斑蝥酸钠注射液含量测定方法的探索和优化

Exploration and optimization of the content determination method of sodium cantharidate Injection

目的探索和优化斑蝥酸钠注射液含量测定项目的操作方法。方法改变溶液振摇参数、振摇时间以及水浴温度等变量,探索适宜的操作方法。结果按优化后方法操作,采用机械振摇,以振摇频率为250次/分振摇15 min,水浴温度为65℃等条件下,含量测定平均结果相比增高了4.0%。该方法重复性RSD为0.20%,平均回收率为98.83%,RSD为0.96%,稳定性结果RSD为0.31%。结论优化后的方法控制更为全面,更能准确地测定注射液中的斑蝥素钠含量。

Objective To explore and optimize the method for the content determination of Sodium Cantharidate Injection.Methods Take different shaking parameters,different shaking time and take different temperature of water bath to explore a optimal detection method.Results Choose a shaking frequency with 250 times/min by mechanical shaking for 15 min,and the water bath temperature is 65℃,according to the established method.And the study shows that the content determination results increased 4.0%on average,with the RSD values for repeatability is 0.20%,the average recovery is 98.83%,the RSD values for the average recovery is 0.96%,the RSD values for stability is 0.31%.Conclusion The optimized method appears to be accurate and reproducible,which can be used for the content determination of of Sodium Cantharidate Injection.