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猪脾转移因子注射液热原检查研究

Lei Xu,Xiaowei Zhu,Yongyin Zhou,Xiumei Xu,Jun Du,Xiaolong Liu,Longyong Lai,Zuogui Lin,Yu Huang

Journal of Animal Husbandry and Veterinary Medicine Fujian（2019）

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Abstract
为了建立猪脾转移因子(TF)的热原检查方法及对TF制造工艺进行验证,按照现行《中国兽药典》附录"热原检查法",对本课题组已授权国家发明专利制备的3批TF开展热原检查研究,将TF以0.5 mL/kg剂量经耳静脉注入每只家兔后,各家兔的体温升高值均小于0.6℃,且各组的3只家兔体温升高值总和均小于1.3℃.结果显示,3批TF热原检查结果均符合现行《中国兽药典》规定.结果表明,发明专利制造工艺可有效去除热原,保证TF制品的安全性.
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