牛黄镇惊丸薄层色谱质控方法的系统研究和应用

Comprehensive evaluation of TLC system for quality control of Niuhuang Zhenjing pills

目的:完善牛黄镇惊丸薄层鉴别方法,实现对产品质量的综合评价。方法:在现行《中华人民共和国药典》2015年版一部牛黄镇惊丸标准的基础上,修订甘草次酸薄层鉴别法。新增防风、薄荷和钩藤3项薄层鉴别项,实现冰片、薄荷、防风的一测多评。同时,采用Chem Pattern软件对所得薄层色谱图进行系统分析,形成多种成分的共有模式,综合评价产品质量,并对不同厂家的样品实现有效的区分。结果:分析发现,不同来源的牛黄镇惊丸在待测成分的有无及含量上存在较明显差异。结论:建立的分析方法可对牛黄镇惊丸的质量进行有效评价。

Objective： To improve the method of thin layer examination of Niuhuang Zhenjing pills for comprehensive evaluation and classification of the product quality. Methods： Based on Pharmacopoeia standard of Niuhuang Zhenjing pills,the thin layer chromatograph of glycyrrhetic acid was revised. The thin layer chromatographs of Saposhnikoviae radix,Uncariae ramulus cum uncis and Menthae haplocalycis herba were added. All of Borneol,Saposhnikoviae radix and Menthae haplocalycis herba could be detected simultaneously. Chem Pattern software was used to systematically analyze the obtained thin layer chromatograms to form a common model of multiple components. It could comprehensively evaluate product quality,and achieve effective classification among enterprises.Results： The results showed that there were significant differences between the enterprise A and B in presence or absence of the measured components. Conclusion： The analytical method established in this study can classify and evaluate the quality of the product effectively.