基于对照制剂的牛黄清胃丸全处方鉴别研究和等级初评价

Whole-ingredient identification and primary grade evaluation of Niuhuang Qingwei Pills based on reference drug

目的对牛黄清胃丸进行全处方鉴别和等级初评价。方法对现行标准规定的显微特征进行总结,新建了番泻叶、石膏的显微鉴别方法和人工牛黄、大黄、冰片的薄层鉴别方法,改进了薄荷的显微鉴别方法,实现了17个药味的全处方鉴别。研制牛黄清胃丸对照制剂,将其作为随行对照应用于样品的全处方鉴别,对制剂的质量等级进行初评价。结果 18个厂家的48批样品的等级初评价结果为10批优质,37批合格,1批不合格。结论所建方法准确、简便、客观,可更加全面地控制牛黄清胃丸的质量,并为进一步建立药品等级标准提供了研究思路和实验基础。

Objective To identify whole ingredients in Niuhuang Qingwei Pills(NQP) and give primary grade evaluation of NQP. Methods Firstly, microscopic characteristics specified by the statutory standard of NQP were summarized. Then new microscopic identification methods were established for Sennae Folium and Gypsum Fibrosum while new thin layer chromatography(TLC) identification methods were established for Bovis Calculus Artifactus, Borneolum Syntheticum, and Rhei Radix et Rhizoma. In addition, microscopic identification method for Menthae Haplocalycis Herba was improved. In this way, whole-ingredient identification of 17 materials were realized. NQP reference drug was developed and applied as accompanying control in whole-ingredient identification and primary grade evaluation of the samples. Results According to the results of 48 samples from 18 manufactures by primary grade evaluation, 10, 37, and 1 samples were classified as superior, qualified, and unqualified, respectively. Conclusion The proposed methods are accurate, simple, and objective, which offers a more comprehensive approach for quality control of NQP. And the methods provide research strategy and experimental basis for further work on establishment of grade standard.