40份药品说明书中含醇辅料标注情况与安全性分析

目的：了解药品说明书中含醇辅料信息的标注情况,为合理使用药品提供参考。方法：根据《药品说明书和标签管理规定》和《化学药品和治疗用生物制品说明书规范细则》,对某院有使用记录的1 587份药品说明书"主要成分"、"辅料"及"注意事项"等项目中有关含醇辅料的标注信息进行统计,并分析筛选出药品说明书中各项下有关辅料含醇的安全性信息。结果：本次调查的1 587份药品说明书中明确标注了含醇辅料信息的药品说明书40份,占调查总数的2.52%。其中辅料含醇信息标注在"辅料"项下的药品说明书36份,标注在"主要成分"项下的药品说明书2份,标注在"包装"项下的1份以及1份药品未做标注,仅在"注意事项"中提及对酒精过敏者慎用。结论：药品说明书中关于含醇辅料信息及安全性信息的标注不规范,建议应对含醇辅料、含量标示及安全性信息等项目进行规范性标注。

Analysis of the labeling and safety of alcoholexcipients in 40 pharmaceutical instructions

OBJECTIVE To understand the labeling information of alcohol excipients in the pharmaceutical instructions of our hospital, provide a reference for the rational use of drugs.METHODS According to "Management Regulations of Drug Instructions and Labels" and "Specifications for Chemical and Therapeutic Biological Products", records of 1 587 drugs with instructions of "major ingredient","excipeints" and "precautions" related to alcohol containing materials were summarized to screen the safety information for alcohol containing excipients.RESULTS Of 1 587 drug instructions in this survey, 40 clearly labeled the information of the alcohol excipients, accounting for 2.52%, including 36 instructions with information on alcohol in "excipients", 2 in "major ingredient", 1 in "package" and 1 not labeled but only mentioned precautious use in patients allergic to alcohol in "precautions".CONCLUSION The labeling information of alcohol containing excipients and safety is not standardized. It is suggested to standardly label the information for alcohol containing excipients, content and safety.