清肺抑火片指纹图谱的建立及其在质量控制中的应用

Fingerprinting of Qingfei Yihuo Tablets and its Application in Quality Control

摘要:

目的: 建立清肺抑火片HPLC指纹图谱。 方法: 采用Ultrasphere^TM-ODS-C₁₈柱(4.6 mm×250 mm,5 μm),流动相0.1%磷酸溶液(A)-乙腈(B)梯度洗脱,检测波长270 nm,流速1.0 mL·min^-1,柱温40℃。 结果: 不同厂家的清肺抑火片指纹图谱变异范围差异显著,同一厂家的产品质量基本稳定在一定水平内。 结论: 该方法可用于测定不同来源清肺抑火片的色谱指纹图谱,并为其全面质量评价和生产工艺监控提供了可行的方法。

Abstract:

Objective: To establish the HPLC fingerprint of Qingfei Yihuo Tablets. Method: Ultrasphere TM-ODS-C₁₈ column (4.6 mm ×250 mm, 5 μm) was used, the mobile phase was 0.1% phosphoric acid solution (A)-acetonitrile (B) gradient elution, the detection wavelength was set at 270 nm. The flow rate was 1 mL·min^-1, and column temperature was kept at 40℃. Result: Fingprints of the tablets from different manufacturers varies significantly, which keep stable at a certain level from the same manufacture. Conclusion: The method can be used for the determination of different source of Qingfei Yihuo Tablets and can provide a feasible method for comprehensive quality evaluation and production process monitoring.