【摘要】 将2批猪细小病毒病弱毒疫苗分别在2—8℃保存11个月、12个月、13个月,-20℃保存22个月、24个月、26个月,进行物理性状、无菌检验、支原体检验、外源病毒检验、安全试验及免疫效力试验,探讨不同保存条件和保存期对疫苗的影响。结果表明:物理性状、无菌检验、支原体检验、外源病毒检验均符合《中国兽药典》的要求。安全试验每批次疫苗接种乳鼠全部健活;以10头份/头的剂量接种PPV HI抗体阴性猪,接种后定期采集血样和鼻肛分泌物进行病毒分离,结果均为阴性。疫苗在2—8℃保存至13个月,-20℃保存至26个月TCID₅₀均≥10^6.25笛/头份;接种PPV HI抗体阴性豚鼠抗体全部转为阳性;疫苗免疫PPV HI抗体阴性猪,免疫后1个月、7个月分别用PPV强毒攻击获得100%保护。更多还原

【Abstract】 Two groups of porcine parvovirus infection attenuated vaccine were stored under 2—8 ℃ for 11,12 and 13 months respectively or under-20 ℃ for 22,24 and 26 months,and the physical characteristics test,sterility test,mycoplasma test,exogenous virus test,safety test and immune efficacy test were carried out to investigate the effects of different preservation condition and preservation period on the vaccine.The results showed that the physical characteristics test,sterility test,mycoplasma test,exogenous virus test accorded with ’ Veterinary Pharmacopoeia of the People’ s Republic of China’.In safety test,all the suckling mice inoculated with each batch of vaccine were healthy.Antibody negative pigs of PPV HI were inoculated with 10 dose/head,the blood sample and secretion of nose or anus were collected regularly for virus isolation,and the results were all negative.The vaccine TCID₅₀ stored under 2—8 ℃ for 13 months or- 20 ℃ for 26 months was ≥ 10^6.25;Antibody negative guinea pigs of PPV HI inoculated with vaccine all turned to positive;Antibody negative pigs of PPV HI inoculated with vaccine got 100% protection against porcine parvovirus infection after inoculated 1 or 7 months.更多还原