现行法规下化学药品稳定性研究与有效期管理分析  

Analysis of Stability Studies and Expiration Date Management of Chemical Medicines Under Current Regulations

作　　者：周雅欣 丁浩 王敏 解竺澎 储藏 王伯阳 ZHOU Yaxin;DING Hao;WANG Min;XIE Zhupeng;CHU Cang;WANG Boyang(Administration for Drug and Instrument Supervision and Inspection of PLAJLSF,Beijing 100078,China;College of Pharmacy,Changzhi Medical College,Shanxi Changzhi 046000,China)

机构地区：[1]联勤保障部队药品仪器监督检验总站,北京100078 [2]长治医学院药学院,山西长治046000

出　　处：《中国医药导刊》2025年第3期301-307,共7页Chinese Journal of Medicinal Guide

摘　　要：化学药品作为市场占比最大的药物,其质量安全一直受到高度重视。本研究通过梳理上市前注册申请和上市后监督管理中涉及稳定性研究和有效期监管的国家现行法规和指导原则等文件,归纳汇总了上市前后化学药品稳定性研究技术要点。影响化学药品稳定性的主要因素包括药品包装材料、温度、湿度、光、极端条件和储存时间等,特殊剂型需结合剂型特点增设质控项目。上市后化学药品有效期管理贯穿生产、流通、使用等各环节,通过开展持续稳定性考察和建立药品全流程追溯体系,最大程度保证药品质量可控。当药品有效期确需调整时,应按照上市后变更有关法规文件完成有效期变更。此外,为进一步完善应急救援等特殊情况下化学药品质量管理体系建设,建议监管部门鼓励制药企业适时公开稳定性数据,加强应急储备药品在极端环境下的质量研究,完善新型制剂技术指导原则,以促进化学药品全链条全时域质量监管。As the chemical medicines with the largest market share,the quality and safety of chemical medicines have always been highly valued.This paper summarizes the technical points of stability study of pre-market and post-market chemical drugs by combing the existing national regulations and documents.The main factors affecting the stability of chemical medicines include drug packaging materials,temperature,humidity,light,extreme conditions and storage time,etc.Special formulations need to be combined with the characteristics of the formulation to set up additional quality control programs.The management of the expiration date supervision of postmarketing chemical medicines is carried out throughout the production,circulation and use,etc.The controlled quality of medicines can be maximized by conducting continuous stability inspections and establishing a full-process traceability system for medicines.When the expiration date of the medicine really needs to be adjusted,the change should be completed in accordance with the post-market change regulatory documents.In addition,in order to further improve the construction of the chemical medicine quality management system in the emergency rescue,it is recommended that regulatory units encourage pharmaceutical companies to disclose stability data in a timely manner,strengthen research on the quality of emergency stockpile drugs in extreme environments,and enrich the technical guidelines for new formulations,so as to promote chemical medicine quality supervision in the whole chain and in the whole time domain.

关 键 词：化学药品 稳定性研究 有效期管理 药品应急管理 

分 类 号：R95[医药卫生—药学]