中药化学对照品标定常见问题分析  

Analysis of Common Problems in Standardization of Traditional Chinese Medicine Chemical Reference Substance

作　　者：刘静[1] 何轶[1] 张聿梅[1] 戴忠[1] 马双成[1] 

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《中国药事》2017年第10期1171-1175,共5页Chinese Pharmaceutical Affairs

摘　　要：目的:分析中药化学对照品标定过程中的常见问题,探讨相应的解决方案。方法:根据标定过程中结构鉴定、纯度分析、水分测定、残留溶剂、无机盐、定值等环节存在的不同问题进行个性化分析,分类总结。结果:通过对中药化学对照品标定过程中常见问题的分析,提出了相应的解决方案。结论:有关问题的解决为中药化学对照品的标定和使用提供了有利的技术支持。Objective To analyze the common problems in standardization of traditional Chinese medicinechemical reference substance （TCMCRS） and to discuss the corresponding solutions. Methods： Differentproblems existing during the process of standardization, such as structural identification, purity analysis,moisture determination, residual solvent, inorganic salt, and calibration assignment were specifically analyzed,classified and summarized. Results： The common problems in standardization of TCMCRS were summarizedand corresponding solutions were put forward. Conclusion： Solutions to the problems provided strong technicalsupport for the standardization and practical use of TCMCRS.

关 键 词：中药化学对照品 结构鉴定 标定赋值 质量平衡法 核磁共振法 

分 类 号：R927[医药卫生—药学]