Objective To provide references for rational use of Chinese patent medicine (CPM). Methods The package inserts of 143 CPM which were prescribed in our hospital were set as subjects, and the contents were analyzed according to pregnancy contraindication stated in Chinese Pharmacopoeia (2015 edition). Results Among the 143 CPM, there were 74 CPM which had the contraindication labels. Only 17 CPM contained prohibited compositions and 33 CPM contained caution compositions. There were 21 CPM which had no prohibited compositions and 3 CPM had prescription confidentiality. But the contraindication labels of only 25 CPM matched with their compositions. The rest did not match with their compositions. Conclusion Some package inserts of CPM about pregnancy contraindication exist content missing and description irregularities. The drug regulatory departments should further strength the supervision and management, and improve the quality of package inserts.%目的 为合理使用中成药提供参考.方法 以我院现有143个中成药品种的药品说明书为调查对象,根据2015年版《中华人民共和国药典》关于妊娠禁忌的要求对药品说明书内容进行分析.结果 143个中成药中有禁忌标注者74个,其中含有禁用成分者17个,含有慎用成分者33个,不含禁忌成分者21个,处方保密者3个;其中只有25个禁忌标注与所含成分相符,其余标注与所含禁忌成分不符.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,监管部门应进一步加强监督管理,不断提高说明书质量.
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