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人用马免疫血清制品质量控制

Quality control of equine-derived immunosera products for human use
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摘要 本文介绍了2020年版《中国药典》第三部中人用马免疫血清制品总论的制定情况,并从生产工艺和产品检定两方面对人用马免疫血清制品质量控制的要点进行了阐述,便于使用者对人用马免疫血清制品的质量控制全面、整体的理解和认识。 This review introduces the formulation of general introduction of equine-derived immunosera products for human use in the Chinese pharmacopoeia 2020 VolumeⅢ,and presents the key points of the quality control of equine-derived immunosera products for human use from two aspects of manufacturing process and quality tests.Therefore,users can have an overall understanding of the quality control of equine-derived immunosera products for human use.
作者 张华捷 曹琰 马霄 ZHANG Huajie;CAO Yan;MA Xiao(National Institutes for Food and Drug Control,Beijing 102629,China;Chinese Pharmacopoeia Commission,Beijing 100061,China)
机构地区 中国食品药品检定研究院 国家药典委员会
出处 《中国药品标准》 CAS 2022年第3期263-266,共4页 Drug Standards of China
基金 国家药品标准提高课题2018S007抗毒素抗血清制品总论建立。
关键词 中国药典 人用马免疫血清制品 质量控制 Chinese pharmacopoeia equine-derived immunosera products for human use quality control
分类号 R921.2 [医药卫生—药学]
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  • 1[1]Note for guidance on production and quality control of animal im-munoglobulin and mmunosera for human use London,24 June 2002CPMP/BWP/3354/99.
  • 2[2]Guidance for industry (For the submission of chemistry,manufac-turing and control and establishment description information for hu-man plasma-derived biological products,animal plasma or serum-derived products) FDA CBER Feb,1999.
  • 3[3]Workshop on standards for inactivation and clearance of infection agents in the manufacture of plasma derivatives from non-human materials for human injectable use (FDA CBER Oct,1999).
  • 4[4]Basic requirements for viral safety of biotechnological/boiological products listed in Japanese Pharmacopoeia.Supplement I of the Japanese Pharmacopoeia 14th edition:1618-1631.December 27,2002.the MHLW Ministerial notification No 395.
  • 5[5]Qualification of animals as origin of animal-derived medicinal prod-ucts provided in the general notices 39 of Japanese Pharmacopoeia and other standard~Supplement of the Japanese Pharmacopoeia 14th edition:1631-1634.December27,2002,the MHLW Minis-tedal notification,No.395.
  • 6[6]Notefor guidance on Virus validation studies:the design,contri-bution and interpretation of studies validating the insctivation and removal viruses London,14 February,1996,CPMP/BWP/268/ 96.
  • 7仇秋菊,宾文凯.马血清破伤风抗毒素与马破伤风免疫球蛋白F(ab′)_2过敏反应比较[J].蛇志,2015,27(3):263-265. 被引量：11

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中国药品标准
2022年 第3期

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