妇科分清丸质量标准研究

Quality Standards of Fuke Fenqing Pill

目的：对妇科分清丸的质量标准进行研究。方法：采用薄层色谱法对妇科分清丸中当归和白芍进行定性鉴别;采用高效液相色谱法对妇科分清丸中的阿魏酸、芍药苷和栀子苷进行定量分析。结果：当归和白芍的薄层色谱法鉴别斑点清晰,阴性对照无干扰;阿魏酸在0.0302～0.302μg范围内线性关系良好,回归方程为Y=1703631X＋5285.22,r=0.9995,加样回收率为101.36%,RSD值为1.31%;芍药苷在0.0584～0.584μg范围内线性关系良好,回归方程为Y=1345323X-831.14,r=0.9998,加样回收率为103.27%,RSD值为0.97%;栀子苷在0.08～0.8μg范围内线性关系良好,回归方程为Y=1713917X-4460.31,r=0.9994,加样回收率为102.01%,RSD值为1.03%。结论：该法简便易行、准确、重现性好,可用于妇科分清丸的质量控制。

Objective：To establish the quality standard of Fuke Fenqing Pill. Methods：Angelicae sinensis Radix and Paeoniae alba Radix of Fuke Fenqing Pill was dentified by TLC. HPLC was applied to determine the content of ferulic acid,paeoniflorin and geniposide. Results：TLC identification methods had good specificities without interference from negative control. Ferulic acid presented a food linearity in the concentration range of 0.0302-0.302 μg. The regression equation was Y=1703631X＋5285.22,r=0.9995. The rate of recovery was 101.36%,RSD=1.31%. The paeoniflorin presented a food linearity in the concentration range of 0.0584-0.584 μg. The regression equation was Y=1345323X-831.14,r=0.9998. The rate of recovery was 103.27%,RSD=0.97%. The geniposide presented a food linearity in the concentration range of 0.08-0.8 μg. The regression equation was Y=1713917X-4460.31,r=0.9994. The rate of recovery was 102.01%,RSD=1.03%. Conclusion：This method is simple,the result shows high precision and repeatability and it can be used for quality control of Fuke Fenqing Pill.