胃痛宁片质量标准的研究

Study on quality standards of Weitongning tablets

目的建立胃痛宁片的质量标准。方法采用TLC法对处方中龙胆粉进行定性鉴别,采用HPLC法测定蒲公英提取物中咖啡酸的质量分数。结果在薄层色谱中可检出龙胆苦苷的特征斑点;咖啡酸回归方程为A=42.128 6ρ-19.133 2(r^2=1),在6.29~62.9μg/m L范围内线性关系良好,平均加样回收率为96.4%,RSD为0.28%(n=6)。结论所建立的定性方法专属性强,定量方法简便、准确,能有效地控制胃痛宁片的质量。

Objective To establish the quality standards for Weitongning tablets. Methods TLC was employed for qualitative identification of Gentiana powder,and HPLC was developed for the determination of caffeic acid in Dandelion extract. Results The TLC spots of gentiopicroside were characteristic. It showed a good linearity for caffeic acid within 6. 29-62. 9 μg/mL（r^2= 1）. The regression equation was A = 42.128 6ρ- 19. 133 2,and the average recovery was 96. 4%（ RSD = 0. 28%,n = 6）. Conclusion The established method is specific,quantitative,simple and accurate,which could effectively control the preparations＇ quality.