军队医院制剂蓝菊清感片质量标准研究

Quality Standard for Military Hospital Preparations Lanjuqinggan Tablets

目的提升军队医院制剂蓝菊清感片的质量标准。方法采用薄层色谱法建立板蓝根、野菊花和黄芩的鉴别,并采用高效液相色谱法建立黄芩苷和阿司匹林的含量测定。结果薄层色谱法鉴别背景无干扰,斑点分离度好。高效液相色谱法色谱峰符合技术要求,黄芩苷线性范围为12.4~62.0μg·ml^(-1),平均加样回收率为97.22%;阿司匹林线性范围为24.1~193.0μg·ml^(-1),平均加样回收率为99.42%。结论新建方法对原有质量标准进行提升,提高了蓝菊清感片制剂的有效性和安全性。

Objective To improve the quality standard for Lanjuqinggan tablets.Methods Thin layer chromatography was used to identify Isatis Root,Wild Chrysanthemum and Scutellaria Baicalensis.Meanwhile,high performance liquid chromatography was used to determine the contents of baicalein and aspirin.Results The background of thin layer chromatography was free of interference,and the separation of spots was clear.The peaks of high performance liquid chromatography met the technical requirements,and the linear range of baicalein was 12.4-62.0μg·ml^(-1),with an average recovery of 97.22%,compared with 24.1-193.0μg·ml^(-1) and 99.42%for aspirin.Conclusion This new method has improved the quality of the previous standard and enhanced the efficacy and safety of Lanjuqinggan tablets.