猪脾转移因子注射液异常毒性检查研究  

Study on toxicity test of pig spleen transfer factor injection

作　　者：徐磊[1] 游开铿[1] 郑青 林祚贵 郜飞燕 胡小榕 傅光华[2] 施少华[2] 刘小龙 许秀梅 杜君 廖惠珍 黄瑜[2] 张渊魁 Xu Lei;You Kaikeng;Zheng Qing;Gao Feiyan;Hu Xiaorong;Lin Zuogui;Fu Guanghua;Shi Shaohua;Liu Xiaolong;Xu Xiumei;Du Jun;Liao Huizhen;Huang Yu;Zhang Yuankui(Fujian Agricultural Vocational Technical College,Fuzhou350119;Institute of Animal Husbandry andVeterinary Medicine,Fujian Academy of Agricultural Sciences,Fuzhou350013;Present(Fuzhou)BiotechCompany Limited,Fuzhou350500;Jofunhwa Biotechnology(Nanjing)Co.Ltd.,Nanjing211102;Bureau of Agriculture and Rural Affairs of Fuzhou City Changle District Bureau,Fuzhou350200)

机构地区：[1]福建农业职业技术学院,福州350119 [2]福建省农业科学院畜牧兽医研究所,福州350013 [3]派生特(福州)生物科技有限公司,福州350500 [4]兆丰华生物科技(南京)有限公司,南京211102 [5]福州市长乐区农业农村局,福建长乐350200

出　　处：《福建畜牧兽医》2020年第6期8-10,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);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);2018年福建省禽病防治重点实验室开放基金课题(KF201902);2020年度福州市科技计划项目(2020-PT-149);福建省畜禽疫病防控技术重大研发平台项目(2014N2003);福建省高层次人才和青年优秀人才访学研修资助计划(闽人社文〔2019〕239号);福建省职业院校专业带头人培养计划(闽教办师〔2019〕40号)资助。

摘　　要：本研究旨在建立猪脾转移因子(TF)的异常毒性检查方法,并对本发明专利TF制造技术进行工艺验证,按照现行《中国兽药典》附录中“异常毒性检查法”,通过小鼠动物模型建立异常毒性检查方法,对本课题组已授权国家发明专利技术所制备3批TF进行异常毒性检查,将TF以0.5 mL/只剂量经腹腔注入小鼠,3组共15只小鼠于腹腔注射后48 h内均健活,均未出现异常情况。结果显示,3批TF无异常毒性且异常毒性检查结果均符合现行《中国兽药典》规定。结果表明,本发明专利TF制造技术对异常毒性的控制效果良好,对TF的安全性提供了保证。In order to establish a toxicity test method for pig spleen transfer factor(TF)and verify the TF manufacture technology of the national invention patents,according to the toxicity test method in the current Chinese Veterinary Pharmacopoeia appendix,the method of toxicity test was established by mouse animal model.Three batches of TF prepared by the national invention patents of the research group were tested on the toxicity test.TF was injected intraperitoneally into mice at a dose of 0.5 mL per mouse.Fifteen mice in three groups were alive within 48 hours after intraperitoneal injection without any abnormality.The results showed that there was no abnormal toxicity in the three batches of TF,and the TF toxicity test results of three batches conformed to the current provisions of the Chinese Veterinary Pharmacopoeia.The results showed that the manufacture technology of national invention patents had excellent toxicity control effect,and the safety of TF products could be ensured.

关 键 词：转移因子 专利制造工艺 异常毒性检查 小鼠 安全性 

分 类 号：S859.7[农业科学—临床兽医学]