9-硝基喜树碱胶囊溶出过程的研究  

The study of dissolution of 9-nitro-camptothecin capsules

作　　者：何琴[1,2] 黄心一[1,2] 

机构地区：[1]重庆医科大学附属成都第二临床医学院 [2]成都市第三人民医院,四川成都610031

出　　处：《华西药学杂志》2012年第2期156-158,共3页West China Journal of Pharmaceutical Sciences

摘　　要：目的建立9-硝基喜树碱(9-NC)胶囊的溶出度测定方法。方法考察了不同溶出介质、转速和温度对溶出试验的影响;选择HPLC法测定9-NC的含量,同时对该测定方法的准确度、精密度、重复性和线性范围进行了评价,测定了同一规格3批样品的溶出曲线。结果 0.05～8μg.mL-19-NC与峰面积的线性关系良好(r=0.9999),平均回收率为99.32%,RSD=0.93%;3批样品在45 min内溶出百分率均大于90%,释放行为符合威布尔分布模型与多项式模型中的四次多项式模型。结论将9-NC释放行为作为控制的指标,能保证其胶囊的质量。OBJECTIVE To establish the dissolution test method for 9-nitro-camptothecin（9-NC）capsules.METHODS The effect of dissolution media,rotative speed and temperature on the dissolution test was investigated.HPLC method was selected to determine the content of 9-NC,and the dissolution curves of 3 batches of 9-NC capsule samples were detected according to the above method.RESULTS HPLC method showed a good linear relationship in the range of 0.05-8 μg·mL-1（r=0.9999） with average recovery of 99.32%（RSD=0.93%）.The dissolution rate of each three samples was over 90% in 45 min.The release behavior was in accordance with Weibull distribution model and the four polynomial model.CONCLUSION The release behavior of 9-NC is needed to control the quality of the capsule.

关 键 词：9-硝基喜树碱 溶出行为 高效液相色谱法 

分 类 号：R94[医药卫生—药剂学]