衍生胶囊质量标准的研究

Quality Standard of Yansheng Capsule

目的建立衍生胶囊的质量标准。方法采用薄层色谱法对方中赤芍和黄芪进行了定性研究;采用高效液相法测定方中淫羊藿苷的含量。结果赤芍、黄芪的TLC斑点清晰、分离度好。淫羊藿苷在0.0952～0.9616μg范围内呈良好的线性关系(r=0.9994),平均加样回收率为100.9%(n=6),RSD=2.42%。结论所见方法简单可靠,可用于该制剂的质量控制。

Objective To establish quality standard of Yansheng capsule. Methods Red peony root and Radix astragali in the capsule were identified by TLC,and the content of icariin in the capsule was determined by HPLC. Results The method was linear at the range of 0. 0952-0. 9616μg （ r = 0. 9994）. The average recovery rate was 100.9% with RSD 2.42% （ n = 6 ）. Conclusion The method is simple, reliable, and can be used for the quality control of this capsule.