CN102692477A - Medicinal composition used for treating fatty liver and quality detection method thereof - Google Patents
Medicinal composition used for treating fatty liver and quality detection method thereof Download PDFInfo
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Abstract
The invention discloses a quality detection method of medicinal composition used for treating fatty liver. Raw materials are screened, the identified medicinal materials are selected, a determination and identification method adopts a thin layer chromatography test, ethyl acetate-methyl alcohol-water (20: 2: 1) is taken as a developer, and experimental results show that sample spots are clear, separation effect is good and no interference is produced in negative control. The raw materials of the medicinal composition are as follows in parts by weight: 50-250 parts of oriental wormwood, 40-200 parts of rough gentian, 15-85 parts of jasmine, 3-18 parts of rheum offcinale, 10-50 parts of white paeony root, 10-50 parts of liquorice, 14-70 parts of pseudo ginseng, 1-6 parts of snake gall, 1-4 parts of bezoar and 0.5-2.5 parts of muscone.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition and preparation thereof, preparation method and quality determining method, be specifically related to a kind of pharmaceutical composition and preparation, preparation method and quality determining method of treating fatty liver, belong to the pharmaceutical technology field.
Background technology
In recent years, the Along with people's living standard improve constantly the change with dietary structure, the incidence of disease of fatty liver is obvious ascendant trend.The morbidity of fatty liver is mainly relevant with liver abnormalities of sugar/lipid metabolism, obesity, long-term heavy drinking, diabetes, virus hepatitis etc., can make progress gradually to be hepatopathy in whole latter stage such as cirrhosis, liver cancer.The intervention of the life style that present treatment to fatty liver is the master with reasonable diet, alcohol prohibition, increase campaign is comparatively effective, but patient's compliance is not enough.Still lack the comparatively desirable lipotropic drug of curative effect clinically; Though medicines such as the Cholestyramine of having reported, hexanicit, Bezafibrate, CI-719 can suppress fatty liver from different links, bad reaction is many, the course of treatment long, the event clinical practice is restricted.The traditional Chinese medical science is thought fatty liver because food and drink does not save or experiences damp evil, or has a liking for food delicious food etc. and cause liver dysfunction, damp-heat accumulation, and blood-vessel obstructive and forming has clear superiority aspect the treatment fatty liver.
Summary of the invention
The object of the invention is to provide a kind of pharmaceutical composition and preparation thereof of treating fatty liver, and second purpose of the present invention is to provide this preparation of drug combination method, and the 3rd purpose of the present invention is to provide the quality determining method of this pharmaceutical composition.
The present invention seeks to realize through following technical scheme.
The bulk drug of pharmaceutical composition of the present invention consists of:
Oriental wormwood 50～250 weight portions, rough gentian 40～200 weight portions, cape jasmine 15～85 amount parts, rheum officinale 3～18 weight portions, the root of herbaceous peony 10～50 weight portions, Radix Glycyrrhizae 10～50 weight portions, pseudo-ginseng 14～70 weight portions, snake gall 1～6 weight portion, cow-bezoar 1～4 weight portion, muscone's 0.5～2.5 weight portion.
The bulk drug composition of pharmaceutical composition of the present invention is preferably:
Oriental wormwood 150 weight portions, rough gentian 120 weight portions, cape jasmine 50 weight portions, rheum officinale 10 weight portions, the root of herbaceous peony 30 weight portions, Radix Glycyrrhizae 30 weight portions, pseudo-ginseng 42.5 weight portions, snake gall 3.5 weight portions, cow-bezoar 2.5 weight portions, muscone's 1.5 weight portions.
The bulk drug composition of pharmaceutical composition of the present invention is preferably:
Oriental wormwood 60 weight portions, rough gentian 190 weight portions, cape jasmine 18 weight portions, rheum officinale 16 weight portions, the root of herbaceous peony 12 weight portions, Radix Glycyrrhizae 48 weight portions, pseudo-ginseng 15 weight portions, snake gall 6 weight portions, cow-bezoar 1 weight portion, muscone's 2.5 weight portions.
The bulk drug composition of pharmaceutical composition of the present invention is preferably:
Oriental wormwood 240 weight portions, rough gentian 50 weight portions, cape jasmine 82 weight portions, rheum officinale 4 weight portions, the root of herbaceous peony 48 weight portions, Radix Glycyrrhizae 12 weight portions, pseudo-ginseng 68 weight portions, snake gall 1 weight portion, cow-bezoar 4 weight portions, muscone's 0.5 weight portion.
The bulk drug composition of pharmaceutical composition of the present invention is preferably:
Oriental wormwood 90 weight portions, rough gentian 170 weight portions, cape jasmine 30 weight portions, rheum officinale 14 weight portions, the root of herbaceous peony 18 weight portions, Radix Glycyrrhizae 42 weight portions, pseudo-ginseng 25 weight portions, snake gall 4 weight portions, cow-bezoar 1.5 weight portions, muscone's 2 weight portions.
The bulk drug composition of pharmaceutical composition of the present invention is preferably:
Oriental wormwood 210 weight portions, rough gentian 70 weight portions, cape jasmine 70 weight portions, rheum officinale 7 weight portions, the root of herbaceous peony 42 weight portions, Radix Glycyrrhizae 18 weight portions, pseudo-ginseng 58 weight portions, snake gall 3 weight portions, cow-bezoar 3.5 weight portions, muscone's 1 weight portion.
The bulk drug composition of pharmaceutical composition of the present invention is preferably:
Oriental wormwood 120 weight portions, rough gentian 140 weight portions, cape jasmine 40 weight portions, rheum officinale 12 weight portions, the root of herbaceous peony 24 weight portions, Radix Glycyrrhizae 36 weight portions, pseudo-ginseng 35 weight portions, snake gall 5 weight portions, cow-bezoar 2 weight portions, muscone's 1.5 weight portions.
The bulk drug composition of pharmaceutical composition of the present invention is preferably:
Oriental wormwood 180 weight portions, rough gentian 100 weight portions, cape jasmine 60 weight portions, rheum officinale 9 weight portions, the root of herbaceous peony 36 weight portions, Radix Glycyrrhizae 24 weight portions, pseudo-ginseng 48 weight portions, snake gall 2 weight portions, cow-bezoar 3 weight portions, muscone's 1.5 weight portions.
Get traditional Chinese medicinal composition raw materials of the present invention; Add conventional auxiliary material; According to common process, process clinical acceptable various preparations and include but not limited to powder, tablet, medicinal tea, hard capsule, soft capsule, dripping pill, pill, honeyed bolus, granule, soft extract with bee honey agent, sustained release preparation, controlled release preparation, quick releasing formulation, oral liquid or ejection preparation.
The preparation method of Chinese medicine composition of the present invention comprises the steps:
A. get rheum officinale, the root of herbaceous peony, pseudo-ginseng pulverize fine powder 1, get snake gall, cow-bezoar, muscone, pulverize fine powder 2;
B. the middle liquid medicine of getting four traditional Chinese medicine materials process routines such as oriental wormwood, rough gentian, cape jasmine, Radix Glycyrrhizae are carried, alcohol precipitation process, get thick paste;
C. in thick paste, add fine powder 1, fine powder 2 and reach conventional auxiliary material and be prepared into clinical acceptable preparation.
Said step B specifically can for: oriental wormwood, rough gentian, cape jasmine, Radix Glycyrrhizae four traditional Chinese medicine material add entry and extract 1～3 time, add 5～10 times of water gagings at every turn, each 1～3 hour, filter, relative density was 1.200～1.230 when merging filtrate was concentrated into 40 ℃～50 ℃; Add ethanol and make soup contain alcohol amount to reach 70%, leave standstill, get supernatant, relative density is the thick paste of 1.25-1.30 when reclaiming ethanol and continuing to be concentrated into 90 ℃-100 ℃.
Said step C specifically can mix in thick paste, adding fine powder 1, fine powder 2 and reaching conventional auxiliary material, granulates, and drying is processed oral solid formulation: tablet, granule, capsule, medicinal tea, powder, pill.
Preferably, the preparation method of Chinese medicine composition tablet of the present invention is:
A. get rheum officinale, the root of herbaceous peony, pseudo-ginseng pulverize fine powder 1, get snake gall, cow-bezoar, muscone, pulverize fine powder 2;
B. get four traditional Chinese medicine materials such as oriental wormwood, rough gentian, cape jasmine, Radix Glycyrrhizae and add entry extraction 2 times, add 8 times of water gagings for the first time, for the second time 6 times of water gagings; Each 2 hours, filter, relative density was 1.200-1.230 when merging filtrate was concentrated into 40 ℃～50 ℃; Adding ethanol makes soup contain alcohol amount to reach 70%; Leave standstill, get supernatant, relative density is the thick paste of 1.25-1.30 when reclaiming ethanol and continuing to be concentrated into 90 ℃-100 ℃;
C. in thick paste, add fine powder 1, fine powder 2 and appropriate amount of auxiliary materials mixing granulation, drying, compressing tablet, every 0.5g promptly gets.
The quality determining method of Chinese medicinal composition preparation of the present invention comprises one or more in the following discrimination method.
A. get drug combination preparation day of the present invention and take 1/2 of output, add methyl alcohol 20ml, reflux 30 minutes filters, the filtrating evaporate to dryness, and residue adds methyl alcohol 1ml makes its dissolving, as need testing solution; It is an amount of that other gets the Gardenoside reference substance, adds methyl alcohol and process the solution that every 1ml contains 0.5mg, as reference substance solution; According to the thin-layered chromatography test, draw each 6 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate; Ethyl acetate-methyl alcohol-water with 10～30:1～3:1 is developping agent, launches, and takes out; Dry; Spray is with 5% vanillic aldehyde sulfuric acid solution, and it is clear to be heated to the spot colour developing at 105 ℃, inspects under the daylight; In the test sample chromatogram, with the corresponding position of reference substance chromatogram on, show the same color spot.
B. get the sample solution of differentiating under a item, as need testing solution; It is an amount of that other gets the Paeoniflorin reference substance, adds methyl alcohol and process the solution that every 1ml contains 1mg, as reference substance solution; According to the thin-layered chromatography test, draw need testing solution 8 μ l, reference substance solution 6 μ l; Putting respectively on same silica gel g thin-layer plate, is developping agent with ethyl acetate-methanol-water of 10～30:1～3:1, launches; Take out, dry, spray is with 5% vanillic aldehyde sulfuric acid solution; It is clear to be heated to spot colour developing at 105 ℃, inspects under the daylight; In the test sample chromatogram, with the corresponding position of reference substance chromatogram on, show the same color spot.
The described reference substance of getting is decided by Pharmacopoeia of People's Republic of China routine sampling amount in right amount.
Pharmaceutical composition of the present invention is a monarch drug in a prescription with the key medicine oriental wormwood of eliminating dampness and heat; Rough gentian can help oriental wormwood heat-clearing and damp-drying drug, purging intense heat and detonicating, is its ministerial drug; Cape jasmine, snake gall, the detoxifcation of rheum officinale clearing heat-fire, clear away heart-fire purging intense heat, the merit of reinforcement monarch-minister drug purging liver and gallbladder excess fire; Liver being bold and firm viscera, the happiness bar reaches and dislikes depression, so the root of herbaceous peony that the adding picric acid is slightly cold among bitter cold with nourish blood, easing the affected liver to relieve pain; With the pseudo-ginseng of sweet little bitter temperature, the Moschus activating blood circulation and dissipating blood stasis of hot temperature, the fraud in the anti-bitter cold wound, warm nature medicine and bitter and cold medicines are 5 warm again and not dry mutually, are adjutant altogether.Radix Glycyrrhizae is sweet flat, helps root of herbaceous peony relieving spasm to stop pain, and the article that relax the property of medicine and anti-bitter cold injure one's stomach, for making medicine.Full side's compatibility is reasonable, and medication is suitable, plays the clearing liver cholagogic altogether, the effect of dampness removing removing jaundice, activating blood circulation and dissipating blood stasis.
The discrimination method of present composition preparation is selected the discriminating medicinal material through the screening to each medicinal material, confirms discrimination method; Experimental result show sample clear spot; Good separating effect, and negative control is noiseless, can reach the purpose that product quality is control effectively.
Chinese medicine composition of the present invention has the clearing liver cholagogic, the function of anti-inflammatory analgesic.The pharmacodynamics comparison test shows the content that can reduce in the fatty liver rat model blood cholesterol and lipid peroxidation product (MDA) in the cholesterol (TC) and hepatic tissue significantly; Have certain effect to preventing and treating fatty liver, can be used for treating acute, chronic hepatitis, cirrhosis.
Following experimental example and embodiment are used to further specify but are not limited to the present invention.
Experimental example 1Present composition preparation is to the drug effect comparison test of big white mouse experimental fatty liver
One, experiment purpose: observe of the effect of present composition preparation, the pharmacodynamic experiment foundation is provided for present composition preparation has the effect of the fatty liver of control to rat fat liver (FLD) model.
Two, experiment material:
(1) animal used as test: cleaning level big white mouse, SD, ♂, 120～140g, 110, conformity certification: 0023665, Shanghai Slac Experimental Animal Co., Ltd..
(2) trial drug:
Present composition tablet (trade name: the Pien Tze Huang liver is precious, press embodiment 1 method and prepares): preparation raw powder not, be the tawny particle, every gram contains crude drug 2.916g, lot number: 0608001.Prepare with distilled water during test.
(3) other medicines and reagent:
1, cholesterol: white crystals, biochemical reagents, Beijing extensive and profound in meaning star biotechnology responsibility company limited, lot number: 20060911.
2, NaTDC: off-white powder, biochemical reagents, Beijing extensive and profound in meaning star biotechnology responsibility company limited, lot number: 20060931.
3, propylthiouracil (PTU) sheet: 50mg * 100 slice, Nantong Jinghua Pharmacy Co. Ltd, product batch number: 060201.
4, Tween-80: 500ml, CP, Dihua worker company limited is won in Tianjin, same lot number of date of manufacture: on September 8th, 2006.
5,1,2-propylene glycol: 500ml, AR, Dihua worker company limited is won in Tianjin, same lot number of date of manufacture: on September 30th, 2006.
6, absolute ethyl alcohol: 500ml, AR, Shanghai development chemical industry one factory, lot number: 20060830.
7, superoxide dismutase (SOD) kit: biological study institute, lot number: 20061107 are built up in Nanjing.
8, MDA (MDA) kit: biological study institute, lot number 20061107 are built up in Nanjing.
9, hydroxyproline (HPY) kit: biological study institute, lot number 20061107 are built up in Nanjing.
10, triglyceride (TG) kit: Zhongsheng Beikong Biological Science & Technology Co., Ltd., lot number: 061081.
11, T-CHOL (TC) kit: Zhongsheng Beikong Biological Science & Technology Co., Ltd., lot number: 060281.
12, ALT (ALT) kit: Lai Shi improved method, the safe clinical reagent of Beijing northization company limited, lot number: 060906.
13, amino transaminase (AST) kit of lucid asparagus: Lai Shi improved method, the safe clinical reagent of Beijing northization company limited, lot number: 060904.
14, methenyl choloride: 500ml, AR, the Shantou City reaches Hao fine chemicals company, lot number: 20060310.
15, methyl alcohol: 500ml, AR, Shanghai development chemical industry one factory, lot number: 200609014.
16, glacial acetic acid: 500ml, AR, Shanghai development chemical industry one factory, lot number: examination-2005-11-01.
17, DONGBAO GANTAI (methionine compound choline sheet): the 0.43g/ sheet (content of dispersion: the 0.21g/ sheet), Dongbao of Tonghua medicine company, company limited, lot number: 060107.
(4) key instrument:
1, steps auspicious BA-88 semi-automatic biochemical analyzer.
2, spectrophotometer: UV-9200.
3, electronic balance: AL204 Mettler-Toledo Instrument (Shanghai) Co., Ltd..
4, constant temperature blender with magnetic force: Mei Ying Pu, HO1-3 Shanghai instrument and meter company limited.
Three, experimental technique:
(1) experiment is divided into groups and dosage:
Animal is bought first adaptability and raises a week.Be divided into 9 groups by the body weight stratified random, 10 of normal control groups, all the other every group 11.
Clinical consumption: sample is 1g, every day three times, is scaled a kilogram dosage=3.0 ÷ 60kg=0.05g/kg.
Rat dosage: sample is all selected 1g/kg for use, and three dosage of 2g/kg and 4g/kg promptly are equivalent to 20,40 and 80 times of the clinical consumption of people, and each group is irritated gastric capacity and is 15ml/kg.
1, normal control group: not modeling, physiological saline is irritated stomach;
2, fatty liver module: modeling+physiological saline is irritated stomach;
3, positive controls: modeling+DONGBAO GANTAI 1.0g/kg.
7, the precious high dose group of Pien Tze Huang liver: the precious 4.0g/kg of modeling+liver.
8, dose groups in the Pien Tze Huang liver treasured: the precious 2.0g/kg of modeling+liver.
9, the precious low dose group of Pien Tze Huang liver: the precious 1.0g/kg of modeling+liver.
(2) modelling:
Merge high fat diet with alcohol and set up the fatty liver rat model, adopt the fat milk administration by gavage.
The fat milk preparation: get lard 25g and put into beaker, magnetic agitation is heated to 100 ℃, adds cholesterol 10g, dissolves, and adds propylthiouracil 1g again, stirs, and adds the 20ml Tween-80 and processes oil phase.Other gets a beaker, adds 50% ethanol 25ml, adds 1.2-propylene glycol 20ml again, is heated to 60 ℃, and then adds the 2g NaTDC, stirs entirely and dissolves, and processes water.Water is slowly added oil phase, limit edged mixing, fat milk 100ml.Refrigerate subsequent use, warm dissolving of time spent.
(3) medication:
Begin simultaneously with modeling, every morning gastric infusion, irritate stomach (ig) for afternoon fat milk 15ml/kg, continuously around.
(4) observation index:
1, generalized case is observed: comprise the state of mind, activity, hair, stool and urine, appetite (surveying feed consumption every day), survey body weight once weekly, and fat milk amount and dose filling stomach according to the weight.
2, serum biochemistry index determining: when experiment finished in 28 days, feedwater fasting 12h weighed.Broken end is got blood 3-4ml, and-30 ℃ of preservations are surveyed serum TC (T-CHOL), TG (triglyceride), ALT (ALT), AST (aspartic transaminase).
3, the liver outward appearance is observed and the liver assessment of indices: observe and damp, the quality of record Hepatic, claim that liver is heavy, calculate liver index (liver weight/weight ratio).
4, the mensuration of liver TC, TG:
Get right lobe of liver and organize 0.5g, use the 4.5ml chloroform: methyl alcohol (2:1 V:V), extracts lipid, shakes frequently, and placement is spent the night, 4000r/min, and centrifugal 10min gets the supernatant soluble fraction, measures TC, TG with stepping auspicious BA-88 semi-automatic biochemical analyzer.
5, liver MDA, SOD, the mensuration of HPY:
The preparation of 10% homogenate: hepatic tissue 1.0g is got at same position, adds 1-2ml ice physiological saline and does to be settled to 10ml after the homogenate.
(1) SOD measures: the 30 μ l of 1% liver tissue homogenate, press the operation of SOD testing cassete instructions;
(2) MDA measures: 10% 0.1ml of liver tissue homogenate, press the operation of MDA kit instructions.
(3) orgotein is measured: the 50 μ l of 0.5% liver tissue homogenate, press the operation of Coomassie brilliant blue kit instructions.
(4) hydroxyproline determination (sample alkali hydrolysis method): press hydroxyproline testing cassete instructions VI operation.
Experimental data is handled with the SPSS13.0 statistical software, the conspicuousness of comparative group differences.
Four, experimental result:
(1) generalized case: duration of test, the normal rats state of mind is good, and is movable normal, hair luster, the colour of skin is ruddy, and stool and urine is normal, the body weight sustainable growth.
The model group rat, the back appearance of one week of modeling is One's spirits are drooping, movable to be reduced, and hair is matt, apparent struggle irritability phenomenon when irritating fat milk, feed consumption lacks than normal group, and body weight gain is slower.Rare soft stool appears after the 3rd week, in addition semiliquid stool, rare soft stool continues to experiment all around to be finished, and the appetite minimizing, and body weight gain is slow.
Give the precious rat generalized case of liver better slightly than model group, it is dirty that the hair pine also appears in second week, drowsiness; Present the irritability phenomenon that resistance is struggled when irritating fat milk; The growth of rat body weight is slowed down along with the increase of dosage, and wherein the high dose group rat body weight increases more sick module slow (P < 0.05).
Individual animal death appears in the group that experimental session has, and the result sees table 1.
The variation of table 1 experimental session rat body weight (g)
Compare with normal group,
△ △P＜0.01; Compare * P with model group<0.05, * * P<0.01.
(2) to the influence of rat fat: the result sees table 2.
The influence of table 2 pair rat fat
Compare with normal group,
△ △P＜0.01; Compare * P with model group<0.05, * * P<0.01.
Table 2 is the result show, sick module serum cholesterol significantly raises, and three dosage that liver is precious all have the effect of remarkable reduction serum cholesterol.
(3) to the influence of rats'liver function: the result sees table 3.
The influence of table 3 pair rat blood serum liver function
Compare with normal group,
△ △P＜0.01; Compare * P with model group<0.05, * * P<0.01
ALT, the AST of model group rat blood serum obviously raise, and the precious height of liver, middle dose groups ALT and model group relatively have the reduction effect.
(4) to the influence of rats'liver lipid: the result sees table 4.
The influence of table 4 pair rat liver homogenate lipid content
Compare with normal group,
△ △P＜0.01; Compare * P with model group<0.05, * * P<0.01
The apparent in view rising of the TC of model group, TG and normal group explains that fatty liver forms.The TC of dose groups obviously reduces in the liver treasured, and showing has the effect that reduces liver inner lipid content.
(5) to the influence of rats'liver index and liver SOD, MDA and HPY, the result sees table 5.
The influence of table 5 pair rats'liver index and liver SOD, MDA and HPY
Compare with normal group,
△ △P＜0.01; Compare * P with model group<0.05, * * P<0.01
Sick module rats'liver index obviously rises greater than the MDA of normal group, liver, SOD obviously descends, the relative normal group of HPY content obviously rises (P 0.05), these all meet the characteristic change of fatty liver.The MDA content of the precious low dose group rat liver of liver reduces significantly, explains that the liver treasured has certain curative effect to the MDA that falls disease mould liver.And the precious low dose group of liver also has the effect of increased SOD content.
Following embodiment all can realize the said effect of above-mentioned experimental example.
Embodiment 1 tablet of the present invention
Prescription: oriental wormwood 150g, rough gentian 120g, cape jasmine 50g, rheum officinale 10g, root of herbaceous peony 30g, Radix Glycyrrhizae 30g, pseudo-ginseng 42.5g, snake gall 3.5g, cow-bezoar 2.5g, muscone 1.5g.
Method for making:
A. get rheum officinale, the root of herbaceous peony, pseudo-ginseng pulverize fine powder 1, get snake gall, cow-bezoar, muscone pulverize fine powder 2,
B. get four traditional Chinese medicine materials such as oriental wormwood, rough gentian, cape jasmine, Radix Glycyrrhizae and add entry extraction 2 times, each 2 hours (8 times of amounts of first pass, second time 6 times of amount); Filter; It is 1.200-1.230 (heat survey 40 ℃-50 ℃) that merging filtrate is concentrated into relative density, adds ethanol and makes soup contain the alcohol amount to reach 70%, leave standstill; Get supernatant, reclaim ethanol and continue to be concentrated into the thick paste that relative density is 1.25-1.30 (heat is surveyed 90 ℃-100 ℃).
C. add fine powder 1, fine powder 2 and appropriate amount of auxiliary materials mixing granulation, drying, compressing tablet promptly gets.
Every 0.5g.Oral, one time 2,3 times on the one.
Embodiment 2 powders of the present invention
Prescription: oriental wormwood 60g, rough gentian 190g, cape jasmine 18g, rheum officinale 16g, root of herbaceous peony 12g, Radix Glycyrrhizae 48g, pseudo-ginseng 15g, snake gall 6g, cow-bezoar 1g, muscone 2.5g.
Said medicine is added conventional auxiliary material,, process powder, obey 1g at every turn, three times on the one according to common process.
Embodiment 3 capsules of the present invention
Prescription: oriental wormwood 240g, rough gentian 50g, cape jasmine 82g, rheum officinale 4g, root of herbaceous peony 48g, Radix Glycyrrhizae 12g, pseudo-ginseng 68g, snake gall 1g, cow-bezoar 4g, muscone 0.5g.
Method for making:
A. get rheum officinale, the root of herbaceous peony, pseudo-ginseng pulverize fine powder 1, get snake gall, cow-bezoar, muscone pulverize fine powder 2,
B. get four traditional Chinese medicine materials such as oriental wormwood, rough gentian, cape jasmine, Radix Glycyrrhizae and add entry extraction 3 times, add 8 times of water gagings for the first time, for the second time 6 times of water gagings; 5 times of water gagings each 1.5 hours, filter for the third time; Relative density was 1.200～1.230 when merging filtrate was concentrated into 40 ℃～50 ℃, added ethanol and made soup contain alcohol amount to reach 70%, leave standstill; Get supernatant, relative density is the thick paste of 1.25-1.30 when reclaiming ethanol and continuing to be concentrated into 90 ℃-100 ℃;
C. add fine powder 1, fine powder 2 and appropriate amount of auxiliary materials mixing granulation, drying, encapsulated, every 0.5g promptly gets.2 of each clothes, three times on the one.
Embodiment 4 honey pill agents of the present invention
Oriental wormwood 90g, rough gentian 170g, cape jasmine 30g, rheum officinale 14g, root of herbaceous peony 18g, Radix Glycyrrhizae 42g, pseudo-ginseng 25g, snake gall 4g, cow-bezoar 1.5g, muscone 2g.
Said medicine is added conventional auxiliary material, according to common process, process honey pill agent, the 1g/ ball is obeyed 1g at every turn, three times on the one.
Embodiment 5 granules of the present invention
Prescription: oriental wormwood 210g, rough gentian 70g, cape jasmine 70g, rheum officinale 7g, root of herbaceous peony 42g, Radix Glycyrrhizae 18g, pseudo-ginseng 58g, snake gall 3g, cow-bezoar 3.5g, muscone 1g.
Method for making:
A. get rheum officinale, the root of herbaceous peony, pseudo-ginseng pulverize fine powder 1, get snake gall, cow-bezoar, muscone pulverize fine powder 2,
B. get four traditional Chinese medicine materials such as oriental wormwood, rough gentian, cape jasmine, Radix Glycyrrhizae and add entry extraction 2 times, add 10 times of water gagings for the first time, for the second time 8 times of water gagings; Each 2 hours, filter, relative density was 1.200～1.230 when merging filtrate was concentrated into 40 ℃～50 ℃; Adding ethanol makes soup contain alcohol amount to reach 70%; Leave standstill, get supernatant, relative density is the thick paste of 1.25-1.30 when reclaiming ethanol and continuing to be concentrated into 90 ℃-100 ℃;
C. add fine powder 1, fine powder 2 and appropriate amount of auxiliary materials mixing granulation, drying, pack, every bag of 1.0g promptly gets.
1 bag of each clothes, three times on the one.
Embodiment 6 oral liquids of the present invention
Oriental wormwood 120g, rough gentian 140g, cape jasmine 40g, rheum officinale 12g, root of herbaceous peony 24g, Radix Glycyrrhizae 36g, pseudo-ginseng 35g, snake gall 5g, cow-bezoar 2g, muscone 1.5g.
Said medicine is added conventional auxiliary material,, process oral liquid according to common process.
Embodiment 7 medicinal tea of the present invention
Oriental wormwood 180g, rough gentian 100g, cape jasmine 60g, rheum officinale 9g, root of herbaceous peony 36g, Radix Glycyrrhizae 24g, pseudo-ginseng 48g, snake gall 2g, cow-bezoar 3g, muscone 1.5g.
Said medicine is added conventional auxiliary material,, process tea in bag, obey 1g at every turn, three times on the one according to common process.
The quality determining method of embodiment 8 tablets of the present invention
Tablet material composition of the present invention and method for making are with embodiment 1.
Differentiate:
A. get these article 1.5g, porphyrize adds methyl alcohol 20ml, and reflux 30 minutes filters, the filtrating evaporate to dryness, and residue adds methyl alcohol 1ml makes its dissolving, as need testing solution.Other gets the Gardenoside reference substance, adds methyl alcohol and processes the solution that every 1ml contains 0.5mg, as reference substance solution.According to thin-layered chromatography (2005 editions one appendix VI B of Chinese Pharmacopoeia) test, draw each 6 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate; With ethyl acetate-methyl alcohol-water (20:2:1) is developping agent, launches, and takes out; Dry; Spray is with 5% vanillic aldehyde sulfuric acid solution, and it is clear to be heated to the spot colour developing at 105 ℃, inspects under the daylight.In the test sample chromatogram, with the corresponding position of reference substance chromatogram on, show the same color spot.
B. get the sample solution of differentiating under a item, as need testing solution.Other gets the Paeoniflorin reference substance, adds methyl alcohol and processes the solution that every 1ml contains 1mg, as reference substance solution.According to thin-layered chromatography (2005 editions one appendix VI B of Chinese Pharmacopoeia) test, draw need testing solution 8 μ l, reference substance solution 6 μ l; Putting respectively on same silica gel g thin-layer plate, is developping agent with ethyl acetate-methanol-water (20:2:1), launches; Take out, dry, spray is with 5% vanillic aldehyde sulfuric acid solution; It is clear to be heated to spot colour developing at 105 ℃, inspects under the daylight.In the test sample chromatogram, with the corresponding position of reference substance chromatogram on, show the same color spot.
The quality determining method of embodiment 9 capsules of the present invention
Capsule raw material composition of the present invention and method for making are with embodiment 3.
Differentiate:
A. get these article 1.5g, porphyrize adds methyl alcohol 20ml, and reflux 30 minutes filters, the filtrating evaporate to dryness, and residue adds methyl alcohol 1ml makes its dissolving, as need testing solution.Other gets the Gardenoside reference substance, adds methyl alcohol and processes the solution that every 1ml contains 0.5mg, as reference substance solution.According to thin-layered chromatography (2005 editions one appendix VI B of Chinese Pharmacopoeia) test, draw each 6 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate; With ethyl acetate-methanol-water (15:2:1) is developping agent, launches, and takes out; Dry; Spray is with 5% vanillic aldehyde sulfuric acid solution, and it is clear to be heated to the spot colour developing at 105 ℃, inspects under the daylight.In the test sample chromatogram, with the corresponding position of reference substance chromatogram on, show the same color spot.
B. get the sample solution of differentiating under a item, as need testing solution.Other gets the Paeoniflorin reference substance, adds methyl alcohol and processes the solution that every 1ml contains 1mg, as reference substance solution.According to thin-layered chromatography (2005 editions one appendix VI B of Chinese Pharmacopoeia) test, draw need testing solution 8 μ l, reference substance solution 6 μ l; Putting respectively on same silica gel g thin-layer plate, is developping agent with ethyl acetate-methyl alcohol-water (15:2:1), launches; Take out, dry, spray is with 5% vanillic aldehyde sulfuric acid solution; It is clear to be heated to spot colour developing at 105 ℃, inspects under the daylight.In the test sample chromatogram, with the corresponding position of reference substance chromatogram on, show the same color spot.
The quality determining method of embodiment 10 granules of the present invention
Granule raw material composition of the present invention and method for making are with embodiment 5.
Differentiate:
A. get these article 1.5g, porphyrize adds methyl alcohol 20ml, and reflux 30 minutes filters, the filtrating evaporate to dryness, and residue adds methyl alcohol 1ml makes its dissolving, as need testing solution.Other gets the Gardenoside reference substance, adds methyl alcohol and processes the solution that every 1ml contains 0.5mg, as reference substance solution.According to thin-layered chromatography (2005 editions one appendix VI B of Chinese Pharmacopoeia) test, draw each 6 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate; With ethyl acetate-methyl alcohol-water (25:2:1) is developping agent, launches, and takes out; Dry; Spray is with 5% vanillic aldehyde sulfuric acid solution, and it is clear to be heated to the spot colour developing at 105 ℃, inspects under the daylight.In the test sample chromatogram, with the corresponding position of reference substance chromatogram on, show the same color spot.
B. get the sample solution of differentiating under a item, as need testing solution.Other gets the Paeoniflorin reference substance, adds methyl alcohol and processes the solution that every 1ml contains 1mg, as reference substance solution.According to thin-layered chromatography (2005 editions one appendix VI B of Chinese Pharmacopoeia) test, draw need testing solution 8 μ l, reference substance solution 6 μ l; Putting respectively on same silica gel g thin-layer plate, is developping agent with ethyl acetate-methanol-water (25:2:1), launches; Take out, dry, spray is with 5% vanillic aldehyde sulfuric acid solution; It is clear to be heated to spot colour developing at 105 ℃, inspects under the daylight.In the test sample chromatogram, with the corresponding position of reference substance chromatogram on, show the same color spot.
Claims (10)
1. quality determining method of treating the pharmaceutical composition of fatty liver is characterized in that this method comprises one or more in the following discrimination method:
A. get it filled and compositions preparation day take 1/2 of output, add methyl alcohol 20ml, reflux 30 minutes filters, the filtrating evaporate to dryness, and residue adds methyl alcohol 1ml makes its dissolving, as need testing solution; It is an amount of that other gets the Gardenoside reference substance, adds methyl alcohol and process the solution that every 1ml contains 0.5mg, as reference substance solution; According to the thin-layered chromatography test, draw each 6 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate; Ethyl acetate-methyl alcohol-water with 10～30:1～3:1 is developping agent, launches, and takes out; Dry; Spray is with 5% vanillic aldehyde sulfuric acid solution, and it is clear to be heated to the spot colour developing at 105 ℃, inspects under the daylight; In the test sample chromatogram, with the corresponding position of reference substance chromatogram on, show the same color spot;
B. get the sample solution of differentiating under a item, as need testing solution; It is an amount of that other gets the Paeoniflorin reference substance, adds methyl alcohol and process the solution that every 1ml contains 1mg, as reference substance solution; According to the thin-layered chromatography test, draw need testing solution 8 μ l, reference substance solution 6 μ l; Putting respectively on same silica gel g thin-layer plate, is developping agent with ethyl acetate-methyl alcohol-water of 10～30:1～3:1, launches; Take out, dry, spray is with 5% vanillic aldehyde sulfuric acid solution; It is clear to be heated to spot colour developing at 105 ℃, inspects under the daylight; In the test sample chromatogram, with the corresponding position of reference substance chromatogram on, show the same color spot;
The bulk drug of said drug combination preparation is formed and the preparation method is: oriental wormwood 50～250 weight portions, rough gentian 40～200 weight portions, cape jasmine 15～85 amount parts, rheum officinale 3～18 weight portions, the root of herbaceous peony 10～50 weight portions, Radix Glycyrrhizae 10～50 weight portions, pseudo-ginseng 14～70 weight portions, snake gall 1～6 weight portion, cow-bezoar 1～4 weight portion, muscone's 0.5～2.5 weight portion; Get bulk drug; Add conventional auxiliary material; According to common process, process clinical acceptable preparation.
2. the quality determining method of pharmaceutical composition as claimed in claim 1 is characterized in that the bulk drug of drug combination preparation described in the quality determining method of this pharmaceutical composition tablet consists of:
Oriental wormwood 60 weight portions, rough gentian 190 weight portions, cape jasmine 18 weight portions, rheum officinale 16 weight portions, the root of herbaceous peony 12 weight portions, Radix Glycyrrhizae 48 weight portions, pseudo-ginseng 15 weight portions, snake gall 6 weight portions, cow-bezoar 1 weight portion, muscone's 2.5 weight portions.
3. the quality determining method of pharmaceutical composition as claimed in claim 1 is characterized in that:
Oriental wormwood 240 weight portions, rough gentian 50 weight portions, cape jasmine 82 weight portions, rheum officinale 4 weight portions, the root of herbaceous peony 48 weight portions, Radix Glycyrrhizae 12 weight portions, pseudo-ginseng 68 weight portions, snake gall 1 weight portion, cow-bezoar 4 weight portions, muscone's 0.5 weight portion.
4. the quality determining method of pharmaceutical composition as claimed in claim 1 is characterized in that the bulk drug of said drug combination preparation consists of:
Oriental wormwood 90 weight portions, rough gentian 170 weight portions, cape jasmine 30 weight portions, rheum officinale 14 weight portions, the root of herbaceous peony 18 weight portions, Radix Glycyrrhizae 42 weight portions, pseudo-ginseng 25 weight portions, snake gall 4 weight portions, cow-bezoar 1.5 weight portions, muscone's 2 weight portions.
5. the quality determining method of pharmaceutical composition as claimed in claim 1 is characterized in that the bulk drug of said drug combination preparation consists of:
Oriental wormwood 210 weight portions, rough gentian 70 weight portions, cape jasmine 70 weight portions, rheum officinale 7 weight portions, the root of herbaceous peony 42 weight portions, Radix Glycyrrhizae 18 weight portions, pseudo-ginseng 58 weight portions, snake gall 3 weight portions, cow-bezoar 3.5 weight portions, muscone's 1 weight portion.
6. the quality determining method of pharmaceutical composition as claimed in claim 1 is characterized in that the bulk drug of said drug combination preparation consists of:
Oriental wormwood 120 weight portions, rough gentian 140 weight portions, cape jasmine 40 weight portions, rheum officinale 12 weight portions, the root of herbaceous peony 24 weight portions, Radix Glycyrrhizae 36 weight portions, pseudo-ginseng 35 weight portions, snake gall 5 weight portions, cow-bezoar 2 weight portions, muscone's 1.5 weight portions.
7. the quality determining method of pharmaceutical composition as claimed in claim 1 is characterized in that the bulk drug of said drug combination preparation consists of:
Oriental wormwood 180 weight portions, rough gentian 100 weight portions, cape jasmine 60 weight portions, rheum officinale 9 weight portions, the root of herbaceous peony 36 weight portions, Radix Glycyrrhizae 24 weight portions, pseudo-ginseng 48 weight portions, snake gall 2 weight portions, cow-bezoar 3 weight portions, muscone's 1.5 weight portions.
8. like the quality determining method of the arbitrary described pharmaceutical composition of claim 1-7, it is characterized in that said drug combination preparation processed by following method:
A. get rheum officinale, the root of herbaceous peony, pseudo-ginseng pulverize fine powder 1, get snake gall, cow-bezoar, muscone, pulverize fine powder 2;
B. the middle liquid medicine of getting four traditional Chinese medicine materials process routines such as oriental wormwood, rough gentian, cape jasmine, Radix Glycyrrhizae are carried, alcohol precipitation process, get thick paste;
C. in thick paste, add fine powder 1, fine powder 2 and reach conventional auxiliary material and be prepared into clinical acceptable preparation;
Said step B specifically can for: oriental wormwood, rough gentian, cape jasmine, Radix Glycyrrhizae four traditional Chinese medicine material add entry and extract 1～3 time, add 5～10 times of water gagings at every turn, each 1～3 hour, filter, relative density was 1.200～1.230 when merging filtrate was concentrated into 40 ℃～50 ℃; Add ethanol and make soup contain alcohol amount to reach 70%, leave standstill, get supernatant, relative density is the thick paste of 1.25-1.30 when reclaiming ethanol and continuing to be concentrated into 90 ℃-100 ℃;
Said step C specifically can mix in thick paste, adding fine powder 1, fine powder 2 and reaching conventional auxiliary material, granulates, and drying is processed oral solid formulation: tablet, granule, capsule, medicinal tea, powder, pill.
9. the quality determining method of pharmaceutical composition as claimed in claim 8 is characterized in that said drug combination preparation processed by following method:
A. get rheum officinale, the root of herbaceous peony, pseudo-ginseng pulverize fine powder 1, get snake gall, cow-bezoar, muscone, pulverize fine powder 2;
B. get four traditional Chinese medicine materials such as oriental wormwood, rough gentian, cape jasmine, Radix Glycyrrhizae and add entry extraction 2 times, add 8 times of water gagings for the first time, for the second time 6 times of water gagings; Each 2 hours, filter, relative density was 1.200-1.230 when merging filtrate was concentrated into 40 ℃～50 ℃; Adding ethanol makes soup contain alcohol amount to reach 70%; Leave standstill, get supernatant, relative density is the thick paste of 1.25-1.30 when reclaiming ethanol and continuing to be concentrated into 90 ℃-100 ℃;
C. in thick paste, add fine powder 1, fine powder 2 and appropriate amount of auxiliary materials mixing granulation, drying, compressing tablet, every 0.5g promptly gets.
10. like the quality determining method of the arbitrary described pharmaceutical composition of claim 1-9, it is characterized in that this method comprises one or more in the following discrimination method:
A. get it filled and compositions preparation day take 1/2 of output, add methyl alcohol 20ml, reflux 30 minutes filters, the filtrating evaporate to dryness, and residue adds methyl alcohol 1ml makes its dissolving, as need testing solution; It is an amount of that other gets the Gardenoside reference substance, adds methyl alcohol and process the solution that every 1ml contains 0.5mg, as reference substance solution; According to thin-layered chromatography test, draw each 6 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, be developping agent with ethyl acetate-methyl alcohol-water of 25:2:1; Launch, take out, dry; Spray is with 5% vanillic aldehyde sulfuric acid solution, and it is clear to be heated to the spot colour developing at 105 ℃, inspects under the daylight; In the test sample chromatogram, with the corresponding position of reference substance chromatogram on, show the same color spot;
B. get the sample solution of differentiating under a item, as need testing solution; It is an amount of that other gets the Paeoniflorin reference substance, adds methyl alcohol and process the solution that every 1ml contains 1mg, as reference substance solution; According to the thin-layered chromatography test, draw need testing solution 8 μ l, reference substance solution 6 μ l; Putting respectively on same silica gel g thin-layer plate, is developping agent with ethyl acetate-methyl alcohol-water of 25:2:1, launches; Take out, dry, spray is with 5% vanillic aldehyde sulfuric acid solution; It is clear to be heated to spot colour developing at 105 ℃, inspects under the daylight; In the test sample chromatogram, with the corresponding position of reference substance chromatogram on, show the same color spot.
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| CN104107212A (en) * | 2014-08-01 | 2014-10-22 | 申洪恩 | Medicine for treating hepatitis disease and production method thereof |
| CN105125766A (en) * | 2015-09-09 | 2015-12-09 | 白玛仁增 | Compound Tibetan medicine preparation for treating fatty liver and alcoholic liver, expelling gall bladder and intestine roundworms and detoxifying |
| CN106109646A (en) * | 2016-08-24 | 2016-11-16 | 漳州片仔癀药业股份有限公司 | A kind of pharmaceutical composition treating acute and chronic hepatitis and preparation method thereof and purposes |
| CN106177045A (en) * | 2016-08-24 | 2016-12-07 | 漳州片仔癀药业股份有限公司 | A kind of pharmaceutical composition with function for protecting liver and reducing enzyme activity and preparation method thereof and purposes |
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| CN101757433A (en) * | 2009-11-02 | 2010-06-30 | 泰一和浦（北京）中医药研究院有限公司 | Traditional Chinese medicine composition for treating acute hepatitis and preparation method thereof |
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| CN1328834A (en) * | 2000-11-15 | 2002-01-02 | 郑国芃 | Capsule for curing cholecystitis |
| US20040105902A1 (en) * | 2002-12-02 | 2004-06-03 | Jiafang Chen | Compositions and methods for treating prostate cancer |
| JP2006045181A (en) * | 2003-11-18 | 2006-02-16 | Sekisui Chem Co Ltd | External composition for skin |
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| CN104107212A (en) * | 2014-08-01 | 2014-10-22 | 申洪恩 | Medicine for treating hepatitis disease and production method thereof |
| CN105125766A (en) * | 2015-09-09 | 2015-12-09 | 白玛仁增 | Compound Tibetan medicine preparation for treating fatty liver and alcoholic liver, expelling gall bladder and intestine roundworms and detoxifying |
| CN106109646A (en) * | 2016-08-24 | 2016-11-16 | 漳州片仔癀药业股份有限公司 | A kind of pharmaceutical composition treating acute and chronic hepatitis and preparation method thereof and purposes |
| CN106177045A (en) * | 2016-08-24 | 2016-12-07 | 漳州片仔癀药业股份有限公司 | A kind of pharmaceutical composition with function for protecting liver and reducing enzyme activity and preparation method thereof and purposes |
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| CN102692477B (en) | 2014-06-11 |
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