CN102671106A - Traditional Chinese medicine preparation for treating fatty liver and method for preparing same - Google Patents
Traditional Chinese medicine preparation for treating fatty liver and method for preparing same Download PDFInfo
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Abstract
The invention relates to a traditional Chinese medicine preparation for treating fatty liver and a method for preparing the same. The traditional Chinese medicine preparation is prepared through the following steps of: taking coptis chinensis, scutellaria baicalensis, roasted Fructus aurantii immaturus, poria cocos, dried orange peels, pinellia ternata, amomum kravanh, sea clam powder, salviae miltiorrhizae, oriental wormwood, liquorice, caulis bambusae in taeniam, wax gourd kernels, semen coicis and red peony root as raw materials, extracting volatile oils from the amomum kravanh and the dried orange peels, extracting the pinellia ternata, the roasted Fructus aurantii immaturus and the coptis chinensis by using ethanol, decocting the other raw materials, and then blending all of the components and performing spray-drying, and then adding auxiliary materials thereto, thereby obtaining the traditional Chinese medicine preparation. According to the traditional Chinese medicine preparation provided by the invention, the poria cocos, the dried orange peels and the pinellia ternata are monarch drugs together functioning in tonifying spleen, tonifying qi, eliminating dampness and resolving phlegm, while the coptis chinensis, scutellaria baicalensis, amomum kravanh, sea clam powder, oriental wormwood and caulis bambusae in taeniam are all ministerial drugs assisting the monarch drugs in enhancing the effects of clearing heat and promoting diuresis, resolving phlegm, softening hard lumps and dispelling nodes; the roasted Fructus aurantii immaturus, salviae miltiorrhizae, red peony root, wax gourd kernels and semen coicis are adjuvants assisting the monarch drugs and the ministerial drugs in soothing the liver, promoting the circulation of qi, promoting blood circulation to remove meridian and dispel nodes, tonifying spleen and eliminating dampness; and the liquorice is used for harmonizing all of the drugs to obtain the messenger drug.
Description
Technical field
The present invention relates to a kind of Chinese medicine of treating fatty liver, belong to technical field of Chinese medicines.
Background technology
Fatty liver is present global common disease, and its modal cause of disease is excessive drinking, obesity, diabetes etc.The sickness rate of its hepatic fibrosis can be up to 25%, and about 1.5%～8.0% patient can make progress and be liver cirrhosis, therefore can think that fatty liver is the hardened cercinoma prophase pathologic change of hepatic fibrosis regulating liver-QI.The primary disease that fatty liver also can be used as metabolism syndrome shows at liver, and is closely related with multiple diseases such as hypertension, atherosclerosis, gout, cholelithiasises, so early diagnosis and timely and effective treatment are significant.
In recent years, both at home and abroad aspects such as fatty liver pathogenesis and treatment are furtherd investigate.Think that pathogeny is quite complicated; Comprise histology and pathological changes such as hepatic tissue structural change, insulin resistant (IR), the release of the various kinds of cell factor, liver inflammatory damage, ferrum particle deposition, proliferation of fibrous tissue, glycolipid metabolism disorder, CYP2E1 high expressed, and proposed " two-hit " theory.
The treatment aspect, up to now, the medicine of inefficacy satisfaction still; Though fatty liver and hyperlipemia are in close relations, many fat-reducing medicaments possibly impel blood fat more to concentrate on liver and carry out metabolism; Increase the weight of to accumulate, damage in the lipid liver liver function; Therefore, fat-reducing medicament still has objection to the therapeutical effect of fatty liver.In addition, multiple hypoglycemic medicine can improve insulin sensitivity, but how with the hepatic injury effect.
With regard to clinical manifestation and sign, surely belong to sick categories such as " obesity ", " distension ", " phlegm retention ", " gathering ", " hypochondriac pain ", " alcoholic jaundice ".Mostly the cause of disease is surfeit delicious food savoury, obesity, or be addicted to drink excessively etc.
We are according to motherland's theory of medicine; Through the principal element of summing up fatty liver formation, the rule and the clinical syndrome characteristics of pathological development; Proposing the insufficiency of the spleen fortuneization of 1. plain body unable is the basic inherent basis that fatty liver takes place; Excessive drinking, to have a liking for food delicious food savoury etc. be the main diseases that forms of fatty liver because of; 2. stagnation of liver-QI with deficiency of the spleen, phlegm and blood stasis are the basic pathogenesis of primary disease, 3. its take place with development be one by void to real, by spleen and liver, by the pathological process of gas and blood, 4. spleen invigorating circulation of qi promoting, dissipating phlegm and resolving masses are the academic arguments of base therapy method.Fatty liver and blood lipid level have dependency, but do not have necessity, and simple blood fat reducing possibly become to making blood fat more to concentrate on liver to carry out metabolism, impel lipid to store up on the contrary and damage liver function.
Summary of the invention
The purpose of this invention is to provide a kind of Chinese medicine preparation of treating fatty liver and preparation method thereof, the many target spots of this kind Chinese medicine are regulated lipid metabolism, recover the liver normal ultrastructure, make disorderly liver fat metabolism normal again, radically reform, and not blood fat reducing and fat are from disappearing.
The technical scheme that the present invention takes is:
A kind of Chinese medicine preparation of treating fatty liver, the weight part ratio of its crude drug consists of: 6～12 parts of Rhizoma Coptidis, 6～18 parts of Radix Scutellariaes, 6～18 parts of Fructus Aurantii Immaturus (parched); 18～30 parts in Poria, 3～15 parts of Pericarpium Citri Reticulataes, 6～12 parts of the Rhizoma Pinelliaes, 6～12 parts in Fructus Amomi Rotundus; 8～30 parts in sea clam powder, 18～30 parts of Radix Salviae Miltiorrhizaes, 18～30 parts of Herba Artemisiae Scopariaes, 3～6 parts in Radix Glycyrrhizae; 6～18 parts of Caulis Bambusae In Taenia, 18～30 parts of Semen Benincasaes, 18～30 parts of Semen Coiciss, 18～30 parts of Radix Paeoniae Rubra.
The Chinese medicine preparation of described treatment fatty liver, the weight part ratio composition of its crude drug is preferably: 6～10 parts of Rhizoma Coptidis, 6～12 parts of Radix Scutellariaes, 6～15 parts of Fructus Aurantii Immaturus (parched); 20～30 parts in Poria, 3～10 parts of Pericarpium Citri Reticulataes, 6～10 parts of the Rhizoma Pinelliaes, 6～10 parts in Fructus Amomi Rotundus; 20～30 parts in sea clam powder, 18～25 parts of Radix Salviae Miltiorrhizaes, 18～25 parts of Herba Artemisiae Scopariaes, 3～6 parts in Radix Glycyrrhizae; 6～10 parts of Caulis Bambusae In Taenia, 20～30 parts of Semen Benincasaes, 20～30 parts of Semen Coiciss, 18～25 parts of Radix Paeoniae Rubra.
The Chinese medicine preparation of described treatment fatty liver, the weight part ratio composition of its crude drug further is preferably: 9 parts of Rhizoma Coptidis, 12 parts of Radix Scutellariaes, 12 parts of Fructus Aurantii Immaturus (parched); 30 parts in Poria, 9 parts of Pericarpium Citri Reticulataes, 9 parts of the Rhizoma Pinelliaes, 9 parts in Fructus Amomi Rotundus; 30 parts in sea clam powder, 24 parts of Radix Salviae Miltiorrhizaes, 24 parts of Herba Artemisiae Scopariaes, 3 parts in Radix Glycyrrhizae; 9 parts of Caulis Bambusae In Taenia, 30 parts of Semen Benincasaes, 30 parts of Semen Coiciss, 24 parts of Radix Paeoniae Rubra.
The method for preparing of the Chinese medicine preparation of above-mentioned treatment fatty liver comprises that step is following:
(1) Fructus Amomi Rotundus, Pericarpium Citri Reticulatae are extracted volatile oil, water liquid and medicinal residues device are in addition preserved;
(2) Rhizoma Pinelliae, Fructus Aurantii Immaturus (parched), Rhizoma Coptidis are extracted 2-3 time with 50-70% (v/v) alcohol heating reflux, merge extractive liquid,, decompression recycling ethanol, concentrated extracting solution are to 50-80 ℃ of relative density 1.10-1.35, and concentrated solution and medicinal residues device are in addition preserved;
(3) with the medicinal residues decocte with water of Radix Scutellariae, Poria, sea clam powder, Radix Salviae Miltiorrhizae, Herba Artemisiae Scopariae, Radix Glycyrrhizae, Caulis Bambusae In Taenia, Semen Benincasae, Semen Coicis, Radix Paeoniae Rubra and step (1) and step (2) gained 2-4 time; Merge decoction liquor; Be evaporated to 50-100 ℃ of relative density 1.03-1.35; The concentrated solution of the water liquid of concentrated solution and step (1) and step (2) merges, and concentrates and be dried to behind the dried cream powder subsequent use once more;
(4) dried cream powder is sprayed into the volatile oil that step (1) is extracted after broken, add supplementary product starch, dextrin, aspartame, process granule, aseptic subpackaged, promptly get.
The described extraction volatile oil of step (1) is the water that adds 6～12 times in Fructus Amomi Rotundus, Pericarpium Citri Reticulatae weight, 4～8 hours extraction times.
The each addition of the described 50-70% of step (2) (v/v) ethanol is the Rhizoma Pinelliae, Fructus Aurantii Immaturus, Rhizoma Coptidis gross mass 6-12 a times, extracts 1-2 hour at every turn.
The described amount of water of step (3) is 6-12 a times of medical material gross mass, decocts 1-2 hour at every turn.
If described drying means adopts spray-dired condition to be: 100～200 ℃ of EATs, 60～120 ℃ of air outlet temperature, nebulizer speed governing 38 ~ 40, feed liquor rotating speed 10～60Hz can get steady and continuous ejection dried powder.If described drying means adopts the condition of drying under reduced pressure to be: 50～100 ℃, below the pressure 2.67KPa.
The addition scope of each adjuvant in the step (4): the part by weight at dextrin and dried cream powder end is 5%～20%; The part by weight at aspartame and dried cream powder end is 0.1%～0.6%.The part by weight at starch and dried cream powder end is 5%～100%.
Poria, Pericarpium Citri Reticulatae, the Rhizoma Pinelliae are monarch drug in the pharmaceutical formulation of the present invention, the merit of playing the invigorating the spleen and benefiting QI drying dampness to eliminate phlegm altogether.Wherein, with in transferring, the strong fortune of spleen is then wet from changing with stomach function regulating, Pericarpium Citri Reticulatae activating QI to eliminate phlegm for Rhizoma Pinelliae drying dampness to eliminate phlegm, and the wet expectorant that goes then is from disappearing, so with the Poria invigorating spleen to remove dampness.Rhizoma Coptidis, Radix Scutellariae, Fructus Amomi Rotundus, sea clam powder, Herba Artemisiae Scopariae, Caulis Bambusae In Taenia are ministerial drug altogether, and auxiliary monarch drug strengthens the merit of clearing away heat-damp and promoting diuresis, resolving phlegm and softening hard masses eliminating stagnation.Rhizoma Coptidis, Radix Scutellariae heat clearing away and dampness develop simultaneously, and reaching wet going and heat is lonely, heat is dried and also changed purpose.Fructus Aurantii Immaturus (parched), Radix Salviae Miltiorrhizae, Radix Paeoniae Rubra, Semen Benincasae, Semen Coicis are adjuvant drug, assist a ruler in governing a country the soothing the liver circulation of qi promoting of the monarch and his subjects, promoting blood circulation to remove obstruction in the collateral eliminating stagnation, invigorating spleen to remove dampness.The capable then blood of gas is capable, and the stagnation of QI is blood stasis then.QI and blood is transferred freely then, and the irritability bar reaches, the strong fortune of temper.The Radix Glycyrrhizae coordinating the actions of various ingredients in a prescription is a messenger drug.
Medicament flavour of a drug of the present invention are more, and single dose medical material amount is big, and paste-forming rate is higher, and the dosage form that content of dispersion such as tablet, capsule are little is uncomfortable, should select content of dispersion bigger, keeps the granule of decoction advantage again, and granule is stable, produces, transports, takes all more convenient.
The specific embodiment
Further specify the present invention below in conjunction with specific embodiment.
Embodiment 1
A kind of Chinese medicine preparation of treating fatty liver, the weight part ratio of its crude drug consists of: Rhizoma Coptidis 9g, Radix Scutellariae 12g, Fructus Aurantii Immaturus (parched) 12g, Poria 30g, Pericarpium Citri Reticulatae 9g; Rhizoma Pinelliae 9g, Fructus Amomi Rotundus 9g, sea clam powder 30g, Radix Salviae Miltiorrhizae 24g, Herba Artemisiae Scopariae 24g; Radix Glycyrrhizae 3g, Caulis Bambusae In Taenia 9g, Semen Benincasae 30g, Semen Coicis 30g, Radix Paeoniae Rubra 24g.
Method for preparing is: Fructus Amomi Rotundus, Pericarpium Citri Reticulatae extract volatile oil, and water liquid and medicinal residues device are in addition preserved, and are subsequent use; The Rhizoma Pinelliae, Fructus Aurantii Immaturus, Rhizoma Coptidis extract secondary with 70% (v/v) alcohol heating reflux, and for the first time with the ethanol extraction of 10 times of the Rhizoma Pinelliaes, Fructus Aurantii Immaturus, Rhizoma Coptidis gross mass 2 hours, the second time was with the ethanol extraction of 8 times of the Rhizoma Pinelliaes, Fructus Aurantii Immaturus, Rhizoma Coptidis gross mass 1 hour; Merge secondary raffinate; Decompression recycling ethanol, the extracting solution concentrating under reduced pressure is concentrated into relative density 1.10; Other preserves by device respectively for concentrated solution and medicinal residues, and is subsequent use; Radix Scutellariae, Poria, sea clam powder, Radix Salviae Miltiorrhizae, Herba Artemisiae Scopariae, Radix Glycyrrhizae, Caulis Bambusae In Taenia, Semen Benincasae, Semen Coicis, Radix Paeoniae Rubra and the decocte with water of preceding two gained medicinal residues 3 times, proportion by subtraction is: 10 times of quality decoctings of medical material boiled 1.5 hours, and 8 times of quality decoctings of medical material boiled 1 hour, and 6 times of quality decoctings of medical material boiled 1 hour; Merge three times extracting solution, concentrating under reduced pressure is concentrated into relative density 1.10, and concentrated solution and preceding two water liquid and concentrated solution merge; Concentrate thick paste, spray drying (EAT 180+5 ℃, 85～90 ℃ of leaving air temps) gets dry extract; Spray into volatile oil after the pulverizing, add starch, dextrin, aspartame adjuvant, (under RH＜40% condition, dry-pressing granulator is regulated pressure to process granule; Be advisable with 2.0～2.5Mpa, cross 60 order shaking screens, fine powder secondary dry-pressing granulating is granulated through secondary; Granularity can be qualified), aseptic subpackaged, promptly get; Mass content in the granule: aspartame 0.2%, dextrin 5%, starch 50%.
Embodiment 2
A kind of Chinese medicine preparation of treating fatty liver, the weight part ratio of its crude drug consists of: Rhizoma Coptidis 6g, Radix Scutellariae 6g, Fructus Aurantii Immaturus (parched) 6g, Poria 18g, Pericarpium Citri Reticulatae 3g; Rhizoma Pinelliae 6g, Fructus Amomi Rotundus 6g, sea clam powder 8g, Radix Salviae Miltiorrhizae 18g, Herba Artemisiae Scopariae 18g; Radix Glycyrrhizae 3g, Caulis Bambusae In Taenia 6g, Semen Benincasae 18g, Semen Coicis 18g, Radix Paeoniae Rubra 18g.
Method for preparing is: Fructus Amomi Rotundus, Pericarpium Citri Reticulatae extract volatile oil, and water liquid and medicinal residues device are in addition preserved, and are subsequent use; The Rhizoma Pinelliae, Fructus Aurantii Immaturus, Rhizoma Coptidis extract secondary with 70% (v/v) alcohol heating reflux, and for the first time with the ethanol extraction of 8 times of the Rhizoma Pinelliaes, Fructus Aurantii Immaturus, Rhizoma Coptidis gross mass 2 hours, the second time was with the ethanol extraction of 6 times of the Rhizoma Pinelliaes, Fructus Aurantii Immaturus, Rhizoma Coptidis gross mass 1 hour; Merge secondary raffinate; Decompression recycling ethanol, the extracting solution concentrating under reduced pressure is concentrated into relative density 1.20; Other preserves by device respectively for concentrated solution and medicinal residues, and is subsequent use; Radix Scutellariae, Poria, sea clam powder, Radix Salviae Miltiorrhizae, Herba Artemisiae Scopariae, Radix Glycyrrhizae, Caulis Bambusae In Taenia, Semen Benincasae, Semen Coicis, Radix Paeoniae Rubra and the decocte with water of preceding two gained medicinal residues 3 times, proportion by subtraction is: 10 times of quality decoctings of medical material boiled 1.5 hours, and 8 times of quality decoctings of medical material boiled 1 hour, and 6 times of quality decoctings of medical material boiled 1 hour; Merge three times extracting solution, concentrating under reduced pressure is concentrated into relative density 1.20, and concentrated solution and preceding two water liquid and concentrated solution merge; Concentrate thick paste, spray drying (EAT 180+5 ℃, 85～90 ℃ of leaving air temps) gets dry extract; Spray into volatile oil after the pulverizing, add starch, dextrin, aspartame adjuvant, (under RH＜40% condition, dry-pressing granulator is regulated pressure to process granule; Be advisable with 2.0～2.5Mpa, cross 60 order shaking screens, fine powder secondary dry-pressing granulating is granulated through secondary; Granularity can be qualified), aseptic subpackaged, promptly get; Mass content in the granule: aspartame 0.5%, dextrin 10%, starch 40%.
Embodiment 3
A kind of Chinese medicine preparation of treating fatty liver, the weight part ratio of its crude drug consists of: Rhizoma Coptidis 10g, Radix Scutellariae 12g, Fructus Aurantii Immaturus (parched) 15g, Poria 30g, Pericarpium Citri Reticulatae 10g; Rhizoma Pinelliae 10g, Fructus Amomi Rotundus 10g, sea clam powder 30g, Radix Salviae Miltiorrhizae 25g, Herba Artemisiae Scopariae 25g; Radix Glycyrrhizae 6g, Caulis Bambusae In Taenia 10g, Semen Benincasae 30g, Semen Coicis 30g, Radix Paeoniae Rubra 25g.
Method for preparing is: Fructus Amomi Rotundus, Pericarpium Citri Reticulatae extract volatile oil, and water liquid and medicinal residues device are in addition preserved, and are subsequent use; The Rhizoma Pinelliae, Fructus Aurantii Immaturus, Rhizoma Coptidis are extracted secondary with 70% (v/v) alcohol heating reflux; For the first time with the ethanol extraction of 12 times of the Rhizoma Pinelliaes, Fructus Aurantii Immaturus, Rhizoma Coptidis gross mass 2 hours, for the second time with the ethanol extraction of 10 times of the Rhizoma Pinelliaes, Fructus Aurantii Immaturus, Rhizoma Coptidis gross mass 1 hour, the merging secondary raffinate; Decompression recycling ethanol; The extracting solution concentrating under reduced pressure, other preserves by device respectively to be concentrated into relative density 1.30 concentrated solutions and medicinal residues, and is subsequent use; Radix Scutellariae, Poria, sea clam powder, Radix Salviae Miltiorrhizae, Herba Artemisiae Scopariae, Radix Glycyrrhizae, Caulis Bambusae In Taenia, Semen Benincasae, Semen Coicis, Radix Paeoniae Rubra and the decocte with water of preceding two gained medicinal residues 3 times, proportion by subtraction is: 10 times of quality decoctings of medical material boiled 1.5 hours, and 8 times of quality decoctings of medical material boiled 1 hour, and 6 times of quality decoctings of medical material boiled 1 hour; Merge three times extracting solution, concentrating under reduced pressure is concentrated into relative density 1.30 concentrated solutions and preceding two water liquid and concentrated solution and merges, concentrate thick paste; Spray drying (EAT 180+5 ℃, 85～90 ℃ of leaving air temps) gets dry extract, and sprays into volatile oil after the pulverizing; Add starch, dextrin, aspartame adjuvant, (under RH＜40% condition, dry-pressing granulator is regulated pressure, is advisable with 2.0～2.5Mpa to process granule; Cross 60 order shaking screens, fine powder secondary dry-pressing granulating is granulated through secondary; Granularity can be qualified), aseptic subpackaged, promptly get; Mass content in the granule: aspartame 1%, dextrin 15%, starch 35%.
Embodiment 4
A kind of Chinese medicine preparation of treating fatty liver, the weight part ratio of its crude drug consists of: Rhizoma Coptidis 12g, Radix Scutellariae 18g, Fructus Aurantii Immaturus (parched) 18g, Poria 30g, Pericarpium Citri Reticulatae 15g; Rhizoma Pinelliae 12g, Fructus Amomi Rotundus 12g, sea clam powder 30g, Radix Salviae Miltiorrhizae 30g, Herba Artemisiae Scopariae 30g; Radix Glycyrrhizae 6g, Caulis Bambusae In Taenia 18g, Semen Benincasae 30g, Semen Coicis 30g, Radix Paeoniae Rubra 30g.
Method for preparing is with embodiment 1.
Embodiment 5
A kind of Chinese medicine preparation of treating fatty liver, the weight part ratio of its crude drug consists of: Rhizoma Coptidis 6g, Radix Scutellariae 6g, Fructus Aurantii Immaturus (parched) 6g, Poria 20g, Pericarpium Citri Reticulatae 3g; Rhizoma Pinelliae 6g, Fructus Amomi Rotundus 6g, sea clam powder 20g, Radix Salviae Miltiorrhizae 18g, Herba Artemisiae Scopariae 18g; Radix Glycyrrhizae 3g, Caulis Bambusae In Taenia 6g, Semen Benincasae 20g, Semen Coicis 20g, Radix Paeoniae Rubra 18g.
Method for preparing is with embodiment 1.
Clinical trial:
One. object of study
(1) patient's physical data
1. case is originated
All 83 examples are observed cases and are all derived from the outpatient of Hospital Attached to Shandong Chinese Medical Univ. in year February in JIUYUE, 2003 to 2005.
2. group technology:
Male's 73 examples, women's 10 examples, all patient's B ultrasonic all show fatty liver in various degree, and obvious history of drinking history person's 67 examples are wherein arranged.83 routine patients are divided into liver fat at random and organize (medication therapy groups of the present invention), DONGBAO GANTAI group (matched group) clearly in the ratio of 2:1.Situation such as two groups of patient's sexes, age, occupation, the course of disease, sick kind, history of drinking history, clinical symptoms sign are all through statistical analysis (X
2Check), difference that there are no significant (P>0.05), have comparability.
(1) respectively organizes sex composition and relatively see table 1
Table 1 liang group patient sex composition analytical table
Two groups of patient's sex compositioies are through statistical analysis (X
2Check), there was no significant difference (P>0.05), sex composition has comparability.
(2) respectively organize the age distribution situation and see table 2
Table 2 liang group patient age (year) the component analysis table
Two groups of patient ages constitute through statistical analysis (X
2Check), there was no significant difference (P>0.05), age structure has comparability.
(3) respectively organize professional distribution situation and see table 3
Table 3 liang group patient occupation situation analysis table
Two groups of patient's occupations constitute through statistical analysis (X
2Check), there was no significant difference (P>0.05), the occupation formation has comparability.
(4) respectively organize course of disease distribution situation and see table 4
Table 4 liang group patient course of disease analytical table
Two groups of patient's courses of disease constitute through statistical analysis (X
2Check), there was no significant difference (P>0.05), course of disease formation has comparability.
(5) the sick distribution situation of planting of each group is seen table 5
The sick situation analysis table of planting of table 5 liang group patient
(6) each group situation of drinking is seen table 6
The table 6 liang group patient situation analysis table of drinking
Two groups of patients drink and constitute through statistical analysis (X
2Check), there was no significant difference (P>0.05), drinking to constitute has comparability.
(7) respectively organize clinical symptoms sign situation and see table 7
Table 7 liang group patient clinical symptoms sign situation analysis table
Two groups of patient's clinical symptoms signs constitute through statistical analysis (X
2Check), difference that there are no significant (P>0.05), clinical symptoms sign formation all has comparability.
(8) respectively organize state of an illness distribution situation and see table 8
Table 8 liang group conditions of patients analytical table
Two groups of conditions of patients distribute and constitute through statistical analysis (X
2Check), difference that there are no significant (P>0.05), the state of an illness distributes to constitute and all has comparability.
(2) case choice criteria
1. Western medicine diagnose standard
(1) alcoholic liver disease diagnostic criteria
1) alcoholic fatty liver diagnostic criteria is formulated standard with reference to Chinese Medical Association's hepatology branch fatty liver and in October, the 2002 Nanjing meeting of alcoholic liver disease group.
1. long-term history of drinking history is arranged, generally surpass 5 years, amount to ethanol 40g/d, women >=20g/d; Or 2 have in week the heavy drinking history (＞80g/d).
2. alcohol prohibition back Serum ALT and AST obviously descend, and recover normal in 4 weeks basically, promptly below 2 times of ULN values (ULN).As before prohibiting against alcoholic drinks ALT and AST < 2.5ULN person should reduce to below the 1.25ULN after then prohibiting against alcoholic drinks.
3. the liver of at least 1 positive: ⑴ alcohol prohibition back enlargement obviously dwindled in 1 week in following 2, recovered normal in 4 weeks basically; ⑵ alcohol prohibition back GGT is active obviously to descend, reduce to below 1.5ULN after 4 weeks, or less than alcohol prohibition preceding 40%.
4. the hepatic injury that viral infection, Developmental and Metabolic Disorder and medicine etc. cause except.
5. imaging examination meets the fatty liver diagnosis.
Fail to meet above-mentioned condition person, should obtain the histodiagnosis evidence.Following items can supply to diagnose reference: AST/ALT＞2; Serum sugar defective transferrins (CDT) increases; Mean corpuscular volume (MCV) increases; Alcoholic liver cell membrane antibody positive, serum glutaminic acid dehydrogenase (GDH)/OCT (OCT)＞0.6, and early stage CT measures liver volume increase (＞720cm3/m2 body surface area).Should note the active low person of II type aldehyde dehydrogenase (ALDH2), amount to ethanol amount＜40g/d and also alcoholic liver disease can take place even drink.Ethanol amount reduction formula is: drinking amount (ml) * alcohol content (%) * 0.8 (ethanol proportion)=g.
2) histodiagnosis of alcoholic liver disease
The histodiagnosis of alcoholic liver disease can be divided into alcoholic fatty liver, alcoholic hepatitis, alcoholic fibrosis and alcoholic cirrhosis 4 types.
1. alcoholic fatty liver: in the Histological change of alcoholic liver disease, alcoholic fatty liver occurs the earliest, and occurrence rate is also the highest.Still can not distinguish with the fatty liver that other reason causes in the morphology, therefore diagnosis must rely on clinical data.Under the low power lens, steatosis accounts for lobules of liver 1/3～1/2 with fatty hepatocyte of storing up and is slight fatty liver; Account for lobules of liver 1/2～2/3 and be the moderate fatty liver; Accounting for lobule 2/3 above person or hepatocyte fills the air steatosis and is fishnet shape person for severe fatty liver.Part can show as the droplet type fatization of cystose specific type.
2. alcoholic hepatitis: alcoholic hepatitis histological characteristic is: the obvious swelling of ⑴ hepatocyte is balloon appearance and becomes, the hepatocyte of lobule central authorities particularly, and visible sometimes huge mitochondrion in the hepatocyte of ballooning degeneration, even necrosis in different degree is arranged; ⑵ there is the many types of nucleus of obvious neutrophilia to soak in portal area and the lobule, the hepatocyte tendency on every side that accumulates in downright bad and spirituosity hyaline bodies (alcohol hyaline body) is arranged; ⑶ the coagulation tendency is arranged in the liver cytoplasm, and ethanol hyaline bodies occurrence rate is high.
3. alcoholic fibrosis: show as extracellular matrix, comprise I, III, type and laminin regulating liver-QI cell peripheral deposition around central veins of liver, form fibrosis around the so-called hepatocyte.Along with the fibrosis progress, the portal area was light to moderate fiber laydown increase and expansion originally, and had elongated fibers in lobule, to extend, and formed so-called " asterism shape fibrosis ".
4. alcoholic cirrhosis: the fiber of formation is at a distance from from the central vein to the portal area, separating lobule.The pseudolobuli fiber is at a distance from general thin narrow, and tuberosity is less, and size is more even, is micronodular cirrhosis, and minority is the main greater tubercle that is mixed with the lesser tubercle.Obviously fat change of hepatocyte simultaneously, the performance of alcoholic hepatitis still can exist.The liver limiting plate is unclear, but does not have piecemeal necrosis.
3) alcoholic liver disease Clinical typing diagnosis
Meet alcoholic liver disease clinical diagnosis standard person, its Clinical typing diagnosis as follows.
1. light-duty (subclinical type) alcoholic liver disease: long-term history of drinking history is arranged, but liver function test is normal basically, liver histological shows as non-specific variation or normal basically, lacks ethanol hyaline bodies and neutrophil infiltration.
2. alcoholic fatty liver: pathological changes is mainly at lobules of liver, and 1/3 above hepatic cell fattydegeneration in the lobules of liver does not have other obvious Histological change under the low power lens, and not making liver biopsy person imaging examination (CT or B ultrasonic) has the fatty liver specific findings.
3. alcoholic hepatitis: as do not do the liver biopsy, clinical alcoholic hepatitis should meet in following diagnostic criteria and the addition item 3 or more than.Diagnostic criteria: the inducement that the increase of a. drinking amount can be used as morbidity or worsens; B.AST is that main serum transaminase raises; C. serum bilirubin rising (＞34.2 μ mol/L).Addition item: a. stomachache; B. heating; C. the peripheral hemogram leukocyte increases; D.ALT increases＞1.5ULN; E.GGT increases＞2ULN.
4. ethanol property hepatitis gravis (liver failure): alcoholic hepatitis merges liver failure performances such as hepatic encephalopathy; Or serious endotoxemia, acute renal failure and digestive tract hemorrhage etc. appear; Although alcohol prohibition, liver continues enlargement, thrombinogen mobility < 40%; Leukocyte obviously increases, and visible most ethanol hyaline bodieses of histology and severe hepatic cytopathy are downright bad.This type comprises and merges the liver cirrhosis person, but except the end-age cirrhosis person.
5. alcoholic fibrosis with (or) liver cirrhosis: be difficult to the diagnosis alcoholic fibrosis according to clinical and lab testing.Do not doing to combine the clinical imageology check result under the liver biopsy situation.Serological testing helps clinical diagnosis like marks such as hyaluronic acid (HA), III procollagen type peptide (P III P), laminin (LN) familial combined hyperlipidemia collagens.When being diagnosed as liver cirrhosis, should divide into compensatory and lose compensatory.
(2) non-alcohol fatty liver diagnostic criteria
Formulate standard with reference to Chinese Medical Association's hepatology branch fatty liver and in October, the 2002 Nanjing meeting of alcoholic liver disease group
1) clinical diagnosis standard
Every 1-4 item that is listed as as follows adds the 5th or the 6th person and can be diagnosed as non-alcoholic fatty liver disease.
1. do not have history of drinking history or drink and amount to amount of alcohol < 40g weekly.
2. viral hepatitis except, total parenteral nutrition etc. can cause the specified disease of fatty liver.
3. except that the protopathy clinical manifestation, symptoms such as weak, abdominal distention, dull pain in liver can appear, can accompany hepatosplenomegaly.
4. the basic normal or serum transaminase rising of liver function increases to the master with ALT, often increases with levels such as Y-GT, TG.
5. Radiologic imaging meets the fatty liver diagnostic criteria.
6. liver histological changes pathology and the diagnostic criteria that meets fatty liver disease.
2) Clinical typing standard
Meet non-alcohol fatty liver clinical diagnosis standard person, its Clinical typing is following
1. nonalcoholic fatty liver
All possess following the 1st～2 to add the 3rd or the 4th person promptly diagnosable.
A. possesses 1～3 of clinical diagnosis standard;
B. liver function test is normal basically;
C. Radiologic imaging meets the fatty liver diagnostic criteria;
D. the liver histological performance meets the simple fatty liver diagnostic criteria.
2.. non-alcoholic stellato-hepatitis
All possess following the 1st～2 to add the 3rd or the 4th person promptly diagnosable.
A. possesses 1～3 of clinical diagnosis standard;
B. Serum ALT levels is higher than 2 times of the normal value upper limit, and the persistent period is greater than 4 weeks;
C. Radiologic imaging meets the fatty liver diagnostic criteria;
D. the liver histological performance meets the fat hepatitis diagnostic criteria.
3. non-alcoholic fatty liver sclerosis
All possess following the 1st to add the 2nd or the 3rd person promptly diagnosable.
A. possesses 1～3 of clinical diagnosis standard;
B. iconography prompting fatty liver is accompanied liver cirrhosis;
C. the liver histological change meets fatty cirrhosis diagnosis mark Huaihe River.
3) imaging diagnosis
Fatty liver B ultrasonic diagnosis basis is:
1. near field, hepatic region echo diffusivity strengthens (being better than kidney and spleen), and far field echo is decayed gradually.
2. the liver flexible innerduct structure shows unclear.
3. the mild to moderate enlargement of liver, the edge angle circle is blunt.
In the color doppler flow imaging prompting liver color Doppler flow signals reduce or be difficult for showing but in the liver blood vessel trend normal.
5. right lobe of liver peplos and tabula echo show unclear or imperfect.
Possess that a person is slight fatty liver in above-mentioned the 1st and the 2-4 item; Possess that two persons are the moderate fatty liver in above-mentioned the 1st and the 2-4 item (should be first add in the 2-4 item one); Possess in above-mentioned the 1st and the 2-4 item two and the 5th person and be severe fatty liver.
Liver cirrhosis: imaging diagnosis is according to being fissure broadening, and Glisson's capsule thickness increases, the liver surface imperfection; Echo/density in the liver/inequality signal is even; Each lobe of the liver ratio is not normal, and portal vein trunk caliber increases slightly, and portal vein per minute blood flow parameter increases; The spleen bulk index increases, thickening of capsule wall of gallbladder or the change of gallbladder form etc.
The CT diagnosis basis is that liver density generally is lower than spleen or liver/spleen CT ratio＜1.Liver density reduces, and the CT value is lower than spleen slightly, and liver/spleen CT ratio＜1.0 are slight; Blood vessel shows that unclear person is moderate in the liver/spleen CT ratio＜0.7, liver; Liver density is showing reduction even is being negative value, and the high-visible person of blood vessel is a severe in the liver/spleen CT ratio＜0.5, liver.
4) histodiagnosis
The pathological change of non-alcohol fatty liver is mainly bulla property or bulla property is the Combination hepatic cell fattydegeneration of main companion's vesicle property, and histodiagnosis can be divided into simple fatty liver, fat hepatitis, fatty liver fibrosis and liver cirrhosis.
The simple fatty liver diagnosis basis is: the hepatic cell fattydegeneration in the low power lens downward view more than 30%, but do not have other obvious Histological change, i.e. NIP, necrosis and fibrosis.30%-50% hepatocyte fat change person is slight fatty liver in the visual field; 50%～75% hepatocyte fat change person is the moderate fatty liver; 75% above hepatocyte fat change person is severe fatty liver.Hepatocyte＜30% that fat becomes in the low power lens downward view are called hepatic cell fattydegeneration.
The fat hepatitis diagnosis basis is: 1. hepatocyte bulla property or be master's Combination steatosis with bulla property; 2. ballooning degeneration of liver cells, even companion hepatocyte necrosis in different degree; 3. inflammation overweights the portal area in the Combination inflammatory cell infiltration in the lobule, or lobule.
Fatty liver fibrosis and liver cirrhosis: have or not according to liver acinus 3 district's fibrosiss, fibrosis of portal vein, the Fibrotic degree regulating liver-QI of bridge formation are hardened that can the fatty liver fibrosis to be divided into 4 phases: S1 be focal or liver acinus 3 district's holes week fibrosiss widely; S2 is a fibrosis around the focal or popularity portal vein of above-mentioned pathological changes 1; S3 is S2 pathological changes+focal or extensive bridging fibrosis; S4 is a fatty cirrhosis, and the fiber of formation forms pseudolobuli at a distance from from the central vein to the portal area, cutting apart lobules of liver.After liver cirrhosis took place, hepatic cell fattydegeneration and inflammation can alleviate, and can disappear fully sometimes.
2. Chinese medical discrimination standard:
Primary symptom: (1) is weak; (2) hypochondriac pain; (3) abdominal distention.
Inferior disease: (1) side of body is mass in the abdomen down; (2) indigestion and loss of appetite; (3) obesity; (4) light red tongue has indentation, white and thin fur; White greasy or BOHUANG and being bored with; (5) stringy and rolling pulse or moisten.
All possess primary symptom, and 1 of inferior disease can be confirmed as assertive evidence.
Tcm symptom quantizes grade scale:
3. case is included in and exclusion standard
(1) includes the case standard in: between 18～65 years old age; Meet diagnostic criteria; This subject study of voluntary participation clinical research, and signature Informed Consent Form person; The end was used liver, renal function was had the medicine person who has a strong impact in 3 months; Do not participate in the other medicines experimenter in 1 month.
(2) get rid of the case standard: age＜18 year old,＞65 years old; Gestation or women breast-feeding their children; The allergic constitution person; The severe pulmonary insufficiency; Anemia; The severe arrhythmia; Hepatic and kidney function obstacle and psychotic; Once suffered from heart infarction, cerebrovascular accident, severe trauma or capital operation patient in half a year; Acute fatty liver in pregnancy; Alcoholic cirrhosis and fatty infiltration of liver; Need accept the diabetics of injection of insulin treatment; The dystrophic fatty liver; The fatty liver relevant (REYE syndrome, lipoprotein deficiency, etc.) with inherited genetic factors; Using treatment such as heparin, thyroxine and other to influence blood lipid metabolism medicine person; All standards of including in that do not meet by the regulation medication, can't not judged the not congruent safety judgement person that affects the treatment of curative effect or data.
(3) rejecting of case and coming off:
1. do not meet the standard of including in,, can't not judge curative effect, or data is not congruent affects the treatment or safety judgement person by the regulation medication.
2. come off, lose visit person naturally in observing.
3. experimenter's compliance poor, severely adverse event, complication take place or should not continue reception test to this medicine allergy etc., bolter etc. is the case that comes off voluntarily.
Two, Therapeutic Method
(1) treatment group
Give the embodiment of the invention 1 Drug therapy.Every bag 6 grams, each 2 bags, the morning, noon and afternoon branch is taken for three times.10 weeks were a course of treatment.Inactive other medicines during the treatment.
(2) matched group
Give the DONGBAO GANTAI treatment.(Chinese Dongbao of Tonghua Pharmaceutical joint stock company limited produces, the accurate word of traditional Chinese medicines: H22024764, and batch number: 040302, main component is: egg is pacified sour 0.1g, adipokinetic hormone 0.1g, vitamin B
12mg, vitamin B
22mg, vitamin B
62mg, calcium pantothenate 3mg, nicotiamide 6mg).1 time 3, every day 3 times, 10 weeks were a course of treatment, the other medicines of stopping using during the treatment.DONGBAO GANTAI is with formulated compound preparations of medicine such as methionine, adipokinetic hormone, folic acid, vitamin B complexes.Wherein, choline is the constituent of lecithin, can promote the synthetic of phospholipid, quickens the intrahepatic fat transhipment, and it is closely related with lipid metabolism with the interior methyl transduction of body, and methionine can provide methyl with synthetic choline.Adipokinetic hormone, folic acid, vitamin B group are the precursor substances of supplying with methyl, are the important component of synthetic choline, and vitamin B group and methionine all have the fat of becoming effect.This medicine ability blood fat reducing improves liver function and hepatopath's gastrointestinal symptom, is the choice drug of clinical treatment fatty liver, with its positive control drug certain cogency and comparability is arranged.
Three, observation index and method
(1) safety is observed
1. general physical examination: T, P, R, BP.
2. blood, urine, stool routine examination inspection, electrocardiogram, kidney function test are checked once before the test and after the off-test.
(2) observation of curative effect
1. before tcm syndrome and the viewing test and test back observed and recorded is 1 time, totally 2 times.
2. liver function, blood fat series, fasting glucose, insulin, TNF-α etc.Check once when liver iconography (B ultrasonic CT) reached off-test before test.Requirement to index test: the experimenter keeps at ordinary times life and dietary habit at duration of test, gets preceding 1 day fasting in evening high-fat meal of blood at every turn.
3. height, body weight, waistline, hip circumference are calculated Body Mass Index (BMI), Yao Wei ∕ hip circumference ratio (WHR), check once before the test and after the off-test.
Body Mass Index is judged and grade scale:
The every routine person under inspection of the mensuration of BMI measures body weight and height on an empty stomach, calculates BMI according to the Quetlet formula.
BMI=body weight (kg)/height
2(m
2),
Measured body weight is with RGZ-120-RT type scale.
Divide 4 groups according to WHO in the suggestion that the fat special task meeting in West Pacific region in 2000 proposes the Asian adults weight classification.The I group: BMI＜23, the optimal BMI of Aisan is 18.5-22.9, II group: BMI 23-24.9, for danger increases, III organizes BMI >=25-29.9, be the fat .IV group of I degree: BIM >=30.0 are that the II degree is fat.
BMI＜23 0 a minute BMI 23-24.91 divides BMI >=25-29.92 to divide BIM >=30.0 3 minute
Four, curative effect determinate standard
(1) comprehensive therapeutic effect criterion
1. clinical cure: clinical symptom disappearance, liver function, blood fat series, fasting glucose, insulin, TNF-α index are normal, and liver iconography (B ultrasonic CT) is normal.
2. produce effects: clinical symptoms is obviously improved, and the abnormal index among liver function, fasting glucose, insulin, the TNF-α descends >=50%, TG descend >=40% or TC descend >=20%.In, severe person, the B ultrasonic image alleviate 1 the degree more than.
3. effective: clinical symptoms takes a turn for the better, and the abnormal index among liver function, fasting glucose, insulin, the TNF-α descends>=20% but<50%.Gently,, severe person's B ultrasonic image before alleviates, but not as good as 1 degree person.
4. invalid: clinical symptoms, blood biochemistry index, the inspection of B ultrasonic image do not have improvement after treatment.
(2) fatty liver curative effect determinate standard
1. blood fat: cure: the inspection of blood fat each item recovers normal.
Produce effects: TG decline >=40% or TC descend >=20%.
Effectively: TG descend>=20% but 40% or TC descend>=10% but<20%.
Invalid: lipids detection does not have obvious improver.
2. liver function: cure: the inspection of liver function each item recovers normal.
Abnormal index among produce effects: ALT, AST, the GGT descends >=50%
Effectively: abnormal index among ATL, AST, the GGT descends>=20% but<50%.
Invalid: These parameters does not have obvious improvement.
3.B ultra: cure: liver echo is normal, and the liver inner tubular structure is clear.
Produce effects: in, severe person, the B ultrasonic image alleviate 1 the degree more than.
Effectively: light, in, severe person's B ultrasonic image before alleviates, but not as good as 1 degree person.
(3) tcm syndrome curative effect determinate standard
The curative effect classification:
Cure: symptom integral improves 100%.
Produce effects: symptom integral improves >=70%
Effectively: symptom integral improves >=30%
Invalid: symptom integral improves < 30%
(4) therapeutic evaluation of cardinal symptom
1. clinic control: after finishing the course of treatment, transference cure.
2. produce effects: after finishing the course of treatment, symptom integral reduces 2 grades.
3. effective: after finishing the course of treatment, symptom integral reduces 1 grade.
4. invalid: as not reach above-mentioned standard person.
(5) statistical procedures method
Data are imported microcomputer, handle through PEMS statistical software (Ver.2.0 of vital statistics teaching and research room of Huaxi Medical Univ), data result with
The q check is taked in expression, statistical method measurement data, and enumeration data adopts X
2Check.The classification enumeration data adopts Ridit to analyze.
Five. experimental result
(1) clinical comprehensive therapeutic effect
52 examples are organized in treatment, cure 17 examples, account for 34.62%; Produce effects 21 examples account for 38.46%; Effective 10 examples account for 19.32%; Invalid 4 examples account for 7.69%.Total effective rate 92.31%.
Matched group 31 examples are cured 2 examples, account for 6.45%; Produce effects 5 examples account for 16.13%; Effective 18 examples account for 58.06%; Invalid 6 examples account for 19.35%.Total effective rate 80.65%.Two groups of significant differences of warp statistics (P 0.01).
(2) tcm syndrome improves situation
Table 9 a liang group patient clinical symptoms sign is improved the situation analysis table
Annotate: compare with matched group:
*P<0.05,
*P<0.01
Tcm syndrome therapeutic index, treatment group are 96%, and matched group is 87%, (P 0.05), the treatment group is superior to matched group.For the doing well,improving situation, liver fat is weak for eliminating clearly, hypochondriac pain, abdominal distention, alleviate the side of body and be better than matched group (P < 0.05orP < 0.01) in the mass in the abdomen aspect down, and two groups all have good improving appetite effect (P>0.05).
(3) biochemical indicator improves situation
(1) Blood Lipid situation
Blood Lipid comparison sheet
before and after the table 10 liang group patient treatment
Annotate: relatively preceding with the treatment of this group:
*P<0.05,
*P<0.01; With after the treatment of control group relatively: △ p<0.05, △ △ p<0.01
TC, TG all obviously reduce in treatment group and the matched group serum, with comparing difference before the treatment separately significantly (P < 0.05orP < 0.01), and the clear effect of liver fat particularly outstanding (P < 0.05orP < 0.01).Simultaneously two groups of serum hdl content obviously raise before the treatment (P < 0.05), and two group differences less (P>0.05).Reducing aspect the LDL, obviously reducing before the clear treatment of liver fat (P < 0.05), and curative effect is superior to DONGBAO GANTAI (P < 0.01), though DONGBAO GANTAI has certain therapeutical effect, with more not obvious before the treatment (P>0.05).
(2) liver function recovery situation
Liver function changes comparison sheet
before and after the table 11 liang group patient treatment
Annotate: relatively preceding with the treatment of this group:
*P<0.05,
*P<0.01; With after the treatment of control group relatively: △ p<0.05, △ △ p<0.01
Table 12 liang group ALT, AST, Y-GT curative effect comparison sheet
Annotate: compare with matched group:
*P<0.05,
*P<0.01
Two groups of medicines all have good efficacy to the improvement of liver function.For the ALT, AST, the Y-GT that raise, treatment group 84% is multiple normal, and with comparing difference before the treatment significantly (P < 0.05), and matched group is normal again 20%, and liver fat is superior to DONGBAO GANTAI (P < 0.05) in the transaminase lowering effect clearly.Treatment group AIB raises before the treatment (P < 0.05), matched group to rising AIB, reduce GLO certain curative effect arranged, but with treatment before no significant difference (P>0.05).
(3) situation of change of blood glucose and insulin resistance index (IR)
GLU, INS, FIRI change comparison sheet
before and after the table 13 liang group patient treatment
Annotate: FIRI is the HOMA-IR value of logarithmetics. relatively preceding with the treatment of this group:
*P<0.05,
*P<0.01; With after the treatment of control group relatively: △ p<0.05, △ △ p<0.01;
Liver fat has good blood sugar lowering, insulin clearly and eliminates the effect of insulin resistant, with before the treatment than difference remarkable (P < 0.05).DONGBAO GANTAI is remarkable to reducing insulin action, with comparing difference before the treatment significantly (P < 0.05), blood sugar lowering is eliminated insulin resistant is more preceding also to take a favorable turn, but through statistical procedures DeGrain (P>0.05).The clear curative effect of liver fat is superior to DONGBAO GANTAI (P < 0.01)
(4) serum T NF – α situation of change
TNF-α changes comparison sheet
before and after the table 14 liang group patient treatment
Annotate: relatively preceding with the treatment of this group:
*P<0.05,
*P<0.01; With after the treatment of control group relatively: △ p<0.05, △ △ p<0.01;
Liver fat is organized serum T NF – α average out to 1.78ng/l clearly before the treatment, and matched group is 1.74ng/l, reduces to 1.42ng/l and 1.60ng/l after the treatment respectively, and effect is (P < 0.05orP < 0.01) obviously, and liver fat is clearly than DONGBAO GANTAI (P < 0.05) evident in efficacy.
(4) Body Mass Index (BMI) and waist-to-hipratio (W/H) change situation
BMI, W/H change comparison sheet
before and after the table 15 liang group patient treatment
Annotate: relatively preceding with the treatment of this group:
*P<0.05,
*P<0.01; With after the treatment of control group relatively: △ p<0.05, △ △ p<0.01;
Liver fat is organized BMI average out to 27.73 clearly before the treatment, and W/H is 0.951, is respectively 26.58 and 0.936 after the treatment.BMI is 27.25 before the DONGBAO GANTAI group treatment, and W/H is 0.956, is respectively 26.63 and 0.952 after the treatment, and the clear curative effect of liver fat is superior to DONGBAO GANTAI (P < 0.01).
(5) the fatty liver calibration changes under the B ultrasonic
The ultra liver image situation of change of table 16B
The table 17 liang ultra efficacy analysis table of group patient B
Annotate: compare with matched group:
*P<0.05,
*P<0.01
Liver fat is organized patient's 52 examples clearly, normal again 26 examples of treatment back B ultrasonic image, and produce effects 15 effective 8 is invalid 3, and total effective rate is 94.23%; Multiple normal 3 examples in DONGBAO GANTAI group 31 example treatment backs, produce effects 5 examples, effective 18 examples, invalid 5 examples, total effective rate is 83.87%.The clear curative effect of liver fat is superior to DONGBAO GANTAI.
(6) safety indexes analysis: safety indexes is carried out statistical procedures, do not find obvious adverse effect.Conclusion: liver fat has the effect of good curing ethanol property and non-alcoholic fatty liver disease clearly, and it can significantly improve patient's clinical symptoms, improves liver function, blood fat reducing, elimination insulin resistant, reduces BMI and W/H value etc.Confirmed that not only liver fat treats the objective curative effect of fatty liver clearly, explained that also the Chinese medicine compound under the determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs principle has the science of many target spots, multi-faceted regulating action to treatment of diseases.
Claims (9)
1. a Chinese medicine preparation of treating fatty liver is characterized in that, the weight part ratio of its crude drug consists of: 6～12 parts of Rhizoma Coptidis, 6～18 parts of Radix Scutellariaes, 6～18 parts of Fructus Aurantii Immaturus (parched); 18～30 parts in Poria, 3～15 parts of Pericarpium Citri Reticulataes, 6～12 parts of the Rhizoma Pinelliaes, 6～12 parts in Fructus Amomi Rotundus; 8～30 parts in sea clam powder, 18～30 parts of Radix Salviae Miltiorrhizaes, 18～30 parts of Herba Artemisiae Scopariaes, 3～6 parts in Radix Glycyrrhizae; 6～18 parts of Caulis Bambusae In Taenia, 18～30 parts of Semen Benincasaes, 18～30 parts of Semen Coiciss, 18～30 parts of Radix Paeoniae Rubra.
2. the Chinese medicine preparation of treatment fatty liver according to claim 1 is characterized in that, the weight part ratio of its crude drug consists of: 6～10 parts of Rhizoma Coptidis, 6～12 parts of Radix Scutellariaes, 6～15 parts of Fructus Aurantii Immaturus (parched); 20～30 parts in Poria, 3～10 parts of Pericarpium Citri Reticulataes, 6～10 parts of the Rhizoma Pinelliaes, 6～10 parts in Fructus Amomi Rotundus; 20～30 parts in sea clam powder, 18～25 parts of Radix Salviae Miltiorrhizaes, 18～25 parts of Herba Artemisiae Scopariaes, 3～6 parts in Radix Glycyrrhizae; 6～10 parts of Caulis Bambusae In Taenia, 20～30 parts of Semen Benincasaes, 20～30 parts of Semen Coiciss, 18～25 parts of Radix Paeoniae Rubra.
3. the Chinese medicine preparation of treatment fatty liver according to claim 1 is characterized in that, the weight part ratio of its crude drug consists of: 9 parts of Rhizoma Coptidis, 12 parts of Radix Scutellariaes, 12 parts of Fructus Aurantii Immaturus (parched); 30 parts in Poria, 9 parts of Pericarpium Citri Reticulataes, 9 parts of the Rhizoma Pinelliaes, 9 parts in Fructus Amomi Rotundus; 30 parts in sea clam powder, 24 parts of Radix Salviae Miltiorrhizaes, 24 parts of Herba Artemisiae Scopariaes, 3 parts in Radix Glycyrrhizae; 9 parts of Caulis Bambusae In Taenia, 30 parts of Semen Benincasaes, 30 parts of Semen Coiciss, 24 parts of Radix Paeoniae Rubra.
4. the method for preparing of the Chinese medicine preparation of each described treatment fatty liver of claim 1-3 is characterized in that, comprises that step is following:
(1) Fructus Amomi Rotundus, Pericarpium Citri Reticulatae are extracted volatile oil, water liquid and medicinal residues device are in addition preserved;
(2) Rhizoma Pinelliae, Fructus Aurantii Immaturus (parched), Rhizoma Coptidis are extracted 2-3 time with the 50-70% alcohol heating reflux, merge extractive liquid,, decompression recycling ethanol, concentrated extracting solution are to 50-80 ℃ of relative density 1.10-1.35, and concentrated solution and medicinal residues device are in addition preserved;
(3) with the medicinal residues decocte with water of Radix Scutellariae, Poria, sea clam powder, Radix Salviae Miltiorrhizae, Herba Artemisiae Scopariae, Radix Glycyrrhizae, Caulis Bambusae In Taenia, Semen Benincasae, Semen Coicis, Radix Paeoniae Rubra and step (1) and step (2) gained 2-4 time; Merge decoction liquor; Be evaporated to 50-100 ℃ of relative density 1.03-1.35; The concentrated solution of the water liquid of concentrated solution and step (1) and step (2) merges, and concentrates and be dried to behind the dried cream powder subsequent use once more;
(4) dried cream powder is sprayed into the volatile oil that step (1) is extracted after broken, add supplementary product starch, dextrin, aspartame, process granule, aseptic subpackaged, promptly get.
5. the method for preparing of the Chinese medicine preparation of treatment fatty liver according to claim 4 is characterized in that, the described extraction volatile oil of step (1) is the water that adds 6～12 times in Fructus Amomi Rotundus, Pericarpium Citri Reticulatae weight, 4～8 hours extraction times.
6. the method for preparing of the Chinese medicine preparation of treatment fatty liver according to claim 4 is characterized in that, the each addition of the described 50-70% ethanol of step (2) is the Rhizoma Pinelliae, Fructus Aurantii Immaturus, Rhizoma Coptidis gross mass 6-12 a times, extracts 1-2 hour at every turn.
7. the method for preparing of the Chinese medicine preparation of treatment fatty liver according to claim 4 is characterized in that, the described amount of water of step (3) is 6-12 a times of medical material gross mass, decocts 1-2 hour at every turn.
8. the method for preparing of the Chinese medicine preparation of treatment fatty liver according to claim 4; It is characterized in that described drying means adopts spray-dired condition to be: 100～200 ℃ of EATs, 60～120 ℃ of air outlet temperature; Nebulizer speed governing 38 ~ 40, feed liquor rotating speed 10～60Hz; Described drying means adopts the condition of drying under reduced pressure to be: 50～100 ℃, and below the pressure 2.67KPa.
9. the method for preparing of the Chinese medicine preparation of treatment fatty liver according to claim 4 is characterized in that, the addition scope of each adjuvant in the step (4): the part by weight at dextrin and dried cream powder end is 5%～20%; The part by weight at aspartame and dried cream powder end is 0.1%～0.6%, and the part by weight at starch and dried cream powder end is 5%～100%.
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Application publication date: 20120919 |