鸡传染性法氏囊病病毒抗血清的研制

Antiserum development for chicken infectious bursal disease virus

【目的】确保鸡传染性法氏囊病病毒(IBDV)抗血清高效力的同时又彻底解决安全性和免疫应激问题,旨在研制出一种高效、安全的鸡传染性法氏囊病(IBD)预防和治疗制品。【方法】以SPF鸡为免疫动物,按照《兽用生物制品试验研究指导技术原则》和《中华人民共和国兽药典》(2010年版)的要求研制IBDV抗血清,经脱毒处理后,对其半成品及成品进行检验。【结果】以IBDVNJ株免疫4周龄SPF鸡获得的抗血清,未脱毒处理前的血清效价≥1∶64,脱毒处理后的成品效价≥1∶32。半成品和成品的检验结果显示,经过脱毒处理后的IBDV抗血清制品呈橙黄色,无菌、无支原体、无外源病毒,对小白鼠、豚鼠和SPF鸡均安全,甲醛和硫柳汞残留量也未超过规定标准。【结论】研制的IBDV抗血清制品符合《中华人民共和国兽药典》的要求,完全可用于IBD的紧急预防和早期治疗,今后可作为一个正规产品上市以满足市场需要。

[Objective]This research developed high performing and safe chicken infectious bursal disease （IBD） prevention and treatment products to ensure the high efficiency of chicken infectious bursal disease virus （IBDV） antiserum and to solve the safety and immunological stress problems at the same time. [Method]Using SPF chicken as the immune animal, the corresponding IBDV antiserum was prepared according to the requirements from （〈Veterinary Biological Prod- ucts Technical Guidance and Principle Experimental Studies）〉 and （（Veterinary Pharmacopoeia of P.R. China〉〉（2010 Ed）. After detoxification treatment, the semi-finished and finished antiserums underwent production inspections. [Result]For the antiserums obtained from IBDV NJ immunized SPF chickens at 4-weeks old, the serum titer before detoxification treat- ment was I〉 1：64, while the serum titer after detoxification treatment was t〉 1：32. From the test results of semi-finished and finished serums, the antiserum products after detoxification treatment were orange-hued, sterile, without mycoplas- ma, and without exogenous virus; the formaldehyde and thimerosal residues also did not exceed the prescribed standards, which were safe to use in mice, guinea pigs, and SPF chickens. [Conclusion]The IBDV antiserum products, developed according to the standards of （〈Veterinary PhaI^nacopoeia of P. R. China〉〉, could be used for emergency IBD prevention and early IBD treatment. The antiserum could also be listed as a formal sales product in the future to meet market demands.