CN102692477B - 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 for the treatment of fatty liver, belong to pharmaceutical technology field.
Background technology
In recent years, along with improving constantly and the change of dietary structure of people's living standard, 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 as the hepatopathy in whole latter stage such as cirrhosis, liver cancer.At present to the treatment of fatty liver, the intervention take reasonable diet, alcohol prohibition, increase campaign as the life style led is comparatively effective, but patient compliance is inadequate.Still lack clinically the comparatively desirable lipotropic drug of curative effect, although the 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 for the treatment of long, event clinical practice is restricted.The traditional Chinese medical science thinks that fatty liver is not because food and drink saves 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 treatment fatty liver.
Summary of the invention
The object of the invention is to provide a kind of pharmaceutical composition and preparation thereof for the treatment of fatty liver, and second object of the present invention is to provide the preparation method of this pharmaceutical composition, and the 3rd object of the present invention is to provide the quality determining method of this pharmaceutical composition.
The present invention seeks to be achieved through the following technical solutions.
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, make 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 and pulverize to obtain fine powder 1, get snake gall, cow-bezoar, muscone, pulverize to obtain fine powder 2;
B. get the four traditional Chinese medicine materials such as oriental wormwood, rough gentian, cape jasmine, Radix Glycyrrhizae through conventional Chinese medicine water extraction, alcohol precipitation process, obtain thick paste;
C. in thick paste, add fine powder 1, fine powder 2 and and conventional auxiliary material be prepared into clinical acceptable preparation.
Described step B is specifically as follows: oriental wormwood, rough gentian, cape jasmine, Radix Glycyrrhizae four traditional Chinese medicine material add water extraction to get 1～3 time, add 5～10 times of water gagings at every turn, and each 1～3 hour, filter, when merging filtrate is concentrated into 40 ℃～50 ℃, relative density is 1.200～1.230; Add ethanol and make liquid contain alcohol amount to reach 70%, leave standstill, get supernatant, the thick paste that when reclaiming ethanol and continuing to be concentrated into 90 ℃-100 ℃, relative density is 1.25-1.30.
Described step C be specifically as follows in thick paste, add fine powder 1, fine powder 2 and and conventional auxiliary material, mix, granulate, dry, make 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 and pulverize to obtain fine powder 1, get snake gall, cow-bezoar, muscone, pulverize to obtain fine powder 2;
B. getting the four traditional Chinese medicine materials such as oriental wormwood, rough gentian, cape jasmine, Radix Glycyrrhizae adds water extraction to get 2 times, add for the first time 8 times of water gagings, 6 times of water gagings for the second time, each 2 hours, filter, when merging filtrate is concentrated into 40 ℃～50 ℃, relative density is 1.200-1.230, adding ethanol makes liquid contain alcohol amount to reach 70%, leave standstill, get supernatant, the thick paste that when reclaiming ethanol and continuing to be concentrated into 90 ℃-100 ℃, relative density is 1.25-1.30;
C. in thick paste, add fine powder 1, fine powder 2 and appropriate amount of auxiliary materials mixing granulation, dry, compressing tablet, every 0.5g, to obtain final product.
The quality determining method of Chinese medicinal composition preparation of the present invention comprises one or more in following discrimination method.
A. get drug combination preparation day of the present invention and take 1/2 of output, add methyl alcohol 20ml, add hot reflux 30 minutes, filter, filtrate evaporate to dryness, residue adds methyl alcohol 1ml dissolves it, as need testing solution; Separately get Gardenoside reference substance appropriate, add methyl alcohol and make the solution of every 1ml containing 0.5mg, product solution in contrast; Test according to thin-layered chromatography, draw the each 6 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, take ethyl acetate-Methanol-water of 10～30:1～3:1 as developping agent, launch, take out, dry, spray, with 5% vanillic aldehyde sulfuric acid solution, is heated to spot colour developing at 105 ℃ clear, under daylight, inspects; In test sample chromatogram, with the corresponding position of reference substance chromatogram on, aobvious same color spot.
B. get the sample solution of differentiating under a item, as need testing solution; Separately get Paeoniflorin reference substance appropriate, add methyl alcohol and make the solution of every 1ml containing 1mg, product solution in contrast; Test according to thin-layered chromatography, draw need testing solution 8 μ l, reference substance solution 6 μ l, put respectively on same silica gel g thin-layer plate, take ethyl acetate-methanol-water of 10～30:1～3:1 as developping agent, launch, take out, dry, spray is with 5% vanillic aldehyde sulfuric acid solution, be heated to spot colour developing at 105 ℃ clear, under daylight, inspect; In test sample chromatogram, with the corresponding position of reference substance chromatogram on, aobvious same color spot.
The described reference substance of getting is determined by Pharmacopoeia of People's Republic of China routine sampling amount in right amount.
Pharmaceutical composition of the present invention is take the key medicine oriental wormwood of eliminating dampness and heat as monarch drug in a prescription; 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 removing toxic substances 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, happiness bar reaches and dislikes depression, therefore among bitter cold, add the root of herbaceous peony that picric acid is slightly cold nourishing blood, easing the affected liver to relieve pain; With the pseudo-ginseng of sweet micro-bitter temperature, the Moschus activating blood circulation and dissipating blood stasis of pungent temperature, the fraud in anti-bitter cold wound, warm nature medicine is warm and not dry again with bitter and cold medicines phase 5, is adjutant altogether.Radix Glycyrrhizae is sweet flat, helps root of herbaceous peony relieving spasm to stop pain, and the product 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 altogether clearing liver cholagogic, effect of dampness removing removing jaundice, activating blood circulation and dissipating blood stasis.
The discrimination method of present composition preparation, by the screening to each medicinal material, is selected discriminating medicinal material, determines discrimination method, experimental result show sample clear spot, good separating effect, and negative control is noiseless, can reach the object that product quality is control effectively.
Chinese medicine composition of the present invention has clearing liver cholagogic, the function of anti-inflammatory analgesic.Pharmacodynamics comparison test shows to reduce significantly the content of cholesterol and lipid peroxidation product (MDA) in cholesterol in Models of Fatty Liver rat blood (TC) and hepatic tissue, 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 for further illustrating but are not limited to the present invention.
experimental example 1the drug effect comparison test of present composition preparation to big white mouse experimental fatty liver
One, experiment purpose: observe the effect of present composition preparation to rat fat liver (FLD) model, provide pharmacodynamic experiment foundation for present composition preparation has the effect of the fatty liver of control.
Two, experiment material:
(1) animal used as test: clean 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: Pien Tze Huang liver treasured, by embodiment 1 method preparation): not preparation raw powder, be tawny particle, every gram containing crude drug 2.916g, lot number: 0608001.When test, prepare with distilled water.
(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 Tablets: 50mg × 100 slice, Nantong Jinghua Pharmacy Co. Ltd, product batch number: 060201.
4, Tween-80: 500ml, CP, Tianjin Bo Di Chemical Co., Ltd., same lot number of date of manufacture: on September 8th, 2006.
5,1,2-PD: 500ml, AR, Tianjin Bo Di Chemical Co., Ltd., 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, alanine aminotransferase (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, 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): 0.43g/ sheet (content of dispersion: 0.21g/ sheet), Dongbao of Tonghua medicine company, company limited, lot number: 060107.
(4) key instrument:
1, step 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 grouping and dosage:
Animal is bought first adaptability and raises one week.Be divided into 9 groups by body weight stratified random, 10 of Normal groups, all the other every group 11.
Quantity: 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, tri-dosage of 2g/kg and 4g/kg, are equivalent to 20,40 and 80 times of people's quantity, respectively organize gavage capacity and are 15ml/kg.
1, Normal group: not modeling, physiological saline gavage;
2, fatty liver module: modeling+physiological saline gavage;
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, dosage group in 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 Rats with Fatty Liver model, adopt Fat Emulsion administration by gavage.
Fat Emulsion preparation: get lard 25g and put into beaker, magnetic agitation is heated to 100 ℃, adds cholesterol 10g, dissolves, then adds propylthiouracil 1g, stirs evenly, and adds 20ml Tween-80 to make oil phase.Separately get a beaker, add 50% ethanol 25ml, then add 1.2-propylene glycol 20ml, be heated to 60 ℃, and then add 2g NaTDC, stir entirely moltenly, make water.Water is slowly added to oil phase, and limit edged mixes, Fat Emulsion 100ml.Refrigerate for subsequent use, warm dissolving of used time.
(3) medication:
Start with modeling simultaneously, every morning gastric infusion, afternoon is to Fat Emulsion 15ml/kg gavage (ig), continuously surrounding.
(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 Emulsion amount and dose gavage according to the weight.
2, Biochemical Indices In Serum is measured: when within 28 days, experiment finishes, feedwater fasting 12h, weighs.Broken end is got blood 3-4ml, and-30 ℃ of preservations are surveyed serum TC (T-CHOL), TG (triglyceride), ALT (alanine aminotransferase), AST (aspartic transaminase).
3, liver outward appearance is observed and liver assessment of indices: observe and record Hepatic pool, quality, claim liver 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 4.5ml chloroform: methyl alcohol (2:1, V:V), extract lipid, shake frequently, placement is spent the night, 4000r/min, centrifugal 10min, gets 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 homogenate.
(1) SOD measures: the 1% 30 μ l of liver tissue homogenate, operate by SOD testing cassete instructions;
(2) MDA measures: 10% 0.1ml of liver tissue homogenate, operates by MDA kit instructions.
(3) orgotein is measured: the 0.5% 50 μ l of liver tissue homogenate, operate by Coomassie brilliant blue kit instructions.
(4) hydroxyproline determination (sample alkali hydrolysis method): press hydroxyproline testing cassete instructions VI operation.
SPSS13.0 statistical software processing for experimental data, the relatively conspicuousness of group difference.
Four, experimental result:
(1) generalized case: duration of test, the normal rats state of mind is good, movable normal, hair luster, the colour of skin is ruddy, and stool and urine is normal, body weight sustainable growth.
Model group rat, after one week, there is One's spirits are drooping, movable minimizing in modeling, hair tarnish, aobvious struggle irritability phenomenon while filling with Fat Emulsion, feed consumption is fewer than normal group, and body weight gain is slower.After the 3rd week, there is rare soft stool, even semiliquid stool, rare soft stool continues to 4th week experiment to be finished, and appetite minimizing, and body weight gain is slow.
Give the precious rat generalized case of liver slightly better than model group, second week also occurs that hair pine is dirty, drowsiness, while filling with Fat Emulsion, present the irritability phenomenon that resistance is struggled, the growth of rat body weight, slow down along with the increase of dosage, wherein high dose group rat body weight increases more sick module slow (P<0.05).
There are indivedual animal deads in the group that experimental session has, the results are shown in Table 1.
The variation of table 1 experimental session rat body weight (g)
With normal group comparison,
△ △p < 0.01; With relatively * P<0.05 of model group, * * P<0.01.
(2) impact on rat fat: the results are shown in Table 2.
The impact of table 2 on rat fat
With normal group comparison,
△ △p < 0.01; With relatively * P<0.05 of model group, * * P<0.01.
Table 2 result shows, sick module serum cholesterol significantly raises, and three dosage of liver treasured, all have the effect of remarkable reduction serum cholesterol.
(3) impact on Liver Function: the results are shown in Table 3.
The impact of table 3 on rat blood serum liver function
With normal group comparison,
△ △p < 0.01; With relatively * P<0.05 of model group, * * P<0.01
ALT, the AST of model group rat blood serum obviously raise, and liver treasured high, middle dosage group ALT and model group relatively have reducing effect.
(4) impact on rats'liver lipid: the results are shown in Table 4.
The impact of table 4 on rat liver homogenate lipid content
With normal group comparison,
△ △p < 0.01; With relatively * P<0.05 of model group, * * P<0.01
TC, the TG of model group and the obvious rising of normal group, illustrate that fatty liver forms.In liver treasured, the TC of dosage group obviously reduces, and showing has the effect that reduces liver inner lipid content.
(5) impact on rats'liver index and liver SOD, MDA and HPY, the results are shown in Table 5.
The impact of table 5 on rats'liver index and liver SOD, MDA and HPY
With normal group comparison,
△ △p < 0.01; With relatively * P<0.05 of model group, * * P<0.01
The MDA that sick module rats'liver index is greater than normal group, liver obviously rises, and SOD obviously declines, the relative normal group of HPY content obviously rises (P<0.05), and these characteristics that all meet fatty liver change.The MDA content of the precious low dose group rat liver of liver reduces significantly, illustrates that 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 effect described in above-mentioned experimental example.
embodiment 1 tablet of the present invention
Formula: 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 and pulverize to obtain fine powder 1, get snake gall, cow-bezoar, muscone and pulverize to obtain fine powder 2,
B. getting the four traditional Chinese medicine materials such as oriental wormwood, rough gentian, cape jasmine, Radix Glycyrrhizae adds water extraction to get 2 times, each 2 hours (8 times of amounts of first pass, second time 6 times of amount), filter, it is that 1.200-1.230(heat is surveyed 40 ℃-50 ℃ that merging filtrate is concentrated into relative density), add ethanol and make liquid contain alcohol amount to reach 70%, leave standstill, get supernatant, reclaiming ethanol continuing, to be concentrated into relative density be that 1.25-1.30(heat is surveyed 90 ℃-100 ℃) thick paste.
C. add fine powder 1, fine powder 2 and appropriate amount of auxiliary materials mixing granulation, dry, compressing tablet, to obtain final product.
Every 0.5g.Oral, one time 2,3 times on the one.
embodiment 2 powder of the present invention
Formula: 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 to conventional auxiliary material, according to common process, make powder, each serving 1g, three times on the one.
embodiment 3 capsule of the present invention
Formula: 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 and pulverize to obtain fine powder 1, get snake gall, cow-bezoar, muscone and pulverize to obtain fine powder 2,
B. getting the four traditional Chinese medicine materials such as oriental wormwood, rough gentian, cape jasmine, Radix Glycyrrhizae adds water extraction to get 3 times, add for the first time 8 times of water gagings, 6 times of water gagings for the second time, 5 times of water gagings for the third time, each 1.5 hours, filter, when merging filtrate is concentrated into 40 ℃～50 ℃, relative density is 1.200～1.230, adds ethanol and makes liquid contain alcohol amount to reach 70%, leaves standstill, get supernatant, the thick paste that when reclaiming ethanol and continuing to be concentrated into 90 ℃-100 ℃, relative density is 1.25-1.30;
C. add fine powder 1, fine powder 2 and appropriate amount of auxiliary materials mixing granulation, dry, encapsulated, every 0.5g, to obtain final product.Each serving 2, three times on the one.
embodiment 4 honey pill agent 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 to conventional auxiliary material, according to common process, make honey pill agent, 1g/ ball, each serving 1g, three times on the one.
embodiment 5 granule of the present invention
Formula: 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 and pulverize to obtain fine powder 1, get snake gall, cow-bezoar, muscone and pulverize to obtain fine powder 2,
B. getting the four traditional Chinese medicine materials such as oriental wormwood, rough gentian, cape jasmine, Radix Glycyrrhizae adds water extraction to get 2 times, add for the first time 10 times of water gagings, 8 times of water gagings for the second time, each 2 hours, filter, when merging filtrate is concentrated into 40 ℃～50 ℃, relative density is 1.200～1.230, adding ethanol makes liquid contain alcohol amount to reach 70%, leave standstill, get supernatant, the thick paste that when reclaiming ethanol and continuing to be concentrated into 90 ℃-100 ℃, relative density is 1.25-1.30;
C. add fine powder 1, fine powder 2 and appropriate amount of auxiliary materials mixing granulation, dry, pack, every bag of 1.0g, to obtain final product.
Each serving 1 bag, three times on the one.
embodiment 6 oral liquid 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 to conventional auxiliary material, according to common process, make oral liquid.
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 to conventional auxiliary material, according to common process, make tea in bag, each serving 1g, three times on the one.
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 this product 1.5g, porphyrize, adds methyl alcohol 20ml, adds hot reflux 30 minutes, filter, and filtrate evaporate to dryness, residue adds methyl alcohol 1ml dissolves it, as need testing solution.Separately get Gardenoside reference substance, add methyl alcohol and make the solution of every 1ml containing 0.5mg, product solution in contrast.Test according to thin-layered chromatography (2005 editions one appendix VI B of Chinese Pharmacopoeia), draw the each 6 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, take ethyl acetate-Methanol-water (20:2:1) as developping agent, launch, take out, dry, spray, with 5% vanillic aldehyde sulfuric acid solution, is heated to spot colour developing at 105 ℃ clear, under daylight, inspects.In test sample chromatogram, with the corresponding position of reference substance chromatogram on, aobvious same color spot.
B. get the sample solution of differentiating under a item, as need testing solution.Separately get Paeoniflorin reference substance, add methyl alcohol and make the solution of every 1ml containing 1mg, product solution in contrast.Test according to thin-layered chromatography (2005 editions one appendix VI B of Chinese Pharmacopoeia), draw need testing solution 8 μ l, reference substance solution 6 μ l, put respectively on same silica gel g thin-layer plate, take ethyl acetate-methanol-water (20:2:1) as developping agent, launch, take out, dry, spray is with 5% vanillic aldehyde sulfuric acid solution, be heated to spot colour developing at 105 ℃ clear, under daylight, inspect.In test sample chromatogram, with the corresponding position of reference substance chromatogram on, aobvious 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 this product 1.5g, porphyrize, adds methyl alcohol 20ml, adds hot reflux 30 minutes, filter, and filtrate evaporate to dryness, residue adds methyl alcohol 1ml dissolves it, as need testing solution.Separately get Gardenoside reference substance, add methyl alcohol and make the solution of every 1ml containing 0.5mg, product solution in contrast.Test according to thin-layered chromatography (2005 editions one appendix VI B of Chinese Pharmacopoeia), draw the each 6 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, take ethyl acetate-methanol-water (15:2:1) as developping agent, launch, take out, dry, spray, with 5% vanillic aldehyde sulfuric acid solution, is heated to spot colour developing at 105 ℃ clear, under daylight, inspects.In test sample chromatogram, with the corresponding position of reference substance chromatogram on, aobvious same color spot.
B. get the sample solution of differentiating under a item, as need testing solution.Separately get Paeoniflorin reference substance, add methyl alcohol and make the solution of every 1ml containing 1mg, product solution in contrast.Test according to thin-layered chromatography (2005 editions one appendix VI B of Chinese Pharmacopoeia), draw need testing solution 8 μ l, reference substance solution 6 μ l, put respectively on same silica gel g thin-layer plate, take ethyl acetate-Methanol-water (15:2:1) as developping agent, launch, take out, dry, spray is with 5% vanillic aldehyde sulfuric acid solution, be heated to spot colour developing at 105 ℃ clear, under daylight, inspect.In test sample chromatogram, with the corresponding position of reference substance chromatogram on, aobvious 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 this product 1.5g, porphyrize, adds methyl alcohol 20ml, adds hot reflux 30 minutes, filter, and filtrate evaporate to dryness, residue adds methyl alcohol 1ml dissolves it, as need testing solution.Separately get Gardenoside reference substance, add methyl alcohol and make the solution of every 1ml containing 0.5mg, product solution in contrast.Test according to thin-layered chromatography (2005 editions one appendix VI B of Chinese Pharmacopoeia), draw the each 6 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, take ethyl acetate-Methanol-water (25:2:1) as developping agent, launch, take out, dry, spray, with 5% vanillic aldehyde sulfuric acid solution, is heated to spot colour developing at 105 ℃ clear, under daylight, inspects.In test sample chromatogram, with the corresponding position of reference substance chromatogram on, aobvious same color spot.
B. get the sample solution of differentiating under a item, as need testing solution.Separately get Paeoniflorin reference substance, add methyl alcohol and make the solution of every 1ml containing 1mg, product solution in contrast.Test according to thin-layered chromatography (2005 editions one appendix VI B of Chinese Pharmacopoeia), draw need testing solution 8 μ l, reference substance solution 6 μ l, put respectively on same silica gel g thin-layer plate, take ethyl acetate-methanol-water (25:2:1) as developping agent, launch, take out, dry, spray is with 5% vanillic aldehyde sulfuric acid solution, be heated to spot colour developing at 105 ℃ clear, under daylight, inspect.In test sample chromatogram, with the corresponding position of reference substance chromatogram on, aobvious same color spot.
Claims (11)
1. treat a quality determining method for the pharmaceutical composition of fatty liver, it is characterized in that the method comprises one or more in following discrimination method:
A. get drug combination preparation 1.5g, add methyl alcohol 20ml, add hot reflux 30 minutes, filter, filtrate evaporate to dryness, residue adds methyl alcohol 1ml dissolves it, as need testing solution; Separately get Gardenoside reference substance appropriate, add methyl alcohol and make the solution of every 1ml containing 0.5mg, product solution in contrast; Test according to thin-layered chromatography, draw the each 6 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, take ethyl acetate-Methanol-water of 15～25:2:1 as developping agent, launch, take out, dry, spray, with 5% vanillic aldehyde sulfuric acid solution, is heated to spot colour developing at 105 ℃ clear, under daylight, inspects; In test sample chromatogram, with the corresponding position of reference substance chromatogram on, aobvious same color spot;
B. get the sample solution of differentiating under a item, as need testing solution; Separately get Paeoniflorin reference substance appropriate, add methyl alcohol and make the solution of every 1ml containing 1mg, product solution in contrast; Test according to thin-layered chromatography, draw need testing solution 8 μ l, reference substance solution 6 μ l, put respectively on same silica gel g thin-layer plate, take ethyl acetate-Methanol-water of 15～25:2:1 as developping agent, launch, take out, dry, spray is with 5% vanillic aldehyde sulfuric acid solution, be heated to spot colour developing at 105 ℃ clear, under daylight, inspect; In test sample chromatogram, with the corresponding position of reference substance chromatogram on, aobvious same color spot;
Bulk drug composition and the preparation method of described drug combination preparation are: 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, make 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 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 the pharmaceutical composition as described in claim 1, is characterized in that: the bulk drug of described drug combination preparation consists of:
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 described 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 described 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 described 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 described 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. the quality determining method of the pharmaceutical composition as described in as arbitrary in claim 1-7, is characterized in that described drug combination preparation makes by the following method:
A. get rheum officinale, the root of herbaceous peony, pseudo-ginseng and pulverize to obtain fine powder 1, get snake gall, cow-bezoar, muscone, pulverize to obtain fine powder 2;
B. get oriental wormwood, rough gentian, cape jasmine, Radix Glycyrrhizae four traditional Chinese medicine material through conventional Chinese medicine water extraction, alcohol precipitation process, obtain thick paste;
C. in thick paste, add fine powder 1, fine powder 2 and conventional auxiliary material to be prepared into clinical acceptable preparation;
Described step B is specially: oriental wormwood, rough gentian, cape jasmine, Radix Glycyrrhizae four traditional Chinese medicine material add water extraction to get 1～3 time, add 5～10 times of water gagings at every turn, and each 1～3 hour, filter, when merging filtrate is concentrated into 40 ℃～50 ℃, relative density is 1.200～1.230; Add ethanol and make liquid contain alcohol amount to reach 70%, leave standstill, get supernatant, the thick paste that when reclaiming ethanol and continuing to be concentrated into 90 ℃-100 ℃, relative density is 1.25-1.30;
Described step C is specially and in thick paste, adds fine powder 1, fine powder 2 and conventional auxiliary material, mixes, and granulates, dry, makes 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 described drug combination preparation makes by the following method:
A. get rheum officinale, the root of herbaceous peony, pseudo-ginseng and pulverize to obtain fine powder 1, get snake gall, cow-bezoar, muscone, pulverize to obtain fine powder 2;
B. getting the four traditional Chinese medicine materials such as oriental wormwood, rough gentian, cape jasmine, Radix Glycyrrhizae adds water extraction to get 2 times, add for the first time 8 times of water gagings, 6 times of water gagings for the second time, each 2 hours, filter, when merging filtrate is concentrated into 40 ℃～50 ℃, relative density is 1.200-1.230, adding ethanol makes liquid contain alcohol amount to reach 70%, leave standstill, get supernatant, the thick paste that when reclaiming ethanol and continuing to be concentrated into 90 ℃-100 ℃, relative density is 1.25-1.30;
C. in thick paste, add fine powder 1, fine powder 2 and appropriate amount of auxiliary materials mixing granulation, dry, compressing tablet, every 0.5g, to obtain final product.
10. as the quality determining method of the pharmaceutical composition of claim 1-7 or 9 as described in arbitrary, it is characterized in that the method comprises one or more in following discrimination method:
A. get drug combination preparation 1.5g, add methyl alcohol 20ml, add hot reflux 30 minutes, filter, filtrate evaporate to dryness, residue adds methyl alcohol 1ml dissolves it, as need testing solution; Separately get Gardenoside reference substance appropriate, add methyl alcohol and make the solution of every 1ml containing 0.5mg, product solution in contrast; According to thin-layered chromatography test, draw the each 6 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, take ethyl acetate-Methanol-water of 25:2:1 as developping agent, launch, take out, dry, spray, with 5% vanillic aldehyde sulfuric acid solution, is heated to spot colour developing at 105 ℃ clear, under daylight, inspects; In test sample chromatogram, with the corresponding position of reference substance chromatogram on, aobvious same color spot;
B. get the sample solution of differentiating under a item, as need testing solution; Separately get Paeoniflorin reference substance appropriate, add methyl alcohol and make the solution of every 1ml containing 1mg, product solution in contrast; Test according to thin-layered chromatography, draw need testing solution 8 μ l, reference substance solution 6 μ l, put respectively on same silica gel g thin-layer plate, take ethyl acetate-Methanol-water of 25:2:1 as developping agent, launch, take out, dry, spray is with 5% vanillic aldehyde sulfuric acid solution, be heated to spot colour developing at 105 ℃ clear, under daylight, inspect; In test sample chromatogram, with the corresponding position of reference substance chromatogram on, aobvious same color spot.
The quality determining method of 11. pharmaceutical compositions as claimed in claim 8, is characterized in that the method comprises one or more in following discrimination method:
A. get drug combination preparation 1.5g, add methyl alcohol 20ml, add hot reflux 30 minutes, filter, filtrate evaporate to dryness, residue adds methyl alcohol 1ml dissolves it, as need testing solution; Separately get Gardenoside reference substance appropriate, add methyl alcohol and make the solution of every 1ml containing 0.5mg, product solution in contrast; According to thin-layered chromatography test, draw the each 6 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, take ethyl acetate-Methanol-water of 25:2:1 as developping agent, launch, take out, dry, spray, with 5% vanillic aldehyde sulfuric acid solution, is heated to spot colour developing at 105 ℃ clear, under daylight, inspects; In test sample chromatogram, with the corresponding position of reference substance chromatogram on, aobvious same color spot;
B. get the sample solution of differentiating under a item, as need testing solution; Separately get Paeoniflorin reference substance appropriate, add methyl alcohol and make the solution of every 1ml containing 1mg, product solution in contrast; Test according to thin-layered chromatography, draw need testing solution 8 μ l, reference substance solution 6 μ l, put respectively on same silica gel g thin-layer plate, take ethyl acetate-Methanol-water of 25:2:1 as developping agent, launch, take out, dry, spray is with 5% vanillic aldehyde sulfuric acid solution, be heated to spot colour developing at 105 ℃ clear, under daylight, inspect; In test sample chromatogram, with the corresponding position of reference substance chromatogram on, aobvious 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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| CN1328834A (en) * | 2000-11-15 | 2002-01-02 | 郑国芃 | Capsule for curing cholecystitis |
| JP2006045181A (en) * | 2003-11-18 | 2006-02-16 | Sekisui Chem Co Ltd | External composition for skin |
| CN101172151A (en) * | 2006-10-31 | 2008-05-07 | 王文喜 | Traditional Chinese medicine for treating pancreatitis and preparation method thereof |
| 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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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1328834A (en) * | 2000-11-15 | 2002-01-02 | 郑国芃 | Capsule for curing cholecystitis |
| JP2006045181A (en) * | 2003-11-18 | 2006-02-16 | Sekisui Chem Co Ltd | External composition for skin |
| CN101172151A (en) * | 2006-10-31 | 2008-05-07 | 王文喜 | Traditional Chinese medicine for treating pancreatitis and preparation method thereof |
| 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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