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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 study the quality standard of gynecologic nourishing pills. Methods: Thin layer chromatography was used to identify the Angelica and Radix Paeoniae Alba in the gynecological differentiation pill. The contents of ferulic acid, paeoniflorin and geniposide in gynecologic patients were determined by high performance liquid chromatography (HPLC). Results: The TLC and TLC of Danggui and Radix Paeoniae Alba were clear, the negative control had no interference. Ferulic acid had a good linearity in the range of 0.0302 ~ 0.302μg, the regression equation was Y = 1703631X + 5285.22, r = 0.9995. The linear regression equation was Y = 1345323X-831.14, r = 0.9998, the recovery rate was 103.27%, and the RSD value was 0.97% ; Geniposide had good linearity in the range of 0.08 ~ 0.8μg, the regression equation was Y = 1713917X-4460.31, r = 0.9994, the recoveries were 102.01% and the RSD was 1.03%. Conclusion: The method is simple, accurate, reproducible, and can be used for quality control of gynecological nodular pellets.