中国药典2015年版颠茄草类制剂修订情况及操作要点

Operational Essentials and Revision Situations of Belladonna Products in Chinese Pharmacopoeia(2015 Edition)

目的介绍中国药典2015年版中颠茄草类制剂的修订情况。方法分析目前颠茄草类制剂存在的主要问题,对新增项目的缘由及操作要点进行探讨。结果修订的质量标准统一了检测方法,增加了特征图谱、掺伪检查等项目,修订了含量测定方法。结论修订的质量标准可更有效的控制颠茄制剂的质量。

OBJECTIVE To discuss the operational essentials and revision situations of belladonna products in Chinese Pharmacopoeia（2015 Edition）. METHODS The major problems of belladonna products were analyzed. The reason and operational essentials for the newly added procedures were also investigated. RESULTS Unitary controlling methods had been formulated for revised quality standards. HPLC specific chromatogram and method for identification of adulteration had been newly added, and quantitative methods had been revised. CONCLUSION Revised quality standards can be used for more effective control of belladonna products.