EDTA络合滴定法测定脑膜炎球菌多糖疫苗原液中的残留钙离子  

Determination of residual content for calcium ion in meningococcal polysaccharide vaccine bulk by compleximetry

作　　者：侯风萍 梁莉 慕艳红 裴钰 傅元欣 魏然 高雪军 HOU Feng-ping LIANG Li MU Yan-hong PEI Yu FU Yuan-xin WEI Ran GAO Xue-jun(The Quality Control Department in Lanzhou Institute of Biological Products Co. , Ltd. , Center for Gansu Provincial Vaccine Engineering Research, Lanzhou 730046, Gansu Province, Chin)

机构地区：[1]兰州生物制品研究所有限责任公司质量检定室甘肃省疫苗工程技术研究中心,甘肃兰州730046

出　　处：《微生物学免疫学进展》2017年第5期25-28,共4页Progress In Microbiology and Immunology

摘　　要：目的建立EDTA络合滴定法,测定A群C群脑膜炎球菌多糖疫苗中残留钙离子含量,为疫苗的质量控制提供依据。方法在p H>12的条件下,用乙二胺四乙酸(ethylenediaminetetraacetic acid,EDTA)滴定液测定C群脑膜炎球菌多糖疫苗原液中的残留钙离子,并对该方法的线性范围、准确性和重复性进行验证及初步应用。结果钙离子质量浓度在0.200 2~1.602 0 mg/m L范围内,钙离子含量与消耗滴定液的体积呈现良好的线性关系,r>0.99;在对照实验碳酸钙和无水氯化钙中,钙离子的回收率分别为100.9%和100.3%,相对标准偏差(RSD)分别为0.35%和0.21%;C群多糖原液加标回收实验中钙离子的回收率为99.7%~101.2%,RSD≤0.77%;测定6批C群脑膜炎球菌多糖原液中的钙离子浓度,RSD均≤5.6%。结论建立的EDTA络合滴定法简便、快速、准确,适用于A群C群多糖疫苗原液中钙离子含量的快速测定。Objective To set up a EDTA compleximetry in determination of residual calcium ion content in group A and C meningococcal polysaccharide vaccine,so as to provide a basis for quality control of the related vaccine. Methods Under the condition of p H 12,by using EDTA（ ethylenediaminetetraacetic acid） solution in titration of residual calcium ion content in bulk of group C polysaccharide vaccine. The method was verified for linearity,accuracy and reproducibility and a preliminary application was performed in the tested process. Results The test showed a good linear relationship between the titrated volume and calcium content,in a range of calcium from 0.200 2 mg/m L to 1.602 0 mg/m L,with r0.99. And calcium recovery rates were 100.9% and 100.3%,respectively,in the control tests for calcium carbonate and anhydrous calcium chloride,with RSD（ relative standard deviation） for 0.35% and 0.21%. The sample were directly titrated by EDTA for three concentration levels,which showed recovery rates obtained between 99.7% and 101.2%,and the RSD were ≤5.6% for calcium ion in tested 6 batches of the bulks. Conclusion The method was simple,fast and accurate,which may be used as a rapid test in determination of calcium ion content in bulk of group A and group C meningococcal polysaccharide vaccine.

关 键 词：络合滴定法 脑膜炎球菌多糖疫苗 测定 钙离子 

分 类 号：R392-33[医药卫生—免疫学]