为考查体外人外周血单个核细胞热原检测法对ACYW135群脑膜炎球菌多糖疫苗的适用性，选取不同厂家共10批供试品，使用体外人外周血单个核细胞热原检测法，采用加样回收干扰实验考察供试品是否存在干扰。结果表明，大部分供试品在最大有效稀释倍数内，IL-6法干扰实验的回收率在50%~200%，且热原物质含量均低于标准限值，均为合格样品。研究表明，体外人外周血单个核细胞热原检测法可用于ACYW135群脑膜炎球菌多糖疫苗热原检测。
To investigate the suitability of meningococcal groups ACYW135 polysaccharide vaccines for human peripheral blood mononuclear cell (PBMC) in vitro pyrogen test (IL-6), 10 batches of vaccines from different manufacturers are collected. The recovery is determinated by human PBMC-IL-6 in vitro pyrogen test with spiking bacterial endotoxin. The recovery of 10 batches of vaccines is between 50%-200%, and the test solutions are at a dilution less than the maximum valid dilution (MVD). The results show that all the 10 batches of vaccines are qualified products in the pyrogen test. The meningococcal groups ACYW135 polysaccharide vaccine is suitable for the human PBMC-IL-6 in vitro pyrogen test to control the pyrogen.
[1] 何开勇, 高华, 季晖. 新的体外热原试验方法研究进展[J]. 药物分析杂志, 2007, 27(5):777-781. He Kaiyong, Gao Hua, Ji Hui. A progress of a new in vitro pyrogen test[J]. Chin J Pharm Anal, 2007, 27(5):777-781.
[2] 贺庆, 谭德讲, 高华, 等. 新型体外热原检测法的研究进展[J]. 中国新药杂志, 2017, 26(4):405-409. He Qing, Tan Dejiang, Gao Hua, et al. Progress in research of novel in vitro pyrogen tests[J]. Chin J Pharm Anal, 2017, 26(4):405-409.
[3] 秦媛媛, 吴彦霖, 刘倩, 等. 三类体外热原检测方法的研究进展[J],中国药事, 2012,26(5):507-512. Qin Yuanyuan, Wu Yanlin, Liu Qian, et al. Research progress of three types of in vitro pyrogen test methods[J]. Chinese Pharmaceutical Affairs, 2012, 26(5):507-512.
[4] 杜颖, 蔡彤, 刘倩, 等. 热原检测的3种方法在非肠道用制品检测中的适用性比较研究[J]. 药物分析杂志, 2013, 33(11):1971-1978. Du Ying, Cai Tong, Liu Qian, et al. Comparative study of the applicability of three methods for pyrogen test on parenteral medical products[J]. Chin J Pharm Anal, 2013, 33(11):1971-1978.
[5] 贺庆, 高华, 谭德讲, 等. 人外周血单个核细胞热原检测法的研究[J]. 药物分析杂志,2012, 32(10):1711-1717. He Qing, Gao Hua, Tan Dejiang, et al. The use of human peripheral blood monocytic cells:A novel method for pyrogen testing[J]. Chin J Pharm Anal, 2012, 32(10):1711-1717.
[6] 李亚南, 乔瑞洁, 梁丽,等. 2~59岁健康人群接种ACYW135群脑膜炎球菌多糖疫苗的免疫原性观察[J]. 微生物学免疫学进展,2012, 40(5):15-19. Li Yanan, Qiao Ruijie, Liang Li, et al. Immunogenicity of meningococcal groups ACYW135 polysaccharide vaccine inoculated in healthy population of age 2-59 years old[J]. Prog in Microbiol Immunol, 2012, 40(5):15-19.
[7] 陈万庚, 马永法, 周爱庆. 国产ACYW135流脑多糖疫苗免疫安全性观察[J]. 现代预防医学, 2011, 38(24):5131-5132. Chen Wangeng, Ma Yongfa, Zhou Aiqing. Observation on the safety of domestic ACYW135 group of epidemic cerebrospinal meningitis polysaccharide vaccine[J]. Modern Preventive Medicine, 2011, 38(24):5131-5132.
[8] NIH. ICCVAM test method evaluation report:Validation status of five in vitro test methods proposed for assessing potential pyrogenicity of pharmaceuticals and other products[EB/OL]. 2008. http://iccvam.niehs.nih.gov/methods/pyrogen/pyr_tmer.htm.
[9] 张媛, 蔡彤, 高华, 等. ACYW135群脑膜炎球菌多糖疫苗人新鲜全血体外热原检测方法适用性考察[J]. 中国药学杂志, 2015, 50(11):983-986. Zhang Yuan, Cai Tong, Gao Hua, et al. The suitability of meningococcal groups ACYW135 polysaccharide vaccine for human whole blood in vitro pyrogen test[J]. Chinese Journal of Pharmaceuticals, 2015, 50(11):983-986.
