Pharmaceutical Study Of Tongmai Fufang Granular

Tongmai Fufang is clinical experience prescription of teaching hospital of chengdu university of TCM,and has significant curative effect for type 2 diabetes and vascular disease caused by diabetes,which pertain to deficiency of both qi and yin and obstruction of meridians.It consist of ginseng,astragalus membranaceusb,pseudo-ginseng,cornus,rehmannia,yams,salvia miltiorrhiza bge,safflower.It has effect of reinforcing qi and enriching blood and promoting blood circulation,which is direct at pathogenesis of diabetes-“deficiency of both qi and yin and obstruction of meridians”.In this paper,we studied the pharmaceutical part of the Tongmai Fufang preparations,mainly including three aspects of the research content,preparation process research,quality standard research and accelerated stability research.Extraction process of preparation technology is based on the basic theory of TCM,choosing chemical composition matched with effcet as an index.Ginseng and pseudo-ginseng are choosed to powder in process of preparation,and the rest of herbal medicines in a prescription is extracted with water..Astragalus glycosides,oganin,loganin,hydroxysafflor yellow A,calycosin-7-O-beta-D-glucoside,acteoside,salvianolic acid B,polysaccharide and extraction rate are choosed as the index,according to the chief,deputy,assistant and envoy compatible regulation,giving each index component the corresponding weight coefficient.Taking the response surface method to study effect of extraction times,water addition,extracting time on extraction process with comprehensive score as evaluation index.The extraction process is as follows: tongmai fang was added with 9 times distilled water,decocted for 50 min for 4 times.The purification process is that solution is to be vacuum concentrated(50~60?)to crude drug:liquid(1:1.5),then centrifuge,and the centrifugate is concentrated to a relative density of 1.24~1.32(60 ?),and then adding ginseng and pseudo-ginseng powder and proper amount of dextrin,vacuum drying(50~60?).After that crushing to fine powder,and mix with 85% ethanol to prepare the particles,dried at 60 ?.TLC methods have been found for ginseng,astragalus membranaceusb,pseudo-ginseng,cornus,salvia miltiorrhiza bge.Also,HPLC method has been established for determining four kinds of saponins in Tongmai Fufang Granular.According to the test results of sample determination,make the content limit,to develop the product per bag containing total notoginsenoside R1,ginsenoside Rg1,ginsenoside Re,and ginsenoside Rb1 shall not be less than 22.24 mg.Drug validity period is set as 1 year,on the basis of the results of 6 months accelerated test.