HPLC测定3厂家磷酸奥司他韦胶囊的溶出度  

Determination of the dissolution of Oseltamivir phosphate capsule from three manufacturers by HPLC

作　　者：顾宝晨[1] 陈蓉[1] 蔡冬明[1] 唐威[1] 刘帅兵[1] 缪丽燕[1] 

机构地区：[1]苏州大学附属第一医院药学部,江苏苏州215006

出　　处：《华西药学杂志》2016年第1期61-63,共3页West China Journal of Pharmaceutical Sciences

摘　　要：目的采用HPLC法考察3厂家磷酸奥司他韦胶囊的溶出度,为药品的采购和临床用药提供参考。方法采用转篮法进行体外溶出度实验,以HPLC-UV法测定含量,计算累计溶出百分率;以威布尔方程拟合溶出度参数T50、Td、T80、m,再利用f2相似因子法对3厂家药物的溶出行为进行分析。结果 3个厂家磷酸奥司他韦胶囊的体外溶出度均符合2010版《中国药典》的规定,但溶出参数T50、Td、T80、m存在一定差异(P<0.01)。结论不同厂家生产的磷酸奥司他韦胶囊的溶出参数存在一定差异,临床用药时应加以注意。OBJECTIVE To compare the in vitro dissolution of Oseltamivir phosphate capsules（ OPC） from three manufacturers by HPLC for the references of clinical application of OPC. METHODS The dissolution test was carried out with basket- rotating method. The content of OPC was determined by HPLC- UV method. The accumulative dissolution percentage was calculated. The Weibull＇S equation was used to fit the dissolution parameters including T50,Td,T80 and m. Then f2 similar factor method was used to analyze the stripping curve of OPC from three manufacturers. RESULTS The in vitro dissolution of OPC from three manufacturers conformed to the requirements of Chinese Pharmacopoeia（ 2010 edition）. But significant differences were found among OPC from three manufacturers in the dissolution parameters including T50,Td,T80 and m（ P〈 0. 01）. CONCLUSION There exists significant difference in dissolution parameters among the OPC from three manufacturers,which should be given attention in clinical application.

关 键 词：磷酸奥司他韦胶囊 高效液相色谱法 溶出度 转篮法 威布尔方程 f2相似因子法 

分 类 号：R917[医药卫生—药物分析学]