治疗用A型肉毒毒素药物研究进展及药学审评思考  

Research progress and pharmaceutical evaluation of therapeutic botulinum toxin type A drugs

作　　者：程速远 胡莹莹 韦薇 CHENG Su-yuan;HU Ying-ying;WEI Wei(Center for Drug Evaluation,National Medical Products Administration,Beijing 100076,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100076

出　　处：《中国新药杂志》2025年第6期631-642,共12页Chinese Journal of New Drugs

摘　　要：近年来,治疗用A型肉毒毒素药物逐渐成为研发热点,申报量逐年增加。由于治疗用肉毒毒素药物分子具有复杂性、高活性与治疗窗较窄等特点,其质量研究是药学开发与评价的主要难点。本文以国内外有代表性的文献为基础,结合审评实践,介绍国内外治疗用肉毒毒素药物开发的最新研究进展及药学评价思考,并就此类产品药学评价(结构特点、菌株选择、生产工艺与质量控制等)提出一些思考和建议。In recent years,therapeutic botulinum toxin type A drugs have gradually become a research and development hot spot,and the number of applications has been increasing year by year.Due to the complexity,high activity,and narrow therapeutic window,their quality research is the main challenge in pharmaceutical development and evaluation.Based on representative literature at home and abroad,combined with review practice,this article introduces the latest research progress and pharmaceutical evaluation considerations in the development of therapeutic botulinum toxin drugs at home and abroad.Some thoughts and suggestions are also put forward on the pharmaceutical evaluation of such products,including structural characteristics,strain selection,production process,and quality control.

关 键 词：治疗用肉毒毒素 质量控制 生物学活性 研究进展 

分 类 号：R95[医药卫生—药学]