复方扶正养肝颗粒的制备工艺研究  

Study on the preparation technology of Compound Fuzhengyanggan Granules

作　　者：陈坤 陈凌云[1] 王华宁[2] CHEN Kun;CHEN Lingyun;WANG Huaning(Yunnan University of Traditional Chinese Medicine,Kunming 650500,China;Yunnan Provincial Hospital of Traditional Chinese Medicine,Kunming 650021,China)

机构地区：[1]云南中医学院,昆明650500 [2]云南省中医医院,昆明650021

出　　处：《西北药学杂志》2019年第3期383-388,共6页Northwest Pharmaceutical Journal

基　　金：云南省卫生和计划生育委员会中药民族药院内制剂研发项目(编号:KY15)

摘　　要：目的优选扶正养肝颗粒的提取工艺和成型工艺。方法建立毛蕊异黄酮葡萄糖苷的HPLC测定方法,通过正交设计实验确定最佳提取工艺。考察不同辅料及用量,以颗粒一次收率和溶化性等为指标,筛选处方中加入辅料的种类、用量及成型工艺参数。结果扶正养肝颗粒的最佳提取工艺:提取3次,每次加12倍量水,每次2 h;最佳成型工艺:赋形剂为糊精-麦芽糊精(1∶2),稠膏-赋形剂(1∶0.4),润湿剂为体积分数为80%的乙醇,用量为15%。结论扶正养肝颗粒的提取工艺和成型工艺稳定可行,质量可控。Objective To optimize the extracting and processing conditions of Compound Fuzhengyanggan Granules (CFG). Methods HPLC method for isoflavones glucoside was established,and the optimal extraction process was confirmed by using an orthogonal design test.The influence of different excipients and wetting agents were investigated,taking forming rate,solubility,and absorption rate as indexes.The prescription materials,ratio,and optimum molding process were screened. Results The optimal extraction procedure of CFG was as follows:12-fold,extracting for 3 times,2 h once.The optimized conditions of CFG were obtained as follows:accessories for the dextrin∶maltodextrin (1∶2),main drug-excipients (1∶0.4),with 80% ethanol as the wetting agent which accounted for15% of the main drug. Conclusion The extraction process and forming process are feasible and stable,and the quality is controllable.

关 键 词：复方扶正养肝颗粒 毛蕊异黄酮葡萄糖苷 正交设计 制备工艺 

分 类 号：R94[医药卫生—药剂学]