对三版《中国药典》一部含黄柏或关黄柏制剂质量控制的探讨  

Quality Control of Preparations with Phellodendron chinense Schneid or Phellodendron amurense Rupr in Three Editions of Chinese Pharmacopoeia

作　　者：单会娇 段立爽 齐歆 杨文 Shan Huijiao Duan Lishuang Qi Xin Yang Wen(Huludao Institute for Drug and Food Control, Huludao 125000, China)

机构地区：[1]葫芦岛市食品药品检验检测中心,葫芦岛125000

出　　处：《中国药事》2016年第11期1136-1142,共7页Chinese Pharmaceutical Affairs

摘　　要：目的:从完善黄柏或关黄柏制剂的质量控制出发,为《中国药典》一部的修订提出一些建议。方法:对三版《中国药典》一部(2005年版至2015年版)含黄柏或关黄柏制剂的质量控制情况进行分析。结果:随着黄柏或关黄柏药材薄层鉴别(TLC)及含量测定指标的变化,含黄柏或关黄柏制剂的质量控制情况并未发生明显变化,尤以薄层色谱鉴别(TLC)最为明显。而在实际检验工作中,黄柏和关黄柏的药材、饮片以及制剂仍有混用现象。结论:通过文献检索发现,对含黄柏或关黄柏制剂的薄层鉴别(TLC)及含量测定指标随黄柏或关黄柏药材变化是具有可行性的。Objective： To provide suggestions for revision of Chinese Pharmacopoeia from the aspect of optimizing quality control of preparations with Phellodendron chinense Schneid and Phellodendron amurense Rupr. Methods： The quality control of preparations with Phellodendron chinense Schneid or Phellodendron amurenseRupr in three editions of Chinese Pharmacopoeia was studied. Results： The quality control of preparations with Phellodendron chinense Schneid and Phellodendron amurense Rupr did not change significantly along with the change of indicators for the determination of TLC（TLC）. In the actual inspection, we found that Phellodendron chinense Schneid and Phellodendron amurense Rupr were mixed. Conclusion： Through literature review, the TLC was feasible for the change detection of Phellodendron chinense Schneid or Phellodendron amurenseRupr, which could help improve the quality control of preparations with Phellodendron chinense Schneid or Phellodendron amurense Rupr.

关 键 词：《中国药典》 黄柏 关黄柏 盐酸小檗碱 质量控制 

分 类 号：R921.2[医药卫生—药学]