胃肠乐片的质量标准研究

Quality Standards of Weichangle Tablets

目的建立胃肠乐片的质量控制方法。方法采用薄层色谱法（TLC）对胃肠乐片处方中的黄柏、秦皮进行定性鉴别;采用HPLC测定制剂中黄芩苷的含量,色谱条件为采用Kromasil色谱柱C18（250 nm×4.6 mm,5μm）;以甲醇-水-磷酸（45∶55∶0.2）为流动相;检测波长为315nm;流速为1.0mL/min。结果胃肠乐片中黄柏和秦皮的TLC鉴别法专属性强,斑点清晰;HPLC含量测定,黄芩苷进样量在0.063 1~0.631μg与峰面积呈良好的线性关系（γ=0.999 8）,黄芩苷的平均回收率为99.30%,RSD=0.92%（n=6）。结论建立的定性定量方法简便、可行,能更有效地控制胃肠乐片的质量。

Objective To establish aquality standard for Weichangle tablets. Methods phellodendron chinense Schneid.,Fraxini Cortex were identified by TLC,and the content of baicalin was determined by HPLC. The chromatographic column was theKromasil C18（250 nm ×4.6 mm,5 μm）. The mobile phase was consisted of methanol-water-phosphoric acid（45∶ 55 ∶ 0. 2）. The detection wavelength was 315 nm; the flow rate was 1. 0 mL /min. Results Phellodendron chinense Schneid.,Fraxini Cortex could be identified by TLC. Baicalin showed a good linear relationship in the range of 0. 063 1-0. 631 μg,γ = 0. 999 8. The average recovery was 99. 30%,RSD = 0. 92%（ n = 6）. Conclusion The method is simple with good reproducibility,and it can be used for the quality control of Weichangle tablets.