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兽用生物制品活菌计数方法改进的研究
张一帜,张媛,罗玉峰,李建,王秀丽,刘元杰,王楠,徐磊,辛凌翔,任小侠,刘博,魏津,马欣,彭小兵,李旭妮,彭国瑞,李俊平
0
(中国兽医药品监察所)
摘要:
活菌计数是细菌类活疫苗质量标准中重要的检验参数,与疫苗的保护效果显著相关。在兽用细菌类生物制品检验和研究当中,活菌计数是目前公认最具精确性和可操作性的活细菌定量方法。现行兽用细菌类生物制品检验中的活菌计数方法依照《中国兽药典》(2015年版三部)附录3405“活菌计数法”执行,但其中有部分内容过于笼统,试验成立标准缺乏科学标准,最终影响细菌活疫苗质量的评判。因此,本研究从检验实际需求出发,参照国内外活菌计数相关规程,通过比对试验研究,对“活菌计数法”中平板干湿程度、菌液滴加方法、菌液分散方法以及试验成立标准进行了改进。改进后的“方法”要求更明确,普适性更高,从而减少了操作误差,提升了“活菌计数法”的规范性、可操作性及检验结果可靠性。
关键词:  活菌计数法,细菌活疫苗,检验技术方法
DOI:
投稿时间:2020-07-01修订日期:2020-08-04
基金项目:
Improvement Study of Standard Bacterial Plate Count for Veterinary Biological Products
,,罗玉峰,,,,,,,,,,,,,,李俊平
(China Institute of Veterinary Drug Control)
Abstract:
The bacterial plate count is a critical test parameter in the quality standard of bacterin vaccine and is significantly related to the protective effect of bacterin vaccine. In the drug control and research of veterinary bacterial biological products, bacterial plate count is currently recognized as the most accurate and operable quantitative method of bacterin vaccine. At present, bacterial plate count method in the inspection of veterinary bacterial biological products is carried out in accordance with the "Chinese Veterinary Pharmacopoeia" (2015 edition III) Appendix 3405 "bacterial plate count parts of the contents are fuzzy description, the test valid requirement could lead to different understandings, ultimately affecting the quality of the bacterin vaccine. Therefore, based on the actual test requirements, this study refers to the relevant regulations for bacterial plate count in China and abroad. And through the comparing research, moist degree of the plate, the way of adding the bacteria droplets, the way of dispersing the bacteria liquor and the test valid requirement of bacterial plate count method" has been determined and improved. The improved "method" requirements are more clear and more universal, which reduces operational errors and improves the standardization, operability and reliability of the "bacterial plate count method".
Key words:  Bacterial  Plate Count,Live  Bacterin Vaccine,Technique  and Method  of Drug  Control

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