摘要
目的:建议完善《中国药典》试药通则,提高药品检验结果的准确性。方法:结合药品检验工作,比较《中国药典》试药通则和国家化学试剂标准以及USP试药通则的差异。结果:《中国药典》试药通则相较于USP的项目和要求均较为简单,且与国家化学试剂标准存在着一定的差异,不利于试药质量的评价和在实际工作中的试药选择。结论:应尽快完善《中国药典》试药通则中的相关内容,确保选用的试药符合药品检验检测的要求。
Objective:Improving reagent chapter of ChP to ensure the accuracy of drug test results.Methods:The differences between ChP,National standards of chemical reagents and USP were compared in combine with drug test practice.Results:The items and requirements of reagent chapter in ChP are simple compared to USP,and have some differences with the national standards of chemical reagent.That is not conducive to quality evaluation of reagent and judgment in the practice.Conclusion:It is necessary to improve reagent chapter of ChP for achieving the drug test needs.
作者
吴越
王玉
张锐
姚令文
WU Yue;WANG Yu;ZHANG Rui;YAO Lingwen(Wuxi Center for Drug Safety Control,Wuxi 214028,China;Jiangsu Institute for Food and Drug Control,Nanjing 210019,China;Jiangxi university of traditional Chinese medicine,Nanchang 330004,China;National Institutes for Food and Drugs Control,Beijing 100050,China)
出处
《中国药品标准》
CAS
2020年第4期339-344,共6页
Drug Standards of China
关键词
试药
化学试剂
国家标准
美国药典
reagents
chemical reagent
Chinese national standards
USP
