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作 者:李占辉 李娜 闫春 胡春红 王为 杨冰 谷海燕 Li Zhanhui;Li Na;Yan Chun;Hu Chunhong;Wang Wei;Yang Bing;Gu Haiyan(Quality Inspection Department,Beijing Biological Products Institute Co.,Ltd.,Beijing 100776,China)
机构地区:[1]北京生物制品研究所有限责任公司质量检定室,100176
出 处:《国际生物制品学杂志》2019年第2期65-68,共4页International Journal of Biologicals
摘 要:目的比较检测A群脑膜炎球菌多糖疫苗中磷含量的中国药典(2015年版)方法(方法1)与欧洲药典(8.0版)方法(方法2)的差异,为今后的方法选择及进一步优化提供参考。方法分别用方法1和方法2检测标准磷溶液和A群脑膜炎球菌多糖疫苗中的磷含量,比较这2种方法的标准曲线、定量限、准确度、精密度、耐用性(溶液稳定性)的差异。结果方法1和方法2标准曲线的决定系数均值分别为0.997 3和0.999 3,定量限分别为3.97和2.16 μg。检测同一批A群脑膜炎球菌多糖疫苗显示,磷含量检测结果的相对标准偏差,方法1和方法2分别为10.3%和7.6%;磷加样回收率,方法1为87.8%~113.1%,方法2为97.1~103.6%。分别将反应溶液放置0、30、60 min后开始比色,方法1和方法2每30 min吸光度升高均值分别为0.059和0.003。结论 2种方法均可用于A群脑膜炎球菌多糖疫苗中磷含量的检测。与方法1相比,方法2的标准曲线线性更佳、检测定量限更低、准确度和精密度更高、耐用性(溶液稳定性)更好。Objective To compare the difference between the Chinese pharmacopoeia (edition 2015) method (Method 1) and European pharmacopoeia 8.0 method (Method 2) for the detection of phosphorus content in group A meningococcal polysaccharide vaccine (MenAPSV), so as to provide reference for the selection and further optimization of methods in the future. Methods The phosphorus contents in the standard solution and MenAPSV were detected. The differences of standard curve, limit of quantitation, accuracy, precision and durability (solution stability) of these 2 methods were compared. Results The average determination coefficients of standard curve were 0.997 3 for Method 1and 0.999 3 for Method 2, and the limits of quantitation were 3.97 μg for Method 1 and 2.16 μg for Method 2. The phosphorus content in MenAPSV detected by these 2 methods showed that the relative standard deviations of detection results were 10.3% for Method 1 and 7.6% for Method 2, and the phosphorus adding recovery rates of Method 1 and Method 2 were 87.8%-113.1% and 97.1%-103.6%, respectively. The colorimetric analysis was started after the solution was placed for 0, 30 and 60 min, respectively. The absorbance increasing values per 30 min were 0.059 for Method 1 and 0.003 for Method 2. Conclusions Both methods can be applied to detect the phosphorus content in MenAPSV. Compared with Method 1, Method 2 has better linearity, lower detection quantitation limit, higher accuracy and precision, and better durability (solution stability).
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