氨磺必利片关键指标表征和质量评价  

Characterization of critical properties and quality evaluation of Amisulpride tablets

作　　者：聂倩兰 程刚[1] NIE Qianlan;CHENG Gang(School of Pharmacy,Shenyang Pharmaceutical University,Shenyang 110016,China)

机构地区：[1]沈阳药科大学药学院,辽宁沈阳110016

出　　处：《中国药剂学杂志(网络版)》2025年第1期9-21,共13页Chinese Journal of Pharmaceutics:Online Edition

摘　　要：目的建立仿制药氨磺必利片体外关键质量评价体系,以有效提高临床试验的通过率。方法参照《NMPA化学药物研究和评价相关指导原则》《中华人民共和国药典》(2020年版)及《英国药典》,对自研氨磺必利片及原研制剂的药物静态分布、微观结构形貌和溶出行为进行表征,并进行临床生物等效性预试验研究。结果中试规模生产工艺稳定可控,各质量性质、药物分布、微观形貌及体外溶出行为均与原研制剂相似,且体内生物等效。结论基于逆向剖析技术开发仿制制剂,并进行科学详细的关键质量特性对比研究,可以大幅提升仿制药研发效率及生物等效性成功率。Objective To establish an in vitro critical quality evaluation system for generic amisulpride tablets to effectively improve the pass rate of clinical trials.Methods With reference to the relevant guiding principles for the research and evaluation of chemical drugs by NMPA,Chinese Pharmacopoeia and British Pharmacopoeia,the static distribution,microstructural morphology and in vitro dissolution behaviors of self-developed amisulpride tablets and the reference product were characterized,whilst clinical bioequivalence test was studied.Results The pilot scale product showed that the developed process was stable,reproducible and controllable.The critical quality properties,drug distribution,microscopic morphology and in vitro dissolution behaviors were similar to that of the reference product,and they were bioequivalent in vivo.Conclusion This paper establishes a scheme of generic drug development based on reverse engineering technology and via scientific and reasonable comparative studies on critical quality characteristics,which will greatly improve the efficiency of drug development and the pass rate of bioequivalence test.This study aims to provide experimental basis and ideas for establishing a key quality evaluation scheme for the development of generic drug.

关 键 词：氨磺必利片 关键质量特性 溶出行为 微观结构 生物等效性 

分 类 号：R94[医药卫生—药剂学]