CN1895623A - Medicinal composition for treating fatty liver, its preparation and use - Google Patents
Medicinal composition for treating fatty liver, its preparation and use Download PDFInfo
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Abstract
An orally taken Chinese medicine for treating fatty liver is prepared from 7 Chinese-medicinal materials including fleece flower root, red sage root, alismatis rhizome, lotus leaf, etc. Its preparing process is also disclosed.
Description
Technical field
The invention belongs to technical field of Chinese medicines, relate to prescription of a kind of pharmaceutical composition for the treatment of fatty liver and its production and application.
Background technology
Fatty liver is that a kind of storing up with hepatic parenchymal cells steatosis and fat is the clinical pathology syndrome of feature.Fatty liver is mainly relevant with obesity, diabetes and dyslipidemia etc., and sickness rate has the trend of obvious rising.At present, modern medicine does not still have specific medicament to the treatment of fatty liver, some blood lipid-lowering medicines in the conventional therapy, and promoting that lipid is transported to liver in the blood carries out metabolism, has increased the weight of the liver fat deposition on the contrary.Chinese medicine prevention fatty liver curative effect is clear and definite, and toxic and side effects is less, is the research focus in lipotropism field.
Summary of the invention
One object of the present invention is to provide a kind of pharmaceutical composition and preparation method for the treatment of fatty liver.
A further object of the present invention is, the application of the compound Chinese medicinal preparation that contains pharmaceutical composition of the present invention aspect preparation treatment fatty liver is provided.
The objective of the invention is to be achieved by the following technical programs:
The pharmaceutical composition of treatment fatty liver of the present invention is made up of the medical material of following weight proportioning: 5～25 parts of baked polygonum capitatums, 5～30 parts of Radix Salviae Miltiorrhizaes, 5～30 parts of Rhizoma Alismatis, 3～25 parts on Folium Nelumbinis, 5～30 parts of Semen Cassiaes, 5～30 parts of Radix Bupleuri (processed with vinegar), 5～30 parts in Rhizoma Curcumae Longae.Wherein more excellent medical material weight proportion is: 10～20 parts of baked polygonum capitatums, 10～20 parts of Radix Salviae Miltiorrhizaes, 10～20 parts of Rhizoma Alismatis, 5～15 parts on Folium Nelumbinis, 15～25 parts of Semen Cassiaes, 8～20 parts of Radix Bupleuri (processed with vinegar), 10～20 parts in Rhizoma Curcumae Longae.Optimum medical material weight proportion is: 15 parts of baked polygonum capitatums, 12 parts of Radix Salviae Miltiorrhizaes, 15 parts of Rhizoma Alismatis, 8 parts on Folium Nelumbinis, 20 parts of Semen Cassiaes, 10 parts of Radix Bupleuri (processed with vinegar), 12 parts in Rhizoma Curcumae Longae.
Preparation of drug combination method of the present invention is to carry out according to the following steps: (1) takes by weighing baked polygonum capitatum, Radix Salviae Miltiorrhizae, Rhizoma Alismatis, Folium Nelumbinis, Semen Cassiae, Radix Bupleuri (processed with vinegar) and Rhizoma Curcumae Longae by recipe quantity, and water or volume fraction are 20～90% alcohol reflux; Can be that gradient is extracted, also can be that the degree such as grade extracts.Wherein gradient is extracted and is: extract solvent is the ethanol of water or different volumes fractional 20～90% at every turn; Its medium degree extracts and is: extract solvent is the ethanol of equal volume fractional 20～90% at every turn.Extract 1 time～4 times; Each extraction time is 1～4 hour; The amount of extracting solvent is generally 4～12 times of medical material weight.Wherein more excellent extraction solvent is 51～85% ethanol; Optimum extraction solvent is 60% ethanol; The amount of extracting solvent is generally 5 times of medical material weight, extracts each 2 hours 3 times.The extracting solution concentrate drying is dried cream, and is standby; (2) with step (1) get dry extract and one or more pharmaceutical excipient mix homogeneously, make oral formulations such as tablet, granule, capsule, pill.Preparations shaping all adopts the preparation method of routine well known to those skilled in the art.
It is dirty in liver spleen two that Chinese medicine thinks that the generation of fatty liver is mainly blamed, and pathogeny is summarised as the liver failing to maintain the normal flow of QI, and damp and hot expectorant is turbid to be pented up, and obstruction of collaterals by blood stasis belongs to deficiency in origin and excess in superficiality.The inventor is according to Chinese medical theory and sum up clinical experience for many years, main etiology and pathogenesis at fatty liver, proposition is this Chinese medicine compound of rule of treatment with " liver and kidney tonifying, dispersing the stagnated live-QI to relieve the stagnation of QI, blood circulation promoting and blood stasis dispelling ", example surplus the treatment Patients with Fatty Liver 1000 in clinical application for many years, and curative effect reaches more than 86%.Pharmacodynamic experiment is the result show: pharmaceutical composition of the present invention can reduce fatty liver rat due to the high glucose and high fat feedstuff, rabbit, the serum of tame duck and TG, the TC of hepatic tissue; improve its liver fat range degree; the transaminase lowering level; have blood lipid regulation, anti-fatty liver, liver-protective effect, experimental fatty liver is had therapeutic outcome preferably.This compound Chinese medicinal preparation mainly is to regulate the disorders of lipid metabolism of body, alleviated the liver fat deposition, this product is used for the treatment of fatty liver, particularly because the fatty liver disease that nutritional disorder, diabetes, medicine damage, metabolism and dyshormonia etc. cause is good especially with the hyperlipidemia person.
Baked polygonum capitatum is a monarch drug in the side, goes into Liver and kidney, enrich and benefit essence and blood.Semen Cassiae is gone into Liver Channel, and liver heat removing is rushed down turbid; Radix Salviae Miltiorrhizae is gone into conscience warp, blood circulation promoting and blood stasis dispelling; The two is ministerial drug altogether.Radix Bupleuri (processed with vinegar) catharsis irritability; The Rhizoma Alismatis diuretic is led turbid; The Rhizoma Curcumae Longae promoting blood circulation to restore menstrual flow; The three is adjuvant drug altogether.Folium Nelumbinis is gone into liver, spleen two warps, inducting the medicines into affected channel, and regulating the liver and spleen is a messenger drug.Seven flavor medicine gathers the merit of liver and kidney tonifying, dispersing the stagnated live-QI to relieve the stagnation of QI, blood circulation promoting and blood stasis dispelling altogether; Treating both the principal and the secondary aspects of a disease at the same time is arranged, the effect of reinforce insufficiency and reduce excessiveness.So our liver and kidney tonifying Zhi Qiben, dispersing liver and promoting blood circulation is controlled its mark, irritability is transferred reach, the strong fortune of temper, the expectorant stasis of blood must disappear, thereby can treat fatty liver effectively.
Application number is that 02132858.7 patent of invention discloses a kind of compound Chinese medicinal preparation for the treatment of fatty liver, contains Radix Salviae Miltiorrhizae, Rhizoma Alismatis in the side.Compare with it, pharmaceutical composition of the present invention has increased Radix Polygoni Multiflori, Semen Cassiae, Radix Bupleuri (processed with vinegar) and Folium Nelumbinis, has deducted Radix Et Rhizoma Rhei.The Radix Polygoni Multiflori effective ingredient can reduce and stop the absorption of enteral lipid matter, promotes the transhipment and the metabolism of lipid material, and the prevention lipid is detained in blood or is penetrated into endarterium, suppresses the HMG-CoA reductase.Semen Cassiae has the serum TC of inhibition rising effect.Radix Bupleuri (processed with vinegar) has tangible effect for reducing blood fat, is remarkable with TG; The Radix Bupleuri (processed with vinegar) Saponin that contains has anti-liver injury, prevents steatosis, blood fat reducing and choleretic effect.Folium Nelumbinis has the function of blood lipid regulation, and main active site is at flavone and alkaloid, and the effect characteristics mainly are the metabolism that promotes cholesterol.Rhizoma Alismatis contains triterpenoid compound, can reduce the generation of the raw material CoA of synthetic cholesterol.And the Radix Et Rhizoma Rhei bitter cold has the effect of heat and toxic materials clearing away, and gas easily injures one's stomach.
Further describe pharmaceutical composition of the present invention at the good effect of treatment aspect the fatty liver below by the pharmacodynamic experiment in the experimental example:
The extracting solution that the pharmaceutical quantities that wherein gives pharmaceutical composition of the present invention refers to the baked polygonum capitatum of recipe quantity, Radix Salviae Miltiorrhizae, Rhizoma Alismatis, Folium Nelumbinis, Semen Cassiae, Radix Bupleuri (processed with vinegar) and Rhizoma Curcumae Longae concentrates dried cream (hereinafter to be referred as pharmaceutical composition of the present invention).
Experiment 1: the influence of the fatty liver rat model that pharmaceutical composition of the present invention brings out high-sugar-fat-diet
The employing high-sugar-fat-diet of feeding brings out rat fat liver model, hepatic tissue TG, the TC of rat model, and serum TG, TC, serum LDL-C, AST, ALP all raise, and the ratio of HDL-C/TC reduces.(dosage is pressed 16g crude drug/kg, 8g crude drug/kg, 4g crude drug/kg) after giving pharmaceutical composition of the present invention, pharmaceutical composition of the present invention can reduce fatty liver rat model hepatic tissue TG, the TC that high-sugar-fat-diet brings out, serum TG, TC, the ratio of rising HDL-C/TC reduces serum LDL-C; Reduce AST, ALP, improve liver function.Concrete result of the test sees Table 1～3.
Table 1 pharmaceutical composition of the present invention is to the influence of fatty liver liver tissues of rats TG, TC
| Group | Dosage (g/kg) | Number of animals (N) | Hepatic tissue TG (mmol/100g hepatic tissue) | Hepatic tissue TC (mmol/100g hepatic tissue) |
| Blank group model group pharmaceutical composition of the present invention pharmaceutical composition of the present invention pharmaceutical composition DONGBAO GANTAI of the present invention | - - 16 8 4 0.35 | 10 12 12 12 12 12 | 1.66±0.32 3.79±0.50 ** 3.18±0.49 Δ 2.87±1.03 ΔΔ 3.65±0.79 3.02±0.46 ΔΔ | 0.66±0.10 1.50±0.18 ** 1.13±0.25 ΔΔ 0.83±0.10 ΔΔ 1.29±0.64 1.24±0.21 Δ |
Annotate: compare with the blank group
*P＜0.01; Compare with model group
ΔP＜0.05,
The Δ ΔP＜0.01
Table 2 pharmaceutical composition of the present invention is to the influence of fatty liver rat blood serum TG, TC, HDL-C/TC, LDL-C
| Group | Dosage (g/kg) | Number of animals (N) | TG (mmol/L) | TC (mmol/L) | HDL-C/TC | LDL-C (mmol/L) |
| Blank group model group pharmaceutical composition of the present invention pharmaceutical composition of the present invention pharmaceutical composition DONGBAO GANTAI of the present invention | - - 16 8 4 0.35 | 10 12 12 12 12 12 | 0.97±0.14 1.47±0.45 ** 0.90±0.42 ΔΔ 0.95±0.42 ΔΔ 1.14±0.40 Δ 0.82±0.23 ΔΔ | 2.07±0.33 4.25±1.07 ** 2.27±0.21 ΔΔ 2.82±0.90 ΔΔ 2.49±0.87 ΔΔ 3.28±1.03 ΔΔ | 0.44±0.08 0.33±0.13 * 0.51±0.07 ΔΔ 0.41±0.14 0.48±0.14 ΔΔ 0.38±0.14 | 0.90±0.11 1.31±0.32 ** 1.16±0.17 1.08±0.15 ΔΔ 1.12±0.21 Δ 1.14±0.21 Δ |
Annotate: compare with the blank group
*P＜0.05,
*P＜0.01; Compare with model group
ΔP＜0.05,
The Δ ΔP＜0.01
Table 3 pharmaceutical composition of the present invention is to the influence of fatty liver rat AST, ALT, ALP ratio
| Group | Dosage (g/kg) | Number of animals (N) | AST (U/L) | ALT (U/L) | ALP (U/L) |
| Blank group model group pharmaceutical composition of the present invention pharmaceutical composition of the present invention pharmaceutical composition DONGBAO GANTAI of the present invention | - - 16 8 4 0.35 | 10 12 12 12 12 12 | 133.50±35.19 163.33±45.70 * 134.08±16.96 Δ 150.42±28.90 142.75±32.44 128.58±25.24 Δ | 86.10±29.64 87.17±28.82 77.92±11.64 80.00±33.90 75.67±23.58 78.33±18.47 | 299.80±34.06 435.83±87.18 ** 333.92±66.83 ΔΔ 329.75±54.82 ΔΔ 339.08±64.22 ΔΔ 356.17±74.71 ΔΔ |
Annotate: compare with the blank group
*P＜0.05,
*P＜0.01; Compare with model group
ΔP＜0.05,
The Δ ΔP＜0.01
This result of the test shows that pharmaceutical composition of the present invention has good therapeutical effect to the fatty liver rat.
Experiment 2: the influence of the rabbit with fatty model that pharmaceutical composition of the present invention brings out high-sugar-fat-diet
The employing high-sugar-fat-diet of feeding brings out the rabbit with fatty model, model group rabbit lobules of liver structure owes clear, the hepatocyte enlargement, many focal necrosis are taken off mistake, the hole gap portion disappears, and remains on a small quantity, and diffusivity, foam sample steatosis appear in hepatocyte, the Combination steatosis appears in part laboratory animal hepatocyte, and a few experiments animal liver cell becomes the master with bulla sample fat; Pathological changes is the most obvious with the lobule central area, and all laboratory animals all can be seen inflammation point-like or little focal necrosis in the lobule, and inflammatory cell is based on mononuclearcell, and visible a small amount of leaflet is examined, and there is the cell infiltration and the proliferation of fibrous tissue of varying degree the portal area.Gavage administration (dosage: the high, normal, basic 8g of being respectively crude drug/kg, 4g crude drug/kg and 2g crude drug/kg) continuously.This result of the test shows that pharmaceutical composition of the present invention can improve fatty liver rabbit hepatic pathology intensity of variation; Reduce experimental fatty liver model rabbit anteserum TG, TC, NEFA that high-sugar-fat-diet brings out, doses reduces hepatic tissue TG; Rising rabbit anteserum SOD reduces MDA, improves its oxidation resistance; Reduce fibronectin, improve hemorheology.
Experiment 3: the influence of the tame duck fatty liver model that high sugar feed is brought out
The employing high sugar feed of feeding brings out tame duck fatty liver model, the hepatic tissue TG of model group man duck, and serum TG, TC, NEFA all raises.(dosage is pressed 8g crude drug/kg, 4g crude drug/kg, the 2g crude drug/kg), pharmaceutical composition of the present invention can reduce the duck liver tissue T G of fatty liver model man that high sugar feed brings out, serum TG to give pharmaceutical composition of the present invention; The ratio of rising HDL-C/TC; Reduce ALP, ALT, improve liver function; Reduce the NEFA in the serum.This result of the test shows that pharmaceutical composition of the present invention has good therapeutical effect to fatty liver man duck.
The specific embodiment
The present invention will be further described below in conjunction with specific embodiment, and following each embodiment only is used to the present invention is described and is not limitation of the present invention.
Embodiment 1
Take by weighing baked polygonum capitatum 50 grams, Radix Salviae Miltiorrhizae 300 grams, Rhizoma Alismatis 50 grams, Folium Nelumbinis 250 grams, Semen Cassiae 50 grams, Radix Bupleuri (processed with vinegar) 300 grams and Rhizoma Curcumae Longae 50 grams,, extract each 1 hour 4 times with 4 times of amount 20% alcohol reflux; Extraction concentrating under reduced pressure drying, 210 grams get dry extract; Add lactose 100 grams, starch 50 grams, microcrystalline Cellulose 40 grams and carboxymethyl starch sodium 30 gram mix homogeneously.Use 5%PVPK
30Solution system soft material, 16 mesh sieves are granulated, 60 ℃ of dryings and granulate.Granule behind the granulate adds magnesium stearate 4 grams, and mix homogeneously is suppressed into pharmaceutical composition tablet of the present invention.
Embodiment 2
Take by weighing baked polygonum capitatum 250 gram, Radix Salviae Miltiorrhizae 50 grams, Rhizoma Alismatis 300 grams, Folium Nelumbinis 30 grams, Semen Cassiae 300 grams, Radix Bupleuri (processed with vinegar) 50 grams and Rhizoma Curcumae Longae 300 grams, measured 90% alcohol reflux 4 hours with 12 times, extract 1 time; Extraction concentrating under reduced pressure drying, 250 grams get dry extract; Add starch 20 grams, microcrystalline Cellulose 60 grams, Pulvis Talci 60 grams, mix homogeneously, the capsule of packing into No. 1.
Embodiment 3
Take by weighing baked polygonum capitatum 150 grams, Radix Salviae Miltiorrhizae 120 grams, Rhizoma Alismatis 150 grams, Folium Nelumbinis 80 grams, Semen Cassiae 200 grams, Radix Bupleuri (processed with vinegar) 100 grams and Rhizoma Curcumae Longae 120 grams,, extract each 2 hours 3 times with 5 times of amount 60% alcohol reflux; Extraction concentrating under reduced pressure drying, 190 grams get dry extract; Add dextrin 250 grams, protein sugar 3 grams, with 75% ethanol system soft material, make granule, 60 ℃ of dryings are crossed 14 mesh sieve granulate, get medicament composition granule of the present invention.
Embodiment 4
Take by weighing baked polygonum capitatum 200 grams, Radix Salviae Miltiorrhizae 100 grams, Rhizoma Alismatis 200 grams, Folium Nelumbinis 150 grams, Semen Cassiae 150 grams, Radix Bupleuri (processed with vinegar) 100 grams and Rhizoma Curcumae Longae 200 grams, earlier with 90% alcohol reflux 2 hours, reuse 51% alcohol reflux 2 hours, last water reflux, extract, 2 hours; Extracting solution concentrating under reduced pressure drying, 230 grams get dry extract; Add the starch mix homogeneously, add the general ball of an amount of ethanol, make pill.
Embodiment 5
Take by weighing baked polygonum capitatum 100 grams, Radix Salviae Miltiorrhizae 200 grams, Rhizoma Alismatis 100 grams, Folium Nelumbinis 50 grams, Semen Cassiae 250 grams, Radix Bupleuri (processed with vinegar) 200 grams and Rhizoma Curcumae Longae 100 grams, earlier with 85% alcohol reflux 2 hours, reuse 60% alcohol reflux 2 hours, last water reflux, extract, 2 hours; Extracting solution concentrating under reduced pressure drying, 220 grams get dry extract; Add dextrin 260 grams, protein sugar 4 grams, mix homogeneously with 75% ethanol system soft material, is made granule, and 60 ℃ of dryings are crossed 14 mesh sieve granulate, get medicament composition granule of the present invention.
Claims (8)
1, a kind of pharmaceutical composition for the treatment of fatty liver is characterized in that it is made up of the medical material of following weight proportioning: 5～25 parts of baked polygonum capitatums, 5～30 parts of Radix Salviae Miltiorrhizaes, 5～30 parts of Rhizoma Alismatis, 3～25 parts on Folium Nelumbinis, 5～30 parts of Semen Cassiaes, 5～30 parts of Radix Bupleuri (processed with vinegar), 5～30 parts in Rhizoma Curcumae Longae.
2, pharmaceutical composition as claimed in claim 1 is characterized in that being raw material by following weight proportioning medical material mainly: 10～20 parts of baked polygonum capitatums, 10～20 parts of Radix Salviae Miltiorrhizaes, 10～20 parts of Rhizoma Alismatis, 5～15 parts on Folium Nelumbinis, 15～25 parts of Semen Cassiaes, 8～20 parts of Radix Bupleuri (processed with vinegar), 10～20 parts in Rhizoma Curcumae Longae.
3, pharmaceutical composition as claimed in claim 1 is characterized in that being raw material by following weight proportioning medical material mainly: 15 parts of baked polygonum capitatums, 12 parts of Radix Salviae Miltiorrhizaes, 15 parts of Rhizoma Alismatis, 8 parts on Folium Nelumbinis, 20 parts of Semen Cassiaes, 10 parts of Radix Bupleuri (processed with vinegar), 12 parts in Rhizoma Curcumae Longae.
4, the preparation of drug combination method of one of a kind of claim 1 to 3 is characterized in that carrying out according to the following steps:
(1) take by weighing baked polygonum capitatum, Radix Salviae Miltiorrhizae, Rhizoma Alismatis, Folium Nelumbinis, Semen Cassiae, Radix Bupleuri (processed with vinegar) and Rhizoma Curcumae Longae by recipe quantity, water or volume fraction are 20～90% alcohol reflux; Extract 1 time～4 times; Each extraction time is 1～4 hour; The amount of extracting solvent is generally 4～12 times of medical material weight; The extracting solution concentrate drying is dried cream, and is standby;
(2) with step (1) get dry extract and one or more pharmaceutical excipient mix homogeneously, make tablet, granule, capsule or pill.
5, as preparation of drug combination method as described in the claim 4, wherein step (1) adopts gradient to extract or wait the degree extraction; Wherein gradient is extracted and is: extract solvent is the ethanol of water or different volumes fractional 20～90% at every turn; Its medium degree extracts and is: extract solvent is the ethanol of equal volume fractional 20～90% at every turn.
6, as preparation of drug combination method as described in the claim 4, wherein the more excellent extraction solvent of step (1) is 51～85% ethanol.
7, as preparation of drug combination method as described in the claim 4, wherein the optimum extraction solvent of step (1) is 60% ethanol; The amount of extracting solvent is 5 times of medical material weight, extracts each 2 hours 3 times.
8, the described pharmaceutical composition of claim 1 to 3, the application aspect preparation treatment fatty liver medicine.
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103432522A (en) * | 2013-08-26 | 2013-12-11 | 赵晶晶 | Chinese medicine formula for treating hyperlipidemia |
| CN104857424A (en) * | 2015-04-27 | 2015-08-26 | 张斌 | Medicine for treating thick blood lipid and preparation method thereof |
| CN105999058A (en) * | 2016-05-31 | 2016-10-12 | 普洱市民族传统医药研究所 | Spanishneedle herb lipid-lowering tablet |
| CN106344885A (en) * | 2016-11-18 | 2017-01-25 | 成都中医药大学 | Food, health product and medicinal composition for treating non-alcoholic fatty liver disease and preparation method and application thereof |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101766737B (en) * | 2008-12-29 | 2012-04-18 | 北京施强时代医药技术开发有限公司 | Liver-soothing lipid-lowing drug composition and preparation method thereof |
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2006
- 2006-06-19 CN CNB2006100143710A patent/CN100427136C/en active Active
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103432522A (en) * | 2013-08-26 | 2013-12-11 | 赵晶晶 | Chinese medicine formula for treating hyperlipidemia |
| CN104857424A (en) * | 2015-04-27 | 2015-08-26 | 张斌 | Medicine for treating thick blood lipid and preparation method thereof |
| CN105999058A (en) * | 2016-05-31 | 2016-10-12 | 普洱市民族传统医药研究所 | Spanishneedle herb lipid-lowering tablet |
| CN105999058B (en) * | 2016-05-31 | 2021-02-02 | 普洱市民族传统医药研究所 | Bidens bipinnata lipid-lowering tablet |
| CN106344885A (en) * | 2016-11-18 | 2017-01-25 | 成都中医药大学 | Food, health product and medicinal composition for treating non-alcoholic fatty liver disease and preparation method and application thereof |
| CN106344885B (en) * | 2016-11-18 | 2019-12-06 | 成都中医药大学 | Pharmaceutical composition for treating non-alcoholic fatty liver disease and preparation method and application thereof |
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