CN1313113C - 'Wudan Xinggan' granular for treating fatty liver, and its prepn. method - Google Patents

'Wudan Xinggan' granular for treating fatty liver, and its prepn. method Download PDF

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Publication number
CN1313113C
CN1313113C CNB2005100440695A CN200510044069A CN1313113C CN 1313113 C CN1313113 C CN 1313113C CN B2005100440695 A CNB2005100440695 A CN B2005100440695A CN 200510044069 A CN200510044069 A CN 200510044069A CN 1313113 C CN1313113 C CN 1313113C
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wudan
xinggan
granule
weight
parts
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CN1724018A (en
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张惠云
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Jilin Xiuzheng Pharmaceutical New Medicine Development Co ltd
Jingyu Tianchi Pharmaceutical Co ltd
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Abstract

The present invention relates to a Wudan Xinggan granule for treating hyperlipemia blood type fatty liver or alcoholic fatty liver diseases and a preparation method of the Wudan Xinggan granule. The medicine of the present invention is prepared from the following active components extracted from raw materials according to weight portions of 600 to 700 portions of red sage roots, 450 to 550 portions of prepared fleece flower roots and 250 to 350 portions of haws. The preparation method of the Wudan Xinggan granule comprises the following steps: alcohol extraction and water extraction of the red sage roots respectively, alcohol extraction of the prepared fleece flower roots and the haws, extract combination, dextrin and rebaudiose addition and packaging. The Wudan Xinggan granule of the present invention has the advantages of simple prescription, good curative effect, small toxic and side effects, simple preparation process and little effective component loss, and the present invention is suitable for commercial process.

Description

Wudan Xinggan granule of treatment fatty liver and preparation method thereof
Technical field
The present invention relates to a kind of Chinese medicine preparation for the treatment of fatty liver and preparation method thereof, particularly a kind of Wudan Xinggan granule for the treatment of hepar adiposum of hyperlipoidemia type or alcohol fatty hepatopathy and preparation method thereof.
Background technology:
Along with the raising of people's living standard, the sickness rate of hepar adiposum of hyperlipoidemia type or alcohol fatty hepatopathy is more and more higher.At present, still there is not ideal specific treatment medicine for fatty liver both at home and abroad.Herb Gynostemmae Pentaphylli assembly commonly used clinically, Max EPA, clofibrate, Leping fat etc., big multiaction relaxes, and curative effect is not remarkable, and the medicine life-time service that has has damage to liver, should not be used for the treatment of fatty liver, and the medicine that has also can produce toxic and side effects.
The compound Chinese medicinal preparation of Chinese patent CN1343514, treatment fatty liver, prescription is chitosan, Radix Polygoni Multiflori Preparata, Radix Salviae Miltiorrhizae, Radix Achyranthis Bidentatae, Rhizoma Alismatis and Semen Cassiae, preparation method is that water extract-alcohol precipitation, spray drying method are made.But its medicament composing prescription is more, the preparation method complexity, and effective ingredient is big, and certain toxic and side effects is arranged.
Summary of the invention
The object of the present invention is to provide that a kind of prescription is simple, the Wudan Xinggan granule of good effect, treatment fatty liver that toxic and side effects is little.
Another object of the present invention is to provide above-mentioned particulate preparation method, this method has that technology is simple, loss of effective components is little.
The present invention relates to a kind of Wudan Xinggan granule for the treatment of fatty liver, extract active component by the raw material of following weight parts and make:
600~700 parts of Radix Salviae Miltiorrhizaes
450~550 parts of Radix Polygoni Multiflori Preparata
250~350 parts of Fructus Crataegis.
Wudan Xinggan granule of the present invention, optimum weight part of described raw material is:
666.7 parts of Radix Salviae Miltiorrhizaes
500 parts of Radix Polygoni Multiflori Preparata
333.3 parts of Fructus Crataegis.
The particulate preparation method of above-mentioned Wudan Xinggan, according to the following steps,
A: Radix Salviae Miltiorrhizae adds 10 times of weight, 8 times of weight, 80% alcohol heating reflux and extracts secondary, and the time was respectively 2 hours, 1 hour, and merge extractive liquid, filters, and being concentrated into 60~75 ℃ of relative densities is 1.20~1.22 clear paste, standby;
B: the medicinal residues after the Radix Salviae Miltiorrhizae alcohol extraction add 8 times of weight, 6 times of weight water, decocted respectively 2 hours, 1 hour, and merging filtrate, being concentrated into 60~75 ℃ of relative densities is 1.20~1.22 clear paste, standby;
C: Radix Polygoni Multiflori Preparata, Fructus Crataegi add 10 times of weight, 8 times of weight, 60% alcohol heating reflux and extract secondary, and 1.5 hours, 1 hour respectively time, merge extractive liquid, filters, and being concentrated into 60~75 ℃ of relative densities is 1.20~1.22 clear paste, standby;
D: above-mentioned clear paste merges, and makes granule with dextrin, steviosin, and packing promptly.
The best proportioning that the particulate preparation method of above-mentioned Wudan Xinggan, steviosin account for the granule gross weight is 0.5%.
Every bag contains danshensu (C 9H 10O 5) must not be less than 20.0mg.
This prescription derive from the lifetime professor of Shandong Traditional Chinese Medicine University, national distinguished veteran doctors of TCM Mr. Zhang Zhenyu long-term treatment hepar adiposum of hyperlipoidemia type or alcohol fatty hepatopathy through proved recipe.The Zhang Zhenyu professor forms we according to the ancient prescription sanction, cures mainly because the surfeit crust is sweet, and insobriety causes spleen injury, dysfunction of the spleen in transportation, poly-humidogene heat, damp-heat accumulation, blood stasis resistance network, disharmony between QI and blood and cause hypochondriac pain, knot hinders and form alcoholophilia in abdomen even QI and blood expectorant is fought, and the wine distension takes place then; Dysfunction of the spleen in transportation, the retardance of the expectorant stasis of blood, hematogenous blockage etc.We are at the main syndrome etiology and pathogenesis, and Radix Salviae Miltiorrhizae is a monarch drug in the side, stasis-dispelling and pain-killing, and promoting blood flow to regulate menstruation, relieving restlessness clears away heart-fire; Ministerial drug Radix Polygoni Multiflori Preparata replenishing blood and nourishing liver, beneficial essence is reinforced the kidney; Adjuvant drug hawthorn digesting eliminate indigestion, promoting the circulation of QI to relieve pain, blood circulation promoting and blood stasis dispelling.Take an overall view of full side, at the main syndrome etiology and pathogenesis, with stasis-dispelling and pain-killing, fat-reducing liver-protecting is main, assistant is with nourishing the liver and kidney, and blood-activating and qi-promoting is conceived to remove the cause of disease, corrects pathogenesis, it is intricately woven together that choosing side sends medicine and its etiology and pathogenesis and site of pathological change, thus the sick damp-heat accumulation of energy mainly treating fatty liver, blood stasis resistance network card.Because of reasonable recipe, method of treatment degree of having suits pathogenesis, so clinical efficacy is reliable and stable.
Wudan Xinggan granule of the present invention has that prescription is simple, a good effect, advantage that toxic and side effects is little.
Preparation method of the present invention have preparation technology simple, be suitable for suitability for industrialized production, advantage that loss of effective components is little.
The specific embodiment
Embodiment 1:
A: get Radix Salviae Miltiorrhizae 600g and add 6000mL, 4800mL80% alcohol heating reflux extraction secondary, 2 hours time, 1 hour, merge extractive liquid, filters, and is concentrated into relative density and is the about 180g of clear paste of 1.20~1.22 (60~75 ℃), and is standby:
B: medicinal residues add water 4800mL, 3600mL, decoct 2 hours, 1 hour, and merging filtrate is concentrated into relative density and is the about 210g of clear paste of 1.20~1.22 (60~75 ℃), and is standby;
C: get Radix Polygoni Multiflori Preparata 450g, Fructus Crataegi 25g and add 7000mL, 5600mL60% alcohol heating reflux extraction secondary, 1.5 hours time, 1 hour, merge extractive liquid, filters, and is concentrated into relative density and is the about 72g of clear paste of 1.20~1.22 (60~75 ℃), and is standby;
D: above-mentioned clear paste merges, and, steviosin 5g an amount of with dextrin makes the 100g granule, and packing promptly.
Usage and consumption: oral, three times on the one, each 6g.
Embodiment 2:
A: Radix Salviae Miltiorrhizae 700g adds 7000mL, the 5600mL80% alcohol heating reflux extracts secondary, and 2 hours time, 1 hour, merge extractive liquid, filters, and is concentrated into relative density and is the about 210g of clear paste of 1.20~1.22 (60~75 ℃), and is standby;
B: medicinal residues add water 5600mL, 4200mL doubly, decoct 2 hours, 1 hour, and merging filtrate is concentrated into relative density and is the about 245g of clear paste of 1.20~1.22 (60~75 ℃), and is standby;
C: Radix Polygoni Multiflori Preparata 550g, Fructus Crataegi 350g add 9000ml, the 720mL60% alcohol heating reflux extracts secondary, and 1.5 hours time, 1 hour, merge extractive liquid, filters, and is concentrated into relative density and is the about 230g of clear paste of 1.20~1.22 (60~75 ℃), and is standby;
D: above-mentioned clear paste merges, and, steviosin 5g an amount of with dextrin makes the 1000g granule, and packing promptly.
Usage and consumption: oral, three times on the one, each 6g.
Embodiment 3:
A: Radix Salviae Miltiorrhizae 666.7g adds 6667mL, the 5333mL80% alcohol heating reflux extracts secondary, and 2 hours time, 1 hour, merge extractive liquid, filters, and is concentrated into relative density and is the about 200g of clear paste of 1.20~1.22 (60~75 ℃), and is standby;
B: medicinal residues add water 5333mL, 4000mL, decoct 2 hours, 1 hour, and merging filtrate is concentrated into relative density and is the about 233g of clear paste of 1.20~1.22 (60~75 ℃), and is standby;
C: Radix Polygoni Multiflori Preparata 500g, Fructus Crataegi 333.3g add 8333mL, the 6666mL60% alcohol heating reflux extracts secondary, and 1.5 hours time, 1 hour, merge extractive liquid, filters, and is concentrated into relative density and is the about 225g of clear paste of 1.20~1.22 (60~75 ℃), and is standby;
D: above-mentioned clear paste merges, and, steviosin 5g an amount of with dextrin makes the 1000g granule, and packing promptly.
Usage and consumption: oral, three times on the one, each 6g.
The invention described above obtains the Wudan Xinggan granule except reaching the general prescription of granule, and this product this product contains danshensu (C for every bag 9H 10O 5) must not be less than 20.0mg.
Stability observing: 3 months reserved sample observing methods are measured the preliminarily stabilised of this preparation, and the result shows that this preparation was stable in 3 months, and its long-time stability await further observation.
With the Wudan Xinggan granule of embodiment 1, carry out following main pharmacodynamics experiment below.The Wudan Xinggan granule is divided into large, medium and small dosage and experimentizes, and the large, medium and small three kinds of dosage of mice are respectively 9.00g/kg, 4.5g/kg, 2.25g/kg, and the large, medium and small three kinds of dosage of rat are respectively 4.50g/kg, 2.25g/kg, 1.13g/kg.
1 Wudan Xinggan granule is to the influence of high fat animal model blood fat, liver fat
The large, medium and small dosage of Wudan Xinggan granule can significantly reduce high fat modeling mice serum TC content; Wudan Xinggan granule low dose can significantly improve modeling mice serum HDL-C content; Dosage can significantly reduce modeling mice serum LDL-C content in the Wudan Xinggan granule.
The large, medium and small dosage of Wudan Xinggan granule can significantly reduce high fat modeling Serum TC content; The big or middle dosage of Wudan Xinggan granule can significantly improve modeling rat blood serum HDL-C content; Wudan Xinggan granule heavy dose can significantly reduce modeling rats'liver TC content; The large, medium and small dosage of Wudan Xinggan granule can significantly reduce modeling rats'liver TG content
2 Wudan Xinggan granules are to the influence of hyperlipidemia type fatty liver rat
Wudan Xinggan granule low dose can reduce modeling rats'liver index significantly; The big or middle dosage of Wudan Xinggan granule can significantly reduce high fat modeling Serum TC content; Dosage can significantly reduce modeling rat blood serum HDL-C content, rising HDL-C/TC in the Wudan Xinggan granule; Dosage can significantly reduce high fat modeling rat blood serum LDL-C content in the Wudan Xinggan granule; Dosage can significantly reduce modeling rats'liver TC content, liver TG content in the Wudan Xinggan granule.
3 Wudan Xinggan granules are to the influence of chmice acute hepatic injury
The large, medium and small dosage of Wudan Xinggan granule is to CCL 4Cause the rising of mouse liver injury Serum ALT remarkable reduction effect is arranged; Dosage is to CCL in the Wudan Xinggan granule 4Modeling mice serum AST raises remarkable reduction effect.
The Wudan Xinggan granule causes the rising of mouse liver injury Serum ALT to ethanol the reduction effect, and does not have the significance meaning with ordinary water group difference; The big or middle dosage of Wudan Xinggan granule can significantly reduce ethanol modeling mice serum AST.
4 Wudan Xinggan granules are to the influence of rat acute alcoholic liver injury
Dosage raises to modeling rat blood serum ALT in the Wudan Xinggan granule remarkable reduction effect; The Wudan Xinggan granule raises to modeling rat blood serum AST the reduction effect; Dosage reduces modeling rat blood serum GSH-PX in the Wudan Xinggan granule significant rising effect; The Wudan Xinggan granule raises to modeling liver tissues of rats MDA greatly remarkable reduction effect; The large, medium and small dosage of Wudan Xinggan granule can significantly improve modeling liver tissues of rats GSH-PX and SOD content.
5 Wudan Xinggan granules are to the influence of rat long term alcohol liver damage
The large and small dosage of Wudan Xinggan granule can significantly reduce the liver index of ethanol hepatopathy modeling rat; Rising has the reduction effect to modeling rat blood serum ALT, but does not have the significance meaning; Wudan Xinggan granule heavy dose can significantly reduce modeling rat blood serum AST, significantly reduces modeling rat blood serum MDA; Wudan Xinggan granule low dose can significantly raise modeling rat blood serum GSH-PX and SOD; The Wudan Xinggan granule raises to modeling liver tissues of rats MDA the reduction effect, but does not have the significance meaning; The large, medium and small dosage of Wudan Xinggan granule all can significantly improve modeling liver tissues of rats GSH-PX and SOD content.
6 Wudan Xinggan granules to the hyperlipidemia model rat in the body, the influence that forms of external thrombus
The large, medium and small dosage group of Wudan Xinggan granule can significantly reduce the formation of hyperlipidemia model rat thrombus in vivo.
The dosage group can significantly reduce the weight in wet base of rats in vitro thrombosis in the Wudan Xinggan granule.
7 Wudan Xinggan granules are to the influence of hyperlipidemia model rat platelet aggregation
The big or middle dosage group of Wudan Xinggan granule can significantly reduce the platelet aggregation rate of rat.
8 Wudan Xinggan granules are to the influence of hyperlipidemia model hemorheology of rat
The big or middle dosage group of Wudan Xinggan granule can significantly reduce whole blood viscosity, the whole blood reduced viscosity in the hyperlipidemia model rat plasma, and middle dosage group can significantly reduce rat model ESR equation K value.
9 Wudan Xinggan granule immunizations influence experimental study
Wudan Xinggan granule heavy dose, low dose can obviously improve carbon clearance index K value, and heavy dose of raising of Wudan Xinggan granule proofreaied and correct carbon clearance index α value.
Wudan Xinggan granule heavy dose can obviously improve the mice serum hemolysin.
Toxicology test
1. acute toxicity test
The Wudan Xinggan granule can not surveyed LD by the prerun test 50, thereby carry out the mice maximum dosage-feeding and measure, recording mice, to irritate the stomach maximum dosage-feeding in one day be 279.0gkg -1(crude drug/body weight), 620 times of the clinical application amount that is equivalent to be grown up are not seen the overt toxicity reaction.The result shows that mice was irritated the particulate safe dose of stomach Wudan Xinggan on the 1st at 279.0gkg -1More than.
2. long term toxicity test
This experimental observation rat continuous irrigation stomach give the toxic reaction 24 weeks of Wudan Xinggan granule the body whole body is produced, and drug withdrawal observed for 4 weeks as convalescent period, to observe the degree of reversibility of toxic reaction.Result of the test shows: during the administration, large, medium and small dosage group rat body weight and food ration change and matched group compares there was no significant difference, hematology, blood biochemical are learned every index and are compared there was no significant difference with matched group, each organ macroscopy of large, medium and small dosage group and matched group relatively do not have significant difference, and finding is compared with matched group and also do not had significant difference under each test period of Wudan Xinggan granule heavy dose of group internal organs section mirror.Test shows that it is more than the 27.0g/kg that continuous 24 weeks of rat gavage the particulate safe dose of Wudan Xinggan.

Claims (4)

1. Wudan Xinggan granule for the treatment of fatty liver is characterized in that: extracts active component by the raw material of following weight parts and makes,
600~700 parts of Radix Salviae Miltiorrhizaes
450~550 parts of Radix Polygoni Multiflori Preparata
250~350 parts of Fructus Crataegis.
2. Wudan Xinggan granule according to claim 1 is characterized in that: the weight portion of described raw material is:
666.7 parts of Radix Salviae Miltiorrhizaes
500 parts of Radix Polygoni Multiflori Preparata
333.3 parts of Fructus Crataegis.
3. claim 1 or the particulate preparation method of 2 described Wudan Xinggans is characterized in that: according to the following steps,
A: Radix Salviae Miltiorrhizae adds 10 times of weight, 8 times of weight, 80% alcohol heating reflux and extracts secondary, and the time was respectively 2 hours, 1 hour, and merge extractive liquid, filters, and being concentrated into 60~75 ℃ of relative densities is 1.20~1.22 clear paste, standby;
B: the medicinal residues after the Radix Salviae Miltiorrhizae alcohol extraction add 8 times of weight, 6 times of weight water, decocted respectively 2 hours, 1 hour, and merging filtrate, being concentrated into 60~75 ℃ of relative densities is 1.20~1.22 clear paste, standby;
C: Radix Polygoni Multiflori Preparata, Fructus Crataegi add 10 times of weight, 8 times of weight, 60% alcohol heating reflux and extract secondary, and 1.5 hours, 1 hour respectively time, merge extractive liquid, filters, and being concentrated into 60~75 ℃ of relative densities is 1.20~1.22 clear paste, standby;
D: above-mentioned clear paste merges, and makes granule with dextrin, steviosin, and packing promptly.
4. the particulate preparation method of Wudan Xinggan according to claim 3, it is characterized in that: steviosin accounts for 0.5% of granule gross weight.
CNB2005100440695A 2005-07-13 2005-07-13 'Wudan Xinggan' granular for treating fatty liver, and its prepn. method Expired - Fee Related CN1313113C (en)

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Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1985909B (en) * 2007-01-08 2010-06-16 江苏济川制药有限公司 Medicine for hyperlipemia and its production process
CN102362903A (en) * 2011-10-03 2012-02-29 周春根 Traditional Chinese medicine for treating hyperlipidemia
CN103041002B (en) * 2013-02-07 2016-04-06 杨波 A kind of protecting liver and expelling toxin recovers Chinese medicine powder of liver function and preparation method thereof
CN104042707B (en) * 2013-11-28 2016-04-13 天津天狮生物发展有限公司 A kind of Chinese medicine composition and preparation method containing Radix Polygoni Multiflori extract
CN106310108A (en) * 2015-06-24 2017-01-11 北大方正集团有限公司 Medicinal composition for treating fatty liver
CN105412278A (en) * 2015-12-11 2016-03-23 普洱淞茂制药股份有限公司 Medicine composition, preparation method thereof, preparation and application
CN107397809A (en) * 2017-07-14 2017-11-28 三峡大学 The application of panax japonicus, the red sage root, hawthorn formula on the medicine for preparing treatment fatty liver disease
CN108310164A (en) * 2018-05-16 2018-07-24 刘朝顺 It is a kind of treat and prevent acute and chronic hepatitis Chinese medicine composition and application

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1263772A (en) * 1999-12-30 2000-08-23 鞠奎信 Hypolipemic capsule
CN1524540A (en) * 2003-02-28 2004-09-01 唐山康琳药业有限公司 Chinese medicine preparation for treating fatty liver and its preparation method

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1263772A (en) * 1999-12-30 2000-08-23 鞠奎信 Hypolipemic capsule
CN1524540A (en) * 2003-02-28 2004-09-01 唐山康琳药业有限公司 Chinese medicine preparation for treating fatty liver and its preparation method

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Address before: 130012 No. 2426 Qianjin Street, Changchun hi tech Development Zone, Jilin

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Granted publication date: 20070502