Study On Prepration Process And Quality Standards Of The Ruanmaihuaban Granules

Ruanmaihuaban Granules is a Compound Chinese medicine preparation which wascomposed by the extracts from eight Chinese herbals such as salvia, epimedium, Dandelion andetc. It has the function of promoting blood circulation to remove blood stasis, strengtheningheart and kidney, resolving phlegm and dispelling cloud.In this paper, the granules’prescription preparation process and quality standards were studied by systematically.The medicine’s effective component could be divided into two parts, one part wasextracted with ethanol, and the other part was extracted with water. The orthogonal experimentwas adopted to optimize the extract processes. Based on the nature of the effective componentof the drugs and the function of the preparation, the extract content and the yield of Icariin andthe TanshinoneⅡAwere separately selected as observation index.Eupolyphaga and Salvia were extracted with ethanol, the optimized process was asfollows:6times of70%ethanol was added to the herbs, refluxing for1.5h, filtered and thefiltrate was collected. Repeated the extraction process for2times, combined the filtrate,recovered the ethanol by vacuum distillation to afford a residue. The resulted residue would beused in the drug powder preparing process. Epimedium, dandelion, turmeric and other herbs inthe prescription were extracted with water, the optimized process was as follows:12times ofwater was added into the herbs, refluxing for1.0h, filtered and the filtrate was collected.Repeated the above process for3times, combined the filtrate, concentrated to the1/8volume.Warmed to70℃, the natural clarifying agent composition ZTC1+1-Ⅱ A was added into,reacted for10minutes; and then, the natural clarifying agent composition ZTC1+1-Ⅱ B wasadded into the reaction mixture, reacted for another10minutes. Cooled to room temperature,standing still for overnight, filtered, combined the filtrate with the above residue, concentratedto afford a cream (relative density from1.30to1.35),vacuum drying, grinding, through80mesh screen, according to extract powder: dextrin (3:1) to mixing,80%ethanol as wettingagent, extrusion granulation, drying at low temperature, sorting granules, repacking, theRuanmaihuaban Granules was prepared finally．Furthermore, the granules of qualitystandards and preliminary stability were studied.The study indicates that the preparation technique was reasonable and practical，thestandard was controllabl e， and the quality of the sample was steady on the whole as well．...