《中国药典》药品检验标准中2种常用树脂规范应用探讨  

Application of Two Common Resins in Drug Inspection Standards in the Chinese Pharmacopoeia

作　　者：王琦[1] 曾志坚[1] 何上儿 WANG Qi;ZENG Zhijian;HE Shang′er(Jiangmen Institute for Drug Control,Jiangmen,Guangdong,China 529030)

机构地区：[1]广东省江门市药品检验所,广东江门529030

出　　处：《中国药业》2021年第16期37-39,共3页China Pharmaceuticals

摘　　要：目的了解大孔吸附树脂和离子交换树脂在药品检验标准中的应用情况。方法对2015年版和2020年版《中国药典(一部)》药品检验标准中树脂的使用情况进行归纳、总结,分析存在的问题。结果《中国药典》相关检验标准中存在树脂的名称使用不规范、树脂预处理方式不明确、吸附和洗脱参数不详细等问题。结论药品标准中需进一步规范树脂的使用,以提高标准的可行性。Objective To understand the application of macroporous adsorption resin and ion-exchange resin in drug inspection standards.Methods The application of resin in the drug inspection standards in the Chinese Pharmacopoeia(2015 Edition and 2020 Edition,VolumeⅠ)was summarized and the existing problems were analyzed.Results There were some problems in the relevant inspection standards in the Chinese Pharmacopoeia,such as improper use of the name of the resin,unclear resin pretreatment methods,and inadequate adsorption and elution parameters.Conclusion The application of resin should be further standardized in the drug standards to improve the feasibility of standards.

关 键 词：《中国药典》 检验标准 大孔吸附树脂 离子交换树脂 使用规范 

分 类 号：R92[医药卫生—药学]