小儿增食片质量标准研究

Study on Quality Standards for Xiao Er Zengshi Tablets

目的:建立小儿增食片的质量标准。方法:采用薄层色谱法对小儿增食片中决明子、山楂、甘草进行鉴别。用高效液相色谱法对决明子中大黄素和大黄酚进行了含量测定。结果:本品定性鉴别薄层色谱特征明显,专属性强;采用天津艾杰尔Venu-sil XBP-C18色谱柱(4.6 mm×250.0 mm,5μm),以甲醇-0.1%磷酸(8218)做为流动相,流速为1.0 mL.min-1,检测波长254 nm。大黄素在0.010 4～0.332 8μg,大黄酚在0.009 8～0.313 6μg之间呈良好的线性关系,大黄素平均回收率为99.15%;大黄酚平均回收率为99.12%。结论:该法简便、准确、专属性强,可作为小儿增食片质量控制方法。

Objective：To establish the quality control standards for Xiao er zengshi tablets.Methods：Semen cassiae and Fructus Crataegi and Radix et Rhizoma Glycyrrhizae in Xiao er zengshi tablets were identified by TLC.Results：Emodin and chrysophanol were determined by HPLC,and using venusil XBP-C18 column（4.6 mm×250 mm,5 μm）,the mobile phase was a mixture of methanol-0.1% phosphoric acid solution（8218）,the flow rate was 1.0 mL·min-1,the wavelength was 254 nm,Emodin and Chrysophanol showed a good linear relationship over the range of 0.010 4-0.332 8 μg and 0.009 8 μg-0.313 6 μg.The average recovery of emodin was 99.15%,chrysophanol was 99.12%.Conclusion：The methods of identification and quantification were accurate,realizableand reproducible.It can be used effectively for the quality control of Xiao er zengshi tablets.