香砂养胃丸(大蜜丸)质量标准改进研究

目的:改进香砂养胃丸(大蜜丸)的质量控制标准。方法:针对原标准存在的部分检测方法专属性不强,重复性差,缺少主要药味的鉴别或含量测定项目,部分含量测定方法不完善等问题,基于2个厂家提供的4批样品,改进其质量控制标准。结果:增加了陈皮、枳实、豆蔻及砂仁的显微鉴别项目。修订了木香、姜厚朴、醋香附的薄层色谱法鉴别项目。删除了陈皮、枳实的薄层色谱鉴别项目。增加了甘草的薄层色谱法鉴别项目。增加了陈皮、枳实中橙皮苷的高效液相色谱法含量测定项目。修订了厚朴酚、和厚朴酚的高效液相色谱法含量测定项目。结论:改进后的方法简便、准确度高,能更有效控制香砂养胃丸(大蜜丸)的质量。

Improvement on the Quality Control Standard of Xiangsha Yangwei Pills (Honey Pills)

Objective:To improve the quality control standard of Xiangsha Yangwei pills (honey pills).Methods:Aiming at the problems existing in original standard,such as specificity is not strong in some of the detection methods,the lack of identification or content determination projects of main medicinal herbs,part of content determination methods are not perfect.So we improved the quality control standard of Xiangsha Yangwei pills (honey pills) base on the 4 batches provided by the 2 manufacturers.Results:We increased the microscopic identification project of tangerine peel,Fructus aurantii Immaturus,cardamom and Amomum villosum Lour;revised the thin layer chromatography identification project of Radix Aucklandiae,Jiang Houpu,vinegar Cyperus rotundus;deleted the thin layer chromatography project of tangerine peel and Fructus aurantii Immaturus;increased the thin layer chromatography project of Glycyrrhiza uralensis and the HPLC content determination method of hesperidin in Citri reticulatae pericarpium and Aurantii fructus immaturus;revised the HPLC content determination project of magnolol,honokiol.Conclusion:The improved method is simple and accurate,compared to the orginal method,which could be better for quality control of Xiangsha Yangwei pills (honey pills).