摘要
欧洲药品局(EMA)于2017年10月发布了番泻叶和果的评估报告及其草药专论修订草案。介绍这3个文件的核心内容,包括因长期滥用的不良反应以及潜在的遗传毒性和致癌性,偶发便秘用药持续时间不得超过1周,禁用于妊娠和哺乳期以及12岁以下儿童,以期对我国番泻叶及其制剂的临床合理使用及有效监管有所裨益。
EMA issued the revised draft assessment report and herb on senna folium and senna fructus in October 2017.This paper introduced its core content,including medication duration of not more than 1 week in occasional constipation,contraindications for pregnancy and lactation as well as children under 12 years old,because of adverse reactions due to long-term abuse and potential genotoxicity and carcinogenicity.Look forward to benefit the clinical rational use and supervision of Sennae Folium and its preparations in China.
作者
萧惠来
XIAO Huilai(Center for Drug Evaluation, China Food and Drug Administration, Beijing 100038, Chin)
出处
《药物评价研究》
CAS
2018年第2期182-188,共7页
Drug Evaluation Research
关键词
欧洲药品局
番泻叶
番泻果
评估报告
欧盟草药专论
EMA
senna folium
senna fructus
assessment report
European Union herbal monograph
