口蹄疫A型灭活疫苗毒种和种子批的研究

Studies on the virus seeds and seed batches of inactivated vaccine against foot-and-mouth disease virus type A

为了保证制苗及攻毒用毒种的质量和稳定性,在对制苗和攻毒毒种的毒力、特异性、保存期、扩繁代次等进行研究的基础上,建立了口蹄疫A型灭活疫苗制苗和攻毒用毒种种子批。结果表明,原始毒种和基础毒种的扩繁代次均控制在5代以内,适宜的保存方法和保存期均为加含 500 mL／L甘油的PBS后在-30℃保存1年、-70℃保存2年;用于生产抗原的工作毒种,最高扩繁代次控制在15代以内,最佳保存方法和保存期为加保护剂后在-20℃保存半年、-70℃保存1 年;用于效力检验的攻毒毒种采用原始毒种。通过制苗和攻毒用毒种种子批的建立,规范了口蹄疫疫苗生产和检验过程中的毒种管理。

Based on studies on virulence, specificity, storage life and passage of foot and-mouth disease virus （FMDV） type A seeds, the virus seed batches for vaccine manufacturing and challenge of the inactivated vaccine against FMDV type A were established in order to ensure quality and stabilization of the vaccine. The passages of master and foundation virus seeds were less than 5, and their storage life was 1 year at -30 ℃ or 2 years at -70 ℃ in PBS containing 500 mL/L of glycerin. The highest passage of producing virus seeds was less than 15, and their storage life was 6 months at -20 ℃ or 1 year at -70℃ The master virus seed was adopted for challenge. The management of virus seed in the production and verification process was standardized through the establishment of seed batches.