科学把握药典定位 创新品种遴选机制

Innovation of the Selection Procedure for the New Monograph of Chinese Pharmacopoeia Based on its Orientation

目的:分析药典品种遴选工作存在的问题,为完善药典品种遴选工作提出建议。方法:对药典功能定位进行分析,系统梳理和总结目前品种遴选工作中存在的问题。结果:药典品种遴选过程中存在着遴选原则不明确、遴选机制不完善、遴选程序不合理、技术要求不明确等问题。结论:应通过细化遴选原则、完善遴选程序、明确技术要求、改进评价方式以及加强基础性工作等方式,完善药典品种遴选工作。

Objective:To analyze the problems in the selection procedure of monograph for Chinese Pharmacopoeia and to put forward suggestions for improving this selection procedure.Methods:The function and orientation of the pharmacopeia were analyzed and the problems existed in the selection procedure were thoroughly summarized.Results:There were many problems in the selection procedure of monograph for Chinese pharmacopoeia.For example,the selection principles were not clear,the selection mechanism should be improved,the selection procedure was unreasonable,and the technical requirements are not clear.Conclusion:The selection principles should be refined,the selection procedure should be improved,technical requirements should be clarified,the evaluation method should be improved and the informational basic work should be strengthened.