| 刘洪祥,杨倩,解慧,曹晓云,白海娇.《欧洲药典》(9.2)2.6.27.细胞制品的微生物检查[J].中国药品标准,2019,20(2):115-118 |
| 《欧洲药典》(9.2)2.6.27.细胞制品的微生物检查 |
| EP9.2 2.6.27.Microbiological Examination OF Cell-Based Preparations |
| 投稿时间：2018-12-27 修订日期：2019-04-02 |
| DOI： |
| 中文关键词: 欧洲药典，细胞制品，微生物检查 |
| 英文关键词: EP,Cell-Based Preparations,Microbiological Examination |
| 基金项目: |
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| 摘要点击次数: 1039 |
| 全文下载次数: 341 |
| 中文摘要: |
| 译者按：我国历版《中国药典》均客观地反映了不同历史时期我国医药产业和临床用药的水平[1]，其也为国家评价药品质量和监管执法提供了法定的依据。随着科技的进步，药品的研发生产、质量提升都有着显著的变化，因此药典也在不断修订升级以新版本弥补旧版本，诸如标准缺失、落后等问题[2]。近年生物制品成为疾病治疗的新热点，广泛应用于临床。我国的《中国药典》三部是针对生物制品撰写的质量标准，但在微生物的相关检验方法上与欧美国家的药典还有差距。故《中国药典》三部在不断结合生物制品特点进行修订与编制，完善国家标准体系，强化质量标准的科学性与先进性[3-4]。本文将《欧洲药典》(9.2)2.6.27.细胞制品的微生物检查[5]章节译出，以期为生物制品的安全性检查和新版药典修订提供参考。 |
| 英文摘要: |
| As the translator’s comments:The past editions of “Pharmacopoeia of the People’s Republic of China" has objectively reflected the development of China's pharmaceutical industry and medicines for clinical use in different historical periods[1]. It also provided a statutory basis for the state to evaluate drug quality and regulatory enforcement. With the advancement of science and technology, the development of pharmaceutical R & D, production quality control have relatively changed, thus the "Pharmacopoeia of the People’s Republic of China" is constantly revised and upgraded the new edition instead of the old to compensate for the lack of standards and backward standards[2].
In recent years, biological products have become the fastest growing and technologically advanced areas in the pharmaceutical industry. As the national standard of biopharmaceuticals, the third volume of “Pharmacopoeia of the People’s Republic of China” currently has a certain gap with the European and American Pharmacopoeia in certain microbial technology requirements,thus requires further improve to strengthen the scientific and advanced quality standards[3-4] . This article is a full-text translation of the European Pharmacopoeia (9.2) 2.6.27. Microbiological examination of cell preparations [5] , aimed at providing reference for the quality control of biological products and the revision of the new Pharmacopoeia. |
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