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Study On The Prepartion And Quality Standards Of Shangfukang Capsule

Posted on:2008-03-16Degree:MasterType:Thesis
Country:ChinaCandidate:M F LvFull Text:PDF
GTID:2181360278471839Subject:Pharmacy
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Shangfukang Capsule,which is made from Panax notoginseng (Burk.) F.H.Chen and other tow kinds of herbs,is an effective prescription in accelerating wound healing.The author has made a systematic study on its preparation and quality standards.1. Study of the preparation(1)Study of the extractionAccording to the analyses of the prescription,the extraction line was confirmed,that was:Panax notoginseng (Burk.)F.H.Chen was extracted by ethanol,Centella asiatica(L.)Urb., Salvia miltiorrhiaz Bge. was extracted by water. Conditions for the extraction were studied by orthogonal experimental design as guided by the content of ginsenoside Rg1,madecassoside.,Salvianolic Acid B.With the content of ginsenoside Rg1 and extracting ratio as index, the optimum alcohol extraction was established. The optimum extracting condition was:2 times of refluxing with 75% ethanol,6 times of ethanol-adding amount and 1.5 hours of refluxing times respectively. With the content of madecassoside.,Salvianolic Acid B and extracting ratio as index, We established the optimum extracting condition:2 times of refluxing with water,10,8 times of water-adding amount and 2.0,1.5 hours of refluxing respectively.(2)Study of the purificationTo optimize the technical parameters of Panax notoginseng (Burk.) F.H.Chen, Centella asiatica(L.)Urb., Salvia miltiorrhiaz Bge. purification with macroporous resin.We use the comparison method with the content of ginsenoside Rgi, madecassoside.,Salvianolic Acid B as index, the optimum purification with macroporous resin for Panax notoginseng (Burk.)F.H.Chen was:the absorped course:the concentration of the sample was 0.6g/ml,the amount of the macroporous resin was 2 times of sample,and the flow rate was 1.5ml/min.the eluted course:The amount of 60% ethanolic elution was 4 times of the column’s volume,the eluted rate was 2.5ml/min.the optimum purification with macroporous resin for Centella asiatica(L.)Urb., Salvia miltiorrhiaz Bge. was:the absorped course:the.concentration of the sample was 0.4g/ml,the amount of the macroporous resin was 2 times of sample,and the flow rate was 1.5ml/min.the eluted course:The amount of 50% ethanolic elution was 3 times of the column’s volume,the eluted rate was 2.5ml/min.Researches about the effects on the purification of water solvent by alcohol were made by using the transferring ratio of madecassoside., Salvianolic Acid B, extracting rate as index.The optimum purification condition was:The percent of alcohol was 60%, relative density of the concentrate was 1.05.(3)Study of the concentation and desiccationUsing the content of ginsenoside Rg1 as index,we contrasted the effect of different temperature after vacuum drying. The author got the following results:60℃~70℃was the best temperature for vacuum drying.(4)Study of the preparation processUsing the angle of repose and hygroscopicity as the norms of the research, we screened out the first-rank excipient and processing technology. The optimized excipient was microcrystalline cellulose.The critical relative humidity of power was 75%.2.Study of Quality StandardsPanax notoginseng (Burk.) F.H.Chen,Centella asiatica(L.)Urb.,Salvia miltiorrhiaz Bge. were identified respectively by TLC.The examinations of capsules were carried by the pharmacopeia.The content of ginsenoside Rg1 was deretmined by HPLC method. The average recovery rate was 99.8%,while RSD was 0.9%.The menthods above are precise, reliable and can be applied for quality control.
Keywords/Search Tags:Shangfukang Capsule, preparation process, quality standards, macroporous resin
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