CN101574476B - 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 PDFInfo
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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
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 article, 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.Through the intravital glutathion of mensuration animal, malonaldehyde and triglyceride level, 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.Through measuring indexs such as the intravital glutathion of animal, malonaldehyde, glutamic oxaloacetic transaminase, GOT, glutamate pyruvate transaminase, triglyceride and T-CHOL; 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.Through indexs such as the intravital glutathion of mensuration animal, malonaldehyde, triglyceride and T-CHOLs, and hepatic tissue pathology section checking, this capsule has protective effect to chemical liver injury.
Chinese invention patent application 200510034145.4 discloses a kind of medicine of treating 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 process.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 extracting again.Through indexs such as the intravital glutamic oxaloacetic transaminase, GOT of mensuration animal, glutamate pyruvate transaminase, white/globulin ratio and T-CHOLs, and hepatic tissue pathology section checking, 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 to relieve the effect of alcohol to sober up be main, or with blood fat reducing, protect the liver with hepatoprotective be main.Ethanol needs all through liver metabolism in vivo, 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 process preparation easy to use.
Another object of the present invention is to provide a kind of method for preparing 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 said medical material is as limiting the present invention.
The above-mentioned medicinal material composition that is used for complementary fat-reducing liver-protecting is through decocting; Or through 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., process 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 method for preparing 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 are with 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 again merges; 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 processes 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 method for preparing 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 method for preparing 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 with " Chinese medicine novel form and new technique ", Chemical Industry Press, 2008.
Another kind comprises the method for preparing 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 again merges; 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 processes 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 method for preparing of the preparation of the above-mentioned medicinal material composition that is used for complementary fat-reducing liver-protecting remerges after can also earlier ethanol extract and aqueous extract being concentrated respectively, and the use spray drying is processed fine powder.Its extracting solution can realize spissated purpose through 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 method for preparing 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 again merges; 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 the aqueous extract of the ethanol extract of step 1 gained and step 2 gained is distinguished concentrating under reduced pressure after, the remix concentrated solution, spray drying is processed 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 method for preparing, 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 method for preparing, 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 method for preparing, aqueous extract concentrates separately can adopt following condition: vacuum 0.08Mpa, temperature 60-70 ℃ of decompression, 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 scheme 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 processed 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 processed 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 notion as the one of which.
Described " decoction " is the most widely used a kind of dosage form of tcm clinical practice.Its preparation method is: after assorting various medical materials according to different weight portions, 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: assort the back to various medical materials according to different weight portions 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 assorting various medical materials according to different weight portions, and the rounded solid preparation of processing 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 assorting various medical materials according to different weight portions, 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 process 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 " claimed medicated wine again.Be that drug immersion is gone in the wine, after the time, the extracting juice that removes slag supplies 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 specified 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 break away from the spirit and the scope of technical scheme 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 is 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 the aqueous extract of the ethanol extract of step 1 gained and step 2 gained is distinguished concentrating under reduced pressure after, the remix concentrated solution, spray drying is processed fine powder 684g;
4) after the 684g fine powder that 66g turtle ' s carapace powder and step 3 is 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 result sees table 1.
Table 1 medicinal material composition is to the influence of Wistar rat blood serum T-CHOL (TC)
Visible by table 1, 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 result sees table 2.
Table 2 medicinal material composition is to the influence of Wistar rat blood serum triglyceride (TG)
Visible by table 2, 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 experiments 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, in automatic clinical chemistry analyzer mensuration, the result sees 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
Visible by table 3, per os gives the tablet 35 days that the embodiment 1 of mice various dose makes, model control group and the comparison of blank group, and 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, the mouse liver lobus sinister is used 10% formalin fixed, does the crosscut routine pathology film-making (FFPE, 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 following:
Ballooning degeneration of liver cells: (cell enlargement, endochylema residual a little)
Steatosis: (occur in the hepatocyte endochylema boundary fat drip cavity) clearly
Endochylema cohesion: (endochylema is had a liking for Yihong and strengthened)
Hydropic degeneration:
Hepatic necrosis: (endochylema is had a liking for Yihong and become coagulation necrosis)
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 result sees table 4.
Table 4 medicinal material composition is to the pathological influence of hepatic tissue section
Visible by table 4; 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 experiments 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.
The experimenter divides into groups: 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 inspection 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: 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, STB 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 property 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.The effect index is used 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 is seen 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 is seen table 6 before and after the test-meal
Cholesterol variation before and after table 6 test-meal (X ± SD)
Own control
*Contrast ##P＜0.01 between P＜0.01 group
● triglyceride changes
The situation of change of triglyceride is seen table 7 before and after the test-meal
Triglyceride variation before and after table 7 test-meal (X ± SD)
Own control
*Contrast between 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 is seen table 8 before and after the test-meal
High density lipoprotein variation before and after table 8 test-meal (X ± SD)
Own control
*Contrast between P＜0.01 group between #P＜0.05 group and contrast ##P＜0.01
● the effect evaluation:
Table 9 is seen in the effect evaluation before and after the test-meal
Table 9 effect is judged
Contrast #P＜0.05 between group
● cardinal symptom is improved situation:
Cardinal symptom improvement situation is seen table 10 and table 11 before and after the test-meal
Table 10 cardinal symptom is improved situation
Expression matched group in " () "
Symptom integral variation before and after table 11 test-meal (X ± SD)
Own control
*Contrast #P＜0.05 between P＜0.01 group
Safety indexes detects:
● heart rate and blood pressure are relatively
Cardinal symptom improvement situation is seen table 12 before and after the test-meal
Heart rate and blood pressure comparison before and after table 12 test-meal (X ± SD)
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 are seen table 13 before and after the test-meal
Blood safety index variation comparison before and after table 13 test-meal (X ± SD)
Experiment shows that above-mentioned each item index is all in normal range before and after the test.
Blood pressure is basically 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.
Before and after the tablet test-meal of the embodiment of the invention 1 preparation, the blood biochemistry except that blood fat, routine blood test, routine urinalysis reach just conventional index and explain that all in normal range these article have 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. medicinal material composition that is used for complementary fat-reducing liver-protecting; In weight portion, said medicinal material composition is processed by following medicine: 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.
2. one kind comprises the described preparation that is used for the medicinal material composition of complementary fat-reducing liver-protecting of claim 1, it is characterized in that said preparation is decoction, powder, pill, tablet, electuary, unguentum, capsule, oral liquid or medicated wine.
3. a method for preparing 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, 2.5-5.0 Radix Salviae Miltiorrhizae, 0.5-1.5 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) again merges; 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) with the ethanol extract and the step 2 of step 1) gained) aqueous extract of gained remerges after concentrating respectively, uses spray drying to process fine powder;
4) with step 2) in remaining 1.0-3.0 Carapax Trionycis with after fine powder that step 3) makes mixes, make tablet after adding hydroxypropyl cellulose, carboxymethyl starch sodium and magnesium stearate adjuvant.
4. a method for preparing 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, 2.5-5.0 Radix Salviae Miltiorrhizae, 0.5-1.5 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) again merges; 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 ethanol extract and the step 2 of step 1) gained) after the aqueous extract of gained distinguishes concentrating under reduced pressure, the remix concentrated solution, spray drying is processed fine powder;
4) with step 2) in remaining Carapax Trionycis with after fine powder that step 3) makes mixes, make tablet after adding hydroxypropyl cellulose, carboxymethyl starch sodium and magnesium stearate adjuvant.
5. according to claim 3 or the 4 described method for preparinies that are used for complementary fat-reducing liver-protecting preparation; It is characterized in that; Said ethanol extract concentrates condition separately: vacuum 0.08Mpa, and temperature 50-60 ℃ of decompression recycling ethanol, and be concentrated into phase density 1.15-1.20 (50 ℃).
6. according to claim 3 or the 4 described method for preparinies that are used for complementary fat-reducing liver-protecting preparation, it is characterized in that said aqueous extract concentrates condition separately and is: vacuum 0.08Mpa, temperature 60-70 ℃ of decompression, and be concentrated into phase density 1.15-1.20 (50 ℃).
7. according to claim 3 or the 4 described method for preparinies that are used for complementary fat-reducing liver-protecting preparation, it is characterized in that described Carapax Trionycis is a turtle ' s carapace powder.
8. the described application that is used for the medicinal material composition of complementary fat-reducing liver-protecting at the medicine of preparation treatment and health care alcoholic liver disease, dyslipidemia, fatty liver and other chemical liver injury of claim 1.
9. the described medicinal material composition that is used for complementary fat-reducing liver-protecting of claim 1 is delaying application drunk or that alleviate drunk symptom.
10. the described preparation that is used for the medicinal material composition of complementary fat-reducing liver-protecting of claim 2 is delaying application drunk or that alleviate drunk symptom.
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| 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 |
| 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 |
| CN102784248B (en) * | 2012-09-03 | 2014-07-02 | 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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| CN1448166A (en) * | 2002-04-03 | 2003-10-15 | 顾奎琴 | Pure natural infusion for relieving alcoholism and protecting liver and prep. thereof |
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| CN1448166A (en) * | 2002-04-03 | 2003-10-15 | 顾奎琴 | Pure natural infusion for relieving alcoholism and protecting liver and prep. thereof |
| CN1528429A (en) * | 2003-10-20 | 2004-09-15 | 上海澳博海洋生物技术开发有限公司 | Chinese medicine preparation with accessory protection action to alcoholic liver injury and preparing method thereof |
| CN101380433A (en) * | 2007-10-22 | 2009-03-11 | 四川省宜宾五粮液集团有限公司 | Combination with antialcoholism action and preparation method thereof |
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Application publication date: 20091111 Assignee: Jiaxing Fu Fu Biotechnology Co., Ltd. Assignor: Xu Lin Contract record no.: 2013330000027 Denomination of invention: Medicinal material composition used for lowering lipid and protecting liver auxiliarily Granted publication date: 20120502 License type: Exclusive License Record date: 20130306 |
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