皮上划痕人用炭疽活疫苗活菌数的测定与分析

Determination and Analysis of Viable Count of Live Attenuated Anthrax Vaccine for Percutaneous Scarification

目的优化皮上划痕人用炭疽活疫苗的运输条件及活菌数测定方法。方法用平皿培养菌落计数法对厂家先后2次送检(第1次为常温下运输3 d,第2次为低温下运输6 h)的皮上划痕人用炭疽活疫苗进行活菌数测定;对第2次送检的7批疫苗分别使用吸量管和移液器取样进行活菌数测定;取第2次送检的1批疫苗,分别使用吸量管和移液器取样进行5次活菌数测定,比较两种工具测定的精密度。结果第1次送检的7批疫苗活菌数均不符合规定,第2次送检的疫苗活菌数显著高于第1次送检样品(P<0.01),均符合规定;使用吸量管和移液器取样对活菌数测定结果影响不大,差异无统计学意义(P>0.05);使用移液器取样测定活菌数的变异系数(11.3%)明显低于使用吸量管取样测定活菌数的变异系数(23.0%)。结论炭疽活疫苗在送检过程中必须低温运输;使用移液器取样测定活菌数精密度高且操作方便,有利于制品的质量控制。

Objective To optimize the condition for transport of live attenuated anthrax vaccine and the determination method for viable count. Methods The viable counts of live attenuated anthrax vaccine for percutaneous scarification submitted by the man- ufacturers under various transport conditions were determined by plate counting. The vaccine transported at normal temperature for 3 d was determined by sampling using measurable pipette. However, even batches of vaccine transported at low temperature for 6 h were determined using measurable pipette and pipettor separately, and one batch using the two tools for 5 times separately. The pre- cisions of determination results by using measurable pipette and pipettor were compared. Results All the seven batches of vaccines transported at normal temperature were unqualified in viable counts. However, the viable counts of vaccines transported at low temperature were qualified and significantly higher than those transported at normal temperature（P 〈 0. 01 ）. The determination results by using measurable pipette and pipettor showed no significant difference （P 〉 0. 05）, of which the coefficients of variation were 11.3% and 23.0% respectively. Conclusion Live attenuated anthrax vaccine shall be transported at low temperature during submission to control tests. Sampling by pipettor for viable counting was precise and easy to handle, which was benefit to the quality control of vaccine.