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

ABSTRACT

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.