不同破伤风抗毒素效价测定方法检测结果差异的分析  

Analysis of difference in determination results of tetanus antitoxin potencies by various methods

作　　者：夏强[1] 于文影[1] 朱晶[1] 林红娟[1] 阮黄松 王馨莹[3] 陈维金[1] 

机构地区：[1]长春生物制品研究所有限责任公司,吉林长春130062 [2]越南国家生物制品和疫苗检定中心 [3]东北师范大学生命科学院,吉林长春130024

出　　处：《中国生物制品学杂志》2015年第11期1211-1213,1218,共4页Chinese Journal of Biologicals

摘　　要：目的分析《中国药典》三部（2010版）及《越南药典》（2010版）方法测定破伤风抗毒素效价结果产生差异的原因。方法分别采用《中国药典》三部（2010版）及《越南药典》（2010版）规定的破伤风抗毒素效价检测方法（小鼠试验法）,同步测定10批破伤风抗毒素供试品效价,比较结果差异;交换两种方法所用的稀释液,进行重复测定。结果两种方法测定结果差异有统计学意义（P〈0.01）,《中国药典》三部（2010版）方法测定结果比《越南药典》（2010版）方法高800~1 000 IU/ml;交换两种方法稀释液后,《中国药典》三部（2010版）方法供试组和对照组小鼠于注射48 h内全部死亡,《越南药典》（2010版）方法供试组和对照组小鼠于注射96 h后无发病症状,两种方法均不成立。结论《中国药典》三部（2010版）方法测定结果明显高于《越南药典》（2010版）方法,稀释液的不同是导致两种方法测定结果差异的原因之一。Objective To analyze the cause for difference in determination results of tetanus antitoxin potencies by the methods in Chinese Pharmacopoeia（Volume Ⅲ,2010 edition）and in Vietnam Pharmacopoeia（2010 edition）.Methods Ten batches of test samples of tetanus antitoxin were determined for potency by mouse tests described in Chinese Pharmacopoeia（Volume Ⅲ,2010 edition） and in Vietnam Pharmacopoeia（2010 edition） respectively,and the results were compared.The test was repeated by exchanging the diluents used in the two methods.Results The determination results by two methods showed significant difference（P 0.01）,while that by the method in Chinese Pharmacopoeia（Volume Ⅲ,2010 edition）was 800 ~ 1 000 IU / ml higher than that by the method in Vietnam Pharmacopoeia（2010edition）.However,after exchange of the diluents,all the mice in test and control groups used for the method in Chinese Pharmacopoeia（Volume Ⅲ,2010 edition） died within 48 h after injection,while those for the method in Vietnam Pharmacopoeia（2010 edition） showed no symptoms 96 h after injection,indicating that neither the test was valid.Conclusion The determination result of tetanus antitoxin potency by the method in Chinese Pharmacopoeia（Volume Ⅲ,2010 edition） was significantly higher than that in Vietnam Pharmacopoeia（2010 edition）.The diluent was one of the causes for the difference in determination results by the two methods.

关 键 词：破伤风抗毒素 效价 

分 类 号：R378.81[医药卫生—病原生物学] R392-33[医药卫生—基础医学]