CN101496894B - Medicament for treating fatty liver and preparation method thereof - Google Patents

Medicament for treating fatty liver and preparation method thereof Download PDF

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CN101496894B
CN101496894B CN2009100681774A CN200910068177A CN101496894B CN 101496894 B CN101496894 B CN 101496894B CN 2009100681774 A CN2009100681774 A CN 2009100681774A CN 200910068177 A CN200910068177 A CN 200910068177A CN 101496894 B CN101496894 B CN 101496894B
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fatty liver
radix
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CN101496894A (en
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宓余强
曹武奎
潘赞红
郑淑文
徐亮
平蕾
张弘
董红筠
时刚
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Tianjin City Infectious Hospital
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Abstract

The invention relates to a drug for treating fatty liver and a method for preparing the same, which belong to drug preparations containing undetermined structures from traditional herbal medicine. The drug is prepared from the following raw materials in portion by weight: 1 to 5 portions of prepared fleece flower root, 3 to 7 portions of tuckahoe, 3 to 7 portions of radix salviae miltiorrhizae, 3 to 7 portions of sicklesenna seed, 3 to 7 portions of hawthorn, 2 to 5 portions of rhizoma alismatis, 1 to 4 portions of lotus leaf, 2 to 5 portions of chicken-bone herb, 1 to 5 portions of fruit of trifoliate orange, 1 to 5 portions of radix curcumae, and 1 to 4 portions of citron, wherein the raw materials are ground into fin powder mechanically and then are prepared into honeyed pills with refined honey. The prepared drug has a total effective rate of 88.3 percent according to 60 nonalcoholic fatty liver sufferers in clinical application; besides, clinical observations show that the drug has definite curative effect, and a treatment group is obviously superior to a control group in the aspects of improving clinical symptoms and improving the curative effect observation of GGT.

Description

Medicine of treatment fatty liver and preparation method thereof
Technical field
The present invention relates to contain the pharmaceutical preparation of not confirming structure from traditional herbal medicines, specifically is a kind of medicine of treating fatty liver and preparation method thereof.
Background technology
Along with improving constantly of living standards of the people, the variation of dietary structure, and eat moving less life style more; Obesity, hyperlipemia, type 2 diabetes mellitus number are on the increase; The number of the infected of non-alcoholic fatty liver disease (NAFLD) is also day by day climbed to a higher point, and just progressively becomes the first hepatopathy of China, and wherein 1/3~1/2 is non-alcoholic stellato-hepatitis (NASH); The liver cirrhosis incidence rate is 15%~25% in the latter 10 years, wherein 30%~40% will die from hepatocarcinoma, liver failure and liver transplantation recurrence.In addition, fatty liver is also closely related with metabolism syndrome, type 2 diabetes mellitus and cardiovascular and cerebrovascular vessel incident.Therefore, NAFLD has become the new challenge in hepatopathy field, and it constitutes a serious threat to human health and social development.
Chinese patent 1215873C discloses a kind of " treatment fatty liver compound Chinese medicinal preparation and method for preparing "; It is processed by following components by weight portion, Fructus Crataegi 2-10 part, Radix Salviae Miltiorrhizae 1-5 part, Hirudo 0.5-3 part, Ganoderma 0.5-3 part, Radix Et Rhizoma Rhei 0.3-1.5 part, Radix Puerariae 0.3-1.5 part, Rhizoma Polygonati 0.3-1.5 part and Radix Bupleuri 0.2-1 part.Above-mentioned selected component is mixed by its ratio of weight and number; Decocte with water; Become thick paste with carry out concentrating under reduced pressure after the medical filtration that decocts gained, the mixing at every turn, again thick paste is carried out vacuum drying or spray drying, granulates, sieves, makes treatment fatty liver compound Chinese medicinal preparation after the drying again.This compound Chinese medicinal preparation is used for clinical total obvious effective rate can reach 72.58%, total effective rate 90.32%.
Summary of the invention
The present invention is exactly in order to solve the treatment problem of non-alcoholic fatty liver disease, and medicine of a kind of treatment fatty liver that can be good for liver, and lowering fat and preparation method thereof is provided.
Chinese medicine belongs to fatty liver " gathering " " hypochondriac pain " " expectorant is turbid " categories such as " feeling of fullness ", and the traditional Chinese medical science thinks that the primary disease cause is many owing to surfeit delicious food savoury, unscrupulous drinking, or experience the epidemic disease caused by damp-heat pathogen poison, or disorder of emotion etc.Its pathologic basis is expectorant, wet, the stasis of blood, long-pending, and diseased region is liver, and is closely related with the spleen kidney.Pathogenesis is a liver failing to maintain the normal flow of QI, dysfunction of the spleen in transportation, and retention of damp-heat in the interior, damp expectorant is turbid, blood stasis, knot blocks the liver venation and causes primary disease mutually.The present invention is just according to this theoretical prescription.Radix Polygoni Multiflori YIN nourishing nourishing the liver in the side, the Poria invigorating spleen to remove dampness, the Radix Salviae Miltiorrhizae blood circulation promoting and blood stasis dispelling, Semen Cassiae liver heat removing and eyesight improving pathogenic fire purging relieving constipation, the hawthorn digesting eliminate indigestion, Rhizoma Alismatis clearing away heat-damp and promoting diuresis diuretic, Fructus Aurantii, the sharp intestinal stasis relieving of Radix Curcumae soothing liver-QI amount to the liver soothing and the spleen invigorating, the effect of blood circulation promoting and blood stasis dispelling consumer product dredge stasis.
Modern pharmacology research proof, the Radix Salviae Miltiorrhizae blood circulation promoting and blood stasis dispelling microcirculation improvement in the prescription of the present invention suppresses the collagen fiber hypertrophy, and Radix Salviae Miltiorrhizae active ingredient tool is removed oxygen-derived free radicals and lipoid peroxidization resistant; The contained equal hexichol alkene composition of Radix Polygoni Multiflori is to the fatty liver of rat and liver function infringement, and the rising of liver lipid peroxidation content has obvious antagonism, and Radix Polygoni Multiflori is rich in phospholipid and can stops cholesterol to be detained at serum at intrahepatic deposition and lipoid; Rhizoma Alismatis can be improved the liver fat metabolism, suppresses exogenous cholesterol absorption, suppresses the formation of TC in the liver; Semen Cassiae, Fructus Crataegi, Semen Cassiae all have the effect of treatment fatty liver, are used for the metabolic different links of fatty liver.Result of study shows that medicine of the present invention is the blood fat reducing level effectively, improves liver function, and losing weight effect alleviates the degree of fatty liver, and treating non-alcoholic fatty liver disease has definite curative effect.
The present invention realizes by following technical scheme.
A kind of medicine of treating fatty liver, it is to process by the raw material of following ratio of weight and number:
Radix Polygoni Multiflori Preparata 1-5 part Poria 3-7 part Radix Salviae Miltiorrhizae 3-7 part Semen Cassiae 3-7 part
Fructus Crataegi 3-7 part Rhizoma Alismatis 2-5 part Folium Nelumbinis 1-4 part Herba Abri 2-5 part
Fructus Aurantii 1-5 part Radix Curcumae 1-5 part Fructus Citri 1-4 part.
The medicine of said treatment fatty liver, it is to process by the raw material of following ratio of weight and number:
Radix Polygoni Multiflori Preparata 2-5 part Poria 4-6 part Radix Salviae Miltiorrhizae 4-6 part Semen Cassiae 4-6 part
Fructus Crataegi 4-6 part Rhizoma Alismatis 3-4 part Folium Nelumbinis 1-2.5 part Herba Abri 3-4 part
Fructus Aurantii 2-4 part Radix Curcumae 2-4 part Fructus Citri 1-2.5 part.
The medicine of said treatment fatty liver, it is to process by the raw material of following ratio of weight and number:
5.3 parts of 5.3 parts of Semen Cassiaes of 5.3 parts of Radix Salviae Miltiorrhizaes of 2.7 parts of Poria of Radix Polygoni Multiflori Preparata
3.5 parts of 1.8 parts of Herba Abris of 3.5 parts of Folium Nelumbinis of 5.3 portions of Rhizoma Alismatis of Fructus Crataegi
1.8 parts of 2.7 portions of Fructus Citris of 2.7 portions of Radix Curcumaes of Fructus Aurantii.
A kind of method for preparing of treating the medicine of fatty liver; Prepared slices of Chinese crude drugs Radix Polygoni Multiflori Preparata 1-5 part, Poria 3-7 part, Radix Salviae Miltiorrhizae 3-7 part, Semen Cassiae 3-7 part, Fructus Crataegi 3-7 part, Rhizoma Alismatis 2-5 part, Folium Nelumbinis 1-4 part, Herba Abri 2-5 part, Fructus Aurantii 1-5 part, Radix Curcumae 1-5 part, Fructus Citri 1-4 part of weighing by ratio of weight and the number of copies after will cleaning earlier; Mix homogeneously; Placed baking oven 60-70 ℃ of dry 12-18 hour, mechanical activation comminution is crossed the 60-80 mesh sieve after becoming fine powder;
Add refined honey 150-170g with every 100g fine powder again and process big honeyed pills, the heavy 9g of every ball, every ball is equivalent to primary crude drug 4.0g.
The present invention of preparation like this is through clinical practice non-alcoholic fatty liver disease patient 60 examples, total effective rate 88.3%; Clinical observation shows that the present invention has definite curative effect, is improving aspect the clinical symptoms and is improving that the treatment group obviously is superior to matched group in the observation of curative effect of GGT.
The specific embodiment
One. method for preparing
Take by weighing the prepared slices of Chinese crude drugs Radix Polygoni Multiflori Preparata 270g, Poria 530g, Radix Salviae Miltiorrhizae 530g, Semen Cassiae 530g, Fructus Crataegi 530g, Rhizoma Alismatis 350g, Folium Nelumbinis 180g, Herba Abri 350g, Fructus Aurantii 270g, Radix Curcumae 270g, the Fructus Citri 180g that clean; Mix homogeneously placed baking oven 60-70 ℃ drying 16 hours, and 80 orders sieved after mechanical activation comminution became fine powder; Every 100g fine powder adds refined honey 150-170g; Process big honeyed pills, every ball weighs 9 ± 0.5g, and every ball is equivalent to primary crude drug 4.0g.Can make honeyed pill 1000 balls according to theoretical recipe quantity.Refined honey system boils Mel 2-3 minute, and relative density is not less than 1.37, and temperature is at 116 ℃-118 ℃, the middle honey of Pressure gauge index between 0.2-0.4.
The method for preparing of the medicine of said treatment fatty liver, the prepared slices of Chinese crude drugs of weighing by above-mentioned ratio of weight and number are condensed into cream through extraction, and drying and granulating is processed tablet, or drop pill, or granule, or capsule formulation.
Two. indication and usage
Function cures mainly: the liver soothing and the spleen invigorating, blood circulation promoting and blood stasis dispelling, intestinal stasis relieving.Be applicable to fatty liver, alcoholic hepatitis, hyperlipemia and various chronic hepatitis and Glutamate pyruvate transaminase rises person.
Usage and dosage: oral every day three times, each 1-2 ball or follow the doctor's advice.
Points for attention: take the suitable low fat of these article, light diet avoids pungent food.
Untoward reaction: do not find untoward reaction.
Contraindication: the careful usefulness of chronic diarrhea loose stool person.
The every ball of specification: 9g/.
Storage: sealing storage, 9 months effect duration.
Three. clinical observation
Use the present invention and treat non-alcoholic fatty liver disease 60 examples, and contrast with silibinin capsule for treating non-alcoholic fatty liver disease 60 examples and to obtain clinical efficacy preferably.Report as follows:
1. data and method
1.1 case history is selected: case history all derives from my fatty liver out-patient of institute totally 120 examples, is divided into two groups at random, and 60 examples are organized in treatment, adopt medicine of the present invention; Matched group 60 examples adopt the silibinin capsule.Treatment group: male 41 examples, women 19 examples, age 20-60 year, mean age scope 42.7 ± 11.8 years old.Matched group: male 46 examples, women 14 examples, age 19-60 year, mean age scope 40.7 ± 12.4 years old.Two groups of age-sex's no significant differences (P>0.05) have comparability.
1.2 diagnostic criteria: all observe " non-alcohol fatty liver practice guidelines " that the case history diagnosis all meets Chinese Medical Association's fatty liver and the formulation in 2006 of alcoholic liver disease group.Inclusion criteria: the color ultra fatty liver of clarifying a diagnosis; Stronger doctor is arranged from property person; Age is at 18-60 between year; Obtain informed consent.Exclusion standard: disease patients such as severe cardiac, brain, kidney; The diabetics of clarifying a diagnosis.
1.3 observation index: symptom (2) liver ultrasonoscopy (3) biochemical indicator glutamate pyruvate transaminase (ALT), glutamic oxaloacetic transaminase, GOT (AST), glutamyl transpeptidase (GGT), triglyceride (TG), T-CHOL (CHO), low-density lipoprotein cholesterol (LDL) (4) Body Mass Index (BMI) before and after (1) treatment.Liver function, lipids detection (adopt the TBA-120FR automatic clinical chemistry analyzer, matched reagent is Japan and light, the color ultra PHILIPS-IU22 that is).
1.4 Therapeutic Method: be for 12 weeks two groups of courses of treatment.
Oral honeyed pill of the present invention is organized in treatment, 2 balls/inferior, and 3 times/day, oral, 4 weeks were a course of treatment, serve on for three courses of treatment.
4 of matched group oral silibinin capsules (Tianjin Tianlishi Group Co.,Ltd's production)/inferior, 3 times/day, oral, 12 weeks of the course of treatment.
During two groups of case treatments, formulate individuation dietary program and suitable exercise scheme, adjust dietary structure simultaneously; The control total amount of heat is taken in, and with high protein and low fat, enriches vitamin; An amount of carbohydrate diet is a principle, and controlling body weight is not used medicines such as other protect the liver, blood fat reducing during the treatment.
1.5 observation of curative effect:
(1) criterion of therapeutical effect: according to the 1st volume of .1993:76 of " new Chinese medicine clinical research guideline " Ministry of Health of the People's Republic of China.
(2) evaluation criteria:
Clinical cure: symptom and sign disappear basically, and color ultra inspection recovers normal, liver function (ALT, AST, GGT), and blood fat: cholesterol (CHO), glyceride (TG), low-density lipoprotein cholesterol (LDL) are reduced to normal range.
Effectively: symptom and sign take a turn for the better, and the color ultra Radiologic imaging of showing takes a turn for the better, make moderate progress decline >=30% or return to normal level of relevant indexs such as liver function, blood fat.
Invalid: as not reach above-mentioned standard.
1.6 statistical procedures: carry out statistical procedures with the SPSS14.0 statistical software.Measurement data is with (x ± s) expression, table two, table three employing t check; Table one, four adopts Ridit to analyze; Table five adopts X 2 test, and (correction of continuity is adopted in 1≤T≤5 o'clock; Accurate probability inspection method is adopted in T<1 o'clock).
2. therapeutic outcome:
2.1 two groups of case comprehensive therapeutic effects relatively: treatment group patient cures 15 examples, 40 examples, invalid 5 routine total effective rates 91.7% take a turn for the better.Matched group is respectively 12 examples, 41 examples, 7 examples, total effective rate 88.3%.Two groups of total effective rates compare (P>0.05), no significant difference.(seeing table 1)
Table 1 liang group treatment back total effective rate relatively
Figure G2009100681774D00041
Compare P>0.05 with the matched group total effective rate
2.2 liver function, change of blood sugar compare (seeing table 2) before and after two groups of treatments
Liver function and blood glucose (GLu) change relatively (x ± s) before and after the treatment of table 2 liang group
Figure G2009100681774D00042
With preceding relatively * P<0.05 of this group treatment, compare △ P>0.05, △ △ P<0.01 after * * P<0.01 and the treatment of control group
2.3 blood fat, BMI change relatively (seeing table 3) before and after two groups of treatments
Blood fat BMI variation comparison before and after the table 3 liang group patient treatment (x ± s)
Figure G2009100681774D00051
With preceding relatively * P<0.05 of this group treatment, compare △ P>0.05 after * * P<0.01 and the treatment of control group
2.4 the color result's (seeing table 4) that changes before and after two groups of treatments
Color ultrasonogram changes (n) before and after the table 4 liang group treatment
Figure G2009100681774D00052
Compare P>0.05 (u=-0.23) with matched group
Above result shows that treatment group and matched group have definite curative effect to the treatment of non-alcoholic fatty liver disease; ALT, AST in improving liver function; Blood fat CHO, TG, LDL aspect; Reduce fasting glucose Glu, Body Mass Index BMI aspect, and do not have significant difference (P>0.05) aspect the variation of liver iconography improving.And the treatment group obviously is superior to matched group (P<0.01) in improving the observation of curative effect of GGT.
2.5 the doing well,improving situation compares (seeing table 5) before and after two groups of treatments
Doing well,improving situation (n) before and after the table 5 liang group treatment
Figure G2009100681774D00053
Two groups of symptoms with the improvement rate as relatively, with △ P<0.05 relatively after the treatment of control group, △ △ P<0.01, △ △ △ P>0.05
Treatment group doing well,improving rate: weak 87.1% (27/31), uncomfortable liver area 96.4% (27/28), anorexia 100% (9/9), abdominal distention 88.9% (24/27), constipation 100% (12/12), loose stool 77.8% (7/9), uncomfortable in chest 100% (18/18); Matched group doing well,improving rate: weak 33.3% (7/21), uncomfortable liver area 63.0% (17/27), anorexia 54.5% (6/11), abdominal distention 55% (11/20), constipation 37.5% (3/8), loose stool 50% (3/6), uncomfortable in chest 55.6% (5/9); Two groups of doing well,improving situation comparative statistics have notable difference (P<0.01 or P<0.05), and curative effect obviously is superior to matched group aspect the clinical symptoms improving in the present invention.

Claims (5)

1. medicine of treating fatty liver, it is to process by the raw material of following ratio of weight and number:
Radix Polygoni Multiflori Preparata 1-5 part Poria 3-7 part Radix Salviae Miltiorrhizae 3-7 part Semen Cassiae 3-7 part
Fructus Crataegi 3-7 part Rhizoma Alismatis 2-5 part Folium Nelumbinis 1-4 part Herba Abri 2-5 part
Fructus Aurantii 1-5 part Radix Curcumae 1-5 part Fructus Citri 1-4 part.
2. according to the medicine of the said treatment fatty liver of claim 1, it is characterized in that this medicine is to process by the raw material of following ratio of weight and number:
Radix Polygoni Multiflori Preparata 2-5 part Poria 4-6 part Radix Salviae Miltiorrhizae 4-6 part Semen Cassiae 4-6 part
Fructus Crataegi 4-6 part Rhizoma Alismatis 3-4 part Folium Nelumbinis 1-2.5 part Herba Abri 3-4 part
Fructus Aurantii 2-4 part Radix Curcumae 2-4 part Fructus Citri 1-2.5 part.
3. according to the medicine of the said treatment fatty liver of claim 1, it is characterized in that this medicine is to process by the raw material of following ratio of weight and number:
5.3 parts of 5.3 parts of Semen Cassiaes of 5.3 parts of Radix Salviae Miltiorrhizaes of 2.7 parts of Poria of Radix Polygoni Multiflori Preparata
3.5 parts of 1.8 parts of Herba Abris of 3.5 parts of Folium Nelumbinis of 5.3 portions of Rhizoma Alismatis of Fructus Crataegi
1.8 parts of Fructus Aurantii 2-4 part Radix Curcumae 2-4 part Fructus Citris.
4. the method for preparing of the medicine of the said treatment fatty liver of claim 1 is characterized in that:
A. prepared slices of Chinese crude drugs Radix Polygoni Multiflori Preparata 1-5 part, Poria 3-7 part, Radix Salviae Miltiorrhizae 3-7 part, Semen Cassiae 3-7 part, Fructus Crataegi 3-7 part, Rhizoma Alismatis 2-5 part, Folium Nelumbinis 1-4 part, Herba Abri 2-5 part, Fructus Aurantii 1-5 part, Radix Curcumae 1-5 part, Fructus Citri 1-4 part of weighing by ratio of weight and the number of copies after will cleaning; Mix homogeneously; Placed baking oven 60-70 ℃ of dry 12-18 hour, mechanical activation comminution is crossed the 60-80 mesh sieve after becoming fine powder;
B. every 100g fine powder adds refined honey 150-170g and processes big honeyed pills, the heavy 9g of every ball, and every ball is equivalent to primary crude drug 4.0g.
5. according to the method for preparing of the medicine of the said treatment fatty liver of claim 1, it is characterized in that: the prepared slices of Chinese crude drugs of weighing by ratio of weight and the number of copies are condensed into cream through extraction, and drying and granulating is processed tablet, or drop pill, or granule, or capsule formulation.
CN2009100681774A 2009-03-19 2009-03-19 Medicament for treating fatty liver and preparation method thereof Expired - Fee Related CN101496894B (en)

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Publication number Priority date Publication date Assignee Title
CN102641469B (en) * 2011-02-22 2014-07-02 北京中医药大学东方医院 Medicinal composition for preventing or treating nonalcoholic steatohepatitis
CN103007081B (en) * 2012-11-27 2013-12-04 鞠法红 Traditional Chinese medicine composition for curing non-alcoholic fatty liver disease
CN103736036A (en) * 2014-01-28 2014-04-23 张怀胜 Drug for treating nonalcoholic fatty liver disease and preparation method thereof
CN105079676A (en) * 2015-09-18 2015-11-25 宋克垣 Medicine for treating fatty liver and preparing method of medicine
CN106109767A (en) * 2016-07-13 2016-11-16 郑亮 A kind of compound preparation preventing and treating non-alcohol fatty liver
CN110123985A (en) * 2019-05-06 2019-08-16 万勇 A kind of lotus leaf blood-fat-lowering granule agent for treating fatty liver

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