兽用生物制品活菌计数方法改进的研究

Improvement Study of Standard Bacterial Plate Count for Veterinary Biological Products

关键词:  活菌计数法  细菌活疫苗  检验技术方法

Key words:  bacterial plate count  live bacterin vaccine  technique and method of drug control

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。现行兽用细菌类生物制品检验中的活菌计数方法部分步骤易产生误差，试验成立标准表述笼统，最终影响到细菌活疫苗质量评判。因此，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、菌液分散方法进行改进，提出及验证以标准差(s)衡量结果的有效性并提供参考值。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。

Abstract:

The bacterial plate count is a critical test parameter in the quality standard for bacterin and is significantly related to the protective effect of bacterin. At present, some steps in the bacterial plate count method are prone to errors, and the test valid requirement is generally stated, which ultimately affects the quality evaluation of live bacterial vaccines. Therefore, based on the actual test requirements, this study referred to the relevant regulations for bacterial plate count in China and abroad. Through the comparing experiments, moist degree of the plate, the way of adding the bacteria droplets, the way of dispersing the bacteria liquor had been adjusted and improved. The standard deviation (s) was proposed and verified to measure the validity of the results, and a reference value was provided. The improved method requirements were more clear and more universal, which reduced operational errors and improved the standardization, operability and reliability of the bacterial plate count method.