如何提高病毒外源因子检测中小鼠和乳鼠检查法的成功率
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摘要
随着生物制品在临床上的应用日益广泛,其安全性也备受关注。根据国家规定,拟上市的生物制品需依照2015版药典要求进行病毒外源因子检测以控制其质量,但其中较为关键的小鼠、乳鼠检查法在实际操作中存在一定的困难,导致检测结果易出现假阴性或假阳性,有鉴于此,本文以广东省医学实验动物中心丰富的检测经验为依据,对小鼠及乳鼠检查法的关键点进行归纳总结,拟提供高效实用的操作方法并提高该检查法的成功率。
The safety of biological products has attracted more and more attention because of its widespread clinical application. According to the regulations of the state, adventitious virus agents of biological products which applied in the clinic should be detected referring the 2015 China Pharmacopeia. However, the mice and the neonatal mice inspection method are hard to achieve successfully leading to the false-negative or the false-positive result. Hence, this article aims at generalizing the critical point of the mice and the neonatal mice inspection method and providing the efficient and practical operating method to get a higher success rate of adventitious virus agent test on the basic of the rich experience of the Guangdong medical laboratory animal center.
The safety of biological products has attracted more and more attention because of its widespread clinical application. According to the regulations of the state, adventitious virus agents of biological products which applied in the clinic should be detected referring the 2015 China Pharmacopeia. However, the mice and the neonatal mice inspection method are hard to achieve successfully leading to the false-negative or the false-positive result. Hence, this article aims at generalizing the critical point of the mice and the neonatal mice inspection method and providing the efficient and practical operating method to get a higher success rate of adventitious virus agent test on the basic of the rich experience of the Guangdong medical laboratory animal center.
引文
[1] 贺倩, 魏至栋, 鱼轲. 疫苗制备中外源病毒检测方法 [J]. 微生物学免疫学进展, 2014, 42(2): 65-69.
[2] Khan A S. Regulatory considerations for raw materials used in biological products [J]. PDA journal of pharmaceutical science and technology, 2010, 64(5): 451-457.
[3] Blumel J. Current European regulations for control of adventitious virus safety [J]. PDA journal of pharmaceutical science and technology, 2011, 65(6): 568-579.
[4] 吕文利, 赵丽萍, 田华,等病毒外源因子检测方法的探讨 [J]. 现代中西医结合杂志, 2004, 23: 3102-3103.
[5] 王红, 彭维, 刘菊,等. 乙脑病毒SA_(14-14-2)减毒株病毒外源因子污染检测分析 [J]. 预防医学情报杂志, 2012, (10): 768-771.
[6] 李慧, 王春华, 罗姗,等. 关于小鼠脑内不同注射手法的探讨 [J]. 实验动物科学, 2013, 30(2): 48-50.
[2] Khan A S. Regulatory considerations for raw materials used in biological products [J]. PDA journal of pharmaceutical science and technology, 2010, 64(5): 451-457.
[3] Blumel J. Current European regulations for control of adventitious virus safety [J]. PDA journal of pharmaceutical science and technology, 2011, 65(6): 568-579.
[4] 吕文利, 赵丽萍, 田华,等病毒外源因子检测方法的探讨 [J]. 现代中西医结合杂志, 2004, 23: 3102-3103.
[5] 王红, 彭维, 刘菊,等. 乙脑病毒SA_(14-14-2)减毒株病毒外源因子污染检测分析 [J]. 预防医学情报杂志, 2012, (10): 768-771.
[6] 李慧, 王春华, 罗姗,等. 关于小鼠脑内不同注射手法的探讨 [J]. 实验动物科学, 2013, 30(2): 48-50.