猪细小病毒病灭活疫苗稳定性研究报告

Stability of Inactivated Vaccine Against Porcine Parvovirus Disease

为了研究猪细小病毒病灭活疫苗(L株,悬浮培养)的稳定性(保存期),将3批猪细小病毒病灭活疫苗实验室制品(批号为201401、201402和201403)于2~8℃保存3、6、9、12、18、24个月后分别进行性状、无菌性和效力等检验。结果显示:3批实验室制品在2~8℃保存24个月,性状、无菌性和效力等检验结果均符合标准。根据试验结果并确保猪细小病毒病灭活疫苗的质量,暂定产品2~8℃保存有效期为18个月。

For the purpose of this study,the stability(storage period)test of the inactivated porcine parvovirus vaccine(L strain,suspension culture)was studied,three batches of porcine parvovirus disease inactivated vaccine laboratory products(batch numbers 201401,201402 and 201403)were stored at 2-8℃for 3,6,9,12,18 and 24 months,After months,the traits,sterility test and potency test would be carried out.The results showed that:three batches of laboratory products were stored at 2-8℃for 24 months,and the test results of properties,sterility and potency all met the standards.According to the test results and in order to ensure the quality of the inactivated porcine parvovirus vaccine,this product was temporarily stored at 2-8℃,and the validity period was tentatively scheduled for 18 months.