试论中药制剂规格标示的合理性及规范性  

Discussion on Rationality and Normality of Strength Marking of Traditional Chinese Medicine

作　　者：吴承云[1] 郑清明[1] 周亚莉[1] 陈勇[2] 宋民宪[2] 夏军平[3] 

机构地区：[1]四川省食品药品安全监测及评审认证中心,成都610017 [2]四川省食品药品监督管理局 [3]国家食品药品监督管理局

出　　处：《中国药事》2012年第1期47-49,共3页Chinese Pharmaceutical Affairs

摘　　要：目的探讨中药制剂规格合理规范的标示方式。方法从药品规格的核心要素及作用,结合中药制剂的安全性、有效性、质量可控性的要求,分析已上市中药制剂规格的现状及存在的问题,论述中药制剂规格的合理性及规范性。结果与结论中药制剂规格采用制成制剂的单位剂量的重量(装量),辅助标示相当于原药材量的通用表述方法及各剂型类别的规格标示方式,具有一定的合理性及规范性,有指导价值和现实意义。Objective To discuss the normal method of marking the strength of Traditional Chinese Medicine （TCM）. Methods From the role and the core factors of the strength of drug, combining with the safety, validity, and quality control of TCM, the current situation and problems of strength marking of TCM on market were analyzed. Results and Conclusion The method was reasonable that the strength of TCM should be marked with the weight （filling） of single dose and their equivalent crude drug （API）.

关 键 词：中药制剂 规格 标示 

分 类 号：R283.6[医药卫生—中药学]