《中国药典》避光标准的实施效果分析及对策

Analysis of the Implementation of Pharmacopeia Standard of Avoiding Light and Countermeasures

目的:调查《中华人民共和国药典》中“避光”标准的实施情况。方法:计算机检索万方、知网数据库2017年1月至2019年10月期间发表的涉及避光概念的论文、药典中“临床用药须知”(2015版)中光不稳定药品的使用注意事项、光不稳定药品的说明书进行汇总分析,调查其中避光概念与药典标准的相符率。结果:在医疗机构科教机构、药检机构发表的论文中,对避光的概念理解有误的比例分别为66.67%、37.5%、20%;“临床用药须知”中2个药品资料中提到的避光概念不准确;2015年以后修订的药品说明书中,3份药品说明书关于药品使用的光环境要求模糊。结论:避光标准的实施存在多方面的问题,需进行规范和矫正。

Objective:The purpose of our research is to investigate the implementation of the"light avoidance"standard in the Pharmacopoeia of the People's Republic of China.Methods:Papers related to the concept of light avoidance in CNKI,Wanfang and other databases from January 2017 to October 2019,notes on the use of light unstable drugs in the Clinical Medication Guidelines of the People's Republic of China(2015 edition)and package inserts of light unstable drugs were investigates for the compliance rates of their concepts of light avoidance to the pharmacopoeia standard.Results:For the published papers,66.67%by medical institutions,37.5%by drug inspection agencies and 20%by scientific research institutions misunderstood the concept of light avoidance.The concept of light avoidance mentioned in two drugs in the"Clinical Medication Guidelines of the People's Republic of China"(2015 Edition)was inaccurate.The specifications on the light environment of drug use were vague in three package inserts revised after 2015.Conclusion:There are still many problems in the implementation of the light avoidance standard,which needs to be corrected.