of amount group is significantly reduced (P ＜ 0.01, P ＜ 0.05), and the GSH of middle and high dosage group significantly raises (P ＜ 0.05, P ＜ 0.01), Each dosage group TG is without significant difference (P ＞ 0.05).
Influence of the table 2 to MDA, GSH, TG content in rat liver homogenate
Note：Δ Δ represents the P ＜ 0.01 compared with negative control group；* the P ＜ 0.05 compared with model control group are represented；* tables Show the P ＜ 0.01 compared with model control group.
3.3 pathology of hepar inspection results
3 are the results are shown in Table, compared with negative control group, rise has pole for the liver cell fat stains scoring of model control group rat Significant difference (P ＜ 0.01), it is successful to show the model, and experimental system is reliable.The liver cell fat of three dosage group rats Compared with model control group, middle and high dosage group reduction has significant difference (P ＜ 0.01, P ＜ 0.01) for fat dyeing scoring.
Table 3 is to rat liver tissue pathological examination result
Note：Δ Δ represents the P ＜ 0.01 compared with negative control group；* represents the P ＜ 0.01 compared with model control group.
4. brief summary：
After oral gavage gives female sd inbred rats within continuous 30 days, it is seen that animal growth is normal.In alcoholic liver injury On the basis of model is set up, middle and high dosage group can significantly reduce the lipid peroxide catabolite malonaldehyde in rat liver homogenate Content (P ＜ 0.01, P ＜ 0.05)；Reduced glutathione content rise in middle and high dosage group rat liver homogenate has conspicuousness Difference (P ＜ 0.05, P ＜ 0.01)；Each dosage group content of triglyceride is compared with model control group without significant difference (P ＞ 0.05).The fat stains scoring of middle and high dosage group, which reduces, significant difference (P ＜ 0.01, P ＜ 0.01), histopathology inspection The fruit that comes to an end is the positive.I.e. said composition has female sd inbred rats the assistant protection function of alcoholic liver injury.
2 safety evaluatio of embodiment is tested
1. experimental method
1.1 sample：1 sample of embodiment.Tested material is prepared with distillation water as solvent during experiment, it is stored refrigerated.
1.2 experimental animal：
1.2.1 feeding environment and feed resource：Experimental animal room is SYXK (river) 2011-043. barriers using credit number System, 20-25 DEG C of temperature, relative humidity 40%-70%.Feed resource is in People's Hospital, Sichuan Prov. of Sichuan Academy of Medical Sciences Institute of lab animals, production licence number are SCXK (river) 2015-01.
1.2.2 animal：Correlation test animal service condition is shown in Table 4.
4 experimental animal list of table
1.3 dosage select to give mode with tested material：
1.3.1 acute oral toxicity test：If mono- dosage group of 15000mg/kg.BW, by the oral gavages of 20ml/kg.BW. Animal fasting 16h before gavage, unlimited drinking-water are observed 7 days after contaminating for the first time.
1.3.2Ames experiment：If the 8th, 40,200,1000,5,000 five dosage groups of μ g/ wares and solvent control group (distillation Water), spontaneous control group and positive controls.
1.3.3 Micronucleus test：If 2000mg/kg.BW, 4000mg/kg.BW, 8000mg/kg.BW are (once most Big gavage amount) three dosage groups, separately set solvent (distilled water) control and cyclophosphamide positive controls (CP, 40mg/kg.BW). By the oral gavages of 20ml/kg.BW, two minor ticks for 24 hours, 30h are observed after contaminating for the first time.
1.3.4 sperm malformation test：If 2000mg/kg.BW, 4000mg/kg.BW, 8000mg/kg.BW are (once maximum to fill Stomach amount) three dosage groups, separately set solvent (distilled water) control group and cyclophosphamide positive controls (CP, 40mg/kg.BW).Often It is pressed
The oral gavages of 20ml/kg.BW continuous 5 days, are observed 35 days after contaminating for the first time.
1.3.5 30 days feeding trials：If tri- dosage groups of 1333mg/kg.BW, 2667mg/kg.BW, 5333mg/kg.BW (25,50,100 times that are respectively equivalent to human body recommended intake), separately set full-valence pellet feed control group.It is first using mixing feeding It is observed 30 days after secondary contamination.
1.4 main agents：Biochemical reagents box, cyclophosphamide, 1,8- dihydroxy anthraquinones, sodium azide, 2- aminofluorenes, 4- nitre Base quinoline-N oxides, mitomycin C, S-9 mixed liquors.
1.5 test method：
1.5.1 acute oral toxicity test：Using maximum tolerated dose method, large and small mouse is randomly divided into two groups respectively, and totally 4 Group, 10 animals of every group of homology same sex.Weigh 75g tested materials add it is spare after distilled water to 200ml mixings.Large and small mouse is secondary to be given Tested material is given, is spaced 4h.The poisoning manifestations and death condition of animal in one week are observed, off-test is put to death animal after weighing and made Gross anatomy.
1.5.2 Salmonella reversion test：Using through β-naphthoflavene and phenobarbital combined induction male rat liver S9, by standard side S is made in method9As activation system after mixed liquor, with indirect mutagen, (20 μ g/ ware 2- aminofluorenes are used for TA97、TA98、TA100, 50 μ g/ wares 1,8- dihydroxy anthraquinones are used for TA102Bacterium) measure S9Activity.Experiment is using TA97、TA98、TA100、TA102Four kinds of bacterial strains, Tested material sets 8,40,200,1000,5,000 five dosage groups of μ g/ wares and solvent control group (distilled water), spontaneous control group and sun Property control group.Tested material working solution is prepared first：5.0g samples accurately are weighed, it is most senior engineer to add distilled water to 100ml mixings Make concentration 50mg/ml, it is highest tested material final concentration (5000 μ g/ wares) that when experiment, which takes 100 μ l of the working solution to add in plate, with It is diluted down again up to following concentration with distilled water 5 based on maximum concentration.0.103MPa20min high pressure steam sterilizations.Adding Be not added with S9Experimental condition under carry out tablet incorporation methods experiment.Three parallel wares of every group of work repeat experiment once.-S9It is positive right According to object：TA97And TA98With the 4- nitroquinoline-N- oxides of 0.5 μ g/ wares；TA100With the sodium azide (NaN of 1.5 μ g/ wares3)； TA102With the mitomycin C (MMC) of 1.0 μ g/ wares；+S9Positive control TA102With 1, the 8- dihydroxy anthraquinones of 50 μ g/ wares, Excess-three bacterial strain uses the 2- aminofluorenes (2-AF) of 20 μ g/ wares.The volume that positive control is added in per ware is 0.1ml.
1.5.3 Micronucleus test：Using 30h dose regimens twice, mouse is randomly divided into 5 groups by male and female respectively, Every group of 5 animals weigh 2.0g, 4.0g, 8.0g sample and distilled water are added separately to weigh 0.04gCP to 20ml and add distilled water extremely respectively 20ml, mixing, twice gavage interval for 24 hours, animal is put to death to 6h cervical dislocations after tested material in second, take breastbone marrow by 《Health food is examined and assessment technique specification》Regulation in (version in 2003) carries out film-making, fixed, after Giemsa dyeing, in oil Every mouse counts the PCE numbers containing micronucleus in 1000 polychromatic erythrocytes (PCE) under mirror, calculates micronucleus cell rate (‰).It sees Examine the ratio of polychromatic erythrocyte and mature erythrocyte (PCE/NCE) in 200 red blood cells.
1.5.4 sperm malformation test：Mouse is randomly divided into 5 groups, every group of 5 animals weigh 8.0g, 16.0g, 32.0g Sample adds distilled water to 80ml respectively, separately weighs 0.04g CP and adds distilled water to 20ml (cyclophosphamide faces the used time and prepares daily), Mixing.Continuous gavage 5 days, the 35th day after tested material is given for the first time, cervical dislocation puts to death animal and bilateral epididymal is taken to carry out film-making, It presses《Health food is examined and assessment technique specification》Regulation in (version in 2003), methanol is fixed, after 1% eosin stains, in height Every animal counts 1000 complete sperms under times mirror, record teratospermia, lopsided type and calculates rate of teratosperm.
1.5.530 day feeding trial：Using mixing feeding, rat is randomly divided into 4 groups, every group of 20 rats, half male and half female. Each 14kg of feed containing tested material is prepared, about 187g, 373g, 747g tested material is weighed respectively, is first added sequentially to 3kg feeds In, because high dose group tested material content is more than 5%, protein is supplemented with 186g casein, after being sufficiently stirred mixing, by remaining feeding Material is added thereto to total amount 14Kg, then after being sufficiently stirred mixing, machine-shaping is spare after Co 60 irradiation.Daily every rat list Cage is fed, continuous 30 days, is observed general performance, behavior, poisoning manifestations and the death of animal daily, is calculated feed twice weekly Amount, and claim a weight according to food intake dose, calculates food utilization, and that blood is taken to put to death is dynamic for anesthesia after fasting during off-test Object, blood sampling measures hematological indices with XT-2000i types Automatic Blood Cell Analyzer, with Japanese Olympus optics strain formula meeting The AU-400 automatic clinical chemistry analyzers of society's production and German Olympus (Europe) diagnose the kit that Co., Ltd provides, and survey Determine blood biochemistry index, dissection animal observation internal organ change, and claim liver,kidney,spleen, testis weight, calculate its dirty body ratio, take liver,kidney,spleen, Stomach and intestine, testis (ovary) make histopathological examination.Animal ad lib, drinking-water during experiment.
1.6 test datas count：Bone marrow micronucleus test use Chi-square Test, sperm malformation test use rank sum test, 30 For its feeding trial data through homogeneity test of variance, variance is neat, carries out variance analysis, if P values are less than 0.05 with Dunnett methods into Row compares two-by-two；If heterogeneity of variance, data conversion is carried out, it is still uneven, it uses rank sum test instead, if P values are less than 0.05, then uses Dunnett ' s T3 methods are compared two-by-two, and above-mentioned statistics uses 11.0 for Windows software processings of SPSS.
1.7 result judgement：
1.7.1 acute oral toxicity test：According to LD50Numerical value judges the toxicity grading of tested material.
1.7.2 Salmonella reversion test：Tested material group time change clump count (returns more than doubling and becomes clump count equal to or more than 2 Be multiplied by untreated control number), and have a dose-response relationship or at least a certain test point have it is repeatable and statistically significant Positive reaction, you can think the tested material mutagenesis testing positive.
1.7.3 Micronucleus test：Compared with the control group, result of the test micronuclear rates has the apparent dosage anti-to test group Should be related to and it is statistically significant when, you can confirm as positive findings.If statistically difference has conspicuousness, but without dose response During relation, then it must carry out repeating experiment.As a result can the person of repetition can be identified as the positive.
1.7.4 sperm malformation test：Each dosage group should be respectively compared with corresponding negative control group, and abnormal rate is extremely Less for times amount of negative control group or through counting significance, and there is dose-response relationship, you can be determined as the positive.
2. experimental result
2.1 couples of large and small equal ＞ 15000mg/kg.BW of mouse acute oral toxicity test result MTD values, by acute toxicity point Grade, belongs to nontoxic grade.
2.2 3 genetic toxicity tests (Salmonella reversion test, mice bone marrow micronucleus and mouse sperms Deformity experiment) result has no mutagenesis.
2.3 30 days feeding trials, it is seen that animal growth is normal, and continued weight increases, and figure is active, and hair is smooth Submissive, stool, urine no abnormality seen changes.Have no that poisoning symptom and death occurs in animal during experiment.Three dosage groups are female great and mighty or powerful The weight weekly of mouse, weekly food-intake, weekly food utilization, total food utilization rate, dirty body ratio, hematological indices and latter stage Compared with the control group, the 4th week food-intake of high dose group significantly reduces (P ＜ 0.05), high dose group to Biochemistry test result Glutamic-pyruvic transaminase significantly reduce (P ＜ 0.05), low middle high dose group T-CHOL significantly reduces (P ＜ 0.01, P ＜ 0.01, P ＜ 0.01), male mouse is low, the lymphocyte of the leucocyte of high dose group and high dose group significantly reduces (P ＜ 0.05, P ＜ 0.05, P ＜ 0.01), neutrality significantly rise (P ＜ 0.05), the high dose group albumin of high dose group significantly raise (P ＜ 0.01), middle dose Amount group urine glutamic-oxalacetic transaminease significantly reduces (P ＜ 0.05).More than institute measured value is in this room range of normal value.Histopathology is examined It looks into as a result, in addition to the spontaneous lesion of animal, has no that tested material high dose group causes animal poisoning damage to change.
3 capsule of embodiment
Supplementary material title Formula ratio (g)
Kudzu root extract 100
Glossy privet fruit extract 50
Raisin tree seed extract 50
Schisandra chinens P.E 30
Capejasmine extract 30
Fructus lycii P.E 30
Magnesium stearate 2
It is made 1000
Preparation method：Above-mentioned 6 kinds of extracts are taken, are uniformly mixed, dry method pelleting adds in magnesium stearate, is uniformly mixed, dress Enter capsule to get.
4 granule of embodiment
Supplementary material title Formula ratio (g)
Kudzu root extract 1000
Glossy privet fruit extract 500
Raisin tree seed extract 500
Schisandra chinens P.E 300
Capejasmine extract 300
Fructus lycii P.E 300
Maltodextrin 3600g
Mannitol 1500g
It is made 1000 bags
Preparation method：By maltodextrin, mannitol, kudzu root extract, glossy privet fruit extract, raisin tree seed extract, five Taste seed extract, capejasmine extract, wolfberry fruit extract add in wet granulator, using 85% ethanol solution as wetting agent preparation Grain, whole grain after particle drying, pack to get.
The preferred embodiment of the present invention has been described above in detail, still, during present invention is not limited to the embodiments described above Detail, within the scope of the technical concept of the present invention, a variety of simple variants can be carried out to technical scheme, this A little simple variants all belong to the scope of protection of the present invention.
It is further to note that the specific technical features described in the above specific embodiments, in not lance In the case of shield, can be combined by any suitable means, in order to avoid unnecessary repetition, the present invention to it is various can The combination of energy no longer separately illustrates.
In addition, various embodiments of the present invention can be combined randomly, as long as it is without prejudice to originally The thought of invention, it should also be regarded as the disclosure of the present invention.

Claims (5)

1. a kind of Chinese medicine composition for preventing hepatic injury, with kudzu root extract, glossy privet fruit extract, raisin tree seed extract, the five tastes Seed extract, Fructus lycii P.E, capejasmine extract are prepared for raw material, and weight proportion is kudzu root extract 80-120 Part, 40-60 parts of glossy privet fruit extract, 40-60 parts of raisin tree seed extract, 24-36 parts of Schisandra chinens P.E, Fructus lycii P.E 24-36 parts, 24-36 parts of capejasmine extract.
2. Chinese medicine composition according to claim 1, which is characterized in that its weight proportion be 100 parts of kudzu root extract, female Loyal 50 parts of seed extract, 50 parts of raisin tree seed extract, 30 parts of Schisandra chinens P.E, 30 parts of Fructus lycii P.E, capejasmine extract 30 parts.
3. solid pharmaceutical preparation made of Chinese medicine composition according to claim 1 or 2, dosage form is tablet, capsule or granule.
4. according to any Chinese medicine compositions of claim 1-3, which is characterized in that the kudzu root extract preparation method For：Take pueraria lobata, add water to cook twice, collecting decoction, filter, filtrate concentration, it is dry to get；
The glossy privet fruit extract preparation method is：The fruit of glossy privet is taken, is added water to cook twice, collecting decoction, is filtered, filtrate is dense Contracting, it is dry to get；
The raisin tree seed extract preparation method is to take hoveniae semoveniae semen, is added water to cook twice, collecting decoction, is filtered, filtrate concentration, It is dry to get；
The Schisandra chinens P.E preparation method adds 75~85% ethyl alcohol heating and refluxing extractions twice, merges to take Schisandra chinensis Extracting solution filters, concentration, it is dry to get；
The Fructus lycii P.E preparation method is to take the fruit of Chinese wolfberry, is added water to cook twice, collecting decoction, is filtered, filtrate concentration, It is dry to get；
The preparation method of the capejasmine extract is added water to cook twice, collecting decoction, filtered, filtrate concentration is done to take cape jasmine It is dry to get.
5. any Chinese medicine compositions of claim 1-4 are preparing the application in preventing liver injury medicament.
CN201711347613.2A 2017-12-05 2017-12-05 A kind of Chinese medicine composition for preventing hepatic injury Pending CN108114083A (en)

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Application publication date: 20180605