The Preparation Technology Study And Quality Standards Research Of Gubenhuatan Tongmai Granules

Gubenhua tantongmai granules consist of Radix Polygoni Multiflori,Exocarpium Citri Grandis,Semen Cassiae,Rhizoma Atractylodis Macrocephalae and so on.It has a good effect on treating Hyperlipidmia and Atherosclerosis proved by clinical practice for many years.The prescription is make up of the theory of TCM and the modern research and clinical experience.Its preparation,quality standards and preliminary stability have been investigated in this paper.1.Study of preparationIn the point of preparation technology,we use the the content of 2,3,5,4′-teterahydroxystibene-2-0-β-D and extracting ratio as evaluating indexes and investigated the optimum preparing and refining conditions by the orthogonal test method and parallel test. The optimum extracting condition is:Soaking the nine herbs with water for 0.5 hour and boiling 2 hours for three times,the amount of water used was 11.5,10 times of the drug mixture respectively. Soaking the Radix Codonopsis,Fructus Lych with water for 1 hour and boiling 1 hours for three times,the amount of water used was 10,8 times of the rug mixture respectively.In the point of technics of purification,we use alcoholprecipitation method.Using the the content of 2,3,5,4′-teterahydroxystibene-2-0-β-D and alcohol-extracting ratio as evaluating indexes,influence on alcohol-precipitation of concentration,concentrated proportion and depositing time has been investigated.We investigated the alcohol-precipitation method conditions by the orthogonal test method and parallel test.The alcohol-precipitation method condition is:concentration of alcohol-extracting is 70%,concentrated proportion is 1.5:1, depositing time is 12 hours.On the basis of these studies,the result indicate that:when ointment:sugar:dextrin=2:2:1,the ratio of moisture absorption is lowest,and liquidity can match the request.2.Study of quality standardThe Rhizoma Atractylodis Macrocephalae,Radix Et Rhizoma Glycyrrhizae,Radix Polygoni Multiflori and Fructus Crataegi were indentified by TLC.For the sake of assays of 2,3,5,4′-teterahydroxystibene-2-0-β-D,the new high performance liquid chromatography methods were developed.The average recovery rates were 99.82%while RSD were 1.29%.Assay methods were validated in the research of context.On the basis of the above-mentioned quantitative analysis menthods for 2,3,5,4′-teterahydroxystibene-2-0-β-D,the quality standard of Gubenhuatantongmai granules was drafted.3.Study of preliminary stabilityWe use sample reserving observation to examine the three batches of Gubenhuatantongmai granules in the aspects of properties,TLC,the determination of the content etc.The results indicate that the preparation is stable.