中国药典2020年版妊娠禁忌相关中成药的分析与思考

Analysis and Reflection on Chinese Patent Medicine Related to Pregnant Contraindications in the Chinese Pharmacopoeia 2020 Edition

目的整理和分析中国药典2020年版收载的妊娠期、哺乳期中成药,为临床药物咨询相关工作提供参考。方法对中国药典2015年版及2020年版一部收载的中成药所涉及的妊娠禁忌相关描述及用药注意事项进行统计、比较、分类和归纳,明确中国药典2020年版收载的妊娠、哺乳期中成药变化情况。结果中国药典2020年版较中国药典2015年版新增54种妊娠禁忌相关中成药,其中新增妊娠期患者慎用中成药14种,忌用中成药13种,禁用中成药20种,新增哺乳期患者禁忌用药7种;中国药典2020年版一部收载的含有禁用中药饮片但注意项下无禁忌说明的中成药共有134种,涉及的禁用中药饮片有22种;同一处方不同剂型的品种注意项下标注的妊娠禁忌不统一的中成药共有4种。结论中国药典2020年版所收载的妊娠、哺乳期中成药较2015年版更加具体,但仍存在饮片、中成药及同一处方不同剂型中成药用药禁忌不统一的情况,建议有关部门尽量建立统一的妊娠、哺乳期用药禁忌标准,为中成药的合理运用提供法律依据。

OBJECTIVE To sort out and analyze the Chinese patent medicinal details of pregnancy and lactation period,which were included in Chinese Pharmacopoeia 2020 Edition,so as to provide reference for clinical drug consultation.METHODS The description of pregnancy contraindications related to all proprietary Chinese patent medicines in Chinese Pharmacopoeia 2015 Edition and 2020 Edition were statistically,compared,classified and summarized to clarify the changes of Chinese patent medicines for pregnancy and lactation period included in Chinese Pharmacopoeia 2020 Edition.RESULTS The Chinese Pharmacopoeia 2020 Edition added 54 Chinese patent medicines related to pregnancy contraindications compared with the Chinese Pharmacopoeia 2015 Edition,in gestation related new drugs,14 species were administrated with caution for pregnant women,13 species were defined to contraindication in pregnancy,and 20 species were divided into“forbidden in pregnancy”domain.Another more,7 types were related to lactation contraindication additional.In the Chinese Pharmacopoeia 2020 Edition(Volume I),134 kinds of Chinese patent medicines containing prohibited ingredients but without contraindications were included,and 22 kinds of prohibited ingredients were involved.There were 4 Chinese patent medicines involved in different pregnancy contraindications marked under the attention item of the same prescription and different dosage forms.CONCLUSION Chinese patent medicines for pregnancy and lactation period in Chinese Pharmacopoeia 2020 Edition are more specific than those in the 2015 edition,but there are still different contraindications in decoction pieces,Chinese patent medicines and different dosage forms of Chinese patent medicines in the same prescription.It is suggested that the relevant departments should try their best to establish a unified contraindication standard for pregnancy and lactation period,so as to provide legal basis for the rational use of Chinese patent medicines.