产后益母丸质量标准研究

The Quality Standards Study of Chanhou Yimu Pills

目的建立产后益母丸质量控制方法。方法采用薄层色谱法对制剂中的益母草、当归、川芎、赤芍、延胡索进行定性鉴别;采用高效液相色谱法测定制剂中芍药苷的含量。结果薄层色谱显色清晰且阴性对照无干扰。芍药苷在0.01288～0.5152mg·mL-1内呈良好的线性关系,平均回收率为102.0%,RSD=1.6%。结论本法操作简便,结果准确、重复性好,可用于产后益母丸的质量控制。

OBJECTIVE To develop a method of quality control for Chanhou Yimu pills. METHODS Herba Leonuri, Radix Angelicae Sinensis, Rhizoma Chuanxiong, Radix Paeoniae Rubra and Rhizoma Cortdalis were identified by TLC. HPLC was used for determination of paeoniflorin. RESULTS The chromatographic spots were identified without the interference of negative control. Paeoniflorin had a good linearity over the concentration range of 0.012 88-0.515 2 mg·mL-1, the average recovery was 102.0% with RSD of 1.6%. CONCLUSION This method was found to be reliable, accurate and specific. It can be used for the quality control of Chanhou Yimu pills.