灯盏花素包合物冻干粉针的含量测定及安全性检查

Determination of the content and safety of the brevescapine inclusion complex freeze-dried powder injection

【目的】建立灯盏花素包合物冻干粉针含量的测定方法并检查其安全性。【方法】采用HPLC法测定其含量,对冻干粉针进行溶血性试验及血管刺激性试验。【结果】在2.0～100.0μg/ml范围内线性关系良好（r=0.9999）,平均回收率为98.9%,RSD为1.2%（n=5）。【结论】所建立的方法简便、灵敏、准确,制得的冻干粉针安全性较好。

[Objective] To develop a method for the determination of content and safety of brevescapine inclusion complex freeze-dried powder injection. [Methods] RP-HPLC was adopted to determine the content and haemolytic and irritation tests were used to determine its safety. [Results] This method had good linearity in the range of 2.0- 100.0μg/ml（ r = 0.9999）, and the average recovery was 98.9% with RSD of 1.2%（ n = 5）. [Conclusions] This method is simple, sensitive and practicable for the assay and the safety is accord with the standard.