清金化痰颗粒的制备工艺及质量控制OA

Objective:To optimize the preparation process of Qingjin Huatan Granules and to control its quality.Methods:The water extraction process of Qingjin Huatan Decoction was optimized by analytic hierarchy process combined with orthogonal experiment,and the preparation process of Qingjin Huatan Granules was further prepared by wet method.The formulation process was evaluated and optimized with the molding rate,moisture absorption rate,angle of repose,granulation performance and meltability as evaluation indicators.The quality standard of Qingjin Huatan Granules was established by thin-layer identification,HPLC content determination and fingerprint analysis.The stability of Qingjin Huatan Granules was studied by accelerated stability experiment.Results:The optimal extraction process of Qingjin Huatan Decoction was 10 times the volume of water,extract twice,and extract for 1 h each time.The optimal granulation process of Qingjin Huatan Granules was to use lactose as an excipient,with a drug-excipient ratio of 1∶0.8,wet with 80％ethanol,make soft material,granulate,dry at 60 ℃ for 1 h,whole grain,packaging.A thin-layer identification method was established for four medicinal herbs:Scutellaria baicalensis Georgi,Gardenia jasminoides Ellis,Citrus reticulata Blanco,and Anemarrhena asphodeloides Bge,as well as a content determination method for baicalin,geniposide,naringin and mangiferin.Ten batches of particle fingerprint patterns were established,with a similarity ranging from 0.976 to 0.999.A total of 18 common peaks were identified in the fingerprint patterns,and 9 chromatographic peaks were determined among them.The results of the accelerated stability test also show that the stability of Qingjin Huatan Granules is good.Conclusion:The preparation process and the established fingerprint chromatogram method are stable,reliable and have good repeatability.Based on this,the quality standard of Qingjin Huatan Granules has been established.