中成药说明书妊娠禁忌调查分析-中国药房.pdfVIP

·中药视窗· 中成药说明书妊娠禁忌调查分析 ＊ 李晓平 ，张长平（航空总医院，北京 100012） 中图分类号 R283；R979.2 文献标志码 B 文章编号 1001-0408（2013）03-0285-04 DOI 10.6039/j.issn.1001-0408.2013.03.33 摘 要 目的：为合理使用中成药提供参考。方法：以我院现有的以及使用过的190种中成药的说明书为调查对象，根据2010年 版《中国药典》中关于妊娠禁忌的要求对说明书内容进行分析判断。结果：190种中成药中，含有禁用成分的34种，含有慎用成分 的64种，但其中只有27种禁忌标注与所含成分相符，其余的无禁忌标注、或标注与所含禁忌成分不相符、或标注与《中国药典》不 一致。有19种中成药中不含禁忌成分但说明书中却有禁忌标注。结论：部分中成药说明书关于妊娠禁忌存在内容缺失、描述不 规范现象，药品监管部门应进一步加强监督管理，不断提高说明书质量，完善《中国药典》妊娠禁忌用药的范围。 关键词 中成药；说明书；《中国药典》；妊娠禁忌；调查分析 Analysis of Pregnancy Contraindication in Package Inserts of Chinese Patent Medicine LI Xiao-ping ，ZHANG Chang-ping（General Aviation Hospital ，Beijing 100012，China ） ABSTRACT OBJECTIVE ：To provide reference for rational use of Chinese patent medicine （CPM ）. METHODS ：The package in- serts of 190CPM which were prescribed in our hospital were analyzed in term of the content according to pregnancy contraindica- tion stated in Chinese Pharmacopoeia （2010 edition）. RESULTS ：Among 190CPM ，there were 34 CPM which contained prohibit- ed composition and 64which contained caution composition. But the contraindication labels of only 27 CPM were match with their composition. The rest had no contraindication labels or were not match with their composition or differ from Chinese Pharmacopoe- ia. In addition ，the package inserts of 19 CPM contained pregnancy contraindication labels but not prohibited composition. CON- CLUSION ：Some package inserts of CPM exist content missing and description irregularities. The drug regulatory departments should further strengthen the supervision and management. It is necessary to improve and enhance the quality of prescription and to improve the pregnancy contraindication contents of Chinese Pharmacopoeia. KEY WORDS Chinese patent medicine ；Package inserts ；Chinese Pharmacopoeia ；Pregnancy contraindication ；Investigation and analysis