重组猪干扰素α1冻干粉针剂对猪的安全性试验研究

Safety Valuation of Recombinant Porcine Interferon alpha 1 Freeze-dried Powder for Injection in Pigs

试验旨在观察自行研制的重组猪干扰素α1冻干粉针剂对猪的安全性。将20头健康仔猪随机分为4组(3组试验组和1组对照组),每组5只,3组试验组分别肌肉注射低、中和高剂量重组猪干扰素α1冻干粉针剂,连续注射7d,对照组同时肌肉注射生理盐水。对动物基本生命体征、血常规、血液生化指标、组织标本病理学指标进行观察。各试验组仔猪的外表及行为特征均正常;体温、体重的变化也在正常范围之内;重要脏器如脑、肺脏、肝脏、心脏和脾脏病理解剖HE染色结果显示无器质性病变发生;血常规、血液生化指标均正常。试验结果表明本项目研制的重组猪干扰素α1冻干粉针剂对仔猪无明显毒副作用,使用安全。

The assay was aimed to study the safety of recombinant porcine interferon alpha 1. Twenty healthy piglets were randomly divided into four groups （three experimental groups and one control group）, three experimental groups were intramuscular injection of low, middle and high dose recombinant porcine interferon alpha 1. Each group continuously infused recombinant porcine interferon alpha 1 for 7 days. Animal vital signs, blood routine examination and tissue pathology indicators were observed. The appearance and behavior characteristics of each experimental group were normal; changes in body temperature and weight were also within the normal range; by HE staining assay,there were no organ lesions in important organs such as brain, lung, liver, heart and spleen; blood routine examination and biochemical indexes were also normal. The results showed that the recombinant porcine interferon alpha 1 had no significant side effects on piglets and was safe to use.