CN105106816B - Protect the traditional Chinese medicine health care product preparation and preparation method thereof of chemical damage - Google Patents
Protect the traditional Chinese medicine health care product preparation and preparation method thereof of chemical damage Download PDFInfo
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Abstract
The invention discloses a kind of traditional Chinese medicine health care product preparations and preparation method thereof for protecting chemical damage; wherein preparation; in parts by weight, it is made of 380~420 parts of pueraria lobata, 300~340 parts of hoveniae semoveniae semen, 280~320 parts of jujube, 280~320 parts of dark plum, 130~170 parts of fructus amomi, 130~170 parts of Radix Glycyrrhizae and 60~100 parts of starch.Prescription and preparation process are optimized in preparation method, preparation process obtained is stable, quality controllable, safe and effective；Pharmacological evaluation proves that health-care preparation of the invention can effectively prevent ethyl alcohol that liver GSH is caused to exhaust the raising with TG content, mitigates hepatic cell fattydegeneration, has the function of preventing liver injury, has auxiliary protection function to chemical damage.Each medicine is derived from natural resources in side, and relative inexpensiveness uses convenient for the common people.
Description
Technical field
The present invention relates to a kind of traditional Chinese medicine health care product preparations and preparation method thereof for protecting chemical damage, belong to health care product
Technical field.
Background technique
Chemical damage is the hepatic injury as caused by chemically Hepatoxic substance.These chemical substances include alcohol,
Chemical toxicant and some drugs in environment.The liver of important removing toxic substances organ as human body has arteria hepatica and vena hepatica double
Blood supply again.Chemical substance can enter liver by gastrointestinal tract portal vein or body circulation and be converted, thus liver be easy by
Toxicant damage into chemicals.There are some pairs of virose objects of liver in the Nature and human industry's production process
Matter, 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 straight
Correlation is connect, necrosis of liver cells, fat deformation, cirrhosis and the liver cancer that liver can be caused different degrees of.Raw material in industrial production,
Intermediate product and final product may have hepatotoxicity wind agitation, therefore, need to very vigilant chemical liver poisoming generation.
Alcoholic liver disease (alcoholic liver disease, ALD) is the liver disease due to caused by long-term heavy drinking
Disease.The pathogenic factor of ALD is single, but its pathogenesis is complex, is not fully understood at present, may be with alcohol and its metabolism
Product to the toxic effect of liver, oxidative stress, endotoxin, immune-mediated and cell factor, Apoptosis, genetic polymorphism,
It is related with many factors such as superposition of virus.Initial stage is usually expressed as fatty liver, and then can develop into alcoholic hepatitis, wine
Essence liver fibrosis and alcoholic cirrhosis, it is acute hepatic that extensive necrosis of liver cells can be seriously induced when excessive drinking even to develop
Failure.Alcohol metabolism, degradation main place be liver.The alcohol that can be taken in human body in liver containing alcohol dehydrogenase becomes
At acetaldehyde, the toxic effect of ethyl alcohol and acetaldehyde can cause the generation of alcoholic liver disease.Wherein acetaldehyde is high-activity compound, and energy liver is thin
Many-sided function of born of the same parents can be interfered by it, influence generation of the mitochondria to ATP, the biosynthesis and excretion of protein, repeatedly
Make liver cell that steatosis, necrosis and regeneration occur, eventually leads to cirrhosis.
Now with the improvement of people's living standards, people also increasingly pay attention to the concern of health, and exploitation is protected
The traditional Chinese medicine health care product of shield chemical damage is of great significance, and also has huge market prospects.
Application No. is 2004100207060 Chinese invention patents to disclose a kind of adjusting blood lipid and protection chemical damage
Traditional Chinese medicine health care product preparation, matched using chitosan oligosaccharide, Schisandra chinensis, pueraria lobata, but the extraction and preparation technique of Chitosan poly oligosaccharide is wanted
Ask higher, therefore the cost is relatively high, restricts its sale.One kind is disclosed application No. is 2009101024750 patent of invention to prevent
The traditional Chinese medicine health care product preparation for controlling alcoholic liver disease, is matched using flower of kudzuvine, hoveniae semoveniae semen, pueraria lobata, dark plum, jujube, fructus amomi, Radix Glycyrrhizae
Than can be with the generation of effectively preventing alcoholic liver disease.But it has been reported that the toxic risk of flower of kudzuvine, be not included in can be used at present
In (food and medicament dual-purpose) list of health food, in the processing of practical health care product, need to remove it, in order to reach identical treatment
Its more remarkable treatment effect is imitated or made, needs to be formulated it and is adjusted.
Summary of the invention
The purpose of the present invention is to provide it is a kind of protect chemical damage traditional Chinese medicine health care product preparation and preparation method thereof,
It is improved on the basis of existing technology, eliminates flower of kudzuvine, has adjusted the recipe quantity of the components such as pueraria lobata, for protection
Chemical damage, especially prevention and treatment alcoholic liver disease is significant in efficacy, and provided dosage form, convenient to take.
In order to solve the above technical problems, one technical scheme adopted by the invention is that:
It is a kind of protect chemical damage traditional Chinese medicine health care product preparation, in parts by weight, it be by pueraria lobata 380~
420 parts, 300~340 parts of hoveniae semoveniae semen, 280~320 parts of jujube, 280~320 parts of dark plum, 130~170 parts of fructus amomi, Radix Glycyrrhizae 130~
Made of 170 parts, 60~100 parts of starch.
Preferably, a kind of traditional Chinese medicine health care product preparation for protecting chemical damage, in parts by weight, it is by pueraria lobata
400 parts, 320 parts of hoveniae semoveniae semen, 300 parts of jujube, 300 parts of dark plum, 150 parts of fructus amomi, 150 parts of Radix Glycyrrhizae, made of 80 parts of starch.
The traditional Chinese medicine health care product preparation is oral preparation, preferably capsule.
It is of the present invention protection chemical damage traditional Chinese medicine health care product preparation the preparation method comprises the following steps: proportionally claiming
The net medicinal material of pueraria lobata, hoveniae semoveniae semen, dark plum, jujube, fructus amomi, Radix Glycyrrhizae is taken, 6~10 times of amount water is added to impregnate 0.5~1.5h, decocts 2~3
Secondary, 1~2h every time, collecting decoction, filtration, filtrate decompression is concentrated into 70 DEG C, relative density is 1.25 under vacuum degree -0.07MPa
~1.28 thick paste, be added starch be uniformly mixed, be made a variety of different dosage forms to get.
Specifically, wherein capsule the preparation method comprises the following steps: proportionally weigh pueraria lobata, hoveniae semoveniae semen, dark plum, jujube, fructus amomi,
The net medicinal material of Radix Glycyrrhizae adds 6~10 times of amount water to impregnate 1~2h, decocts 1~1.5 hour for the first time, and for the second time plus 5~7 times of amount water decoct
1~1.5h, collecting decoction, filtration, filtrate decompression is concentrated into 70 DEG C, relative density is 1.25~1.28 under vacuum degree -0.07MPa
Thick paste, continuation be dried under reduced pressure at 70 DEG C, vacuum degree -0.07MPa 5~7 hours, crush, cross 65 meshes, dried cream powder is made,
Then supplementary product starch is proportionally added in dried cream powder again, after mixing, crosses 24 meshes with 90~98% ethyl alcohol, pelletizes,
60~80 DEG C drying 3~5 hours, cross 24 meshes, whole grain, total mix, filling capsule is to get capsule.
Preferably, capsule the preparation method comprises the following steps: proportionally weighing pueraria lobata, hoveniae semoveniae semen, dark plum, jujube, fructus amomi, Radix Glycyrrhizae
Net medicinal material adds 8 times of amount water to impregnate 1h, decocts 1 hour for the first time, and for the second time plus 6 times of amount water decoct 1h, and collecting decoction filters, filter
Liquid is concentrated under reduced pressure into 70 DEG C, the thick paste that relative density is 1.25~1.28 under vacuum degree -0.07MPa, continues in 70 DEG C, vacuum
It is dried under reduced pressure 6 hours, crushes under degree -0.07MPa, cross 65 meshes, dried cream powder is made, then proportionally add in dried cream powder again
Enter supplementary product starch, after mixing, cross 24 meshes with 95% ethyl alcohol, pelletize, 60 DEG C drying 4 hours, mistake 24 meshes, whole grain, always
Mixed, filling capsule is to get capsule.
In the preparation method of the traditional Chinese medicine health care product preparation of aforementioned protection chemical damage, the filtration uses 80 purposes not
The steel mesh that becomes rusty carries out.
Traditional Chinese medicine health care product preparation of the present invention with pueraria lobata, hoveniae semoveniae semen, jujube, dark plum, fructus amomi, Radix Glycyrrhizae additional starch purification and
At each specific effect of ingredient is as follows in side:
Pueraria lobata: property sweet, acrid, warm returns liver, the heart, the spleen channel.It brings down a fever, promotes the production of body fluid to quench thirst with expelling pathogenic factors from muscles and skin, promoting eruption, Shengyang Zhixie, promoting menstruation
It is active, relieving alcoholism.It has a headache for fever caused by exogenous pathogens, stiff nape and back is thirsty, it quenches one's thirst, measles without adequate eruption, hot dysentery, diarrhea, dizziness and headache,
Hemiplegia, chest impediment and cardialgia, wine poison wound in.Pharmacological research proves, pueraria lobata have cardiovascular and cerebrovascular, relieve the effect of alcohol, be antitumor, is hypoglycemic,
Reducing blood lipid inhibits tyrosinase activity, is anti-inflammatory, estrogen-like, improves memory, adjusts the effects of endocrine.
Hoveniae semoveniae semen: meridian distribution of property and flavor is sweet and neutral.Return heart, spleen, stomach meridian have and quench the thirst, relieving restlessness, relieving alcoholism, diuresis.For
Drunk, dysphoria with smothery sensation is thirsty, vomiting, difficult urination.Pharmacological research proves that hoveniae semoveniae semen has significant relieving alcoholism and protecting livers, anti-liver fiber
Change and anti-aging, fatigue-resisting function.
Jujube: meridian distribution of property and flavor is sweet, warm.Returns spleen, stomach, the heart channel of Hang-Shaoyin.Tonifying middle-Jiao and Qi, nourishing blood and tranquilization.It is out of strength for spleen eating less
Loose stool, hysteria of womam.Pharmacological research proves that jujube has the pharmacological action of cAMP and cGMP sample substance, antiallergic action, maincenter mind
Inhibited effect, complement inhibitory activity inhibit meninx atpase activity, antimutagenic activity, the release for inducing prostaglandin, prevention
A variety of effects such as saprodontia, protection liver, enhancing muscular strength.
Dark plum: meridian distribution of property and flavor is flat to be sour, puckery.Return liver, spleen, lung, large intestine channel.With astringing lung-QI, puckery intestines promote the production of body fluid, claming ascaris.With
In chronic cough of deficiency lung, protracted dysentery and diarrhea, abnormal heat is quenched one's thirst, and the ascariasis of biliary tract vomits abdominal pain.Pharmacological research proves that dark plum has expelling parasite, antibacterial, anti-mistake
Quick, antitumor, liver protection, eliminates the effects of fatigue, anti-aging at the anti-fibrinolytic of suppression blood coagulation.
Fructus amomi: meridian distribution of property and flavor is acrid in flavour and warm in nature.Returns spleen, stomach, kidney channel.It is warming spleen and stopping diarrha with dampness elimination appetizing, regulating the flow of vital energy and preventing miscarriage.For
Turbi damp obstructing in middle-JIAO, gastral cavity ruffian is not hungry, deficiency-cold in spleen and stomach, vomiting and diarrhea, hyperemesis gravidarum, threatened abortion.Pharmacological research proves that fructus amomi has significantly
Analgesia, anti-ulcer effect；Antibody cell is formed, gastric acid secretion, gastric enzyme eupepsy has significant inhibiting effect；To stomach and intestine
Conveying function has facilitation.
Radix Glycyrrhizae: meridian distribution of property and flavor is sweet and neutral.Return heart, lung, spleen, stomach meridian.With invigorating the spleen and benefiting qi, clearing heat and detoxicating, expelling phlegm and arresting coughing,
Relieving spasm to stop pain, coordinating the drug actions of a prescription.For weakness of the spleen and the stomach, fatigue and weakness, shortness of breath and palpitation, coughing with a lot of sputum, stomach duct and abdomen, four limbs contraction,
Carbuncle sore tumefacting virus alleviates drug toxicity, strong.Pharmacological research proves, Radix Glycyrrhizae has removing toxic substances, antibacterial, antitumor, immunological regulation, right
The effects of hepatitis virus resisting.
This product formula follows China's traditional Chinese medicine theory, and the property of pueraria lobata sweet and cool-natured is used in side, taste is walked, can promote the production of body fluid only
Yearningly, fluid deficiency and thirst, giving consideration to both the incidental and fundamental, for monarch drug in a prescription are caused for alcohol retention of damp-heat in the interior.It is secondary sweet, flat with hoveniae semoveniae semen, quench the thirst, relieving restlessness, with
Solution excess heat hurt saliva cause it is thirsty vexed, separately there is the function of relieving alcoholism to effect a permanent cure with eliminating evil；The property of the sweet temperature of jujube, helps qi and blood metaplasia with nourishing the liver
Blood, and take into account tonifying spleen and help fortune with righting；The tart flavour levelling of dark plum, which focuses on, promotes the production of body fluid, based on temporary solution；Three medicines are total to principal drug assistance as ministerial drug.
The pungent-warm of fructus amomi, helps the advantageous dampness elimination of spleen health movement, burnt mechanism of qi in pungent row, is for adjutant for sweet etc. in gastral cavilty turgor, mouth.It is sweet
Grass takes into account strengthening spleen and invigorating qi, has coordinating the drug actions of a prescription, for adjuvant.Above all medicines share, and embody liver and spleen with controlling, qi and blood is taken into account, eliminating evil
The formula feature of righting.
In order to ensure the curative effect of the traditional Chinese medicine health care preparation in the present invention, applicant carries out preparation process and pharmacological function
Corresponding experimental study is optimized in conjunction with the physicochemical property of drug using orthogonal experiment according to the drug ingedient of square taste of traditional Chinese medicine
Prescription and preparation process make process stabilizing, quality controllable, safely and effectively pure Chinese medicinal preparation；Animal experiment study table
Bright, prophylactic can be with effective protection chemical damage.The main contents of experimental study are as follows:
(1) technique correlative study
1, the foundation that extraction process is worked out
Each the effective elements of the medicine and property in foundation side design this product process route.
The side based on " the flower of kudzuvine ball " that the flower of kudzuvine in gold dollar epoch " Treatise on the spleen and stomach " is neutralized the effect of alcoholic drinks in soup and Ming Dynasty's " Prescriptions for Universal Relief ", in conjunction with
The civil regular convention formula in Guizhou, through adding and subtracting.Original side is to use with decoction or big honeyed bolus.To keep original side's curative effect, according to existing
Each the effective elements of the medicine and property, which are tested us and selected, in laws and regulations requirement and side takes water as a solvent the medicines of 6 taste medicines in extraction side
Imitate ingredient.
Modern research shows that pueraria lobata is rich in effective components such as isoflavones, saponin(es in side；Pharmacological research is found, different contained by pueraria lobata
Flavone compound has the effects that Antialcoholic liver-protecting using Puerarin as representative, has very big value of exploiting and utilizing.Hoveniae semoveniae semen
Effective component is saponin(e and glucosides, alkaloid, fatty acid etc., and water-soluble portion has the work of preferably treatment alcoholism liver protection
Property.Other a few taste medicines then contain the effective components such as flavones, volatile oil.The effective component of each herbal medicine is special in this process synthesis consideration side
Property and production it is practical, selected water for Extraction solvent.The use of organic solvent is compared, purified water is selected to make Extraction solvent more
Safety, economic, environmental protection, fast, the bioavilability height of absorption etc. have advantage.In Extraction technique investigation, we are using orthogonal
Extraction conditions and technological parameter are studied in design.Selected functional component: the recovery rate of general flavone and Puerarin as
Technique inspection target, to improve Product Process reasonability and quality controllability.
Suitable starch is added in the disadvantages of easy to moisture absorption for water extract in pelletization, on the one hand can reduce said preparation
Hygroscopicity, and mobility of particle can be increased, improve product sucting wet stability and content uniformity qualification rate.
2, the selection and foundation of dosage form
It is liquid preparation (decoction or oral solution), Yi Ji great mostly that successive dynasties, which are used to prevent and treat alcoholic liver disease and prevent and treat wine poison,
The more primary solid pharmaceutical preparation such as honeyed bolus, there is clearly disadvantageous place in practice, and if decoction prescription is big, dose is big,
The cumbersomes such as decoction every time are not suitable for commercialization.The big prescription of pill, large dosage, original powder are used as medicine, work slow, bioavailability
Low disadvantage.
Capsule is made by modern biotechnology extraction purification and preparation means in this product, can reduce dose, improves biology benefit
Expenditure, dosage form is classical, conveniently takes, carries and stores, convenient for large-scale production, the controllability and stabilization of raising product quality
Property.Therefore this product has selected hard capsule.
3, the selection of process route
The investigation of 3.1 medicinal material water absorption rates
It takes and is ground into coarse powder and each three parts of uniformly mixed medicinal material about 100g, it is accurately weighed.Respectively plus water 500ml, sufficiently
It after shaking, places 24 hours, filtration, then weighs every part of medicinal material weight, calculate water absorption rate, be shown in Table 1.
1 medicinal material coarse powder water absorption rate of table is investigated
The result shows that the water absorption of medicinal material is about 2 times of medicinal material weight, therefore when decocting first time, 2 times of medicinal materials should be added
The water of amount.
The selection of 3.2 extraction processes
(1) orthogonal test
Using 3 factor, 3 horizontal quadrature test, with solvent usage (A), extraction time (B), extraction time (C) be examination because
Element design L9(34) orthogonal arrage tested, every group parallel three parts.Using general flavone and puerarin content as evaluation index, screening is most
Good technique.
Coarse powder 40g is taken, with water boiling and extraction, filtering, filtrate decompression recycling is dry to get dry extract, and measures content.Factor level
Arrangement is shown in Table 2, the results are shown in Table 3, variance analysis is shown in Table 4.
2 factor level table of table
3 orthogonal experiments of table
Note: comprehensive score Z=(X/Xmax*50+Y/Ymax*50)
4 analysis of variance table of table
Note: F0.05 (2,2)=19.000；F0.01 (2,2)=99.000
The above range analysis result can be seen that factor influences size and is followed successively by B > A > C, and optimised process is A1B1C2,
I.e. plus 6 times of amount water, it extracts 2 times, every time 1 hour；The results of analysis of variance shows solvent usage, extraction time, extraction time to mentioning
Effect is taken not make significant difference.In view of the water absorption rate of each medicinal material, therefore final technique is pueraria lobata, hoveniae semoveniae semen, jujube, dark plum, sand
Benevolence, Radix Glycyrrhizae sort, and are ground into coarse powder, and after adding 8 times of amount water to impregnate 1 hour, heating is decocted 1 hour, and filtration, the dregs of a decoction add 6 times of amounts again
Water decocts 1 hour.
(2) extraction process is verified
Verification test: by the process conditions of above-mentioned determination, three batches of pilot scale verification tests the results are shown in Table 5.
5 verification test result of table
Verification test result reasonable, the general flavone rate of transform is up to 59.7%, and the Puerarin rate of transform is up to 52.7%.By
This determines extraction process are as follows: after pueraria lobata, hoveniae semoveniae semen, jujube, dark plum, fructus amomi, Radix Glycyrrhizae add 8 times of amount water to impregnate 1 hour, heating is decocted
1 hour, filtration, the dregs of a decoction added 6 times of amount water again, decocted 1 hour.Thick paste is made in merging filtrate, concentration.
4, preparation process selects
4.1 auxiliary materials determine
Starch is a kind of common excipient substance, and chemical property is stablized, do not work with most drugs, in air
Without deliquescing, safety, universality are strong, economical for moisture absorption, are easily accepted by patients.This product selects soluble starch as auxiliary material.
4.2 granulation wetting agents determine
This product dried cream powder is extraction process by water, and since hygroscopicity is stronger, mobility is poor, therefore considers appropriate amount of auxiliary materials granulation side
Method, trial test have tried out the ethanol solution of water and various concentration as wetting agent respectively, as a result select 95% ethyl alcohol as wetting
Agent is easy to pelletize, and good product dispersibility, particle is uniform, and drying time is short.
The selection of 4.3 granulating process
Test mainly has been carried out to granulating process to compare, and is shown in Table 6 and table 7, it is determined that granulating process route.
6 preparation process of table screens 1 (powder directly fills capsule)
Test result, dust pollution is big, is unfavorable for labour protection, poor fluidity, and content uniformity is big.
7 preparation process of table screens 2 (capsule is filled after granulation)
Test result, no dustiness are flown upward, and are conducive to labour protection, good fluidity, and content uniformity deviation is smaller.
5, particle flow Journal of Sex Research
5.1 experimental materials: using laboratory process self-control capsule sample (lot number 1,2,3)
5.2 test methods: angle of repose measurement uses fixed funnel method, and 3 funnels are connected and are fixed on bracket simultaneously water
Placing flat above graph paper, make distance H of the mouth away from graph paper under funnel, carefully pour into sample along hopper walls most upper
Funnel in, until the cone tips formed on graph paper touch nethermost bell mouth.Circle is measured by graph paper
The diameter (2R) of cone bottom calculates angle of repose α according to formula tan α=H/R.
The measurement of 5.3 sample angles of repose
It takes sample appropriate, is operated and calculated by angle of repose measuring method, replication 5 times, take mean value.As a result dry cream is measured
The angle of repose of powder is 42.28 °, and the angle of repose of shaped granule is 35.95 °, the results are shown in Table 8,9.
8 dried cream powder angle of repose measurement result of table
The angle of repose measurement result of 9 shaped granule of table
5.4 verifying
(1) capsule content uniformity measures
3 batches of trial production samples are taken, presses and measures its loading amount respectively under " Chinese Pharmacopoeia " (2010 editions) annex capsule item
Difference, 3 batches meet regulation, show that mobility of particle is good, reach filling requirement.As a result 10 be see the table below:
10 capsule content uniformity measurement result of table
(2) determination of moisture
3 batches of trial production samples are taken, moisture is measured by GB5009.3-2010 (the first method), is shown in Table 11:
11 determination of moisture result of table
6, the Study on Hygroscopicity of preparations shaping particle
Bottom: being filled the glass desicator of sodium chloride supersaturated solution by 6.1 experimental methods, are put into 25 DEG C of constant incubators
In for 24 hours, relative humidity in drying box is 75%.In the weighing bottle bottom of constant weight, be put into dried to constant weight sample about
1g, correct amount are placed in above-mentioned drier (weigh the cap opening), save in 25 DEG C of constant incubators, respectively at 4,6,
8,12,24,36,48,60,72,84,96,108, weighed quality after 120h, is calculated by formula 1 Moisture percentage, the results are shown in Table 12.
12 Moisture percentage measurement result of table
Using Moisture percentage as ordinate, humidity exposure time is abscissa, makees sucting wet curve, sees Fig. 1.It can from Fig. 1
Out, hygroscopicity slightly improves after particle is made in dried cream powder, illustrates that supplementary product starch, which is added, can increase the resistance to water soak of this product.It is dry
The hygroscopic capacity of cream powder and shaped granule is all stepped up with the extension of standing time, and after placing about 8h, hygroscopic capacity is super
9% is crossed, the water content of " Chinese Pharmacopoeia " regulation capsule must not exceed 9%, therefore should shorten production process as far as possible, avoid particle
Exposure duration is too long and cause Moisture high UCL in air, agglomerates after the moisture absorption, influences the presentation quality and stability of product.
The measurement of 6.2 critical relative moistures
The supersaturated solution that various concentration sulfuric acid solution and salt are prepared by table 13, is respectively placed in glass desicator, in 25
It is placed 48 hours in DEG C insulating box, its interior humidity balance is made to constitute the environment of different relative humidity (RH).It takes and has dried to perseverance
The shaped granule 1g of weight, is laid in the weighing bottle bottom of constant weight, thickness about 2mm, and above-mentioned difference phase is respectively put into after precision weighing
To (weigh the cap opening) in the drier of humidity, is weighed after being placed 7 days in 25 DEG C of constant incubators, calculate each relative humidity
Under Moisture percentage, the results are shown in Table 13.
Hydroscopicity of the medicinal powder at 25 DEG C under the different relative humidity of table 13
Using Moisture percentage as ordinate, relative humidity (RH) is abscissa mapping, obtains critical relative moisture (CRH) song
Line makees tangent line at CRH curve both ends respectively, and the abscissa of two points of intersection of tangents is critical relative moisture, as a result sees Fig. 2.
Critical value whether critical relative moisture is drug moisture absorption, can according to it is determined that production when ambient humidity.By Fig. 2
It is found that the critical relative moisture of the medicinal powder is about 80%.Therefore crushing, mixing, whole grain and packing when, workshop condition it is relatively wet
Degree should control 80% the influence hereinafter, to avoid moisture to pharmaceutical properties and stability.It produces in practice, the workshop GMP humidity
It controls 60% hereinafter, being suitble to the production of said preparation.
7, pilot process verification test
Three batches of scale up test are carried out by the preparation process drafted, production technology indices are detected, this system is examined
The reasonability of standby technique, the results are shown in Table 14:
14 3 batches of pilot plant test data of table and result
Carry out three batches of scale up test by the preparation process that drafts, production technology indices detected, to product into
The reasonability of this preparation process is examined in row performance rating.Three batches of total yield rates of test are between 91.2%-95.0%.Test knot
Fruit shows that this preparation process highway route design reasonable, technique working condition meet plant produced requirement, process stabilizing, quality
Controllably.
(2) pharmacological function correlative study
1, experimental animal: SPF grades of Kun Ming mices, male, 6~8 week old, weight: 18~22g is tested by Guangdong Province
Animal center provides, and experimental animal produces quality certification number: SCXK (Guangdong) 2008-0002, the certification of fitness number: 0102880.Particle
Feed is also provided by Guangdong Province's Experimental Animal Center.It raises in SPF grades of Animal Lab.s, experimental animal uses credit number:
SYXK (Guangdong) 2008-0011.20~25 DEG C of room temperature, humidity 40~70%.
2, dosage selection gives mode with tested material: experiment sets 0.27, tri- 0.53,1.60g/kg BW dosage groups, is people
5,10,30 times of body recommended daily dosage, separately set blank control group, ethanol control group.Sample is given in stomach-filling, and each dosage group is by daily
Once, each 0.20ml/10g BW stomach-filling is given given the test agent, blank control group and model control group and is given by equivalent capability stomach-filling
Give pure water.Specific dosage is as follows:
Blank control group 0.00g/kg BW
Ethanol control group 0.00g/kg BW
Low dose group 0.27g/kg BW is equivalent to 5 times of recommended daily dosage.
Middle dose group 0.53g/kg BW is equivalent to 10 times of recommended daily dosage.
High dose group 1.60g/kg BW is equivalent to 30 times of recommended daily dosage.
3, key instrument and reagent: Hitachi's 7600-010 full automatic biochemical apparatus.MDA, GSH detection kit are built up by Nanjing
It provides.TG detection kit is provided by Zhong Shengbeikong Biotechnology Ltd..
4, test method
After experimental animal adapts to three days in laboratory conditions, be randomly divided into blank control group, ethanol control group and it is low,
Middle and high three dosage groups, every group of 12 mouse.Three dosage groups give tested material, blank by various dose stomach-filling respectively daily
Control group and ethanol control group give pure water by equivalent capability stomach-filling, animal of weighing weekly, give given the test agent amount with adjustment, altogether
30 days.Each dosage group and ethanol control group give 50% ethyl alcohol with the stomach-filling of 0.12ml/10g BW dosage when off-test, empty
Equivalent capability pure water is given in white control group stomach-filling, and groups of animals fasting is put to death after 16 hours, takes hepatic tissue that liver homogenate is made, and surveys
Determine malonaldehyde (MDA), reduced glutathione (GSH), triglycerides (TG), and takes liver lobus sinister frozen section, oil red dye
Color, light microscopic observation pathological change.
5, test data counts: statistics is for statistical analysis using 11.0 statistical package of SPSS, and statistical method is adopted
With variance analysis and rank sum test.
6, result judges:
(1) liver MDA, reduced form GSH and three Testing index results of triglycerides (TG) are positive.
(2) liver MDA, wantonly two indexs are positive in three Testing index of reduced form GSH and triglycerides (TG) and pathology
Histological indications are positive.
7, test result
Influence of the preparation made of 7.1 present invention to animal subject weight
By table 15 as it can be seen that each dosage group the weight of animals is compared with blank control group, no significant difference (P > 0.05),
Show this given the test agent on the weight of animals without influence.
15 lush nine of table relaxes influence of the board Pueraria lobota trifoliate orange capsule to animal subject weight
Influence of the preparation made of 7.2 present invention to animal subject hepatic tissue MDA, TG content
By table 16 as it can be seen that ethanol control group MDA, TG content increases compared with blank control group, difference has significant
(P < 0.05) shows that liver injury model is set up.Each dosage group TG content reduces compared with ethanol control group, and difference has conspicuousness meaning
Adopted (P < 0.01), experimental result are positive.
16 lush nine of table relaxes influence of the board Pueraria lobota trifoliate orange capsule to hepatic tissue MDA, TG content
Note: 1. △ △ indicate ethanol control group P < 0.01 compared with blank control group.(T inspection)
2.** indicates dosage group P < 0.01 compared with ethanol control group.(variance analysis)
Influence of the preparation made of 7.3 present invention to animal subject hepatic tissue GSH content
By table 17 as it can be seen that ethanol control group GSH content reduces compared with blank control group, difference have significant (P <
0.05), show that liver injury model is set up.Each dosage group GSH content increases compared with ethanol control group, and difference has very significant
Meaning (P0.01), experimental result are positive.
17 lush nine of table relaxes influence of the board Pueraria lobota trifoliate orange capsule to hepatic tissue GSH content
Note: 1. △ indicate ethanol control group P < 0.05 compared with blank control group.(T inspection)
2.*, * * indicate dosage group P < 0.05, P < 0.01 compared with ethanol control group.(variance analysis)
The influence that preparation made of 7.4 present invention changes animal subject hepatic pathology
By table 18 as it can be seen that the pathology of livers of ethanol control group and each dosage group animal is with hepatic cell fattydegeneration
Main, diseased region is mainly around lobuli hepatis.Ethanol control group is compared with blank control group, and having apparent hepar damnification, (liver is thin
Born of the same parents' steatosis), through statistical test, difference has significant (P < 0.01), shows that alcoholic liver injury model is set up.High agent
Compared with ethanol control group, difference has significant (P < 0.05) amount group hepatic cell fattydegeneration, liver pathomorphology inspection
Come to an end the fruit positive.
18 lush nine of table relaxes the influence that board Pueraria lobota trifoliate orange capsule changes animal subject liver pathomorphology
Note: standards of grading: 0 is substantially normal；I sick cell accounts for the 1/4 of whole visual field；II sick cell accounts for whole visual field
1/2；III sick cell accounts for the 3/4 of whole visual field；IV sick cell accounts for whole visual field.
1. △ △ indicates ethanol control group P < 0.05 compared with blank control group, P < 0.01.(rank sum test)
2.* indicates dosage group P < 0.05, P < 0.01 compared with ethanol control group.(rank sum test)
8, conclusion
(1) compared with ethanol control group, given the test agent reduces each dosage group hepatic tissue TG content, and experimental result is positive.
(2) compared with ethanol control group, given the test agent increases each dosage group hepatic tissue GSH content, and experimental result is positive.
(3) compared with ethanol control group, given the test agent cannot reduce each dosage group Liver MDA, experimental result yin
Property.
(4) compared with ethanol control group, each dosage group hepatic cell fattydegeneration of given the test agent subtracts compared with ethanol control group
Gently, liver pathomorphology inspection result is positive.
To sum up, health-care preparation of the invention can effectively prevent ethyl alcohol that liver GSH is caused to exhaust the liter with TG content
Height mitigates hepatic cell fattydegeneration, has the function of preventing liver injury.
According to above-mentioned biochemical and pathological examination as a result, " health food is examined and assessment technique specification (2003 according to the Ministry of Public Health
Version) " criterion, preparation of the invention to chemical damage have auxiliary protection function.
(3) comparative test
Prescription 1: application No. is a kind of 200910102475.0 patent of invention " traditional Chinese medicine health care products for preventing and treating alcoholic liver disease
Prescription disclosed in preparation and preparation method thereof ".
Prescription 2: prescription of the present invention belongs to the improvement prescription to prescription 1.
It is specific to improve reason are as follows:
1, since flower of kudzuvine is not included in " the food and medicament dual-purpose list " or " can be used for the item name of food that national Bureau of Drugs Supervision promulgates
It is single " in, risk that Gu Fangzhong has flower of kudzuvine to have regulation in declaring.Consider to remove flower of kudzuvine in prescription, adjusts other prescriptions proportion, with
Guarantee effect.
2, through trial test, after removing flower of kudzuvine, adjusted pueraria lobata and prescription other drugs proportion, through volunteer's test-meal, two
Prescription dispelling effects of alcohol is suitable.
In 3 months in 20 aspiration examination trenchermans, same people carries out test-meal to two prescription samples respectively, before drinking
Half an hour takes 4, it is had a stomach upset, is dizzy in drinking and after drinking, the symptoms such as vomiting are than not edible obvious good, wine for readme
What amount was significantly increased, if taking 4 again after drinking, second day people is relatively awake.And two imperceptible notable differences of prescription (are shown in Table
19)。
The aspiration examination trencherman's readme dispelling effects of alcohol of table 19
| Compare | Capacity for liquor | It has a stomach upset | Vomit phenomenon | Dizziness |
| Prescription 1 | Increase () | Alleviate | It reduces | Light or nothing |
| Prescription 2 | Increase | Comfortably | It reduces | Light or nothing |
| It does not take | Without increase and decrease | There is sense of discomfort | Vomiting | It is dizzy |
Currently, prescription of the present invention through Disease Control and Prevention Center of Guangdong Province experiments have shown that, this product is safe and non-toxic, to chemical damage have
There is auxiliary treatment functio.New recipe evaluate center audit and pass through by national health food, and core sends out official written reply.
The beneficial effects of the present invention are:
(1) inventive formulation follows China's traditional Chinese medicine theory, and the property of pueraria lobata sweet and cool-natured is used in side, taste is walked, can promote the production of body fluid
Quench the thirst, causes fluid deficiency and thirst, giving consideration to both the incidental and fundamental, for monarch drug in a prescription for alcohol retention of damp-heat in the interior.It is secondary sweet, flat with hoveniae semoveniae semen, quench the thirst, relieving restlessness,
With solve excess heat hurt saliva cause it is thirsty vexed, separately there is the function of relieving alcoholism to effect a permanent cure with eliminating evil；The property of the sweet temperature of jujube, helps qi and blood metaplasia with nourishing the liver
Blood, and take into account tonifying spleen and help fortune with righting；The tart flavour levelling of dark plum, which focuses on, promotes the production of body fluid, based on temporary solution；Three medicines are total to principal drug assistance as ministerial drug.
The pungent-warm of fructus amomi, helps the advantageous dampness elimination of spleen health movement, burnt mechanism of qi in pungent row, is for adjutant for sweet etc. in gastral cavilty turgor, mouth.It is sweet
Grass takes into account strengthening spleen and invigorating qi, has coordinating the drug actions of a prescription, for adjuvant.Above all medicines share, and embody liver and spleen with controlling, qi and blood is taken into account, eliminating evil
The formula feature of righting.
(2) applicant improves original proportion, eliminates flower of kudzuvine, has adjusted the recipe quantity of the components such as pueraria lobata,
Showing new recipe still through animal experiment has the function of good protection chemical damage, can be with effectively preventing alcohol
The generation of property hepatopathy.And belong to nontoxic grade, it is used as health food safe.
(3) present invention is that " the flower of kudzuvine ball " neutralized the effect of alcoholic drinks in soup and Ming Dynasty's " Prescriptions for Universal Relief " with the flower of kudzuvine in gold dollar epoch " Treatise on the spleen and stomach " is
Square foundation, in conjunction with the civil regular convention formula in Guizhou, through adding and subtracting.Original side is to use with decoction or big honeyed bolus.To keep original side to treat
Effect is tested us according to the effective elements of the medicine each in side and property and has been selected taking water as a solvent the drug effects of 6 taste medicines in extraction side
Ingredient.
Modern research shows that pueraria lobata is rich in effective components such as isoflavones, saponin(es in side；Pharmacological research is found, different contained by pueraria lobata
Flavone compound has the effects that Antialcoholic liver-protecting using Puerarin as representative, has very big value of exploiting and utilizing.Hoveniae semoveniae semen
Effective component is saponin(e and glucosides, alkaloid, fatty acid etc., and water-soluble portion has the work of preferably treatment alcoholism liver protection
Property.Other a few taste medicines then contain the effective components such as flavones, volatile oil.The effective component of each herbal medicine is special in this process synthesis consideration side
Property and production it is practical, selected water for Extraction solvent.The use of organic solvent is compared, purified water is selected to make Extraction solvent more
Safety, absorbs the advantages that fast, bioavilability is high at economic, environmental protection.
(4) in Extraction technique investigation, we grind extraction conditions and technological parameter using orthogonal design
Study carefully.Selected functional component: the recovery rate of general flavone and Puerarin is as technique inspection target, to improve Product Process reasonability
And quality controllability.
(5) suitable starch is added in the disadvantages of easy to moisture absorption for water extract in pelletization, on the one hand can reduce the system
The hygroscopicity of agent, and mobility of particle can be increased, improve product sucting wet stability and content uniformity qualification rate.
(6) capsule can be made by modern biotechnology extraction purification and preparation means in this product, can reduce dose, mention
High bioavilability, dosage form is classical, conveniently takes, carries and stores, convenient for large-scale production, the controllability of raising product quality
And stability.
Detailed description of the invention
Fig. 1 is invention formulation particle sucting wet curve.
Fig. 2 is invention formulation Particles at Critical relative humidity curve.
Fig. 3 is 1 traditional Chinese medicine health care product capsule production technological process of the embodiment of the present invention.
Specific embodiment
A kind of preparation for the traditional Chinese medicine health care product capsule for protecting chemical damage of embodiment 1
GMP requirement should be met by preparing used production environment and management, crush, sieving, mix in formulation manufacturing processes,
Meeting GB17405-1998, " health food well produces rule to the technical process such as granulation, drying, whole grain, total mix, inner packing
Model " production clean area under the conditions of operate, other steps are operated in general production district.Concrete operations are as follows:
1, pre-treatment: hoveniae semoveniae semen, dark plum, jujube, fructus amomi sort spare；Pueraria lobata, Radix Glycyrrhizae sort, are sliced when necessary, spare.
Each supplementary material should all can just be received after the assay was approved by respective standard.
2, ingredient: weighing each supplementary material by formula rate, spare.Pronucleus is weighed to the supplementary material name of an article, lot number, specification, number
Amount；It is weighed with electronic scale.
3, extract: pueraria lobata, hoveniae semoveniae semen, dark plum, jujube, fructus amomi, Radix Glycyrrhizae, for the first time plus 8 times of amount water impregnate 1h, and it is small to decoct 1
When, second plus 6 times of amount water decoction 1h, collecting decoction, filtration (stainless (steel) wire, 80 mesh).
4, be concentrated: filtrate decompression is concentrated into the thick paste that relative density is 1.25~1.28 (70 DEG C, vacuum degree -0.07MPa).
5, dry: 70 DEG C, vacuum degree -0.07MPa is dried under reduced pressure 6 hours, is crushed, and 65 meshes are crossed.
6, it mixes: dried cream powder addition starch is uniformly mixed.
7, pelletize: 95% ethyl alcohol wet granulation crosses 24 meshes.
8, whole grain: 60 DEG C of wet granular dry 4h, with 24 mesh sieves.
9, total mix: particle mixes in V-Mixer.
10, capsule is filled: particle is filling with No. 0 capsule, and loading amount 0.4g/.Capsule shells should meet " Chinese Pharmacopoeia " 2010
Requirement under year two items of page 1204 of version.
11, inner packing: qualified capsule will be examined to be packed with oral stable medicinal polythene bottle with high density, per bottled 32
Grain, oral stable medicinal polythene bottle with high density should meet the regulation of YBB00122002.
12, outer packing, inspection, storage.(its production technological process is shown in Fig. 3)
A kind of preparation for the traditional Chinese medicine health care product capsule for protecting chemical damage of embodiment 2
GMP requirement should be met by preparing used production environment and management, crush, sieving, mix in formulation manufacturing processes,
Meeting GB17405-1998, " health food well produces rule to the technical process such as granulation, drying, whole grain, total mix, inner packing
Model " production clean area under the conditions of operate, other steps are operated in general production district.Concrete operations are as follows:
1, pre-treatment: hoveniae semoveniae semen, dark plum, jujube, fructus amomi sort spare；Pueraria lobata, Radix Glycyrrhizae sort, are sliced when necessary, spare.
Each supplementary material should all can just be received after the assay was approved by respective standard.
2, ingredient: weighing each supplementary material by formula rate, spare.Pronucleus is weighed to the supplementary material name of an article, lot number, specification, number
Amount；It is weighed with electronic scale.
3, extract: pueraria lobata, hoveniae semoveniae semen, dark plum, jujube, fructus amomi, Radix Glycyrrhizae, for the first time plus 6 times of amount water impregnate 1.5h, decoct
Amount water decocts 1h within 1.5 hours, second plus 7 times, and collecting decoction filters (stainless (steel) wire, 80 mesh).
4, be concentrated: filtrate decompression is concentrated into the thick paste that relative density is 1.25~1.28 (70 DEG C, vacuum degree -0.07MPa).
5, dry: 70 DEG C, vacuum degree -0.07MPa is dried under reduced pressure 5 hours, is crushed, and 65 meshes are crossed.
6, it mixes: dried cream powder addition starch is uniformly mixed.
7, pelletize: 90% ethyl alcohol wet granulation crosses 24 meshes.
8, whole grain: 70 DEG C of wet granular dry 3h, with 24 mesh sieves.
9, total mix: particle mixes in V-Mixer.
10, capsule is filled: particle is filling with No. 0 capsule, and loading amount 0.4g/.Capsule shells should meet " Chinese Pharmacopoeia " 2010
Requirement under year two items of page 1204 of version.
11, inner packing: qualified capsule will be examined to be packed with oral stable medicinal polythene bottle with high density, per bottled 32
Grain, oral stable medicinal polythene bottle with high density should meet the regulation of YBB00122002.
12, outer packing, inspection, storage.
A kind of preparation for the traditional Chinese medicine health care product capsule for protecting chemical damage of embodiment 3
GMP requirement should be met by preparing used production environment and management, crush, sieving, mix in formulation manufacturing processes,
Meeting GB17405-1998, " health food well produces rule to the technical process such as granulation, drying, whole grain, total mix, inner packing
Model " production clean area under the conditions of operate, other steps are operated in general production district.Concrete operations are as follows:
1, pre-treatment: hoveniae semoveniae semen, dark plum, jujube, fructus amomi sort spare；Pueraria lobata, Radix Glycyrrhizae sort, are sliced when necessary, spare.
Each supplementary material should all can just be received after the assay was approved by respective standard.
2, ingredient: weighing each supplementary material by formula rate, spare.Pronucleus is weighed to the supplementary material name of an article, lot number, specification, number
Amount；It is weighed with electronic scale.
3, extract: pueraria lobata, hoveniae semoveniae semen, dark plum, jujube, fructus amomi, Radix Glycyrrhizae, for the first time plus 10 times of amount water impregnate 1h, and it is small to decoct 1
When, second plus 5 times of amount water decoction 1h, collecting decoction, filtration (stainless (steel) wire, 80 mesh).
4, be concentrated: filtrate decompression is concentrated into the thick paste that relative density is 1.25~1.28 (70 DEG C, vacuum degree -0.07MPa).
5, dry: 70 DEG C, vacuum degree -0.07MPa is dried under reduced pressure 7 hours, is crushed, and 65 meshes are crossed.
6, it mixes: dried cream powder addition starch is uniformly mixed.
7, pelletize: 98% ethyl alcohol wet granulation crosses 24 meshes.
8, whole grain: 70 DEG C of wet granular dry 5h, with 24 mesh sieves.
9, total mix: particle mixes in V-Mixer.
10, capsule is filled: particle is filling with No. 0 capsule, and loading amount 0.4g/.Capsule shells should meet " Chinese Pharmacopoeia " 2010
Requirement under year two items of page 1204 of version.
11, inner packing: qualified capsule will be examined to be packed with oral stable medicinal polythene bottle with high density, per bottled 32
Grain, oral stable medicinal polythene bottle with high density should meet the regulation of YBB00122002.
12, outer packing, inspection, storage.
A kind of traditional Chinese medicine health care product granule preparation for protecting chemical damage of embodiment 4
GMP requirement should be met by preparing used production environment and management, crush, sieving, mix in formulation manufacturing processes,
The technical process such as granulation, drying, inner packing are in the production for meeting GB17405-1998 " health food Good Manufacture Practice ke "
It is operated under the conditions of clean area, other steps are operated in general production district.Concrete operations are as follows:
1, pre-treatment: hoveniae semoveniae semen, dark plum, jujube, fructus amomi sort spare；Pueraria lobata, Radix Glycyrrhizae sort, are sliced when necessary, spare.
Each supplementary material should all can just be received after the assay was approved by respective standard.
2, ingredient: weighing each supplementary material by formula rate, spare.Pronucleus is weighed to the supplementary material name of an article, lot number, specification, number
Amount；It is weighed with electronic scale.
3, it extracts: proportionally weighing the net medicinal material of pueraria lobata, hoveniae semoveniae semen, dark plum, jujube, fructus amomi, Radix Glycyrrhizae, add 6 times of amount water loggings
1h is steeped, is decocted 2 times, each 1.5h, collecting decoction, is filtered (stainless (steel) wire, 80 mesh).
4, be concentrated: filtrate decompression is concentrated into the thick paste that relative density is 1.25~1.28 (70 DEG C, vacuum degree -0.07MPa).
5, dry: 70 DEG C, vacuum degree -0.07MPa is dried under reduced pressure 6 hours, crosses 65 meshes.
6, it crushes, mixing: being added appropriate soluble starch, pelletizes.
6, it dispenses: it is packed, 10g/ bags.
7, outer packing, inspection, storage.
A kind of preparation for the traditional Chinese medicine health care product oral solution for protecting chemical damage of embodiment 5
Production environment used by preparing and management should meet GMP requirement, alcohol precipitation in formulation manufacturing processes, concentration, dilution,
The technical process such as filling, inner packing are in the production clean area item for meeting GB17405-1998 " health food Good Manufacture Practice "
It is operated under part, other steps are operated in general production district.Concrete operations are as follows:
1, pre-treatment: hoveniae semoveniae semen, dark plum, jujube, fructus amomi sort spare；Pueraria lobata, Radix Glycyrrhizae sort, are sliced when necessary, spare.
Each supplementary material should all can just be received after the assay was approved by respective standard.
2, ingredient: weighing each supplementary material by formula rate, spare.Pronucleus is weighed to the supplementary material name of an article, lot number, specification, number
Amount；It is weighed with electronic scale.
3, the net medicinal material of pueraria lobata, hoveniae semoveniae semen, dark plum, jujube, fructus amomi, Radix Glycyrrhizae is proportionally weighed, 10 times of amount water is added to impregnate
0.5h is decocted 3 times, each 1h, collecting decoction, is filtered (stainless (steel) wire, 80 mesh).
4, be concentrated: filtrate decompression is concentrated into the clear cream that relative density is 1.25~1.28 (70 DEG C, vacuum degree -0.07MPa).
5, alcohol precipitation: ethyl alcohol is recovered under reduced pressure in 60% ethanol precipitation 24 hours, filtering.
6, filling: it is diluted with water to each prescription 2500ml, it is 10ml/ bottles filling.
7, outer packing, inspection, storage.
Claims (8)
1. a kind of traditional Chinese medicine health care product preparation for protecting chemical damage, which is characterized in that in parts by weight, it is by Pueraria lobota
It is 380~420 parts of root, 300~340 parts of hoveniae semoveniae semen, 280~320 parts of jujube, 280~320 parts of dark plum, 130~170 parts of fructus amomi, sweet
Made of 130~170 parts and 60~100 parts of starch of grass.
2. a kind of traditional Chinese medicine health care product preparation for protecting chemical damage according to claim 1, which is characterized in that according to
Listed as parts by weight, it is by 400 parts of pueraria lobata, 320 parts of hoveniae semoveniae semen, 300 parts of jujube, 300 parts of dark plum, 150 parts of fructus amomi, Radix Glycyrrhizae 150
Part and 80 parts of starch made of.
3. a kind of traditional Chinese medicine health care product preparation for protecting chemical damage according to claim 1, which is characterized in that described
Traditional Chinese medicine health care product preparation be oral preparation.
4. a kind of traditional Chinese medicine health care product preparation for protecting chemical damage according to claim 3, which is characterized in that described
Oral preparation be capsule.
5. the preparation side of the traditional Chinese medicine health care product preparation of chemical damage is protected described in any one according to claim 1~4
Method, which is characterized in that proportionally weigh the net medicinal material of pueraria lobata, hoveniae semoveniae semen, dark plum, jujube, fructus amomi, Radix Glycyrrhizae, add 6~10 times of amount water
0.5~1.5h is impregnated, is decocted 2~3 times, 1~2h, collecting decoction, filtration, filtrate decompression are concentrated into 70 DEG C, vacuum degree-every time
The thick paste that relative density is 1.25~1.28 under 0.07MPa is proportionally added into supplementary product starch and is uniformly mixed, is made a variety of different
Dosage form to get.
6. a kind of preparation method of traditional Chinese medicine health care product preparation for protecting chemical damage according to claim 5, special
Sign is, proportionally weighs the net medicinal material of pueraria lobata, hoveniae semoveniae semen, dark plum, jujube, fructus amomi, Radix Glycyrrhizae, add 6~10 times of amount water impregnate 1~
2h is decocted 1~1.5 hour for the first time, and second plus 5~7 times of amount water 1~1.5h of decoction, collecting decoction, filtration, filtrate decompression
It is concentrated into 70 DEG C, the thick paste that relative density is 1.25~1.28 under vacuum degree -0.07MPa, is continued in 70 DEG C, vacuum degree -
It is dried under reduced pressure 5~7 hours, crushes under 0.07MPa, cross 65 meshes, dried cream powder is made, then proportionally add in dried cream powder again
Enter supplementary product starch, after mixing, cross 24 meshes with 90~98% ethyl alcohol, pelletize, 60~80 DEG C drying 3~5 hours, mistake 24 mesh
Sieve, whole grain, total mix, filling capsule is to get capsule.
7. a kind of preparation method of traditional Chinese medicine health care product preparation for protecting chemical damage according to claim 6, special
Sign is, proportionally weighs the net medicinal material of pueraria lobata, hoveniae semoveniae semen, dark plum, jujube, fructus amomi, Radix Glycyrrhizae, and 8 times of amount water is added to impregnate 1h, first
Secondary to decoct 1 hour, for the second time plus 6 times of amount water decoct 1h, and collecting decoction filters, and filtrate decompression is concentrated into 70 DEG C, vacuum degree-
The thick paste that relative density is 1.25~1.28 under 0.07MPa, continuation are dried under reduced pressure 6 hours at 70 DEG C, vacuum degree -0.07MPa,
It crushes, crosses 65 meshes, dried cream powder is made, supplementary product starch is then proportionally added in dried cream powder again, after mixing, use
95% ethyl alcohol crosses 24 meshes, granulation, 60 DEG C drying 4 hours, mistake 24 meshes, whole grain, total mix, filling capsule is to get capsule.
8. a kind of preparation method of traditional Chinese medicine health care product preparation for protecting chemical damage according to claim 6 or 7,
It is characterized in that, the filtration is carried out using the stainless (steel) wire of 80 mesh.
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| CN106511838B (en) * | 2016-12-30 | 2019-07-26 | 河南中医药大学 | A kind of Chinese medicinal granule for treating alcoholic liver injury |
| CN109045239B (en) * | 2018-11-07 | 2021-11-02 | 贵州师范大学 | Traditional Chinese medicine extract, preparation method thereof and application thereof in preparation of anti-cancer drugs |
| CN114521648A (en) * | 2020-11-23 | 2022-05-24 | 辽宁医学诊疗科技研发中心有限公司 | Food composition with auxiliary protection function on chemical liver injury and preparation method thereof |
| CN116077610B (en) * | 2022-12-01 | 2024-04-12 | 湖北药昇中药科技有限公司 | Traditional Chinese medicine composition for relieving alcoholic liver injury, preparation method and application thereof |
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| CN101011170A (en) * | 2006-11-07 | 2007-08-08 | 北京汉潮联创中药科技有限公司 | Antialcoholic plant beverage and its preparation method |
| CN101152288A (en) * | 2007-10-19 | 2008-04-02 | 中国热带农业科学院热带生物技术研究所 | Traditional Chinese medicine with anti-inebriation function |
| CN101502627A (en) * | 2009-03-20 | 2009-08-12 | 贵阳云岩青青生物科技有限公司 | Chinese medicine health product preparation for preventing and treating alcoholic liver disease and preparation method thereof |
| CN102579958A (en) * | 2012-03-31 | 2012-07-18 | 西南大学 | Alcoholism-relieving and liver-protecting composition, extract, preparation method and preparation of extract |
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|---|---|---|---|---|
| CN101011170A (en) * | 2006-11-07 | 2007-08-08 | 北京汉潮联创中药科技有限公司 | Antialcoholic plant beverage and its preparation method |
| CN101152288A (en) * | 2007-10-19 | 2008-04-02 | 中国热带农业科学院热带生物技术研究所 | Traditional Chinese medicine with anti-inebriation function |
| CN101502627A (en) * | 2009-03-20 | 2009-08-12 | 贵阳云岩青青生物科技有限公司 | Chinese medicine health product preparation for preventing and treating alcoholic liver disease and preparation method thereof |
| CN102579958A (en) * | 2012-03-31 | 2012-07-18 | 西南大学 | Alcoholism-relieving and liver-protecting composition, extract, preparation method and preparation of extract |
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