折光率快速测定碘海醇注射液含量的方法研究  

Rapid Determination of Iohexol Injection by a Refractive Index Method

作　　者：刘茜[1] 金薇[1] 李丹 乐健[1] 杨永健[1] 

机构地区：[1]上海市食品药品检验所,上海201203

出　　处：《中国药师》2018年第3期521-523,共3页China Pharmacist

摘　　要：目的:建立折光率与碘海醇注射液的化学计量关系。方法:采用Rudolph J257与Mettler Toledo RE40D折光仪对多企业生产的碘海醇注射液进行测定,将折光率与电位滴定法测得的含量结果建立化学计量关系式C=2.828R-3.769。结果:对76批次样品的电位滴定测得的含量结果与经折光率计算得到的模拟结果进行比较,模拟结果与实测结果的相对偏差小于2%,辅料不干扰测定。结论:本法简便、快速、准确,可用于碘海醇产品的过程控制及市场监督。Objective： To develop a stoichiometric relationship between iohexol injection and its refractive index. Methods： Rudolph J257 and Mettler Toledo RE40D were adopted to determine the refractive index of iohexol injection produced by different factories. The relationship between the refractive index and the concentration of iohexol determined by potentiometric titration was described as C = 2. 828 R-3. 769. Results： The relative deviation of simulated content calculated by the stoichiometric and titration content was less than 2%. Little contribution by excipients could be ignored. Conclusion： The proposed method shows simplicity,rapidity and accuracy,which can be applied in the process control and the market supervision of iohexol.

关 键 词：碘海醇 折光率 含量测定 化学计量学 快速定量分析 

分 类 号：R917[医药卫生—药物分析学]