八味益肾丸的质量控制研究

Quality Control of Bawei Yishen Pills

目的 建立八味益肾丸的质量控制方法.方法 采用TLC法对蚕蛾和当归进行定性鉴别;采用HPLC法对淫羊藿苷进行定量分析.结果 薄层色谱斑点清晰,阴性对照无干扰;淫羊藿苷进样量在0.0126~0.0756mg/ml范围内线性关系良好（r=0.9998）,平均加样回收率为95.8%,RSD为0.31%.结论 所建立的方法能准确可靠地进行定性、定量检测,重复性好,可作为本产品的质量控制方法.

Objective To establish effective methods for the determination of Bawei Yishen Pills. Methods TLC was performed to identify Silk-worm moth and angelica Bawei Yishen Pills. HPLC was used to determine the contents of icariin. Results The spots on TLC plates were clear without interference. The calibration curves were linear within the range of 0. 0126-0. 0756 mg/ml for icariin, the average recovery rate was 95.8%, RSD=0.31%. Conclusions：The method is simple, reliable, accurate and reproducible. It is suitable for the quality control of Bawei Yishen Pills.