猪脾转移因子注射液热原检查研究  

Study on pyrogen test of pig spleen transfer factor injection

作　　者：徐磊[1] 朱晓玮 周永银 许秀梅 杜君 刘小龙 赖隆永 林祚贵 黄瑜[4] Xu Lei;Zhu Xiaowei;Zhou Yongyin;Xu Xiumei;Du Jun;Liu Xiaolong;Lai Longyong;Lin Zuogui;Huang Yu(Fujian Agricultural Vocational Technical College,Fuzhou 350119;Nanjing Tianbang Bio-industry Company Limited,Nanjing 211102;Present(Fuzhou)Biotech Company Limited,Fuzhou 350500;Institute of Animal Husbandry and Veterinary Medicine,Fujian Academy of Agricultural Sciences,Fuzhou 350013)

机构地区：[1]福建农业职业技术学院,福州350119 [2]南京天邦生物科技有限公司,南京211102 [3]派生特(福州)生物科技有限公司,福州350500 [4]福建省农业科学院畜牧兽医研究所,福州350013

出　　处：《福建畜牧兽医》2019年第6期1-3,共3页Fujian Journal of Animal Husbandry and Veterinary medicine

基　　金：2019年度福建省科技计划项目（2019N0025）;2018年福建省中青年教师教育科研项目（职业院校专项，JZ180531）;2018年福建省禽病防治重点实验室开放基金课题（KF201902）;福建农业职业技术学院省部共建福建省动物保健与食品安全应用技术协同创新中心项目（教职成函〔2019〕10号、闽教科〔2017〕49号）;2016年度福建省科技计划项目（2016S0002）;福建省畜禽疫病防控技术重大研发平台项目（2014N2003）;2019年度江苏省博士后科研资助计划（2019K072）;2019年度福州市科技计划项目（2019-G-34）;2019年福建农业职业技术学院科技项目（2019JS005）资助

摘　　要：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。In order to establish a pyrogen test method for pig spleen transfer factor(TF) and verify the manufacture process of TF, according to the pyrogen test method in the current Chinese Veterinary Pharmacopoeia appendix, three batches of TF prepared by the national invention patents of the research group were studied on the pyrogen test. After TF injected into the ear vein of each rabbit at a dose of 0.5 mL/kg, the increase of body temperature in all rabbits was less than 0.6 ℃, and the total increase of body temperature in three rabbits of each group was less than 1.3 ℃. The results showed that the TF pyrogen test results of three batches conformed to the current provisions of the Chinese Veterinary Pharmacopoeia. The results showed that the pyrogen could be effectively removed by the manufacture process of national invention patents, and the safety of TF products could be ensured.

关 键 词：转移因子 专利制造工艺 热原检查 家兔 安全性 

分 类 号：R28[医药卫生—中药学]