Study On Prepration Process And Quality Control Of Yangjingzhongyu Granule

Objective: Sterility is a relatively common and complex clinical syndrome withthe increasing prevalence, which has become a global medical and sociologicalprobleme for human development and health. The traditional Chinese medicinegranule which was studied on preparation, quality standard and preliminary stabilityin this paper was based on Yangjingzhongyu Decoction.Methods:(1) Study of water-extraction technology: HPLC was used to quantitative byusing the content of paeoniflorin as the index. Extraction technology were optimizedby L9(34) orthogonal design method, with consideration: the amount of water, thetimes of extraction and time length of extraction.(2) Study of purification technology: Purification technology were optimized bycomparing alcohol precipitation method and high speed centrifuging method with thecontent of paeoniflorin and extracting ratio as the index.(3) Study of concentration and drying technology: the contents of paeoniflorinwas used as index to determine the optimum concentration and drying conditions．(4) Study of formulation technology: formalizing properties, hygroscopicity,flowability and dissolubility was used as index to investigate the formulationtechnique.(5) Study of quality standard: Radix Paeoniae Alba and fructus corni in thisYangjingzhongyu Granule were identified by TLC, and the content of paeoniflorinwas determined by HPLC.(6) Study of preliminary stability: We examine long term stability andaccelerated stability of Yangjingzhongyu Granule in the aspects of properties, TLC,the determination of the content etc for6months, respectively.Results:(1) The optimum condition of water-extraction:10times as much water,extracted60min for3times. (2) The optimum condition of purification:12000rpm centrifuging for10min.(3) The optimum condition of concentration and drying:80℃at-0.08~-0.10MP,respectively.(4) The optimum condition of formulation: mixing the amount of extractionpowder with lactose by1:1.75ratio in preparation formula.(5) The draft standard of TLC and content determination is established. Thecontent of paeoniflorin should be more than12mg in Yangjingzhongyu Granule.(6) That the above parameters were not changed significantly indicates a goodstability of the preparation.Conclusions: The preparation procedure is reasonable and feasible, the qualitystandard can be used effectively for the quality control and the product quality isstability. The results of this study can establish stable foundation for developing newtraditional chinese medicine to cure sterility．...