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目的:建立四味抗痨丸的质量控制标准。方法:利用薄层色谱法对四味抗痨丸处方中的白芍、大黄、巴豆进行定性鉴别;采用高效液相色谱法测定四味抗痨丸中芍药苷的含量。色谱条件:以十八烷基硅烷键合硅胶为填充剂;以乙腈-0.1%磷酸溶液(14:86)为流动相;检测波长为230 nm;柱温30℃;流速为1.0 mL·min-1;进样量为10μL。结果:白芍、大黄、巴豆采用相应的薄层鉴别方法,薄层展开后均显示与对照药材相同的特异性斑点,分离效果好。芍药苷质量在2.55×10﹣3μg～0.51μg范围内与峰面积有良好的线性关系。平均回收率为97.5%,RSD为0.57%。结论:该方法准确、可靠、专属性强,为建立四味抗痨丸质量控制标准提供依据。
Objective: To establish the quality control standard of Siwei Kangbei. Methods: The contents of paeoniflorin in Sifangganjian pills were determined by thin-layer chromatography (TLC). Chromatographic conditions: octadecylsilane bonded silica as a filler; acetonitrile-0.1% phosphoric acid solution (14:86) as mobile phase; detection wavelength of 230 nm; column temperature 30 ℃; flow rate of 1.0 mL · min- 1; injection volume of 10μL. Results: Radix Paeoniae Alba, Radix et Rhizoma Rhei and Radix et Rhizoma Rhei were identified by the corresponding TLC. After the TLC was developed, the same speckles were observed as those of the control. The separation effect was good. Paeoniflorin quality in the 2.55 × 10-3μg ~ 0.51μg range and the peak area has a good linear relationship. The average recovery was 97.5% with a RSD of 0.57%. Conclusion: The method is accurate, reliable and specific. It provides the basis for establishing the quality control standard of Siwei Anti-Jiao Pills.