鼠疫、布氏菌、炭疽活疫苗浓度测定通用参考品的研制  

Preparation of universal national reference materials for determining the concentrations of plague, brucellosis and anthrax vaccine

作　　者：魏东[1] 尤明强[2] 裴明玉[2] 庄新海[3] 翟雷[2] 魏然[3] 王国治[1] 李恪梅[1] 

机构地区：[1]中国食品药品检定研究院结核病疫苗室,北京100050 [2]兰州生物制品研究所有限责任公司菌苗室二室,730046 [3]兰州生物制品研究所有限责任公司质量检定室,730046

出　　处：《中国医药生物技术》2015年第5期392-397,共6页Chinese Medicinal Biotechnology

基　　金："重大新药创制"国家科技重大专项(2014ZX09304311-002)

摘　　要：目的将现用鼠疫、布氏菌、炭疽活疫苗3套浓度测定参考品整合成一套通用参考品。方法确定通用参考品吸光度值,从3套鼠疫、布氏菌及炭疽疫苗浓度测定用参考品共9个浓度中选取代表性3个浓度参考品;利用现用3种活疫苗浓度测定用参考品的线性方程,计算通用参考品所代表各种疫苗的浓度;制备参考品并进行质量控制;观察参考品的长期稳定性;组织3个实验室进行协作验证。结果确定通用参考品吸光度值为0.350、0.494、0.665;确定通用参考品所代表各种疫苗浓度;完成通用参考品的制备,各项检定符合规定;对4℃冷藏保存参考品进行稳定性研究,变异系数小于2.0%;经3个实验室协作验证,各实验室使用2种参考品的测定结果误差均小于2.0%。结论在现有参考品的基础上整合成一套鼠疫、布氏菌、炭疽活疫苗分光光度法浓度测定通用参考品,并为以后建立分光光度法细菌浓度测定通用参考品奠定基础。Objective To establish a universal national reference materials for determining the concentrations of plague, brucellosis and anthrax vaccine. Methods Firstly, absorbance of universal national reference materials were established. Secondly, correlation between absorbanceof universal national reference materials and concentrations of three kinds of vaccine was studied using respective national reference material. The universal references were prepared. The stability of the references was tested by measuring absorbance. Finally, the universal reference materials were compared with old reference materials by three professional laboratories. Results Absorbance of universal national reference materials were 0.350, 0.494 and 0.665. The relationship between absorbance of universal national reference materials and the concentrations of three kinds of vaccine was determined. Reference materials were successfully established. The reference materials stored at 4 ℃ were stable. By measuring three batches of each vaccine with two kinds of reference materials, the result errors were less than 2.0%. Conclusion A set of universal national reference materials for determining the concentrations of plague, brucellosis and anthrax vaccine is established.

关 键 词：鼠疫菌苗 布氏菌苗 炭疽菌苗 分光光度法 紫外线 

分 类 号：R392-33[医药卫生—免疫学]