肠胃宁胶囊的质量标准研究

Study on the Quality Standards for Changweining Capsules

目的研究肠胃宁胶囊的质量标准。方法建立黄芩、甘草、白芍的薄层色谱鉴别方法,建立黄芩苷的高效液相色谱含量测定方法,流动相为甲醇-水-磷酸（45∶55∶0.2）,紫外检测器,检测波长为315 nm,流速为1 ml.min-1,理论塔板数按黄芩苷峰计算应不低于2 500。结果薄层色谱中能检出黄芩、甘草、白芍,薄层色谱斑点清晰,阴性无干扰;黄芩苷在100～2 500 ng范围内线性关系良好,回归方程为lgy=0.933 2lgx-2.864 1,r=0.999 2,平均加样回收率为99.28%,RSD为1.77%（n=5）。结论方法简便,可控,适用于肠胃宁胶囊的质量控制。

Objective To study the quality standards for Changweining Capsules. Methods The TLC methods for identification of Radix Seutellariae, Radix Glycurhizae, Radix Paeoniae Alba were established. A simple HPLC was established for the determination of baiealin. The mobile phase was methanol - water - phosphoric acid （45： 55： 0. 2）. Results Radix Scutellariae, Radix Glycyrrhizae, Radix Paeoniae Alba could be detected. The blackspots were clear on the thin - layer chromatography and the negative sample was no interference. Baiealin showed a linear relationship within the concentration range of 100 - 2500 ng, r = 0. 999 2. The average recovery was 99.28% and RSD was 1.77% （ n = 5 ）. Conclusion The method is suitable for the quality control of Changweining Capsules.