161种中成药妊娠期及哺乳期妇女用药标注调查分析

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Abstract Objective To investigate and analyze the medication labeling of pregnant and lactating women in the manual of traditional Chinese 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 medication of pregnant and lactating women, and guiding the safe medication of pregnant and lactating women.Methods A total of 161 instructions for traditional Chinese patent medicine from the pharmacy of Ruijin Hospital in January 2019 were 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 2015 version of the Pharmacopoeia of the People′s Republic of China (referred to as the "Chinese Pharmacopoeia") (425-1748 pages) regarding the labeling of pregnant and lactating women.Results Of the 161 drug instructions, 44 of them were clearly marked as prohibited, 9 of them were taboo, 35 of them were used with caution, 15 of them were should be used under the guidance of doctors, and 58 of them were unclear.There were 17 species that were banned by the Chinese Pharmacopoeia, 8 species were forbidden, and 15 species were used with caution.A total of 17 of them were listed by the Chinese Pharmacopoeia as prohibited, 8 of them were taboo, 15 of them were cautious, and 50 of them were not mentioned in the Chinese Pharmacopoeia.There were still 71 kinds of traditional Chinese patent medicine not listed in the Chinese Pharmacopoeia.In addition, the 20 kinds of Chinese patent medicines included in the pregnancy drug identification information didn′t match the pregnancy medication information in the instructions.In the instructions of traditional Chinese patent medicine, 45.3% of them were unclear in safety of medication for pregnant women, 31.1% of them were not mentioned in the Chinese Pharmacopoeia about safety of medication for pregnant women, and only 12.4% of them included in the Chinese Pharmacopoeia about safety of medication for pregnant women didn′t match the pregnancy medication information in the instructions.Conclusion In the actual use of traditional Chinese patent medicine, the information about pregnancy medication labeling is unclear or not mentioned or does not match the information contained in the Chinese Pharmacopoeia.The three parties of the State Food and Drug Administration,drug manufacturing enterprises and medical and health institutions should pay enough attention to it and actively take corresponding measures to improve it, so as to guide the clinical safe use of drugs.

Key words： Traditional Chinese patent medicine Instruction Pregnancy Reasonable medication

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	YU Li-Jun
	MA Shi-yu

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YU Li-Jun,MA Shi-yu. Investigation analysis of labeling on drug use for pregnant and lactating women in 161 kinds of traditional Chinese patent medicine[J]. 中国当代医药, 2020, 27(23): 171-175转179.

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http://dangdaiyiyao.com/EN/ OR http://dangdaiyiyao.com/EN/Y2020/V27/I23/171

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