CN110420264A - A kind of Chinese medicine composition and its preparation method and application - Google Patents

A kind of Chinese medicine composition and its preparation method and application Download PDF

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CN110420264A
CN110420264A CN201910640819.7A CN201910640819A CN110420264A CN 110420264 A CN110420264 A CN 110420264A CN 201910640819 A CN201910640819 A CN 201910640819A CN 110420264 A CN110420264 A CN 110420264A
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chinese medicine
medicine composition
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food
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CN110420264B (en
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肖伟
杨晓筱
李曼曼
张海弢
王婧
范业文
郭小莉
柏伟荣
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Jiangsu Kanion Pharmaceutical Co Ltd
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    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/105Plant extracts, their artificial duplicates or their derivatives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/25Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
    • A61K36/258Panax (ginseng)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/488Pueraria (kudzu)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
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    • A61K36/53Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • A61K36/537Salvia (sage)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/57Magnoliaceae (Magnolia family)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/72Rhamnaceae (Buckthorn family), e.g. buckthorn, chewstick or umbrella-tree
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/79Schisandraceae (Schisandra family)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23VINDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00Food compositions, function of food ingredients or processes for food or foodstuffs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30Extraction of the material
    • A61K2236/33Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/331Extraction 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
    • AHUMAN NECESSITIES
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    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30Extraction of the material
    • A61K2236/39Complex extraction schemes, e.g. fractionation or repeated extraction steps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/50Methods involving additional extraction steps
    • A61K2236/51Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying

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Abstract

The present invention provides a kind of Chinese medicine compositions and its preparation method and application.The Chinese medicine composition is made of 1-8 parts of Radix Salviae Miltiorrhizaes, 1-6 parts of pueraria lobatas, 1-6 parts of hoveniae semoveniae semens, 0.5-5 portions of Radix Notoginseng and 0.5-5 portions of Schisandra chinensis.The present composition have Radix Salviae Miltiorrhizae, pueraria lobata, hoveniae semoveniae semen, Radix Notoginseng, Schisandra chinensis comprehensive function; and it mutually acts synergistically; the effect for greatly improving one-component, proves through functional experiment, and composition of the invention has good auxiliary protection function to chemical damage.And preparation method is simple, is suitble to the needs of scale industrial production.

Description

A kind of Chinese medicine composition and its preparation method and application
Technical field
The invention belongs to hepatic injury technical fields, and in particular, to a kind of Chinese medicine composition with liver protection effect and its Preparation method and application.
Background technique
Chemical damage is primarily referred to as from harmful chemicals such as work living environment, food, drug and heavy drinkings Hepatic injury caused by substance.As the liver of the important removing toxic substances organ of human body, there is arteria hepatica and vena hepatica double blood supply.Change Substance can enter liver by gastrointestinal tract portal vein or body circulation and be converted, therefore liver is easy by the poison in chemicals Property material damage.Often there are some pairs of virose substances of liver in industrial processes, referred to as " hepatotropic poison ".This A little poisonous substances are generally existing in crowd, and incubation period is short, and the process of lesion is directly related with infective dose, strong and weak according to toxicity, These hepatotropic poisons can be divided into three classes: (1) hypertoxic class: including phosphorus, trinitrotoluene, carbon tetrachloride, chloronaphthalene, methacrylaldehyde etc.;(2) Hypertoxic type: arsenic, mercury, antimony, aniline, chloroform, arsenic hydride, dimethylformamide etc.;(3) lower toxicity: dinitrophenol dinitrophenolate, acetaldehyde, organic Phosphorus, acrylonitrile, lead etc..
In recent years, patients with liver deficiency is more and more, comes therewith, and various protect liver prescriptions occurs in market, but it is effectively Ingredient is unknown, and the mechanism of action is unclear, fails to provide enough pharmacology and pathology are explained, while to carry out relevant animal Or human trial, toxic hazard are indefinite.Therefore, develop and develop it is curative for effect to chemical damage have auxiliary protect The product of shield effect has become an important topic of today's society.
Summary of the invention
In view of this, the Chinese medicine composition for having auxiliary protection function the invention is intended to provide a kind of pair of chemical damage, By weight, the composition includes 1-8 parts of Radix Salviae Miltiorrhizaes, 1-6 parts of pueraria lobatas, 1-6 parts of hoveniae semoveniae semens, 0.5-5 portions of Radix Notoginseng and 0.5-5 part five Taste.
In some embodiments of the invention, the Chinese medicine composition includes 8 parts of Radix Salviae Miltiorrhizaes, 6 parts of pueraria lobatas, 6 parts of hoveniae semoveniae semens, 5 Part Radix Notoginseng and 5 portions of Schisandra chinensis.
In some embodiments of the invention, the Chinese medicine composition includes 6 parts of Radix Salviae Miltiorrhizaes, 5 parts of pueraria lobatas, 5 parts of hoveniae semoveniae semens, 4 Part Radix Notoginseng and 3 portions of Schisandra chinensis.
In some embodiments of the invention, the Chinese medicine composition includes 5 parts of Radix Salviae Miltiorrhizaes, 3 parts of pueraria lobatas, 3 parts of hoveniae semoveniae semens, 2 Part Radix Notoginseng and 2 portions of Schisandra chinensis.
The present invention also provides a kind of methods for preparing above-mentioned Chinese medicine composition comprising step:
It takes medicinal material to be added 6-10 times and measures water boiling and extraction 2-4 times, Extracting temperature is 90-100 DEG C, 1-3 hours each, filter It crosses, merging filtrate obtains filtrate;
Gained filtrate is concentrated under reduced pressure under the conditions of 60 ± 5 DEG C -80 ± 5 DEG C, being concentrated into relative density is 1.10-1.30, Then it is dried under reduced pressure to obtain dry extract under the conditions of 60 ± 5 DEG C -80 ± 5 DEG C, the dry extract grinding and sieving obtains in described Drug composition.
The invention further relates to above-mentioned Chinese medicine compositions to prevent and treat the application in hepatic injury.
The present invention also provides a kind of drug, food or health care product, the drug, the food or the health care product are by upper Acceptable auxiliary material or additive on Chinese medicine composition and pharmacy or food is stated to be made.
In some embodiments of the invention, the auxiliary material includes dextrin, microcrystalline cellulose, magnesium stearate, lactose, crosslinking Sodium carboxymethylcellulose, cornstarch, wheaten starch, potato starch or silica.
In some embodiments of the invention, the drug is Chinese materia medica preparation.
In some embodiments of the invention, the dosage form of the Chinese materia medica preparation is tablet, granule or capsule.
Radix Salviae Miltiorrhizae has the function of activating microcirculation and removing stasis medicinal.Pueraria lobata is China's traditional Chinese medicine, first recorded in Shennong's Herbal, main department's hair Table expelling pathogenic factors from muscles and skin, antipyretic promotes the production of body fluid at invigorating vital function and promoting eruption.Hoveniae semoveniae semen has significant antialcoholism action.Radix Notoginseng has the function of activating microcirculation and removing stasis medicinal.Schisandra chinensis Have the function of that tonifying Qi is promoted the production of body fluid.Radix Salviae Miltiorrhizae and pueraria lobata are shared with activating microcirculation and removing stasis medicinal, and the two compatibility is the concrete embodiment of rising Yang stagnation resolvation method; " Radix Salviae Miltiorrhizae-Radix Notoginseng " is classical clinical compatibility medicine pair, and Radix Salviae Miltiorrhizae has both the function enriched blood and invigorated blood circulation, Radix Notoginseng while removing blood stasis and hemostasis, Also there is the effect of Xu-tonic;Pueraria lobata and hoveniae semoveniae semen share, and can reduce ethanol content in rat blood.
Present invention combination Chinese medicine and present-day medical knowledge select the integration of drinking and medicinal herbs of State Bureau's promulgation or can use health food Raw material, scientific compatibility form.Prescription definite functions, no incompatibility, edible safety is effective, can play good health-care effect.
It is proved through functional experiment, composition of the invention has good auxiliary protection function to chemical damage.And And preparation method is simple, is suitble to the needs of scale industrial production.
Additional aspect and advantage of the invention will be set forth in part in the description, and will partially become from the following description Obviously, or practice through the invention is recognized.
Specific embodiment
The person that is such as not specified actual conditions is tested below, is carried out according to conventional conditions or manufacturer's recommended conditions, it is used Bulk pharmaceutical chemicals or auxiliary material and reagents or instruments used without specified manufacturer are that can be produced by the routine of commercially available acquisition Product.Unless otherwise stated, otherwise all percentage, ratio, ratio or number be by weight.
Unless otherwise defined, it anticipates known to all professional and scientific terms as used herein and one skilled in the art Justice is identical.In addition, any method similar to or equal to what is recorded and material can all be applied and the present invention.
Following preparation methods in relation to the present composition or preparation only enumerate the obtained through refining method of the present invention, but do not answer This is interpreted as preparation method of the invention and is only limited to above-mentioned cited method.
Component used in the present invention such as Radix Salviae Miltiorrhizae, pueraria lobata, hoveniae semoveniae semen, Radix Notoginseng and Schisandra chinensis are commercially available Chinese medicine.The present invention Composition can directly pulverize, be also possible to by extract made from the conventional means of this field etc..
The preparation of Chinese medicine composition
Embodiment 1
8 parts of Radix Salviae Miltiorrhizae, 6 parts of pueraria lobata, 6 parts of hoveniae semoveniae semen, 5 parts of Radix Notoginseng, 5 parts of Schisandra chinensis are taken, 6 times of amount water is added to extract 4 times, extracts temperature Degree is 90-100 DEG C, and 1 hour every time, filtration, merging filtrate was concentrated under reduced pressure into relative density 1.30 under the conditions of 80 ± 5 DEG C, so It is dried under reduced pressure to obtain dry extract at 60 ± 5 DEG C afterwards, is crushed through Universalpulverizer, after sieving to obtain the final product.
Embodiment 2
6 parts of Radix Salviae Miltiorrhizae, 5 parts of pueraria lobata, 5 parts of hoveniae semoveniae semen, 4 parts of Radix Notoginseng, 3 parts of Schisandra chinensis are taken, 10 times of amount water is added to extract 2 times, is extracted Temperature is 90-100 DEG C, and 2 hours every time, filtration, merging filtrate was concentrated under reduced pressure into relative density 1.10 under the conditions of 60 ± 5 DEG C, Then it is dried under reduced pressure to obtain dry extract at 80 ± 5 DEG C, it is crushed through Universalpulverizer, after sieving to obtain the final product.
Embodiment 3
5 parts of Radix Salviae Miltiorrhizae, 3 parts of pueraria lobata, 3 parts of hoveniae semoveniae semen, 2 parts of Radix Notoginseng, 2 parts of Schisandra chinensis are taken, 8 times of amount water is added to extract 3 times, extracts temperature Degree is 90-100 DEG C, and 1.5 hours every time, filtration, merging filtrate was concentrated under reduced pressure into relative density 1.20 under the conditions of 70 ± 5 DEG C, Then it is dried under reduced pressure to obtain dry extract at 70 ± 5 DEG C, is crushed through Universalpulverizer, after sieving to obtain the final product.
Comparative example 1
Chinese medicine composition is prepared, which is mentioned by 5 parts of Salvia root P.Es, 3 parts of kudzu root extracts, 3 parts of hoveniae semoveniae semens After taking object, 2 parts of Schisandra chinens P.Es, 2 parts of tea polyphenols to mix to obtain the final product.Wherein, Salvia root P.E, kudzu root extract, hoveniae semoveniae semen mention Taking object, Schisandra chinens P.E, tea polyphenols, specific preparation process is as follows:
The preparation method of raisin tree seed extract: medicinal material hoveniae semoveniae semen being eluriated, drying, and fritter, smashed trifoliate orange is made in crushing Dulcis weighing, is put into extractor, extracts under reflux state.When first time refluxing extraction, water, amount of water are added in extractor It is 8-10 times (W/W) of hoveniae semoveniae semen weight, is heated to starting timing after boiling, refluxing extraction 2 hours;It is complete to first time refluxing extraction Cheng Hou, second of refluxing extraction operation is the same as the first time;After the completion of second of refluxing extraction, third time amount of water is grasped twice with preceding Make identical (W/W), the timing since being heated to after boiling, refluxing extraction 1.5 hours.Merge filtrate obtained by refluxing extraction three times, it will Filtrate is concentrated under reduced pressure in 70-80 DEG C of temperature values, and obtaining specific gravity is 1.0-1.1 concentrate.Spray drying crushes, mistake 80 meshes obtain raisin tree seed extract after screening.
The preparation method of Salvia root P.E: medicinal material Radix Salviae Miltiorrhizae being cleaned, drying, and fritter is made in crushing.Smashed Radix Salviae Miltiorrhizae claims It is put into extractor after weight, the ethyl alcohol of content 85% is added, ethyl alcohol extracts three times at reflux.First time refluxing extraction When, amount of alcohol added is 8-10 times (W/W) of Radix Salviae Miltiorrhizae weight, the timing since being heated to after boiling, refluxing extraction 2 hours;To After the completion of refluxing extraction, second of operation is same as above;After the completion of second of refluxing extraction, third time is added with containing gauge The ethyl alcohol of lattice, identical weight refluxing extraction 1.5 hours, merges the filtering of filtrate obtained by refluxing extraction three times, in 70-80 DEG C of temperature It is worth reduced pressure in range, obtaining specific gravity is 1.0-1.1 concentrate, is spray-dried, and is crushed, and 80 meshes are crossed, and Radix Salviae Miltiorrhizae is obtained after screening Extract.
The preparation method of kudzu root extract: medicinal material pueraria lobata being eluriated, drying, and fritter is made in crushing, and smashed pueraria lobata claims It resets in extractor, is extracted three times under reflux state.When first time refluxing extraction, water is added in extractor, amount of water is 10 times (W/W) of pueraria lobata weight are heated to starting timing after boiling, refluxing extraction 2 hours;After the completion of first time refluxing extraction, Second of refluxing extraction operation is the same as the first time;After the completion of second of refluxing extraction, third time amount of water is 8 times of pueraria lobata weight (W/W), the timing since being heated to after boiling, refluxing extraction 1.5 hours.Merge filtrate obtained by refluxing extraction three times, filtrate is existed It is concentrated under reduced pressure in 70 DEG C of temperature values, obtaining specific gravity is 1.0-1.1 concentrate.Spray drying crushes, and crosses 80 meshes, sieve Kudzu root extract is obtained after point.
Green-tea extract (tea polyphenols) preparation method: this pharmaceutical composition tea polyphenols are mentioned by Guizhou Meitan large leaf category green tea Take preparation gained.It after green tea cleans, crushes, is put into extractor, amount of water is 10 times of amounts (W/W) for crushing green tea weight, micro- Lower 2 water of boiling state extracts, and extracts 1.5 hours every time, obtains green tea coarse filtration liquid.By extracting solution ultrafiltration, through polyamide column chromatography, It is eluted with 75% ethanol solution of content, by ethanol eluate in 50-70 DEG C of temperature values, vacuum degree 0.04-0.08MPa item It is concentrated under part, then concentrate is filtered, spray drying is carried out under conditions of 150-165 DEG C of inlet temperature, 70-80 DEG C of outlet air and is removed Dissolvent residual crushes, and crosses 80 meshes, obtains green-tea extract (tea polyphenols) after screening.
The preparation method of Schisandra chinens P.E: medicinal material Schisandra chinensis is eluriated, drying, fritter is made in crushing, by the five of crushing It is put into extractor after the weighing of taste, ethyl alcohol extracts three times.65% ethyl alcohol of content is added when first time alcohol extracting, additional amount is the five tastes 8 times of sub- weight extract 2 hours;65% ethyl alcohol of content is added when second of alcohol extracting, additional amount is the 7 of Schisandra chinensis initial weight Times, it extracts 2 hours;65% ethyl alcohol of content is added when third time alcohol extracting, additional amount is 6 times of Schisandra chinensis initial weight, extracts 1.5 Hour.Ethyl alcohol is recycled, merges and extracts gained filtrate three times, filtrate is concentrated under reduced pressure in 75-80 DEG C of temperature values, is compared Weight is 1.0-1.1 concentrate, and 80 meshes are crossed in spray drying, and Schisandra chinens P.E is obtained after screening.
Comparative example 2
The Chinese medicine composition of this comparative example preparation is extracted by 5 parts of Salvia root P.Es, 3 parts of kudzu root extracts, 3 parts of hoveniae semoveniae semens Object, 2 parts of Schisandra chinens P.Es are after mixing to obtain the final product.Wherein, Salvia root P.E, kudzu root extract, raisin tree seed extract, the five tastes The specific preparation step of seed extract is identical as comparative example 1.
Comparative example 3
5 parts of Radix Salviae Miltiorrhizae, 3 parts of pueraria lobata, 3 parts of hoveniae semoveniae semen, 2 parts of Schisandra chinensis are taken, adds 8 times of amount water to extract 3 times, Extracting temperature 90- 100 DEG C, 1.5 hours every time, filtration, merging filtrate was concentrated under reduced pressure into relative density 1.20 under the conditions of 70 ± 5 DEG C, then exists 70 ± 5 DEG C are dried under reduced pressure to obtain dry extract, crush through Universalpulverizer, then sieving is added 2 parts of tea polyphenols, are uniformly mixed, i.e., .Wherein, the specific preparation step of tea polyphenols is identical as comparative example 1.
Comparative example 4
5 parts of Radix Salviae Miltiorrhizae, 3 parts of pueraria lobata, 3 parts of hoveniae semoveniae semen, 2 parts of Schisandra chinensis are taken, adds 8 times of amount water to extract 3 times, Extracting temperature 90- 100 DEG C, 1.5 hours every time, filtration, merging filtrate was concentrated under reduced pressure into relative density 1.20 under the conditions of 70 ± 5 DEG C, then exists 70 ± 5 DEG C are dried under reduced pressure to obtain dry extract, crush through Universalpulverizer, sieving to get.
Comparative example 5
5 parts of Radix Salviae Miltiorrhizae, 3 parts of pueraria lobata, 3 parts of hoveniae semoveniae semen, 2 parts of Radix Notoginseng are taken, adds 8 times of amount water to extract 3 times, Extracting temperature 90-100 DEG C, 1.5 hours every time, filtration, merging filtrate was concentrated under reduced pressure into relative density 1.20 under the conditions of 70 ± 5 DEG C, then 70 ± 5 DEG C are dried under reduced pressure to obtain dry extract, crush through Universalpulverizer, sieving to get.
Comparative example 6
5 parts of Radix Salviae Miltiorrhizae, 3 parts of pueraria lobata, 2 parts of Schisandra chinensis, 2 parts of Radix Notoginseng are taken, adds 8 times of amount water to extract 3 times, Extracting temperature 90-100 DEG C, 1.5 hours every time, filtration, merging filtrate was concentrated under reduced pressure into relative density 1.20 under the conditions of 70 ± 5 DEG C, then 70 ± 5 DEG C are dried under reduced pressure to obtain dry extract, crush through Universalpulverizer, sieving to get.
Comparative example 7
3 parts of pueraria lobata, 3 parts of hoveniae semoveniae semen, 2 parts of Schisandra chinensis, 2 parts of Radix Notoginseng are taken, adds 8 times of amount water to extract 3 times, Extracting temperature 90- 100 DEG C, 1.5 hours every time, filtration, merging filtrate was concentrated under reduced pressure into relative density 1.20 under the conditions of 70 ± 5 DEG C, then exists 70 ± 5 DEG C are dried under reduced pressure to obtain dry extract, crush through Universalpulverizer, sieving to get.
Comparative example 8
5 parts of Radix Salviae Miltiorrhizae, 3 parts of hoveniae semoveniae semen, 2 parts of Schisandra chinensis, 2 parts of Radix Notoginseng are taken, adds 8 times of amount water to extract 3 times, Extracting temperature 90- 100 DEG C, 1.5 hours every time, filtration, merging filtrate was concentrated under reduced pressure into relative density 1.20 under the conditions of 70 ± 5 DEG C, then exists 70 ± 5 DEG C are dried under reduced pressure to obtain dry extract, crush through Universalpulverizer, sieving to get.
Auxiliary material screening
Embodiment 4
Different auxiliary material is screened, determines the type and its dosage of diluent, wetting agent, disintegrating agent, lubricant.This reality The dry extract that example uses is applied as obtained by embodiment 3.
1, the selection of diluent
(1) diluent type
In the selection course of diluent, according to the property of intermediate, microcrystalline cellulose, starch, three kinds of lactose systems are selected Medicine often uses auxiliary material, screens to three kinds of auxiliary materials, and 90% ethyl alcohol softwood is added, and observes softwood situation processed and graininess, In 65 DEG C of constant pressure and dries.20 mesh sieves collect 20-60 mesh particle weight, calculate particle yield, the results are shown in Table 1.
The screening of 1 diluent type of table
As shown in Table 1, different auxiliary material is selected, certain influence is generated to material state after granulation, using microcrystalline cellulose Effect is best, softwood modest viscosity processed, is easily sieved, and easily pelletizes, and particle is loose after granulation, therefore selects microcrystalline cellulose as this The diluent of invention.
(2) diluent dosage
The dosage of diluents microcrystalline cellulose is investigated, proportionally (microcrystalline cellulose: dry extract) 1 is distinguished: 3,1:2,2:3,1:1 weigh material, are uniformly mixed, softwood processed, in 65 DEG C of constant pressure and dries.20 mesh sieves collect 20-60 mesh Grain weight, calculates particle yield, the results are shown in Table 2.
The screening of 2 diluent dosage of table
As shown in Table 2, with the increase of microcrystalline cellulose and dry extract ratio, particle qualification rate is higher, works as amount ratio When example is 2:3 and 1:1, particle yield considers without significant difference from production is practical, preferably with microcrystalline cellulose and dry extract 2: 3 ratio is added.
2, the selection of wetting agent
Taking appropriate microcrystalline cellulose and dry extract (ratio 2:3) to be separately added into the ethyl alcohol of various concentration is wetting agent, is used The granulation of 20 mesh screens, observes softwood situation processed and graininess, and 65 DEG C of dryings, then by 20 mesh screen whole grains, collects 20-60 Mesh particle weight calculates particle yield, the results are shown in Table 3.
The screening of 3 wetting agent of table
As shown in Table 3,90% ethyl alcohol softwood is suitable, not the group of rising, and is easily sieved, easily molded, particle is loose, and particle yield Height, therefore select 90% ethyl alcohol for wetting agent of the invention.
3, the selection of disintegrating agent
(1) disintegrating agent type
Chinese medicine dry extract meets water and becomes sticky, and moisture penetrates into label in disintegrating procedue, is easy to cause disintegration difficult, it is therefore desirable to Adding disintegrating agent improves the disintegration situation of tablet.According to above-mentioned investigation determine condition, softwood processed, add disintegrating agent, tabletting, with Disintegration time limited is inspection target, investigates the influence of carboxyrnethyl starch sodium and croscarmellose sodium to tablet disintegration time limit, knot Fruit is shown in Table 4.
The screening of 4 disintegrating agent type of table
Known by table 4, is had clear improvement after adding disintegrating agent to the disintegration time limited of product, addition carboxyrnethyl starch sodium and crosslinking carboxylic Sodium carboxymethylcellulose pyce can be such that disintegration time limited reduces, and the effect of croscarmellose sodium is better than carboxyrnethyl starch sodium, therefore Selective cross-linking sodium carboxymethylcellulose is as disintegrating agent.
(2) disintegrating agent dosage
Influence of the different disintegrating agent adding proportions to disintegration time limited is investigated, the results are shown in Table 5.
5 disintegrating agent dosage of table is investigated
As shown in Table 5, when croscarmellose sodium additive amount reach granulation after particle 5% when, disintegration time limited is Disintegration time limited can be extended through significantly reducing, and after considering coating, comprehensively considered, preferably 5% croscarmellose sodium is made For disintegrating agent.
4, the selection of lubricant
Lubricant can reduce the frictional force between tablet and punch die hole wall, and magnesium stearate is hydrophobic lubricant, easily with Grain mixes, and the bright and clean beauty of plate surface after tabletting is most widely used.For the mobility for improving particle of the present invention, meet tablet forming technique requirement, While above-mentioned addition disintegrating agent, addition magnesium stearate carries out tabletting, as lubricant with the finish of particle and angle of repose As inspection target, the additive amount of magnesium stearate is determined.It the results are shown in Table 6.
The selection of 6 lubricant of table
As shown in Table 6, its mobility can preferably be improved by adding 1.0% magnesium stearate, and tablet finish is good, be suitble to Continuous tabletting and coating, it is thus determined that the magnesium stearate of addition 1% is as lubricant.The preparation of tablet
Embodiment 5
The Chinese medicine composition being prepared in embodiment 3 is weighed, right amount of auxiliary materials is added, is uniformly mixed, granulation, tabletting, packet Clothing to get.
The preparation of granule
Embodiment 6
The Chinese medicine composition being prepared in embodiment 3 is weighed, right amount of auxiliary materials is added, is uniformly mixed, pelletizes, is dry, whole Grain to get.
The preparation of capsule
Embodiment 7
The Chinese medicine composition being prepared in embodiment 3 is weighed, right amount of auxiliary materials is added, is uniformly mixed, pelletizes, is dry, whole Grain, it is filling, packaging to get.
Effect experiment
Embodiment 8
ICR small white mouse used is tested, cleaning grade, 18-22g is male, and SPF grades.
Blank group: giving distilled water, according to 0.2mL/10g weight to intragastric administration on mice.
Model group: giving distilled water, according to 0.2mL/10g weight to intragastric administration on mice.
Experimental group: composition prepared by embodiment 1-3 and comparative example 1-8 is given according to every 1 kg body weight of mouse and is combined Composition is configured to aqueous solution by the standard that 0.6 gram of object, according to 0.2mL/10g weight stomach-filling mouse.
130 ICR mouse are randomly divided into 13 groups, every group 10.Embodiment 1-3 and comparative example 1- is given in daily oral stomach-filling Composition in 8, blank group, model group give distilled water.After 30 days, groups of animals fasting 16h overnight, model group and respectively experiment 0.5% carbon tetrachloride solution 0.2mL/10g weight is given in stomach-filling of group, and blank group gives olive oil, and each experimental group is given Composition (with carbon tetrachloride stomach-filling interval 4 hours or more).Animal is put to death after giving carbon tetrachloride 24 hours, takes blood system from blood Clearly, ALT, AST are measured.
Before modeling, each group mouse can normal diet, fur is smooth, and activity is good.Reaction is quick, and groups of animals weight is by the phase Increase.After carbon tetrachloride modeling, mouse activity is obvious in addition to blank group weakens, and fur is dim, and finds that model group mouse has work It is dynamic to slow down, instability of gait phenomenon.
Experimental result is shown in Table 7 and table 8:
The influence fed to mouse weight in table 7 30 days
Compared with blank group:#Indicate P < 0.05;##Indicate P < 0.01.
8 each group serum alt of table, AST content
Compared with blank group:#Indicate P < 0.05;##Indicate P < 0.01;Compared with model group: * indicates P < 0.05;* table Show P < 0.01.
As shown in Table 7, groups of animals is after 30 days feed, and weight increased, and compared with blank group, no significance difference Different (P > 0.05).
As shown in Table 8, after 0.5% carbon tetrachloride of stomach-filling of animal, compared with normal group, in model group mice serum ALT, AST horizontal significantly raised (P < 0.01);Compared with model group, the composition of embodiment 1-3 and comparative example 1 can be significant ALT, AST (P < 0.01, P < 0.05) in mice serum are reduced, wherein embodiment 1-3 conspicuousness is stronger.
In addition, in composition in comparative example 1 each raw material respectively by extracting, concentration, it is dry, the techniques such as crush and be made and mention Object is taken, composition is then prepared, technical process is sufficiently complex, and crude drug is replaced extract by embodiment 1-3, and by tea Polyphenol replaces with Radix Notoginseng, merges extraction, not only can simplify preparation process, improve efficiency, and effect is more excellent.
To sum up, it is seen that the traditional chinese medicine composition of the invention has good protective effect to chemical damage.And its preparation side Method is simple, is suitble to the needs of scale industrial production.
Obviously, the above embodiment is merely an example for clearly illustrating the present invention, and not to embodiment It limits.For those of ordinary skill in the art, other different forms can also be made on the basis of the above description Variation or variation.There is no necessity and possibility to exhaust all the enbodiments.And it thus amplifies out apparent Variation or variation be still in the protection scope of this invention.

Claims (10)

1. a kind of Chinese medicine composition, which is characterized in that by weight, the Chinese medicine composition includes 1-8 parts of Radix Salviae Miltiorrhizaes, 1-6 portions of Pueraria lobotas Root, 1-6 part hoveniae semoveniae semen, 0.5-5 portions of Radix Notoginseng and 0.5-5 portions of Schisandra chinensis.
2. Chinese medicine composition according to claim 1, which is characterized in that the Chinese medicine composition includes 8 parts of Radix Salviae Miltiorrhizaes, 6 parts Pueraria lobata, 6 parts of hoveniae semoveniae semens, 5 portions of Radix Notoginseng and 5 portions of Schisandra chinensis.
3. Chinese medicine composition according to claim 1, which is characterized in that the Chinese medicine composition includes 6 parts of Radix Salviae Miltiorrhizaes, 5 parts Pueraria lobata, 5 parts of hoveniae semoveniae semens, 4 portions of Radix Notoginseng and 3 portions of Schisandra chinensis.
4. Chinese medicine composition according to claim 1, which is characterized in that the Chinese medicine composition includes 5 parts of Radix Salviae Miltiorrhizaes, 3 parts Pueraria lobata, 3 parts of hoveniae semoveniae semens, 2 portions of Radix Notoginseng and 2 portions of Schisandra chinensis.
5. a kind of method for preparing any Chinese medicine composition in claim 1-4, which is characterized in that comprising steps of
It taking medicinal material to be added 6-10 times and measures water boiling and extraction 2-4 times, Extracting temperature is 90-100 DEG C, it is 1-3 hours each, it filters, closes And filtrate, obtain filtrate;
Gained filtrate is concentrated under reduced pressure under the conditions of 60 ± 5 DEG C -80 ± 5 DEG C, being concentrated into relative density is 1.10-1.30, then Be dried under reduced pressure to obtain dry extract under the conditions of 60 ± 5 DEG C -80 ± 5 DEG C, by the dry extract grinding and sieving to get.
6. any Chinese medicine composition is preventing and treating the application in hepatic injury in claim 1-4.
7. a kind of drug, food or health care product, which is characterized in that the drug, the food or the health care product are wanted by right Any Chinese medicine composition in 1-4 is asked to be made with acceptable auxiliary material in pharmacy or food or additive.
8. drug according to claim 7, food or health care product, which is characterized in that the auxiliary material includes dextrin, crystallite fibre Tie up element, magnesium stearate, lactose, croscarmellose sodium, cornstarch, wheaten starch, potato starch or silica.
9. drug according to claim 7, food or health care product, which is characterized in that the drug is Chinese materia medica preparation.
10. drug according to claim 9, food or health care product, which is characterized in that the dosage form of the Chinese materia medica preparation is piece Agent, granule or capsule.
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CN102188513A (en) * 2011-05-25 2011-09-21 遵义陆圣康源科技开发有限责任公司 Medical composition with auxiliary protection function for chemical liver damage
CN104306550A (en) * 2014-09-30 2015-01-28 青岛百瑞吉生物工程有限公司 Application of traditional Chinese medicine composition in preparing liver-protecting medicine
CN104474135A (en) * 2014-04-29 2015-04-01 遵义陆圣康源科技开发有限责任公司 Pharmaceutical composition with auxiliary protection function of treating chemical liver injury
CN104667195A (en) * 2015-03-26 2015-06-03 江苏康缘药业股份有限公司 Composition for protecting liver, preparation method thereof and traditional Chinese medicine preparation
CN106214773A (en) * 2016-07-29 2016-12-14 神威药业集团有限公司 A kind of to chemical liver injury compositions having assistant protection function and preparation method thereof
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Publication number Priority date Publication date Assignee Title
CN102188513A (en) * 2011-05-25 2011-09-21 遵义陆圣康源科技开发有限责任公司 Medical composition with auxiliary protection function for chemical liver damage
CN104474135A (en) * 2014-04-29 2015-04-01 遵义陆圣康源科技开发有限责任公司 Pharmaceutical composition with auxiliary protection function of treating chemical liver injury
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