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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 a method for the determination of dissolution of 9-nitrocamptothecin (9-NC) capsules. The effects of different dissolution media, rotation speed and temperature on the dissolution test were investigated. The content of 9-NC was determined by HPLC. Meanwhile, the accuracy, precision, repeatability and linearity of the method were evaluated. Dissolution curve of 3 batches of samples. Results The linear relationship between peak area and concentration of 0.05 ~ 8μg.mL-19-NC was good (r = 0.9999), the average recovery was 99.32% and RSD was 0.93%. The dissolution percentage of three batches of samples was more than 90% The behavior is consistent with the fourth degree polynomial model in Weibull distribution model and polynomial model. Conclusion 9-NC release behavior as an indicator of control, to ensure the quality of its capsules.