摘要
随着我国经济和医药产业的发展,《中华人民共和国药典》(以下简称《中国药典》)作为我国药品的法典也在不断进行修订升级,以实现完善标准体系、提升质量控制、满足临床需求、接轨国际标准等目标[1-3]。近年来无菌短货架期产品,如各种细胞和基因产品成为临床研究和疾病治疗的热点[4-5],该类产品大多具有个体化生产、低剂量产出、短效期使用、终端产品无法采取灭菌措施等特点[6-7],在微生物安全性控制上与其它类产品有着显著的差异性[8-9]。现行《中国药典》2015年版中针对细菌、霉菌和酵母菌的无菌检测需要14天,同时检验需大量产品以保证低污染产品检验的准确性。尽管药典中传统的微生物检验方法是安全可靠的金标准,但现阶段无法满足该类产品质量控制和快速放行的要求。因此,迫切需要建立科学合理的质量控制手段,以避免生产企业的巨额经济损失和患者的使用安全隐患。采取改进和创新性的替代方法,弥补现行《中国药典》中微生物检查方法,实现产品微生物的安全性需求势在必行,故本文将《美国药典》于2019年12月新增章节“<1071>无菌短货架期产品放行的快速微生物检查法:依据风险评估的方法[10]”译出,以期为短货架期产品安全检查和新版药典增订相关通则及指导原则提供借鉴和参考。
With the development of Chinese economy and the pharmaceutical industry,the Chinese Pharmacopoeia,as a code for Chinese medicines,is constantly being revised and upgraded to achieve the goals of improving the standard system,promoting quality control,meeting clinical needs,and conforming to international standards.In the recent years,sterile short-life products,such as various cell and gene products with hotspots in clinical research and disease treatment,have characterized in individualized production,low-dose output,short-term use,and terminal products cannot be sterilized,which of those products have significant differences with other types in terms of microbial safety control.Sterility testing of bacteria,molds and yeasts in the current Chinese Pharmacopoeia 2015 requires 14 days.At the same time,a large number of products are required to ensure the accuracy of low-pollution products.Although the traditional microbial test method in the Pharmacopoeia is a safe and reliable gold standard,it cannot meet the requirements for quality control and rapid release of such products at this stage.Therefore,it is urgent to establish scientific and reasonable quality control methods to avoid huge economic losses in production enterprises and hidden dangers to patient safety.It is imperative to adopt the improved and innovative alternative methods to make up for the current microbial inspection methods in the Chinese Pharmacopoeia,to achieve the safety requirements.This article translates a new added chapter of the United States Pharmacopoeia in December 2019<1071>The rapid microbiological tests for release of sterile short-life products:a risk-based approach,in order to provide reference for the short-life product safety inspection and the relevant general principles and guidelines of the new edition of the Pharmacopoeia.
作者
刘洪祥
李娅男(译)
白海娇
曹晓云(校审)
LIU Hongxiang;LI Yanan;BAI Haijiao;CAO Xiaoyun(Tianjin Institute for Drug Control,Tianjin 300070,China)
出处
《中国药品标准》
CAS
2020年第3期195-201,共7页
Drug Standards of China
