关于我国药典重组DNA技术产品总论的思考

自1982年全球第一个生物技术药物“基因重组人胰岛素”、1989年中国批准第一个生物技术药物“重组人干扰素α1b”上市以来,生物技术药物已成为制药业中发展最快、活力最强和技术含量最高的领域。药品的规范生产与质量控制与其安全有效性密切相关,欧美药典中均设有对此类药品质量控制的总体要求。《中国药典》2010版三部已收录包括12类共计34个品种的重组DNA技术产品各论,在进一步保障药品安全、提高质量控制水平的编制指导思想下,《中国药典》2015版拟纳入对重组DNA技术产品的总体要求,本文就相关起草工作从产品涉及范畴、制造与产品检定等方面进行阐述。

Points to Consider for the General Monograph of Products Rrepared by Recombinant DNA Technology in Chinese Pharamacopeia

Since the first biopharmaceutical-"recombinant human insulin" was licensed by US FDA in 1982, and "recombinant human interferon α1b", the first biopharmaceutical in China was approved in 1989, biopharmaceutical industry has become the fastest growing, most dynamic and technology-intensive field. Good manufacture practice and quality control are key contributions to the safety and efficacy of these drugs. General requirements for the control of monoclonal antibodies are embodied in European and United States Pharmacopeia. Currently there are 12 product categories and 34 monographs embodied in Chinese Pharmacopeia volumn Ⅲ edition 2010. In the coming new 2015 edition, a general monograph of products prepared by recombinant DNA technology is intend to be drafted and included under the directions to further improve drug safety as well as to upgrade the technology level of quality control. This paper is to pave the way for the drafting of monograph of recombinant DNA products from the aspects including scope, manufacture and release control etc.