CN101574476A - Medicinal material composition used for lowering lipid and protecting liver auxiliarily - Google Patents

Medicinal material composition used for lowering lipid and protecting liver auxiliarily Download PDF

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CN101574476A
CN101574476A CNA2009100520700A CN200910052070A CN101574476A CN 101574476 A CN101574476 A CN 101574476A CN A2009100520700 A CNA2009100520700 A CN A2009100520700A CN 200910052070 A CN200910052070 A CN 200910052070A CN 101574476 A CN101574476 A CN 101574476A
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徐琳
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Abstract

The invention discloses a medicinal material composition used for lowering lipid and protecting liver auxiliarily, which comprises the following medicinal materials: hovenia dulcis thumb, alisma orientale, turtle shell, pawpaw, dried old orange peel, rhizoma atractylodis, salvia miltiorrhiza, rhizoma polygonati, hawthorn and lotus leaf. The composition has the efficacies of combining tonification and purgation, paying attention to both superficies and hypostasis, eliminating dampness and invigorating blood circulation synchronously, regulating the flow of qi, resolving lump, supplementing qi and nourishing yin, and can remove turbid damp and alcoholic toxicant, regulate mechanism of qi to be smooth, dispel blood stasis and dredge collaterals, and remove pathogenic factors for the reinforcement of vital energy. Verified by zoopery, the medicinal material composition has assistant lipid-lowering function and assistant protection function against chemical liver injury. The medicinal material composition can play the role of assistant protection on the liver when neutralizing the effect of alcoholic drinks, sobering up, delaying intoxication or relieving intoxication symptoms.

Description

The medicinal material composition that is used for complementary fat-reducing liver-protecting
Technical field
The present invention relates to a kind of medicinal material composition, relate in particular to a kind of compositions that forms by medical material compatibilities such as Fructus Crataegi, Radix Salviae Miltiorrhizae, Rhizoma Polygonati, Folium Nelumbinis, Rhizoma Alismatis and Carapax Trionycis, and the application in blood fat reducing and chemical liver injury auxiliary treatment.
Background technology
Along with the quick raising of Chinese people people's livelihood running water product, the patient of adult's dyslipidemia of China increases fast.Adult's blood fat of China present 1/3rd is higher.The consumption figure of ethanol surge simultaneously, the generation of alcoholic liver disease also significantly increases.In the states such as serious western countries and Japanese Korea S of indulging in excessive drinking, alcoholic cirrhosis accounts for the 50-70% of patient with liver cirrhosis.So alcoholic liver disease comes into one's own abroad very early, and Japan especially since the eighties just about the research of alcoholic liver disease treatment and health care, and China does not cause enough attention as yet.
Chinese invention patent application 02116334.0 discloses a kind of Chinese medicine composition with blood lipid regulation and the effect of therapeutical chemistry liver damage.Said composition is made up of Radix Puerariae, 100-600 Semen Hoveniae (Fructus Hoveniae), 100-600 Fructus Crataegi, 100-600 Poria, the 30-300 Rhizoma Atractylodis Macrocephalae, 100-600 Fructus Schisandrae Chinensis and the 30-300 Radix Glycyrrhizae of weight portion 300-900.The intravital glutathion of animal, malonaldehyde and triglyceride level after measured, and hepatic tissue pathology section checking, this Chinese medicine composition has prevention and therapeutical effect to chemical liver injury and hyperlipidemia.
Chinese invention patent application 03122873.9 discloses a kind of rescue liver-protecting medicine composition and method of making the same that prevents chemical liver injury.Said composition only is made up of soybean extract, wolfberry fruit extract, L-cysteine, can also add Fructus Crataegi extract, Rhizoma Alismatis extract, vitamin C, vitamin B6, calcium pantothenate, folic acid, vitamin B12.Indexs such as the intravital glutathion of animal, malonaldehyde, glutamic oxaloacetic transaminase, GOT, glutamate pyruvate transaminase, triglyceride and T-CHOL after measured, and hepatic tissue pathology section checking, this Chinese medicine composition has treatment, the effect of prevention chemical liver injury, but and relieving alcoholism and protecting the liver.
Chinese invention patent application 200410080509.8 discloses a kind of health-caring capsule that chemical liver injury is had auxiliary protection function.This capsule is that 0.1-0.25 Fructus Schisandrae Chinensis, 1-2.5 chitin and 0.1-0.4 Radix Puerariae are formed by weight portion.The section of indexs such as the intravital glutathion of animal, malonaldehyde, triglyceride and T-CHOL, and hepatic tissue pathology after measured checking, this capsule has protective effect to chemical liver injury.
Chinese invention patent application 200510034145.4 discloses a kind of medicine for the treatment of hyperlipidemia, fatty liver, hepatic fibrosis.This medicine comprises weight portion 10-35 Fructus Crataegi, 6-20 Rhizoma Curcumae Longae, 5-12 Radix Notoginseng, 3-20 Cortex Magnoliae Officinalis, 5-16 Radix et Rhizoma Rhei (stir-fried with wine), 8-20 Pericarpium Citri tangerinae, 5-19 Fructus Citri Sarcodactylis, 10-25 Herba Taraxaci, 10-30 Semen Ziziphi Spinosae and 5-15 Rhizoma Alismatis etc.
Chinese invention patent application 200510134267.0 discloses a kind of fat-reducing liver-protecting medicine and preparation method thereof, and it mainly is to be raw material with weight portion 0.1-1 Monas cuspurpureus Went, 4-15 Herb Gynostemmae Pentaphylli, 3-12 Radix Puerariae, 2-8 Flos Chrysanthemi, 3-12 Herba Taraxaci and 3-12 Rhizoma Alismatis.These raw materials through alcohol extraction concentrate, steps such as the water concentration contracts, pulverizing, drying and tabletting make.This medicine has blood fat reducing, strengthens the lipid metabolism of liver, suppresses liver cell fatty degeneration, reduces chemical liver injury, liver cell is played a good protection, and has the effect that blood fat reducing and strong liver protect the liver simultaneously.
Chinese invention patent application 200610012064.9 discloses a kind of pure Chinese medicine liver-protecting health food.Its extract by weight portion 8-15 Rhizoma Curcumae Longae, 3-8 Radix Salviae Miltiorrhizae, 3-8 Semen Cassiae and 2-5 Pericarpium Citri Reticulatae Viride is formed, zoopery proves, health food of the present invention can reduce triglyceride (TG) content in the hepatic tissue of alcoholic liver injury rat model, improve reduced glutathion (GSH) content in its hepatic tissue, the steatosis that alleviates its hepatic tissue is crossed degree, and the body weight of rat is not had obvious influence.Have the function that chemical liver injury is had auxiliary protection function, having has assistant protection function to alcoholic liver injury.
Chinese invention patent application 200610031011.1 discloses a kind of compound oral administration preparation that chemical liver injury is had protective effect.Said preparation is made up of weight percentage 8-20 Pericarpium Citri Reticulatae, 5-12 Radix Salviae Miltiorrhizae, 6-15 Semen Hoveniae (Fructus Hoveniae), 4-10 Radix Angelicae Sinensis, 6-15 Radix Rhodiolae, 10-15 Herba Centellae, 5-12 Rhizoma Zingiberis, 10-25 Radix Bupleuri and 4-10 Radix Puerariae, makes through extraction again.Indexs such as the intravital glutamic oxaloacetic transaminase, GOT of animal, glutamate pyruvate transaminase, white/globulin ratio and T-CHOL, and hepatic tissue pathology section checking after measured, said preparation has the hepatic injury of alleviation pathological symptom, can be used as the auxiliary treatment of hepatitis.
Chinese invention patent application 200710002520.6 discloses a kind of compound preparation, its preparation method and application thereof of lowering fat and protecting liver.Compound preparation comprises weight portion 1-27 Rhizoma Cyperi, 1-27 Fructus Schisandrae Chinensis, 1-27 Semen Cassiae and 1-27 Semen Hoveniae (Fructus Hoveniae).Said preparation has prevention and effects such as treatment viral hepatitis, icterohepatitis, chemical liver injury, alcoholic liver injury, fatty liver, hyperlipidemia, diabetes and obesity.
Above-mentioned patent application or relieve the effect of alcohol to sober up, or based on blood fat reducing, protect the liver and hepatoprotective.Ethanol needs all in vivo by liver metabolism, thus whether drunk can not be as liver-protective index, and delay drunk or alleviate drunk symptom can not the liver protecting.
Summary of the invention
One object of the present invention is to provide a kind of medicinal material composition that is used for complementary fat-reducing liver-protecting.Said composition has miscellaneous function to blood fat reducing, and chemical liver injury is had assistant protection function.
Another object of the present invention is to provide a kind of medicinal material composition preparation that is used for complementary fat-reducing liver-protecting.Pharmaceutical composition matched with adjuvant make preparation easy to use.
Another object of the present invention is to provide a kind of preparation method that is used for the medicinal material composition preparation of complementary fat-reducing liver-protecting.
Pericarpium Citri Reticulatae, its dampness of regulating the flow of vital energy can be manageed it and can fall, and can reduce phlegm with it, can make gas suitable again.
Rhizoma Alismatis, its promoting diuresis to eliminate damp pathogen, through bladder.Use Rhizoma Alismatis positive so-called " the not diuresis that dehumidifies, Fei Qizhi is also ", wet go then expectorant do not have give birth to.
Rhizoma Atractylodis, its bitter temperature is hot dry, and the present invention gets its drying damp and strengthening spleen function, removes the damp and hot heresy of alcoholism.
Radix Salviae Miltiorrhizae, its nourishing blood and promoting blood circulation, simply and merit with four things, the interaction energy of its blood circulation promoting and blood stasis dispelling removes the stagnant blood stasis of Liver Channel taste, and can tonification the stagnate cloudy blood of wear and tear of the effect of nourishing blood to tranquillize the mind.
Carapax Trionycis, its hard masses softening and resolving, the alcoholism expectorant foul smell of the loosing blood stasis that stagnates pents up institute and becomes long-pending, in addition can nourishing YIN for suppressing the hyperactive YANG, can the interior with the passing of time cloudy liquid of damage that stagnates of tonification body.
Fructus Crataegi, it can promoting digestion and removing stagnation, and can invigorate blood circulation.
Fructus Chaenomelis, its removing dampness to restore normal function of the stomach, Folium Nelumbinis dampness removing yang invigorating.
Rhizoma Polygonati, its YIN nourishing invigorating the spleen and replenishing QI is with tonifying deficiency.
Semen Hoveniae (Fructus Hoveniae), its alcoholic intoxication diuresis.
Folium Nelumbinis, its dampness removing yang invigorating.
A kind of medicinal material composition that is used for complementary fat-reducing liver-protecting comprises following medical material: Semen Hoveniae (Fructus Hoveniae), Rhizoma Alismatis, Carapax Trionycis, Fructus Chaenomelis, Pericarpium Citri Reticulatae, Rhizoma Atractylodis, Radix Salviae Miltiorrhizae, Rhizoma Polygonati, Fructus Crataegi and Folium Nelumbinis.
Another kind is used for the medicinal material composition of complementary fat-reducing liver-protecting, comprises following medical material: Semen Hoveniae (Fructus Hoveniae), Rhizoma Alismatis, Carapax Trionycis, Fructus Chaenomelis, Pericarpium Citri Reticulatae, Rhizoma Atractylodis, Radix Salviae Miltiorrhizae, Rhizoma Polygonati and Fructus Crataegi.
Another kind is used for the medicinal material composition of complementary fat-reducing liver-protecting, comprises following medicinal materials in part by weight: 0.5-1.5 Semen Hoveniae (Fructus Hoveniae), 0.5-1.5 Rhizoma Alismatis, 1.0-3.0 Carapax Trionycis, 0.5-1.5 Fructus Chaenomelis, 0.5-1.5 Pericarpium Citri Reticulatae, 0.5-1.5 Rhizoma Atractylodis, 2.5-5.0 Radix Salviae Miltiorrhizae, 0.5-1.5 Rhizoma Polygonati, 2.5-5.0 Fructus Crataegi and 1.0-3.0 Folium Nelumbinis.
Another kind is used for the medicinal material composition of complementary fat-reducing liver-protecting, is made up of following medicinal materials in part by weight: 0.5-1.5 Semen Hoveniae (Fructus Hoveniae), 0.5-1.5 Rhizoma Alismatis, 1.0-3.0 Carapax Trionycis, 0.5-1.5 Fructus Chaenomelis, 0.5-1.5 Pericarpium Citri Reticulatae, 0.5-1.5 Rhizoma Atractylodis, 2.5-5.0 Radix Salviae Miltiorrhizae, 0.5-1.5 Rhizoma Polygonati, 2.5-5.0 Fructus Crataegi and 1.0-3.0 Folium Nelumbinis.
The above-mentioned medicinal material composition that is used for complementary fat-reducing liver-protecting, its medical material can be to process through modes such as chopping, grinding and dryings in advance, and concrete form can be decoction pieces or powder etc.Those skilled in the art can select the medical material of different shape according to the actual fabrication needs, and the concrete form of described medical material is as limiting the present invention.
The above-mentioned medicinal material composition that is used for complementary fat-reducing liver-protecting is passed through decocting; Or by organic solvent (as: ethanol) extraction; Or with a part of medical material decocting, another part medical material organic solvent extraction, at last after modes such as merging prepare, again with various adjuvants, as: disintegrating agent, dispersant, correctives, excipient etc., make various preparations.Its dosage form can be decoction, powder, pill, drop pill, tablet, electuary, unguentum, sublimed preparation, injection, capsule, oral liquid and medicated wine etc.
A kind of preparation method that comprises the preparation of the above-mentioned medicinal material composition that is used for complementary fat-reducing liver-protecting comprises the steps:
1) the following medical material of weight portion: 0.5-1.5 Fructus Chaenomelis, 0.5-1.5 Pericarpium Citri Reticulatae, 0.5-1.5 Rhizoma Atractylodis, 2.5-5.0 Radix Salviae Miltiorrhizae, 0.5-1.5 Rhizoma Polygonati and 2.5-5.0 Fructus Crataegi use 50-75% (v/v) alcohol reflux more than 1 time, greater than 1 hour, obtain ethanol extract and medical material solid residue at every turn;
2) in weight portion 1.0-3.0 Carapax Trionycis, take out 50%-90% (w/w) and add the following medical material of weight portion: 0.5-1.5 Semen Hoveniae (Fructus Hoveniae), 0.5-1.5 Rhizoma Alismatis, 1.0-3.0 Folium Nelumbinis, the medical material solid residue that obtains with step 1 merges again, water decocts more than 1 time then, greater than 1 hour, leave standstill filtration then and obtain aqueous extract at every turn;
3) after being mixed, the aqueous extract of the ethanol extract of step 1 gained and step 2 gained makes fine powder;
4) with remaining 1.0-3.0 Carapax Trionycis in the step 2 with after fine powder that step 3 makes mixes, make tablet after adding hydroxypropyl cellulose, carboxymethyl starch sodium and magnesium stearate adjuvant.
The preparation method of the preparation of the above-mentioned medicinal material composition that is used for complementary fat-reducing liver-protecting, wherein, in preparation ethanol extract process, used ethanol is generally 50-75% (v/v), preferentially selects 65-70% (v/v).Each concentration of alcohol that refluxes use can be identical or different, and the amount of alcohol of use also can be identical or different, and each return time also can be identical or different.In preparation aqueous extract process, each water yield that decocts use can be identical or different, and each decocting time also can be identical or different.
The preparation method of the preparation of the above-mentioned medicinal material composition that is used for complementary fat-reducing liver-protecting leaves standstill that to filter be for the water extract after realizing decocting boiled and the purpose of the residual solid-liquid separation of medical material.Those skilled in the art can expect variety of way to realize isolating purpose, and its concrete mode is as limiting the present invention.
Granulation technique can be specifically referring to " modern practical Chinese medicine novel form new technique ", People's Health Publisher, 2001; " analysising drug form of Chinese medicine preparation technology ", chemical industry publishing house, 2006 and " Chinese medicine novel form and new technique ", Chemical Industry Press, 2008.
Another kind comprises the preparation method of the preparation of the above-mentioned medicinal material composition that is used for complementary fat-reducing liver-protecting, comprises the steps:
1) the following medical material of weight portion: 0.5-1.5 Fructus Chaenomelis, 0.5-1.5 Pericarpium Citri Reticulatae, 0.5-1.5 Rhizoma Atractylodis, 2.5-5.0 Radix Salviae Miltiorrhizae, 0.5-1.5 Rhizoma Polygonati and 2.5-5.0 Fructus Crataegi were measured 70% (v/v) alcohol refluxs 2 hours with 10 times earlier, 8 times of amounts of reuse, 70% (v/v) alcohol reflux 1.5 hours obtains ethanol extract and medical material solid residue;
2) in weight portion 1.0-3.0 Carapax Trionycis, take out 50%-90% (w/w) and add the following medical material of weight portion: 0.5-1.5 Semen Hoveniae (Fructus Hoveniae), 0.5-1.5 Rhizoma Alismatis, 1.0-3.0 Folium Nelumbinis, the medical material solid residue that obtains with step 1 merges again, decocted 2 hours with 8 times of water gagings earlier then, 8 times of water gagings of reuse decocted 3 hours, left standstill at last to filter to obtain aqueous extract;
3) after being mixed, the aqueous extract of the ethanol extract of step 1 gained and step 2 gained makes fine powder;
4) with remaining 1.0-3.0 Carapax Trionycis in the step 2 with after fine powder that step 3 makes mixes, make tablet after adding hydroxypropyl cellulose, carboxymethyl starch sodium and magnesium stearate adjuvant.
The preparation method of the preparation of the above-mentioned medicinal material composition that is used for complementary fat-reducing liver-protecting remerges after can also be earlier ethanol extract and aqueous extract being concentrated respectively, uses spray drying to make fine powder.Its extracting solution can realize spissated purpose by distilling under reduced pressure.Those skilled in the art can expect variety of way to concentrate purpose, and its concrete mode is as limiting the present invention.
Another kind comprises the preparation method of the preparation of the above-mentioned medicinal material composition that is used for complementary fat-reducing liver-protecting, comprises the steps:
1) the following medical material of weight portion: 0.5-1.5 Fructus Chaenomelis, 0.5-1.5 Pericarpium Citri Reticulatae, 0.5-1.5 Rhizoma Atractylodis, 2.5-5.0 Radix Salviae Miltiorrhizae, 0.5-1.5 Rhizoma Polygonati and 2.5-5.0 Fructus Crataegi were measured 70% (v/v) alcohol refluxs 2 hours with 10 times earlier, 8 times of amounts of reuse, 70% (v/v) alcohol reflux 1.5 hours obtains ethanol extract and medical material solid residue;
2) in weight portion 1.0-3.0 Carapax Trionycis, take out 75%-85% (w/w) and add the following medical material of weight portion: 0.5-1.5 Semen Hoveniae (Fructus Hoveniae), 0.5-1.5 Rhizoma Alismatis, 1.0-3.0 Folium Nelumbinis, the medical material solid residue that obtains with step 1 merges again, decocted 2 hours with 8 times of water gagings earlier then, 8 times of water gagings of reuse decocted 3 hours, left standstill at last to filter to obtain aqueous extract;
3) earlier with the aqueous extract of the ethanol extract of step 1 gained and step 2 gained respectively behind the concentrating under reduced pressure, the remix concentrated solution, spray drying is made fine powder;
4) with remaining 1.0-3.0 Carapax Trionycis in the step 2 with after fine powder that step 3 makes mixes, make tablet after adding hydroxypropyl cellulose, carboxymethyl starch sodium and magnesium stearate adjuvant.
In the above-mentioned various preparation method, the medical material Carapax Trionycis is generally turtle ' s carapace powder, and its particle diameter is generally less than 200 orders, preferentially selects particle diameter less than 100 orders.
In the above-mentioned various preparation method, ethanol extract concentrates separately can adopt following condition: vacuum 0.08Mpa, temperature 50-60 ℃ of decompression recycling ethanol, and be concentrated into phase density 1.15-1.20 (50 ℃).The reduced pressure that those skilled in the art can select to be fit to is to concentrate ethanol extract, and its actual conditions is as limiting the present invention.
In the above-mentioned various preparation method, aqueous extract concentrates separately can adopt following condition: vacuum 0.08Mpa, temperature 60-70 ℃ of decompression recycling ethanol, and be concentrated into phase density 1.15-1.20 (50 ℃).The reduced pressure that those skilled in the art can select to be fit to is with the condensed water extracting solution, and its actual conditions is as limiting the present invention.
The beneficial effect that technical solution of the present invention realizes:
The present invention has the match compositions that forms of multi-flavor medical materials such as Semen Hoveniae (Fructus Hoveniae), Rhizoma Alismatis, Carapax Trionycis, Fructus Chaenomelis, Pericarpium Citri Reticulatae, Rhizoma Atractylodis, Radix Salviae Miltiorrhizae, Rhizoma Polygonati and Fructus Crataegi to attack to mend and takes in concurrently, giving consideration to both the incidental and fundamental, plays dampness invigorate blood circulation, the regulate the flow of vital energy effect of eliminating stagnation and boosting qi and nourishing yin altogether.It can make turbid damp change, and alcoholism can be separated, QI movement being in harmonious way, the stasis of blood dispel ruton and vital QI recovered after pathogens eliminated.
The tablet per os of the various dose that pharmaceutical composition of the present invention is made gives the chemical liver injury mice use after, compare with model control group, the glutamate pyruvate transaminase vigor has remarkable reduction (P<0.05), hepatic necrosis average mark and hepatocyte all kinds grand average significantly reduce (P<0.01), and weight of mice is had no adverse effects.According to " health food check and assessment technique standard " (2003 editions) (health ministry was issued the documents in 2003), the pharmaceutical composition that is somebody's turn to do has assistant protection function to chemical liver injury.
The tablet per os of the various dose that pharmaceutical composition of the present invention is made gives the hyperlipidemia mice use after, compare with model control group, serum total cholesterol significantly reduces (P<0.05), and serum levels of triglyceride significantly reduces (P<0.01), and weight of mice is had no adverse effects.According to " health food check and assessment technique standard " (2003 editions), the pharmaceutical composition that is somebody's turn to do has auxiliary lipid-lowering function.
Medicinal material composition of the present invention can play complementary protective effect to liver when relieving the effect of alcohol, sober up, delaying drunk or alleviating drunk symptom.
Term involved in the present invention is identical with its general notion.
Described " decoction " is the most widely used a kind of dosage form of tcm clinical practice.Its preparation method is: after according to different weight portions various medical materials being assorted, and water or yellow wine, or after the equal amounts of wine and water immersion, decoct certain hour again, the extracting juice that removes slag then is decoction.It usually uses as for oral administration, have absorb fast, curative effect is fast and be convenient to use as one feels fit according to the state of an illness.
Described " powder " branch takes orally and two kinds of externals.Its preparation method is: according to different weight portions various medical materials are assorted the back and grind, become mixed uniformly dried powder.It has simple for production, be convenient to take carry, absorb very fast, save medical material and characteristics such as not perishable.
Described " pill " is a kind of common formulations of tcm clinical practice, have honeyed pill, the watered pill, paste pill, concentrated pill etc. several.Its preparation method is: after according to different weight portions various medical materials being assorted, and the rounded solid preparation of making as excipient with honey, water or rice paste, batter, wine, vinegar, medicine juice etc.It has characteristics such as absorb slowly, the efficacy of a drug is lasting and volume is little, is convenient to take, carries and stores.
Described " drop pill " is a kind of of solid dispersion preparation, refers to splash in the immiscible coolant after solid or liquid medicine and the substrate mixing heating and melting, shrinks a kind of quick-effective preparation that is condensed into ball.
Described " tablet " also is a kind of common formulations of tcm clinical practice.Its preparation method is generally: after according to different weight portions various medical materials being assorted, through being mixed with adjuvant by fine drug powder or extract behind processing or the refine, be pressed into the solid preparation of disk shape or other shapes.
Described " electuary ", its preparation method are earlier the Chinese medicine refine to be become thick paste, add part medicated powder, Icing Sugar or adjuvant again and make granule powder drying and form.
Described " unguentum " is divided into two kinds of the externals that reach for oral administration.To assort the back to various medical materials according to different weight portions and decoct, extracting juice concentrates and forms semi-solid preparation.
Described " oral liquid " also is a kind of common formulations of tcm clinical practice.Its preparation method is generally: adopt suitable solvent and method, the extracts active ingredients in the Chinese medicine is come out, and be scattered in confession made in solvent liquid preparation for oral administration.
Described " capsule ", its preparation method system, perhaps goes into to add medicated powder or adjuvant and is filled in the preparation that forms in the Capsules in Capsules the medicinal powder of medicine or extract direct packaging." Chinese pharmacopoeia was subdivided into soft capsule, hard capsule and enteric coated capsule again with capsule in the version rules of preparations in 2000.
Described " medicated wine " claims medicated wine again.Be that drug immersion is gone in the wine, after the time, the extracting juice that removes slag is for for oral administration or external.
Described " 10 times of amounts " and " 8 times of amounts " refer to the multiple of medical material gross weight.
The specific embodiment
Below describe technical scheme of the present invention in detail.Listed examples of the present invention is only unrestricted in order to technical scheme of the present invention to be described, although the present invention is had been described in detail with reference to preferred embodiment, those of ordinary skill in the art is to be understood that, can make amendment or be equal to replacement the technical scheme of invention, and not breaking away from the spirit and scope of technical solution of the present invention, it all should be encompassed in the claim scope of the present invention.
The reagent that the present invention is used is not if clearly indicate, then all available from Sigma-aldrich (Sigma-Aldrich).
Embodiment 1 preparation tablets
Prepare the medicinal material composition tablet according to following step:
1) 187.5g Fructus Chaenomelis, 187.5g Pericarpium Citri Reticulatae, 187.5g Rhizoma Atractylodis, 625g Radix Salviae Miltiorrhizae, 312.5g Rhizoma Polygonati and 625g Fructus Crataegi are placed container, earlier with 10 times of alcohol refluxs of measuring 70% (v/v) after 2 hours, the alcohol reflux of 8 times of amounts of reuse 70% (v/v) 1.5 hours obtains ethanol extract and medical material solid residue;
2) the medical material solid residue that 375g Carapax Trionycis, 187.5g Semen Hoveniae (Fructus Hoveniae), 187.5g Rhizoma Alismatis, 375g Folium Nelumbinis and step 1 are obtained places container jointly, after decocting 2 hours with 8 times of water gagings earlier then, 8 times of water gagings of reuse decocted 3 hours, left standstill at last to filter to obtain aqueous extract;
3) earlier with the aqueous extract of the ethanol extract of step 1 gained and step 2 gained respectively behind the concentrating under reduced pressure, the remix concentrated solution, spray drying is made fine powder 684g;
4) after the 684g fine powder that 66g turtle ' s carapace powder and step 3 are made mixes, add adjuvant hydroxypropyl cellulose 27g, carboxymethyl starch sodium 20g and magnesium stearate 5g and make 1000 in tablet.
Embodiment 2 auxiliary antilipemic zooperies
The Wistar male rat is divided into the administration group of a matched group and three various dose, and totally four groups, every group of 12 animals.Four treated animals all give the high lipid food of same composition and identical deal.Three groups of administration treated animals give embodiment 1 made tablet, and the dosage of its per kilogram of body weight is respectively: 0.27g, 0.53g and 1.6g.Every day, per os was irritated stomach 1 time, and the continuous irrigation stomach is measured serum total cholesterol and triglyceride after 32 days.Matched group gives the water of equal volume every day at every turn.
High lipid food is formed: 78.8% normal feedstuff (Institute of Experimental Animals, Chinese Academy of Medical Sciences), 1% cholesterol, 10% yolk powder, 10% Adeps Sus domestica and 0.2% cholate.
Measure serum total cholesterol:
Four treated animal fasting were got blood after 16 hours, and centrifugal 10 minutes of 3000rpm gets serum.Use T-CHOL test kit (Zhongsheng Beikong Biological Science ﹠ Technology Co., Ltd.) to measure, the results are shown in Table 1.
Table 1 medicinal material composition is to the influence of Wistar rat blood serum T-CHOL (TC)
Figure A20091005207000131
By table 1 as seen, relatively, serum total cholesterol raises, and has significant difference (P<0.01) before matched group and the experiment, shows that animal model sets up successfully.Before the administration, the serum total cholesterol of each treated animal and matched group (0g/kg body weight) compare, difference that there are no significant (P>0.05).Administration group (1.60g/kg body weight) is compared with matched group, and serum total cholesterol significantly reduces (P<0.05).
Measure triglyceride:
Four treated animal fasting were got blood after 16 hours, and centrifugal 10 minutes of 3000rpm gets serum.Use triglyceride test kit (Zhongsheng Beikong Biological Science ﹠ Technology Co., Ltd.) to measure, the results are shown in Table 2.
Table 2 medicinal material composition is to the influence of Wistar rat blood serum triglyceride (TG)
Figure A20091005207000132
By table 2 as seen, relatively, serum levels of triglyceride raises, and has significant difference (P<0.01) before matched group and the experiment, shows that animal model sets up successfully.Before the administration, the serum levels of triglyceride of each treated animal and matched group (0g/kg body weight) compare, difference that there are no significant (P>0.05).Administration group (1.60g/kg body weight) is compared with matched group, and serum levels of triglyceride significantly reduces (P<0.01).
According to the criterion of above-mentioned every experimental result and " health food check and assessment technique standard " (2003 editions), medicinal material composition of the present invention has auxiliary lipid-lowering function.
Embodiment 3 assistant chemical liver damage protective effects
Male Kunming strain mice is divided into the administration group of a model control group, a blank group and three various dose, and totally four groups, every group of 12 animals.Five treated animals all give the high lipid food of same composition and identical deal.Three groups of administration treated animals give embodiment 1 made tablet, and the dosage of its per kilogram of body weight is respectively: 0.53g, 1.07g and 3.20g.Every day, per os was irritated stomach 1 time, and the continuous irrigation stomach is measured glutamate pyruvate transaminase and hepatic tissue section pathological analysis after 35 days.Matched group gives the water of equal volume every day at every turn.
After the 33rd day, with each treated animal fasting 16 hours, model control group and the disposable filling stomach of each administration group gave 1% carbon tetrachloride of dosage per kilogram of body weight 80mg at successive administration.The blank group gives the vegetable oil of equal volume.
Measure glutamate pyruvate transaminase:
Put to death animal after 24 hours being tried carbon tetrachloride, get serum and separate, measure at automatic clinical chemistry analyzer, the results are shown in Table 3 with glutamate pyruvate transaminase test kit (Zhongsheng Beikong Biological Science ﹠ Technology Co., Ltd.).
Table 3 medicinal material composition is to the influence of glutamate pyruvate transaminase vigor
By table 3 as seen, per os gives the tablet 35 days that the embodiment 1 of mice various dose makes, model control group and blank group relatively, the glutamate pyruvate transaminase vigor significantly raises (P<0.01), shows that animal model sets up successfully.Administration group (3.20g/kg body weight) is compared with model control group, and the glutamate pyruvate transaminase vigor significantly reduces (P<0.05).
The liver tissue slices pathological analysis:
Put to death animal after 24 hours being tried carbon tetrachloride, mouse liver lobus sinister 10% formalin fixed is done the crosscut routine pathology film-making (paraffin embedding, H.E. dyeing) of drawing materials from the leftlobe of liver middle part.
From the pathological change that one of liver is looked closely wild opening entry cell, observe whole tissue slice continuously with 40 times of object lens.The major lesions type has ballooning degeneration of liver cells, steatosis, endochylema cohesion, hepatocyte hydropic degeneration and necrocytosis.The standard that score is judged is as follows:
Ballooning degeneration of liver cells: (cell enlargement, endochylema residual a little)
Figure A20091005207000151
Steatosis: (occur in the hepatocyte endochylema boundary fat drip cavity) clearly
Figure A20091005207000152
Endochylema cohesion: (endochylema is had a liking for Yihong and strengthened)
Figure A20091005207000153
Hydropic degeneration:
Figure A20091005207000161
Hepatic necrosis: (endochylema is had a liking for Yihong and become coagulation necrosis)
Figure A20091005207000162
Write down the area in the shared visual field of various pathological changes in each visual field respectively, and the pathological changes total points in the observed visual field of accumulative total, the results are shown in Table 4.
Table 4 medicinal material composition is to the pathological influence of hepatic tissue section
By table 4 as seen, per os gives the tablet 35 days that the embodiment 1 of mice various dose makes, model control group and blank group relatively, hydropic degeneration and hepatic necrosis average mark, all kinds grand average significantly raise (P<0.01), show that animal model sets up successfully.Administration group (3.20g/kg body weight) is compared with model control group, and hepatic necrosis average mark, all kinds grand average significantly reduce (P<0.01).
According to the criterion of above-mentioned every experimental result and " health food check and assessment technique standard " (2003 editions), medicinal material composition of the present invention has the miscellaneous function to chemical liver injury.
The experiment of embodiment 4 auxiliary antilipemic human experiments
Human experiment is tested into the group standard: blood sampling is 2 times in half a year, twice serum total cholesterol (TC) all 〉=5.2mmol/L or serum levels of triglyceride (TG) all 〉=the simple dyslipidemia person of 1.65mmol/L.
Human experiment experiment exclusion standard:
● the age is under-18s or over-65s person;
● gestation or women breast-feeding their children, allergic constitution or to this given the test agent allergy sufferers;
● serious disease and spiritual patients such as merging is had the inclination, cerebrovascular, liver, kidney, digestive tract;
● take the article relevant in a short time, have influence on judgement person as a result with being tried function;
● do not take given the test agent by standard, data not umbra is rung effect or safety judgement person.
Experimenter's grouping: two kinds of forms of contrast between experiment employing self cross-reference and group.The experimenter is divided into experimental group and matched group at random, and experimental group is taken and tried thing, and matched group is a blank.
The tablet (every 0.8g) of experimenter's taking dose: embodiment 1 preparation.Everyone every day 2 times, each 4, dose is 6.4g/ day, continuous 45 days.
Instrument and reagent: CA-500 type blood counting instrument, RM-200 urinates ten analysers, the AUTOLAB automatic clinical chemistry analyzer, the biochemical reagents box is all provided by Zhongsheng Beikong Biological Science ﹠ Technology Co., Ltd..
Observation index:
Each is checked once before and after the following observation index experiment.
1. safety is observed:
● general situation: comprise spirit, sleep, diet, defecation, blood pressure etc.
● blood, urine, just routine examination: red blood cell count(RBC), hemoglobin, numeration of leukocyte, routine urinalysis, just routine examination.
● blood biochemistry checking: serum albumin ALB, total protein TP, glutamic oxaloacetic transaminase, GOT AST, glutamate pyruvate transaminase ALT, total bilirubin TBIL, carbamide UREA, inosine CRE, blood glucose GLU.
● Abdominal B type ultrasonography, electrocardiogram, X line fluoroscopy of chest (carrying out before on-test)
2. effect observation:
● laboratory examination: detect serum total cholesterol (TC), triglyceride (TG), HDL-C (HDL-C), observe serum total cholesterol (TC) level and reduce percentage rate, triglyceride (TG) level and reduction percentage rate, HDL-C (HDL-C) level and ascensional range.
Date processing and result judge:
1. date processing:
With the SPSS of statistical software computational analysis data.All own control data adopt paired t-test, two groups of means relatively adopt t check in groups, and the latter need carry out homogeneity test of variance, and the data of nonnormal distribution or heterogeneity of variance are carried out suitable variable conversion, after waiting to satisfy the normal state homogeneity of variance, carry out the t check with data converted; If translation data still can not satisfy the requirement of normal state homogeneity of variance, use t ' check or rank test instead; But the coefficient of variation is too big as data (CV>50%) is used rank test.Effect index X 2Check.
2. effect criterion:
● effectively: TC reduces>10%; TG reduces>15%; HDL-C rising>0.104mmol/L.Cholesterol, triglyceride, HDL-C, test-meal group self relatively reach and the matched group group between comparing difference significance is arranged, or HDL-C significantly is not lower than matched group.
● invalid: as not reach effective standard person
Experimental result
● general situation:
The experimenter is divided into experimental group and matched group at random, conformance with standard experimenter's 100 examples, every group 50 example.The experimenter tests inspections such as preceding routine blood test, routine urinalysis, stool routine examination, hepatic and renal function, Chest X-rays, electrocardiogram, B ultrasonic, all in normal range, the grouping situation sees Table 5, the preceding two groups of patient ages of test-meal, sex, blood fat rising time, cholesterol and the equal no significant difference of triglyceride (P>0.05) have comparability.No significant changes such as spirit, sleep, diet, defecation, blood pressure before and after the examination trencherman test-meal.
The last version of table 5 test-meal data relatively
● cholesterol changes
The situation of change of cholesterol sees Table 6 before and after the test-meal
Cholesterol variation before and after table 6 test-meal (X ± SD)
Figure A20091005207000202
Contrast ##P<0.01 between own control * * P<0.01 group
● triglyceride changes
The situation of change of triglyceride sees Table 7 before and after the test-meal
Triglyceride variation before and after table 7 test-meal (X ± SD)
Contrast between own control * * P<0.01 group between #P<0.05 group and contrast ##P<0.01
● high density lipoprotein changes
The situation of change of high density lipoprotein sees Table 8 before and after the test-meal
High density lipoprotein variation before and after table 8 test-meal (X ± SD)
Figure A20091005207000211
Contrast between own control * * P<0.01 group between #P<0.05 group and contrast ##P<0.01
● the effect evaluation:
The effect evaluation sees Table 9 before and after the test-meal
Table 9 effect is judged
Figure A20091005207000212
Contrast #P<0.05 between group
● cardinal symptom is improved situation:
Cardinal symptom improvement situation sees Table 10 and table 11 before and after the test-meal
Table 10 cardinal symptom is improved situation
Figure A20091005207000213
Expression matched group in " () "
Symptom integral variation before and after table 11 test-meal (X ± SD)
Figure A20091005207000221
Contrast #P<0.05 between own control * * P<0.01 group
Safety indexes detects:
● heart rate and blood pressure are relatively
Cardinal symptom improvement situation sees Table 12 before and after the test-meal
Heart rate and blood pressure comparison before and after table 12 test-meal (X ± SD)
Figure A20091005207000222
Experiment shows that heart rate and blood pressure are all in normal range before and after the test.
● blood, urine and stool routine examination safety index
Blood, urine and stool routine examination situation of change see Table 13 before and after the test-meal
Blood safety index variation comparison before and after table 13 test-meal (X ± SD)
Figure A20091005207000231
Experiment shows that above-mentioned every index is all in normal range before and after the test.
Blood pressure is substantially in normal range before and after test-meal preabdomen B ultrasonic, electrocardiogram, the fluoroscopy of chest of X line, test-meal.
Case is taken off the mistake rate: test-meal group and matched group respectively are 52 examples, and the test-meal of wherein test-meal group has the not check on time at the appointed time of 2 examples when finishing; Matched group has the not check on time at the appointed time of 2 examples.Test-meal group and matched group respectively have 2 examples to meet experimenter's exclusion standard, effective every group 50 example of case, and case is taken off the mistake rate and is 3.85%.
The human experiment experiment conclusion:
100 routine satisfactory hyperlipidemia experimenters are divided into test-meal group and matched group at random, and the test-meal group is taken magnificent unicorn board Radix Salviae Miltiorrhizae Carapax Trionycis sheet after 45 days on request, the cholesterol 0.63 ± 0.66mM that on average descends, decline percentage rate 10.24%; Triglyceride 0.32 ± the 0.46mM that on average descends, decline percentage rate 15.70%; High density lipoprotein 0.11 ± the 0.16mM that on average raises, in 50 examples, effective 13 examples, total effective rate 26.00%.Before and after the test of test-meal group cholesterol, triglyceride self relatively, and after the test-meal between test-meal group and matched group group comparing difference significance (P<0.05) is all arranged.According to auxiliary lipid-lowering function criterion in " health food check and assessment technique standard " (version in 2003), think that the tablet of the embodiment of the invention 1 preparation has the effect of auxiliary antilipemic.
The tablet test-meal front and back of the embodiment of the invention 1 preparation, the blood biochemistry except that blood fat, routine blood test, routine urinalysis reach just, and conventional index illustrates that all in normal range this product has no adverse effects to the experimenter is healthy.
After the tablet test-meal of the embodiment of the invention 1 preparation, do not meet quick and other untoward reaction.

Claims (10)

1. a medicinal material composition that is used for complementary fat-reducing liver-protecting comprises following medical material: Semen Hoveniae (Fructus Hoveniae), Rhizoma Alismatis, Carapax Trionycis, Fructus Chaenomelis, Pericarpium Citri Reticulatae, Rhizoma Atractylodis, Radix Salviae Miltiorrhizae, Rhizoma Polygonati, Fructus Crataegi and Folium Nelumbinis.
2. a medicinal material composition that is used for complementary fat-reducing liver-protecting comprises following medicinal materials in part by weight: 0.5-1.5 Semen Hoveniae (Fructus Hoveniae), 0.5-1.5 Rhizoma Alismatis, 1.0-3.0 Carapax Trionycis, 0.5-1.5 Fructus Chaenomelis, 0.5-1.5 Pericarpium Citri Reticulatae, 0.5-1.5 Rhizoma Atractylodis, 2.5-5.0 Radix Salviae Miltiorrhizae, 0.5-1.5 Rhizoma Polygonati, 2.5-5.0 Fructus Crataegi and 1.0-3.0 Folium Nelumbinis.
3. one kind comprises the preparation that is used for the medicinal material composition of complementary fat-reducing liver-protecting as claimed in claim 1 or 2, it is characterized in that described preparation is decoction, powder, pill, drop pill, tablet, electuary, unguentum, capsule, oral liquid or medicated wine.
4. a preparation method that is used for complementary fat-reducing liver-protecting preparation comprises the steps:
1) the following medical material of weight portion: 0.5-1.5 Fructus Chaenomelis, 0.5-1.5 Pericarpium Citri Reticulatae, 0.5-1.5 Rhizoma Atractylodis, Radix Salviae Miltiorrhizae, 0.5-1.5,2.5-5.0 Rhizoma Polygonati and 2.5-5.0 Fructus Crataegi use volume ratio 50%-75% alcohol reflux more than 1 time, greater than 1 hour, obtain ethanol extract and medical material solid residue at every turn;
2) in weight portion 1.0-3.0 Carapax Trionycis, take out 50wt%-90wt%, add the following medical material of weight portion: 0.5-1.5 Semen Hoveniae (Fructus Hoveniae), 0.5-1.5 Rhizoma Alismatis, 1.0-3.0 Folium Nelumbinis, the medical material solid residue that obtains with step 1 merges again, water decocts more than 1 time then, greater than 1 hour, leave standstill filtration then and obtain aqueous extract at every turn;
3) after being mixed, the aqueous extract of the ethanol extract of step 1 gained and step 2 gained makes fine powder;
4) with remaining 1.0-3.0 Carapax Trionycis in the step 2 with after fine powder that step 3 makes mixes, make tablet after adding hydroxypropyl cellulose, carboxymethyl starch sodium and magnesium stearate adjuvant.
5. a preparation method that is used for complementary fat-reducing liver-protecting preparation comprises the steps:
1) the following medical material of weight portion: 0.5-1.5 Fructus Chaenomelis, 0.5-1.5 Pericarpium Citri Reticulatae, 0.5-1.5 Rhizoma Atractylodis, Radix Salviae Miltiorrhizae, 0.5-1.5,2.5-5.0 Rhizoma Polygonati and 2.5-5.0 Fructus Crataegi were measured volume ratio 70% alcohol refluxs 2 hours with 10 times earlier, 8 times of amounts of reuse volume ratio, 70% alcohol reflux 1.5 hours obtains ethanol extract and medical material solid residue;
2) in weight portion 1.0-3.0 Carapax Trionycis, take out 50wt%-90wt% and add the following medical material of weight portion: 0.5-1.5 Semen Hoveniae (Fructus Hoveniae), 0.5-1.5 Rhizoma Alismatis, 1.0-3.0 Folium Nelumbinis, the medical material solid residue that obtains with step 1 merges again, decocted 2 hours with 8 times of water gagings earlier then, 8 times of water gagings of reuse decocted 3 hours, left standstill at last to filter to obtain aqueous extract;
3) after being mixed, the aqueous extract of the ethanol extract of step 1 gained and step 2 gained makes fine powder;
4) with remaining 1.0-3.0 Carapax Trionycis in the step 2 with after fine powder that step 3 makes mixes, make tablet after adding hydroxypropyl cellulose, carboxymethyl starch sodium and magnesium stearate adjuvant.
6. a preparation method that is used for complementary fat-reducing liver-protecting preparation comprises the steps:
1) the following medical material of weight portion: 0.5-1.5 Fructus Chaenomelis, 0.5-1.5 Pericarpium Citri Reticulatae, 0.5-1.5 Rhizoma Atractylodis, Radix Salviae Miltiorrhizae, 0.5-1.5,2.5-5.0 Rhizoma Polygonati and 2.5-5.0 Fructus Crataegi were measured volume ratio 70% alcohol refluxs 2 hours with 10 times earlier, 8 times of amounts of reuse volume ratio, 70% alcohol reflux 1.5 hours obtains ethanol extract and medical material solid residue;
2) in weight portion 1.0-3.0 Carapax Trionycis, take out 75wt%-85wt% and add the following medical material of weight portion: 0.5-1.5 Semen Hoveniae (Fructus Hoveniae), 0.5-1.5 Rhizoma Alismatis, 1.0-3.0 Folium Nelumbinis, the medical material solid residue that obtains with step 1 merges again, decocted 2 hours with 8 times of water gagings earlier then, 8 times of water gagings of reuse decocted 3 hours, left standstill at last to filter to obtain aqueous extract;
3) earlier with the aqueous extract of the ethanol extract of step 1 gained and step 2 gained respectively behind the concentrating under reduced pressure, the remix concentrated solution, spray drying is made fine powder;
4) with remaining Carapax Trionycis in the step 2 with after fine powder that step 3 makes mixes, make tablet after adding hydroxypropyl cellulose, carboxymethyl starch sodium and magnesium stearate adjuvant.
7. according to the described preparation method that is used for complementary fat-reducing liver-protecting preparation of one of claim 4-6, it is characterized in that described Carapax Trionycis is a turtle ' s carapace powder.
8. the medicinal material composition that is used for complementary fat-reducing liver-protecting according to claim 1 and 2, the application in the medicine of preparation treatment and health care alcoholic liver disease, dyslipidemia, fatty liver and other chemical liver injury.
9. the medicinal material composition that is used for complementary fat-reducing liver-protecting according to claim 1 and 2 is delaying drunk or is alleviating application in the drunk symptom.
10. the preparation that is used for the medicinal material composition of complementary fat-reducing liver-protecting according to claim 3 is delaying drunk or is alleviating application in the drunk symptom.
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CN102008678A (en) * 2010-12-14 2011-04-13 徐樊 Chinese medicinal preparation for treating fatty liver
CN102552462A (en) * 2012-01-12 2012-07-11 中山火炬职业技术学院 Effervescent preparation as well as preparation method and application thereof
CN102742829A (en) * 2011-04-18 2012-10-24 北京天植百桂生物技术有限公司 Dietetic therapy product for regulating blood fat and preparation method thereof
CN102784248A (en) * 2012-09-03 2012-11-21 赵全成 Chinese medicine composition for preventing and treating alcoholic liver injury
CN105795271A (en) * 2016-03-30 2016-07-27 黄山树德堂食品饮料有限公司 Stomach moistening and detoxifying healthy beverage and preparation method thereof

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CN102008678A (en) * 2010-12-14 2011-04-13 徐樊 Chinese medicinal preparation for treating fatty liver
CN102008678B (en) * 2010-12-14 2012-05-30 徐樊 Chinese medicinal preparation for treating fatty liver
CN102742829A (en) * 2011-04-18 2012-10-24 北京天植百桂生物技术有限公司 Dietetic therapy product for regulating blood fat and preparation method thereof
CN102552462A (en) * 2012-01-12 2012-07-11 中山火炬职业技术学院 Effervescent preparation as well as preparation method and application thereof
CN102552462B (en) * 2012-01-12 2013-08-14 中山火炬职业技术学院 Effervescent preparation as well as preparation method and application thereof
CN102784248A (en) * 2012-09-03 2012-11-21 赵全成 Chinese medicine composition for preventing and treating alcoholic liver injury
CN105795271A (en) * 2016-03-30 2016-07-27 黄山树德堂食品饮料有限公司 Stomach moistening and detoxifying healthy beverage and preparation method thereof

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