关键词: font-size:medium, ">中成药；说明书；妊娠禁忌；中国药典；临床用药须知

Abstract: Objective： To analysis the instruction of pregnancy contraindication of Chinese patent medicine (CPM), and provide reference for rational drug use. Methods: Package inserts of CPM used in our hospital during January to June 2020 were collected. Referring to the pregnancy contraindicated materials and decoction pieces in Chinese Pharmacopoeia（part 1，2020 edition）, and based on “note” item in Chinese Pharmacopoeia and Chinese Pharmacopeia Guidelines for Clinical Drug Use, problems existing in pregnancy contraindication instruction in package inserts of CPM were compared and analyzed. Results: For 273 kinds of CPM used in our hospital, 96 were included in Chinese Pharmacopoeia and 106 were included in Chinese Pharmacopeia Guidelines for Clinical Drug Use. The rate of inclusion was relatively low. Only 8 kinds of CPM′s ingredients were in complete accordance with the instructions of pregnancy contraindication in package inserts, Chinese Pharmacopoeia and Chinese Pharmacopeia Guidelines for Clinical Drug Use, showing poor concordance. Conclusion: The pregnancy contraindication instructions are seriously missing in package inserts of CPM, and the patient's situation needs to be taken into consider in clinical medication during pregnancy based on the various datas to give individualized suggestions.
   

Key words: font-size:medium, ">Chinese patent medicine； Package inserts； Pregnancy contraindications； Chinese Pharmacopoeia； Chinese Pharmacopeia Guidelines for Clinical Drug Use