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目的:提高利胆止痛胶囊质量标准,增加含量测定项以对药品进行更好的质量控制。方法:采用HPLC对制剂方中赤芍进行含量测定。安捷伦Agilent Extend-C18(4 mm×250 mm,5μm)色谱柱,流动相乙腈-0.1%磷酸溶液(15∶85),检测波长230 nm,流速1 mL·min-1,理论板数按芍药苷峰计算应不低于4 000。结果:芍药苷在0.144～0.720μg呈良好的线性关系,精密度试验RSD 0.54%,样品在24 h内基本稳定(RSD 1.17%),重复性试验RSD 1.48%,平均加样回收率为97.77%(RSD 1.48%)。依正文方法进行了10批样品的含量测定,利胆止痛胶囊芍药苷的平均含量0.772 0 mg/粒。结论:该方法专属性强,灵敏度高、重复性好,可用于该制剂的质量控制。
OBJECTIVE: To improve the quality standards of Lilengzhitong capsule and to increase the content determination items to carry out better quality control on the drugs. Methods: The content of Radix Paeoniae Rubra was determined by HPLC. The Agilent Extend-C18 column (4 mm × 250 mm, 5 μm) was used with a mobile phase of acetonitrile-0.1% phosphoric acid solution (15:85) at a detection wavelength of 230 nm and a flow rate of 1 mL · min- Peak calculation should not be less than 4 000. Results: Paeoniflorin had a good linear relationship at 0.144 ~ 0.720μg. The precision of RSD was 0.54%. The content of paeoniflorin was stable within 24 hours (RSD 1.17%), RSD of reproducibility was 1.48% and the average recovery was 97.77% (RSD 1.48%). According to the text method, the content of 10 batches of samples was determined. The average content of paeoniflorin in the capsule of “Li Dan Zhitong Capsule” was 0.772 mg / tablet. Conclusion: This method is specific, sensitive and reproducible. It can be used for the quality control of this preparation.