CN106177746A - A kind of to chemical liver injury compositions with auxiliary protection function and preparation method thereof - Google Patents
A kind of to chemical liver injury compositions with auxiliary protection function and preparation method thereof Download PDFInfo
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- CN106177746A CN106177746A CN201510225576.2A CN201510225576A CN106177746A CN 106177746 A CN106177746 A CN 106177746A CN 201510225576 A CN201510225576 A CN 201510225576A CN 106177746 A CN106177746 A CN 106177746A
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- paeoniae alba
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Abstract
The invention discloses a kind of to chemical liver injury compositions with auxiliary protection function and preparation method thereof.Said composition is to be prepared from according to a certain weight ratio by Radix Puerariae extract, Radix Paeoniae Alba extract, Radix Glycyrrhizae extract, Japanese raisintree fruit extract, Rhizoma Curcumae Longae extract, and it can be made into any common dosage forms, preferred oral preparation.The present composition has the function of auxiliary protection to chemical liver injury.
Description
Technical field
The present invention relates to a kind of to chemical liver injury compositions with auxiliary protection function and preparation method thereof, belong to the technical field of health food.
Background technology
During hepatopathy, liver function has infringement in various degree, its understand, excretory function and stock and regeneration capacity reduce, hepatic blood flow reduce, the medicine of various entrance livers makes metabolic burden increase the weight of, thus occur in environment disturbance, in turn result in hepatic injury.Hepatic injury is the pathological changes result of various hepatic disease, occurrence factor and the pathomechanism of hepatic injury have been made numerous studies at modern medicine by the many scholars of recent year, think in terms of the treatment of hepatic injury caused by antiradiation drug and there is no specific drug, using rest more, strengthen nutrition, vitimin supplement and symptomatic treatment etc., severe patient is even forced to terminate medication.
Hepatic injury is the disease of clinical common harm human health, and the pathological factor ratio that hepatic injury relates to is wide, such as virus, biology, medicine, physics and chemistry, ethanol etc., can result in hepatic injury.
Along with the development of society, the people of hepatic injury gets more and more, the health food of hepatic injury auxiliary protection is had the biggest adaptation population.Successive dynasties medical book Huangdi's Internal Classics, Shennong's Herbal, " prescriptions worth thousand gold ", Compendium of Material Medica, " Mingyi Bielu " etc. all describe the Chinese herbal medicine of hepatoprotective.More occurred in that various hepatoprotective prescription modern age, but the Chinese medicine decocting cooking method that the many employings of manufacture method are traditional, effective ingredient is failed to understand, the mechanism of action is unclear, not thering is provided enough pharmacologys and pathology to explain, do not carry out animal or the human trial being correlated with simultaneously, toxicity hazardness is indefinite.Thus, the medicine having auxiliary protection function to chemical liver injury developing determined curative effect has become the task of top priority of preventing and treating liver damage disease.
Summary of the invention
It is an object of the present invention to provide a kind of compositions that chemical liver injury is had auxiliary protection function.
Another object of the present invention there is provided the preparation method of said composition.
The present invention is achieved by the following technical solutions:
The present invention is made up of following components in parts by weight:
Radix Puerariae extract 50-300 part, Radix Paeoniae Alba extract 20-200 part, Radix Glycyrrhizae extract 10-150 part, Japanese raisintree fruit extract 5-70 part, Rhizoma Curcumae Longae extract 1-15 part.
It is preferably:
Radix Puerariae extract 150-250 part, Radix Paeoniae Alba extract 50-150 part, Radix Glycyrrhizae extract 20-80 part, Japanese raisintree fruit extract 15-40 part, Rhizoma Curcumae Longae extract 5-10 part.
More preferably:
Radix Puerariae extract 200 parts, Radix Paeoniae Alba extract 100 parts, Radix Glycyrrhizae extract 50 parts, Japanese raisintree fruit extract 25 parts, Rhizoma Curcumae Longae extract 7.5 parts.
In the present invention, the mechanism of action of each component is as follows:
Radix Puerariae: cool in nature, gas is put down, sweet in the mouth, enters spleen, stomach warp.Having the effects such as heat clearing away, pathogenic fire reducing, toxin expelling, master helps digestion, solves all poison, controls on sky row.Modern study finds that Radix Puerariae has significant protective effect to chronic hepatic injury animal model, and its mechanism is relevant with protecting the effects such as liver plasma membrane, removing free radical, anti peroxidation of lipid and fibrosis.
The Radix Paeoniae Alba: property is bitter, sour, is slightly cold, returns liver, spleen channel.There is suppressing the hyperactive liver pain relieving, nourishing blood for regulating menstruation, astringing YIN to stop sweating.For dizziness of having a headache, hypochondriac pain, stomachache, limb pain twin, blood deficiency and yellow complexion, menoxenia, spontaneous perspiration, effect of night sweat.Research shows, the Radix Paeoniae Alba has and protects the liver and Detoxication, and Liver Damage in Rats caused by D-galactosamine and AFB1 is raised by Radix Paeoniae Alba extract with ALT, raises the gross activity of lactic acid dehydrogenase caused by the latter (SLDH) and isozyme thereof, all has obvious inhibiting effect.Showing with duck young bird AFB1 detoxification experiment, Radix Paeoniae Alba extract has the effect destroying aflatoxin in a specified time.Radix Paeoniae Alba ethanol extract has certain Degradation to Aspergillus flavus poison rope B1 in vitro.Radix Paeoniae Alba extract 250mg/kg gavage, has trivial solution toxic action to mice T-2 toxin poisoning.
Radix Glycyrrhizae: property is put down, sweet in the mouth returns 12 warps.Invigorating the spleen and replenishing QI, heat-clearing and toxic substances removing, expelling phlegm for arresting cough, relieving spasm to stop pain, coordinating the actions of various ingredients in a prescription.For weakness of the spleen and stomach, fatigue and weakness, shortness of breath and palpitation, cough with copious phlegm, gastral cavity abdomen, extremity contraction urgency pain, carbuncle sore tumefacting virus, cushion toxicity, strong.Research shows, Radix Glycyrrhizae has antiinflammatory and the function of resistance state reflection, the most clinically mainly as demulcent.Radix Glycyrrhizae can also promote stomach mucus to be formed and secretion, extends the epithelial cell life-span, has anti-inflammatory activity, be usually used in the treatment of chronic ulcer and duodenal ulcer.
Japanese raisintree fruit: property is put down, sweet in the mouth enters the heart, spleen channel, and relieving restlessness of quenching the thirst, disappear damp and hot, alcoholic intoxication.Modern study shows that Japanese raisintree fruit has anti peroxidation of lipid and protection hepatic injury effect; fibrosis and hepatocellular degeneration temple and inflammatory cell infiltration can be alleviated, make mitochondrial membrane recover in time, reduce reticulum dilatation; promote that cell regeneration, retardance hepatic fibrosis develop.
Rhizoma Curcumae Longae: property is worked hard, temperature, return spleen, Liver Channel.Having removing blood stasis circulation of qi promoting, effect of inducing menstruation to relieve menalgia, for trusted subordinate's feeling of fullness distending pain, brachialgia, lump in the abdomen, women's blood stasis amenorrhea, puerperal, the stasis of blood stopped the diseases such as stomachache, injury from falling down, carbuncle.Research shows, Rhizoma Curcumae Longae has choleretic effect, Curcuma and preserved material can increase the bile secretion of dog, makes bile component recover normal, and increases gallbladder contraction, and its effect is weak and lasting, sustainable 1～2 hour.Curcumin or its sodium salt have choleretic effect, and intravenous injection, in Canis familiaris L., can reduce the content of solid constituent and increase choleresis, but from the point of view of total absolute value, cholate, bilirubin, cholesterol secretory volume all increase, and fatty acid composition keeps constant.The volatile oil proposed in another kind of congener increases bile secretion, and pigment then causes gallbladder contraction.Curcumen is cholesterol solvent, may be used to treat Biliary Calculi.50% Curcuma can promote appetite.
Take following preparation technology to make each component in the present invention preferably play drug effect, the preferably component to described proportioning, but cannot be used for limiting the scope of the invention.
The preparation method of the present composition is as follows:
Take the Radix Puerariae extract of described weight portion, Radix Paeoniae Alba extract, Radix Glycyrrhizae extract, Japanese raisintree fruit extract, Rhizoma Curcumae Longae extract, sieve, mixing, it is not added with or adds appropriate amount of auxiliary materials, technique makes the preparation accepted on pharmaceutics routinely.
As the oral drugs of the solid dosage form such as conventional tablet (dispersible tablet, effervescent tablet, oral cavity disintegration tablet, buccal tablet, chewable tablet, effervescent tablet), capsule (hard capsule, soft capsule), granule, pill (drop pill), powder can be made, it is also possible to make the oral drugs of the liquid forms such as syrup, medicated wine, tincture, oral liquid；Can be to make the external used medicine of the external preparation forms such as unguentum, gel, ointment, cataplasma, emplastrum, liniment, lotion, liniment.Therefore, in this pharmaceutical composition in addition to effective ingredient, it is also possible to containing pharmaceutically acceptable adjuvant.
The preparation technology of the preparations such as tablet described here, capsule, granule relates to employing wet granulation or the dry granulation of granulating process.
Adjuvant described here, can be different according to different preparations, such as diluent conventional in the solid preparations such as tablet, capsule, granule, disintegrating agent, excipient, binding agent, lubricant, surfactant, filler etc.；Surfactant conventional in the liquid forms such as syrup, oral liquid, diluent, preservative, stabilizer, correctives, thickening agent, fluidizer etc.；Acceptable oil base conventional in the external preparation form such as gel, ointment, aqueous matrix, preservative, antioxidant, wetting agent, Percutaneous absorption enhancer, surfactant etc..
nullIts conventional adjuvant such as starch、Lactose、Sucrose、Dextrin、Maltodextrin、Icing Sugar、Microcrystalline Cellulose、Mannitol、Xylitol、Polyethylene Glycol、Calcium sulfate、Calcium hydrogen phosphate、Calcium carbonate、Modified starch、Sorbitol、Erythritol、Polyvinylpyrrolidone、Heavy Magnesium Carbonate、Sodium carboxymethyl cellulose、Hydroxypropyl methylcellulose、Methylcellulose、Ethyl cellulose、Carboxymethylstach sodium、Hydroxypropyl cellulose、Hydroxypropyl methyl cellulose、PVP K30、Kaolin、Pregelatinized Starch、Magnesium stearate、Pulvis Talci、Micropowder silica gel、Stevioside、Glycine betaine、Aspartame、Citric acid、Glycyrrhizin、Saccharin sodium、Crystal sugar、Mel、Citric acid、Sodium bicarbonate、Sodium carbonate、Carrageenan、Agar、Gelatin、Sodium alginate、Xanthan gum、Guar gum、Tragcanth、Arabic gum、Locust bean gum、POLY-karaya、Stearic acid、Glyceryl monostearate、Polyacrylamide、Cross linked sodium polyacrylate、Polyvinyl alcohol、Carbomer、Sorbic acid、Potassium sorbate、Ethyl hydroxybenzoate、Benzyl alcohol、Nipalgin、Thimerosal、Dimethyl sulfoxide、Azone、Triethanolamine、Sodium hydroxide、Glycerol、Propylene glycol、BHT、BHA、Sodium lauryl sulphate、Tweens、Spans etc..
The preparation method of present composition tablet is:
Take the Radix Puerariae extract of described weight portion, Radix Paeoniae Alba extract, Radix Glycyrrhizae extract, Japanese raisintree fruit extract, Rhizoma Curcumae Longae extract, sieve respectively, add appropriate filler, binding agent, be sufficiently mixed, pelletize, be dried, granulate, add moderate lubrication agent, mixing, tabletting, coating or not coating, obtain tablet.
Wherein, described filler refers to one or more in mannitol, pregelatinized Starch, dextrin, lactose, microcrystalline Cellulose；Binding agent refers to one or more in ethanol, starch slurry, sodium carboxymethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, PVP K30；Lubricant refers to one or more in magnesium stearate, micropowder silica gel, Pulvis Talci.
The preparation method of present composition tablet is preferably:
Take the Radix Puerariae extract of described weight portion, Radix Paeoniae Alba extract, Radix Glycyrrhizae extract, Japanese raisintree fruit extract, Rhizoma Curcumae Longae extract, sieve respectively, add appropriate lactose, microcrystalline Cellulose, PVP K30, be sufficiently mixed, alcohol granulation, it is dried, granulate, adds appropriate magnesium stearate, mixing, tabletting, coating, obtain tablet.
Wherein, the consisting of of film coating agent: hypromellose, glyceric acid acetas, tartrazine aluminum lake, Brilliant blue aluminum lake, Sunset yellow aluminum lake, titanium dioxide, Pulvis Talci.
Radix Puerariae extract in the present invention, Radix Paeoniae Alba extract, Radix Glycyrrhizae extract, Japanese raisintree fruit extract, Rhizoma Curcumae Longae extract can be obtained by buying commercially available product or take following preparation method to obtain:
Radix Puerariae extract: taking Radix Puerariae and add water or the ethanol extraction of variable concentrations, extracting solution concentrate drying obtains crude extract；Or use further decoction and alcohol sedimentation technique, organic solvent extractionprocess, column chromatography, carbon dioxide supercritical extraction method, steam distillation one or more be used in combination suitably refine after extract；Above-mentioned crude extract or extract are Radix Puerariae extract；
Radix Paeoniae Alba extract: taking the Radix Paeoniae Alba and add water or the ethanol extraction of variable concentrations, extracting solution concentrate drying obtains crude extract；Or use further decoction and alcohol sedimentation technique, organic solvent extractionprocess, column chromatography, carbon dioxide supercritical extraction method, steam distillation one or more be used in combination suitably refine after extract；Above-mentioned crude extract or extract are Radix Paeoniae Alba extract；
Radix Glycyrrhizae extract: extracting liquorice adds water or the ethanol extraction of variable concentrations, extracting solution concentrate drying obtains crude extract；Or use further decoction and alcohol sedimentation technique, organic solvent extractionprocess, column chromatography, carbon dioxide supercritical extraction method, steam distillation one or more be used in combination suitably refine after extract；Above-mentioned crude extract or extract are Radix Glycyrrhizae extract；
Japanese raisintree fruit extract: taking Japanese raisintree fruit and add water or the ethanol extraction of variable concentrations, extracting solution concentrate drying obtains crude extract；Or use further decoction and alcohol sedimentation technique, organic solvent extractionprocess, column chromatography, carbon dioxide supercritical extraction method, steam distillation one or more be used in combination suitably refine after extract；Above-mentioned crude extract or extract are Japanese raisintree fruit extract；
Rhizoma Curcumae Longae extract: taking Rhizoma Curcumae Longae and add water or the ethanol extraction of variable concentrations, extracting solution concentrate drying obtains crude extract；Or use further decoction and alcohol sedimentation technique, organic solvent extractionprocess, column chromatography, carbon dioxide supercritical extraction method, steam distillation one or more be used in combination suitably refine after extract；Above-mentioned crude extract or extract are Rhizoma Curcumae Longae extract.
Following preparation method is preferably taked to obtain:
Radix Puerariae extract: take Radix Puerariae and add 4-20 times amount 20-95% ethanol extraction 1-4 time, each 1-3 hour, extracting solution merged, and filtered, and decompression filtrate recycling ethanol, to without alcohol taste, continues to concentrate, dry, pulverize into fine powder, be Radix Puerariae extract；
Radix Paeoniae Alba extract: take the Radix Paeoniae Alba and add 4-20 times amount 20-95% ethanol extraction 1-4 time, each 1-3 hour, extracting solution merged, and filtered, and decompression filtrate recycling ethanol, to without alcohol taste, continues to concentrate, dry, pulverize into fine powder, be Radix Paeoniae Alba extract；
Radix Glycyrrhizae extract: extracting liquorice adds 4-20 times amount water reflux, extract, 1-4 time, each 1-3 hour, extracting solution merges, and filters, and filtrate concentrates, and dry, pulverize into fine powder, is Radix Glycyrrhizae extract；
Japanese raisintree fruit extract: take Japanese raisintree fruit and add 4-20 times amount water reflux, extract, 1-4 time, each 1-3 hour, extracting solution merged, and filtered, and filtrate concentrates, and dry, pulverize into fine powder, is Japanese raisintree fruit extract；
Rhizoma Curcumae Longae extract: take Rhizoma Curcumae Longae and add 4-20 times amount 20-95% ethanol extraction 1-4 time, each 1-3 hour, extracting solution merged, and filtered, and decompression recycling ethanol, to without alcohol taste, dry, pulverize into fine powder, is Rhizoma Curcumae Longae extract.
Adoptable concrete operations and/or using method when above-mentioned effective medicinal ingredient is extracted, both can be with the ingredient of described each proportional quantities as raw material, extract decomposite mode after its effective medicinal ingredient respectively, it would however also be possible to employ the mode of common extraction again after mixing by each medicine material of described proportional quantities.The actual conditionses such as ideal required when using different extraction means, equipment and extract or optimal Extracting temperature, solvent load, extraction time, extraction time, then can be screened by test according to practical situation and find.
The present invention relates to a kind of compositions, it is on the basis of existing theory of Chinese medical science, filters out the prescription to chemical liver injury with auxiliary protection function, carries out scientific compatibility, plays its mutual synergism, thus obtains a kind of formula having and protecting the liver function.
The detailed description of the invention of form by the following examples, is described in further detail the foregoing of the present invention.But this should not being interpreted as, the scope of the above-mentioned theme of the present invention is only limitted to below example.All technology realized based on foregoing of the present invention belong to the scope of the present invention.
Detailed description of the invention
Embodiment 1
Radix Puerariae extract 200g, Radix Paeoniae Alba extract 100g, Radix Glycyrrhizae extract 50g, Japanese raisintree fruit extract 25g, Rhizoma Curcumae Longae extract 7.5g
Take the Radix Puerariae extract of described weight portion, Radix Paeoniae Alba extract, Radix Glycyrrhizae extract, Japanese raisintree fruit extract, Rhizoma Curcumae Longae extract, sieve respectively, add appropriate lactose, microcrystalline Cellulose, PVP K30, be sufficiently mixed, alcohol granulation, it is dried, granulate, adds appropriate magnesium stearate, mixing, tabletting, coating, obtain tablet.
Wherein, the consisting of of film coating agent: hypromellose, glyceric acid acetas, tartrazine aluminum lake, Brilliant blue aluminum lake, Sunset yellow aluminum lake, titanium dioxide, Pulvis Talci.
Embodiment 2
Radix Puerariae extract 300g, Radix Paeoniae Alba extract 20g, Radix Glycyrrhizae extract 150g, Japanese raisintree fruit extract 5g, Rhizoma Curcumae Longae extract 15g
Take the Radix Puerariae extract of described weight portion, Radix Paeoniae Alba extract, Radix Glycyrrhizae extract, Japanese raisintree fruit extract, Rhizoma Curcumae Longae extract, sieve respectively, add appropriate lactose, microcrystalline Cellulose, PVP K30, be sufficiently mixed, alcohol granulation, it is dried, granulate, adds appropriate magnesium stearate, mixing, tabletting, coating, obtain tablet.
Wherein, the consisting of of film coating agent: hypromellose, glyceric acid acetas, tartrazine aluminum lake, Brilliant blue aluminum lake, Sunset yellow aluminum lake, titanium dioxide, Pulvis Talci.
Embodiment 3
Radix Puerariae extract 50g, Radix Paeoniae Alba extract 200g, Radix Glycyrrhizae extract 10g, Japanese raisintree fruit extract 70g, Rhizoma Curcumae Longae extract 1g
Take the Radix Puerariae extract of described weight portion, Radix Paeoniae Alba extract, Radix Glycyrrhizae extract, Japanese raisintree fruit extract, Rhizoma Curcumae Longae extract, sieve respectively, add appropriate lactose, microcrystalline Cellulose, PVP K30, be sufficiently mixed, alcohol granulation, it is dried, granulate, adds appropriate magnesium stearate, mixing, tabletting, coating, obtain tablet.
Wherein, the consisting of of film coating agent: hypromellose, glyceric acid acetas, tartrazine aluminum lake, Brilliant blue aluminum lake, Sunset yellow aluminum lake, titanium dioxide, Pulvis Talci.
Embodiment 4
Radix Puerariae extract 250g, Radix Paeoniae Alba extract 50g, Radix Glycyrrhizae extract 80g, Japanese raisintree fruit extract 15g, Rhizoma Curcumae Longae extract 10g
Take the Radix Puerariae extract of described weight portion, Radix Paeoniae Alba extract, Radix Glycyrrhizae extract, Japanese raisintree fruit extract, Rhizoma Curcumae Longae extract, sieve respectively, add appropriate lactose, microcrystalline Cellulose, PVP K30, be sufficiently mixed, alcohol granulation, it is dried, granulate, adds appropriate magnesium stearate, mixing, tabletting, coating, obtain tablet.
Wherein, the consisting of of film coating agent: hypromellose, glyceric acid acetas, tartrazine aluminum lake, Brilliant blue aluminum lake, Sunset yellow aluminum lake, titanium dioxide, Pulvis Talci.
Embodiment 5
Radix Puerariae extract 150g, Radix Paeoniae Alba extract 150g, Radix Glycyrrhizae extract 20g, Japanese raisintree fruit extract 40g, Rhizoma Curcumae Longae extract 5g
Take the Radix Puerariae extract of described weight portion, Radix Paeoniae Alba extract, Radix Glycyrrhizae extract, Japanese raisintree fruit extract, Rhizoma Curcumae Longae extract, sieve respectively, add appropriate lactose, microcrystalline Cellulose, PVP K30, be sufficiently mixed, alcohol granulation, it is dried, granulate, adds appropriate magnesium stearate, mixing, tabletting, obtains tablet.
Embodiment 6
Radix Puerariae extract 180g, Radix Paeoniae Alba extract 120g, Radix Glycyrrhizae extract 60g, Japanese raisintree fruit extract 30g, Rhizoma Curcumae Longae extract 7g
Take the Radix Puerariae extract of described weight portion, Radix Paeoniae Alba extract, Radix Glycyrrhizae extract, Japanese raisintree fruit extract, Rhizoma Curcumae Longae extract, sieve respectively, add appropriate lactose, xylitol, mixing, pelletize, be dried, encapsulated, obtain capsule.
Embodiment 7
Radix Puerariae extract 210g, Radix Paeoniae Alba extract 90g, Radix Glycyrrhizae extract 40g, Japanese raisintree fruit extract 20g, Rhizoma Curcumae Longae extract 8g
Take the Radix Puerariae extract of described weight portion, Radix Paeoniae Alba extract, Radix Glycyrrhizae extract, Japanese raisintree fruit extract, Rhizoma Curcumae Longae extract, sieve respectively, add appropriate adjuvant, mixing, make pill.
Embodiment 8
Radix Puerariae extract 280g, Radix Paeoniae Alba extract 80g, Radix Glycyrrhizae extract 120g, Japanese raisintree fruit extract 50g, Rhizoma Curcumae Longae extract 10g
Taking the Radix Puerariae extract of described weight portion, Radix Paeoniae Alba extract, Radix Glycyrrhizae extract, Japanese raisintree fruit extract, Rhizoma Curcumae Longae extract, sieve respectively, add appropriate suspensoid, flavoring agent, preservative, mixing, add water constant volume, filters, subpackage, obtains oral liquid.
Embodiment 9
Radix Puerariae extract 60g, Radix Paeoniae Alba extract 190g, Radix Glycyrrhizae extract 20g, Japanese raisintree fruit extract 60g, Rhizoma Curcumae Longae extract 2g
Take the Radix Puerariae extract of described weight portion, Radix Paeoniae Alba extract, Radix Glycyrrhizae extract, Japanese raisintree fruit extract, Rhizoma Curcumae Longae extract, sieve respectively, mixing, make powder.
Embodiment 10
Radix Puerariae extract 290g, Radix Paeoniae Alba extract 30g, Radix Glycyrrhizae extract 140g, Japanese raisintree fruit extract 7g, Rhizoma Curcumae Longae extract 14g
Take the Radix Puerariae extract of described weight portion, Radix Paeoniae Alba extract, Radix Glycyrrhizae extract, Japanese raisintree fruit extract, Rhizoma Curcumae Longae extract, sieve respectively, add appropriate mannitol, microcrystalline Cellulose, mixing, alcohol granulation, be dried, granulate, obtain granule.
Embodiment 11
Radix Puerariae extract 160g, Radix Paeoniae Alba extract 140g, Radix Glycyrrhizae extract 30g, Japanese raisintree fruit extract 30g, Rhizoma Curcumae Longae extract 6g
Take the Radix Puerariae extract of described weight portion, Radix Paeoniae Alba extract, Radix Glycyrrhizae extract, Japanese raisintree fruit extract, Rhizoma Curcumae Longae extract, sieve respectively；Add appropriate mannitol, pregelatinized Starch, starch slurry, be sufficiently mixed, alcohol granulation, be dried, granulate, add appropriate magnesium stearate, mixing, tabletting, coating, obtain tablet.
Embodiment 12
Radix Puerariae extract 240g, Radix Paeoniae Alba extract 60g, Radix Glycyrrhizae extract 70g, Japanese raisintree fruit extract 20g, Rhizoma Curcumae Longae extract 9g
Take the Radix Puerariae extract of described weight portion, Radix Paeoniae Alba extract, Radix Glycyrrhizae extract, Japanese raisintree fruit extract, Rhizoma Curcumae Longae extract, sieve respectively；Add appropriate microcrystalline Cellulose, hydroxypropyl methyl cellulose, hydroxypropyl cellulose, be sufficiently mixed, alcohol granulation, be dried, granulate, add appropriate Pulvis Talci, micropowder silica gel, mixing, tabletting, obtain tablet.
Embodiment 13
Radix Puerariae extract 220g, Radix Paeoniae Alba extract 110g, Radix Glycyrrhizae extract 55g, Japanese raisintree fruit extract 30g, Rhizoma Curcumae Longae extract 8g
Take the Radix Puerariae extract of described weight portion, Radix Paeoniae Alba extract, Radix Glycyrrhizae extract, Japanese raisintree fruit extract, Rhizoma Curcumae Longae extract, sieve respectively；Add appropriate xylitol, sorbitol, pregelatinized Starch, dextrin, be sufficiently mixed, alcohol granulation, be dried, granulate, add appropriate magnesium stearate, mixing, tabletting, coating, obtain tablet.
Embodiment 14
Radix Puerariae extract 180g, Radix Paeoniae Alba extract 110g, Radix Glycyrrhizae extract 45g, Japanese raisintree fruit extract 20g, Rhizoma Curcumae Longae extract 7g
Take the Radix Puerariae extract of described weight portion, Radix Paeoniae Alba extract, Radix Glycyrrhizae extract, Japanese raisintree fruit extract, Rhizoma Curcumae Longae extract, sieve respectively；Add appropriate erythritol, microcrystalline Cellulose, sodium carboxymethyl cellulose, be sufficiently mixed, alcohol granulation, be dried, granulate, add appropriate magnesium stearate, mixing, tabletting, obtain tablet.
Embodiment 15
Radix Puerariae extract 200g, Radix Paeoniae Alba extract 100g, Radix Glycyrrhizae extract 50g, Japanese raisintree fruit extract 25g, Rhizoma Curcumae Longae extract 7.5g
Take the Radix Puerariae extract of described weight portion, Radix Paeoniae Alba extract, Radix Glycyrrhizae extract, Japanese raisintree fruit extract, Rhizoma Curcumae Longae extract, sieve respectively, mixing, tabletting, obtain tablet.
Radix Puerariae extract in above example 1-15, Radix Paeoniae Alba extract, Radix Glycyrrhizae extract, Japanese raisintree fruit extract, Rhizoma Curcumae Longae extract may each be takes following either method to obtain:
Radix Puerariae extract: taking Radix Puerariae and add water or the ethanol extraction of variable concentrations, extracting solution concentrate drying obtains crude extract；Or use further decoction and alcohol sedimentation technique, organic solvent extractionprocess, column chromatography, carbon dioxide supercritical extraction method, steam distillation one or more be used in combination suitably refine after extract；Above-mentioned crude extract or extract are Radix Puerariae extract；
Being preferably: take Radix Puerariae and add 4-20 times amount 20-95% ethanol extraction 1-4 time, each 1-3 hour, extracting solution merges, and filters, and decompression filtrate recycling ethanol, to without alcohol taste, continues to concentrate, dry, pulverize into fine powder, be Radix Puerariae extract.
Radix Paeoniae Alba extract: taking the Radix Paeoniae Alba and add water or the ethanol extraction of variable concentrations, extracting solution concentrate drying obtains crude extract；Or use further decoction and alcohol sedimentation technique, organic solvent extractionprocess, column chromatography, carbon dioxide supercritical extraction method, steam distillation one or more be used in combination suitably refine after extract；Above-mentioned crude extract or extract are Radix Paeoniae Alba extract；
Being preferably: take the Radix Paeoniae Alba and add 4-20 times amount 20-95% ethanol extraction 1-4 time, each 1-3 hour, extracting solution merges, and filters, and decompression filtrate recycling ethanol, to without alcohol taste, continues to concentrate, dry, pulverize into fine powder, be Radix Paeoniae Alba extract.
Radix Glycyrrhizae extract: extracting liquorice adds water or the ethanol extraction of variable concentrations, extracting solution concentrate drying obtains crude extract；Or use further decoction and alcohol sedimentation technique, organic solvent extractionprocess, column chromatography, carbon dioxide supercritical extraction method, steam distillation one or more be used in combination suitably refine after extract；Above-mentioned crude extract or extract are Radix Glycyrrhizae extract；
Being preferably: extracting liquorice adds 4-20 times amount water reflux, extract, 1-4 time, each 1-3 hour, extracting solution merges, and filters, filtrate reduced in volume, dry, pulverize into fine powder, be Radix Glycyrrhizae extract.
Japanese raisintree fruit extract: taking Japanese raisintree fruit and add water or the ethanol extraction of variable concentrations, extracting solution concentrate drying obtains crude extract；Or use further decoction and alcohol sedimentation technique, organic solvent extractionprocess, column chromatography, carbon dioxide supercritical extraction method, steam distillation one or more be used in combination suitably refine after extract；Above-mentioned crude extract or extract are Japanese raisintree fruit extract；
Being preferably: take Japanese raisintree fruit and add 4-20 times amount water reflux, extract, 1-4 time, each 1-3 hour, extracting solution merges, and filters, filtrate reduced in volume, dry, pulverize into fine powder, be Japanese raisintree fruit extract
Rhizoma Curcumae Longae extract: taking Rhizoma Curcumae Longae and add water or the ethanol extraction of variable concentrations, extracting solution concentrate drying obtains crude extract；Or use further decoction and alcohol sedimentation technique, organic solvent extractionprocess, column chromatography, carbon dioxide supercritical extraction method, steam distillation one or more be used in combination suitably refine after extract；Above-mentioned crude extract or extract are Rhizoma Curcumae Longae extract；
Being preferably: take Rhizoma Curcumae Longae and add 4-20 times amount 20-95% ethanol extraction 1-4 time, each 1-3 hour, extracting solution merges, and filters, and decompression recycling ethanol, to without alcohol taste, dry, pulverize into fine powder, is Rhizoma Curcumae Longae extract.
Or, Radix Puerariae extract, Radix Paeoniae Alba extract, Radix Glycyrrhizae extract, Japanese raisintree fruit extract, Rhizoma Curcumae Longae extract are obtained by buying commercially available product.
According to foregoing, without departing under basic fundamental thought premise of the present invention, according to ordinary technical knowledge and the customary means of this area, it is clear that the amendment of other various ways can also be made, replace and change.
The beneficial effect of of the present invention compositions be expanded on further by following experiment:
One, present composition safety evaluatio test
1, acute toxicity test: the acute oral LD50 of male and female mice is all higher than 100000mg/kg, belongs to nontoxic level thing.
2, micronucleus test result is negative, show its to mouse bone marrow cells chromosomal aberration without induction property.
3, sperm malformation test result is negative, shows that it is in vivo without genotoxicity.
4, Salmonella reversion test result is negative, shows that it is without potential carcinogenecity.
5,30 days feeding trial results show that experimental animal growing state is good, hematology, biochemical analysis, main dirty soma learn check result compared with matched group, equal no significant difference, further demonstrate that its safety.
Two, the present composition has carried out " auxiliary protection function to chemical liver injury " animal functional evaluation test according to " function of health food assessment process and the method for inspection " (version in 2003), and method and result are as follows:
1, trial drug
Medicine group 1: prepare according to the embodiment of the present invention 1；
Medicine group 2: prepare according to the embodiment of the present invention 2；
Medicine group 3: prepare according to the embodiment of the present invention 3；
Normal group；
Model control group.
2, experimental animal
Healthy mice 50, body weight 18-22g.
3, test method
50 mices are randomly divided into 5 groups, i.e. Normal group, liver injury model matched group, medicine group 1 of the present invention, medicine group 2, medicine group 3, each dosage group is according to corresponding dosage gavage, Normal group and model control group drink distilled water, continuous 30 days, the 30th day each dosage group and model group CCl4Contamination, dosage 24mg/kg, lumbar injection.31st day, five groups of mices were plucked eyeball and take blood, centrifugal, took serum, measured biochemical indicator: serum glutamic pyruvic transminase (ALT), glutamic oxaloacetic transaminase, GOT (AST), and took liver and carry out histopathologic examination.Result of the test Spss software statistics.
4, result of the test
(1) biochemistry detection result
Table
1
The present composition impact on mice biochemical indicator
| Group | Number of animals (only) | ALT(IU/L) | AST(IU/L) |
| Normal group | 10 | 35±10* | 80±5* |
| Model control group | 10 | 592±105 | 684±37 |
| Medicine group 1 | 10 | 208±59* | 358±34* |
| Medicine group 2 | 10 | 256±66* | 343±48* |
| Medicine group 3 | 10 | 271±82* | 379±60* |
Compare with model control group, *: P ＜ 0.05
As shown in Table 1, ALT, AST content of Normal group is significantly lower than carbon tetrachloride model group, there is significant difference, illustrates that model is set up；ALT, AST content of three medicine groups of the present composition substantially reduces, and compares with model control group, all there is significant difference (P ＜ 0.05).The prompting present composition has the effect of auxiliary protection to chemical liver injury.
(2) liver histopathology checks total mark
Table
2
Liver histopathology checks integration
| Group | Granular degeneration | Hydropic degeneration | Balloon degeneration | Steatosis | Endochylema condenses | Necrocytosis | Inflammatory cell infiltration | Total score | Average mark |
| Normal control | 14 | 0 | 0 | 1 | 2 | 0 | 0 | 17 | 1.7* |
| Model comparison | 14 | 6 | 4 | 8 | 27 | 27 | 10 | 92 | 9.2 |
| Medicine group 1 | 12 | 4 | 1 | 3 | 8 | 10 | 7 | 45 | 4.5* |
| Medicine group 2 | 12 | 5 | 2 | 4 | 10 | 9 | 7 | 49 | 4.9* |
| Medicine group 3 | 11 | 4 | 2 | 6 | 8 | 11 | 9 | 51 | 5.1* |
Compare with model control group, *: P ＜ 0.05
As shown in Table 2, the pathology integration of Normal group is significantly lower than model control group, there is significant difference, illustrates that model is set up.Three medicine groups of the present composition are compared with model control group, and pathology integration is decreased obviously, and there is significant difference (P ＜ 0.05).The prompting present composition has the effect of auxiliary protection to chemical liver injury.
Embodiment of the present invention 4-15 has carried out similar test the most according to the method described above, and result is identical with the above results.
Three, conclusion
Consolidated statement 1, table 2 understand, and the present composition can substantially reduce mice ALT, AST content, hence it is evident that reduces pathology integration, and compares with model control group, all there is significant difference (P ＜ 0.05).Therefore, according to Ministry of Public Health " health food inspection and assessment technique specification " (version in 2003), it is determined that the present composition has the auxiliary protection function to chemical liver injury.
Claims (11)
1. the compositions that chemical liver injury is had auxiliary protection function; it is characterized in that, it is made up of the component of following weight portion: Radix Puerariae extract 50-300 part, Radix Paeoniae Alba extract 20-200 part, Radix Glycyrrhizae extract 10-150 part, Japanese raisintree fruit extract 5-70 part, Rhizoma Curcumae Longae extract 1-15 part.
Compositions the most according to claim 1, it is characterized in that, it is made up of the component of following weight portion: Radix Puerariae extract 150-250 part, Radix Paeoniae Alba extract 50-150 part, Radix Glycyrrhizae extract 20-80 part, Japanese raisintree fruit extract 15-40 part, Rhizoma Curcumae Longae extract 5-10 part.
3. the preparation method of compositions described in claim 1 or 2, it is characterised in that it is prepared:
Take the Radix Puerariae extract of described weight portion, Radix Paeoniae Alba extract, Radix Glycyrrhizae extract, Japanese raisintree fruit extract, Rhizoma Curcumae Longae extract, sieve, mixing, it is not added with or adds appropriate amount of auxiliary materials, technique makes the preparation accepted on pharmaceutics routinely.
Preparation method the most according to claim 3, it is characterised in that described preparation refers to oral formulations.
Preparation method the most according to claim 4, it is characterised in that described preparation refers to tablet, granule, capsule, pill, powder, oral liquid.
Preparation method the most according to claim 5, it is characterised in that tablet is prepared:
Take the Radix Puerariae extract of described weight portion, Radix Paeoniae Alba extract, Radix Glycyrrhizae extract, Japanese raisintree fruit extract, Rhizoma Curcumae Longae extract, sieve respectively, add appropriate filler, binding agent, be sufficiently mixed, pelletize, be dried, granulate, add moderate lubrication agent, mixing, tabletting, coating or not coating, obtain tablet.
Preparation method the most according to claim 6, it is characterised in that described filler refers to one or more in mannitol, pregelatinized Starch, dextrin, lactose, microcrystalline Cellulose, xylitol, sorbitol, erythritol；Binding agent refers to one or more in ethanol, starch slurry, sodium carboxymethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, PVP K30；Lubricant refers to one or more in magnesium stearate, micropowder silica gel, Pulvis Talci.
Compositions the most according to claim 1 and 2, it is characterised in that described Radix Puerariae extract, Radix Paeoniae Alba extract, Radix Glycyrrhizae extract, Japanese raisintree fruit extract, Rhizoma Curcumae Longae extract are prepared obtaining:
Radix Puerariae extract: taking Radix Puerariae and add water or the ethanol extraction of variable concentrations, extracting solution concentrate drying obtains crude extract；Or use further decoction and alcohol sedimentation technique, organic solvent extractionprocess, column chromatography, carbon dioxide supercritical extraction method, steam distillation one or more be used in combination suitably refine after extract；Above-mentioned crude extract or extract are Radix Puerariae extract；
Radix Paeoniae Alba extract: taking the Radix Paeoniae Alba and add water or the ethanol extraction of variable concentrations, extracting solution concentrate drying obtains crude extract；Or use further decoction and alcohol sedimentation technique, organic solvent extractionprocess, column chromatography, carbon dioxide supercritical extraction method, steam distillation one or more be used in combination suitably refine after extract；Above-mentioned crude extract or extract are Radix Paeoniae Alba extract；
Radix Glycyrrhizae extract: extracting liquorice adds water or the ethanol extraction of variable concentrations, extracting solution concentrate drying obtains crude extract；Or use further decoction and alcohol sedimentation technique, organic solvent extractionprocess, column chromatography, carbon dioxide supercritical extraction method, steam distillation one or more be used in combination suitably refine after extract；Above-mentioned crude extract or extract are Radix Glycyrrhizae extract；
Japanese raisintree fruit extract: taking Japanese raisintree fruit and add water or the ethanol extraction of variable concentrations, extracting solution concentrate drying obtains crude extract；Or use further decoction and alcohol sedimentation technique, organic solvent extractionprocess, column chromatography, carbon dioxide supercritical extraction method, steam distillation one or more be used in combination suitably refine after extract；Above-mentioned crude extract or extract are Japanese raisintree fruit extract；
Rhizoma Curcumae Longae extract: taking Rhizoma Curcumae Longae and add water or the ethanol extraction of variable concentrations, extracting solution concentrate drying obtains crude extract；Or use further decoction and alcohol sedimentation technique, organic solvent extractionprocess, column chromatography, carbon dioxide supercritical extraction method, steam distillation one or more be used in combination suitably refine after extract；Above-mentioned crude extract or extract are Rhizoma Curcumae Longae extract.
Compositions the most according to claim 8, it is characterised in that described Radix Puerariae extract, Radix Paeoniae Alba extract, Radix Glycyrrhizae extract, Japanese raisintree fruit extract, Rhizoma Curcumae Longae extract are prepared obtaining:
Radix Puerariae extract: take Radix Puerariae and add 4-20 times amount 20-95% ethanol extraction 1-4 time, each 1-3 hour, extracting solution merged, and filtered, and decompression filtrate recycling ethanol, to without alcohol taste, continues to concentrate, dry, pulverize into fine powder, be Radix Puerariae extract；
Radix Paeoniae Alba extract: take the Radix Paeoniae Alba and add 4-20 times amount 20-95% ethanol extraction 1-4 time, each 1-3 hour, extracting solution merged, and filtered, and decompression filtrate recycling ethanol, to without alcohol taste, continues to concentrate, dry, pulverize into fine powder, be Radix Paeoniae Alba extract；
Radix Glycyrrhizae extract: extracting liquorice adds 4-20 times amount water reflux, extract, 1-4 time, each 1-3 hour, extracting solution merges, and filters, and filtrate concentrates, and dry, pulverize into fine powder, is Radix Glycyrrhizae extract；
Japanese raisintree fruit extract: take Japanese raisintree fruit and add 4-20 times amount water reflux, extract, 1-4 time, each 1-3 hour, extracting solution merged, and filtered, and filtrate concentrates, and dry, pulverize into fine powder, is Japanese raisintree fruit extract；
Rhizoma Curcumae Longae extract: take Rhizoma Curcumae Longae and add 4-20 times amount 20-95% ethanol extraction 1-4 time, each 1-3 hour, extracting solution merged, and filtered, and decompression recycling ethanol, to without alcohol taste, dry, pulverize into fine powder, is Rhizoma Curcumae Longae extract.
Compositions the most according to claim 1 and 2, it is characterised in that described Radix Puerariae extract, Radix Paeoniae Alba extract, Radix Glycyrrhizae extract, Japanese raisintree fruit extract, Rhizoma Curcumae Longae extract are to obtain by buying commercially available product.
Compositions described in 11. claim 1 or 2 has the application of the health food of auxiliary protection function for preparation to chemical liver injury.
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110478398A (en) * | 2019-09-06 | 2019-11-22 | 吉林省中医药科学院（吉林省中医药科学院第一临床医院） | A kind of pair of alcoholic liver injury has the Chinese medicine composition and preparation method of defencive function |
| CN110604798A (en) * | 2019-10-11 | 2019-12-24 | 山东金宇桐生物有限公司 | Curcumin composition effervescent tablet |
| CN111060648A (en) * | 2020-01-18 | 2020-04-24 | 河北中医学院 | Rapid double-information thin-layer identification method for hovenia dulcis thunb medicinal materials, particles and target decoction dry powder |
| CN112107626A (en) * | 2020-10-02 | 2020-12-22 | 辽宁泰阳医药科技开发有限公司 | Pharmaceutical composition and preparation method and application thereof |
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Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102670763A (en) * | 2012-06-01 | 2012-09-19 | 广州市奥海生物科技有限公司 | Composition with auxiliary protection effect on chemical liver injury and preparation method of composition |
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Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102670763A (en) * | 2012-06-01 | 2012-09-19 | 广州市奥海生物科技有限公司 | Composition with auxiliary protection effect on chemical liver injury and preparation method of composition |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN110478398A (en) * | 2019-09-06 | 2019-11-22 | 吉林省中医药科学院（吉林省中医药科学院第一临床医院） | A kind of pair of alcoholic liver injury has the Chinese medicine composition and preparation method of defencive function |
| CN110604798A (en) * | 2019-10-11 | 2019-12-24 | 山东金宇桐生物有限公司 | Curcumin composition effervescent tablet |
| CN111060648A (en) * | 2020-01-18 | 2020-04-24 | 河北中医学院 | Rapid double-information thin-layer identification method for hovenia dulcis thunb medicinal materials, particles and target decoction dry powder |
| CN111060648B (en) * | 2020-01-18 | 2022-03-11 | 河北中医学院 | Rapid double-information thin-layer identification method for hovenia dulcis thunb medicinal materials, particles and target decoction dry powder |
| CN112107626A (en) * | 2020-10-02 | 2020-12-22 | 辽宁泰阳医药科技开发有限公司 | Pharmaceutical composition and preparation method and application thereof |
| CN115487280A (en) * | 2022-10-19 | 2022-12-20 | 浙江中医药大学 | Traditional Chinese medicine composition for relieving alcoholism, protecting liver and promoting liver regeneration, preparation and preparation method thereof |
| CN115487280B (en) * | 2022-10-19 | 2023-12-19 | 浙江中医药大学 | Traditional Chinese medicine composition for dispelling effects of alcohol, protecting liver and promoting liver regeneration as well as preparation and preparation method thereof |
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