中国当代医药2020年8月第27卷第23期CHINA MODERN MEDICINE Vol.27No.23August 2020·调查研究·
夸张的词语
161种中成药妊娠期及哺乳期妇女用药标注
调查分析苏轼写的古诗
于丽君1
马诗瑜2▲
1.上海市松江区方塔中医医院，上海201699;
食品安全作文2.上海交通大学医学院附属瑞金医院，上海200025
[摘要]目的调查分析上海交通大学医学院附属瑞金医院(以下简称为“瑞金医院”)中成药说明书中关于妊娠期及哺乳期妇女用药标注情况，为进一步加强妊娠期及哺乳期妇女合理用药、指导妊娠期及哺乳期妇女安全用药提供参考依据。方法2019年1月，收集瑞金医院调剂药房中成药说明书共161份，对有关妊娠期及哺乳期妇女用药标注情况进行统计分析，按照不同分类方法进行比较，同时对照2015年版《中华人民共和国药典》(简称“《中国药典》”)一部下“成方制剂”(425~1748页)中有关妊娠期及哺乳期妇女用药标注
情况，并进行比较。结果161种药品说明书中，明确标注禁用的有44种，忌用的有9种，慎用的有35种，在医生指导下应用的有15种，尚国家法定假日有哪些天
如何打排球不明确的有58种；被《中国药典》收录为禁用的有17种，忌用的有8种，慎用的有15种。《中国药典》中未提及妊娠相关用药信息的50种，未被《中国药典》收录的中成药尚有71种。除此之外，被收录的20种中成药妊娠用药标识信息与说明书中的妊娠用药信息不符；有45.3%的中成药说明书中在妊娠用药信息标注中语焉不详,31.1%的中成药在《中国药典》中妊娠用药信息未提及,12.4%的中成药在《中国药典》中收录的妊娠用药信息与说明书中妊娠用药信息不符的情况。结论现实使用的中成药说明书中有关妊娠用药信息标注存在语焉不详或未提及或与《中国药典》收载说明书信息不符的情况，国家食品药品监督管理部门、药品生产企业和医疗卫生机构三方人员均应予以足够重视，积极采取相对应措施予以改善，以指导药品临床安全使用。
[关键词]中成药；说明书；妊娠；合理用药
[中图分类号]R969[文献标识码]A [文章编号]1674-4721(2020)8(b)-0171-06Investigation analysis of labeling on drug u for pregnant and lactating women in 161kinds of traditional Chine patent medicine新年祝福语领导
YU Li-Jun 1MA Shi-yu 2▲
周杰伦琴伤1.Fangta Traditional Chine Medicine Hospital of Songjiang District in Shanghai City,Shanghai 201699,China;
2.Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine,Shanghai 200025,China [Abstract]Objective To investigate and analyze the medication labeling of pregnant and lactating women in the man⁃ual of traditional Chine patent medicine from Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine (referred to as the "Ruijin Hospital"),and to provide the reference for further strengthening the rational medi⁃cation of pregnant and lactating women,and guiding the safe medication of pregnant and lactating women.Methods A total of 161instructions for traditional Chine patent medicine from the pharmacy of Ruijin Hospital in January 2019were collected,the medication labeling of pregnant and lactating women was statistically analyzed.The comparisons were made according to different classification methods,and the "medical formulations"under the 2015version of the Pharmacopoeia of the People′s Republic of China (referred to as the "Chine Pharmacopoeia ")(425-1748pages)re⁃garding the labeling of pregnant and lactating women.Results Of the 161drug instructions,44of them were clearly marked as prohibited,9of them were taboo,35of them were ud with caution,15of them were should be ud under the guidance of doctors,and 58of them were unclear.There were 17species that were banned
by the Chine Pharma⁃copoeia ,8species were forbidden,and 15species were ud with caution.A total of 17of them were listed by the Chine Pharmacopoeia as prohibited,8of them were taboo,15of them were cautious,and 50of them were not men⁃
tioned in the Chine Pharmacopoeia .There were still 71kinds of traditional Chine patent medicine not listed in the Chine Pharmacopoeia .In addition,the 20kinds of Chine patent medicines included in the pregnancy drug identification information didn′t match the preg⁃
nancy medication information in the instructions.In the [作者简介]于丽君(1984-)，女，本科，主管中药师，研究方
向：医院药学
▲通讯作者：马诗瑜(1990-)，女，硕士，主管中药师，研究方向：临床药学、中药学、临床药理学171定点医院查询
