折射仪法测定氯化钙注射液含量  

Determination of calcium chloride injection content byrefractive method

作　　者：范加金 张晓杰 王立增 曹大伟 郑霞[3] FAN Jiajin;ZHANG Xiaojie;WANG Lizeng;CAO Dawei;ZHENG Xia(Shandong Taibang Biological Products Co.,Ltd.,Taian 271000,China;Shandong Maternal and Child Health Care Hospital,Jinan 250000,China;Taian Maternal and Child Health Care Hospital,Taian 271000,China)

机构地区：[1]山东泰邦生物制品有限公司,山东泰安271000 [2]山东省妇幼保健院,济南250000 [3]泰安市妇幼保健院,山东泰安271000

出　　处：《中国药品标准》2022年第3期326-329,共4页Drug Standards of China

摘　　要：目的:建立快速测定氯化钙注射液含量的折射仪法。方法:采用全自动折射仪,光束值589 nm,样品池20℃,以折光率(x)为横坐标,相应钙离子浓度(y)为纵坐标建立线性回归方程,验证了该方法的线性范围,重复性、稳定性、准确度。结果:在本实验条件下,氯化钙浓度在12~60 mmol·L^(-1)时,线性方程为:y=0.000026x+1.332960,R^(2)=0.999875,重复性RSD为0.34%,4 d的含量检测稳定性良好;平均回收率为100.58%±0.61%,RSD为0.60%;以折射仪法测定氯化钙注射液的含量与药典EDTA滴定法数据不存在差异,同一制品6个平行样测定相对标准偏差分别0.34%、1.2%。结论:本法可用于氯化钙注射液含量的测定。Objective:To establish a refractive method for the rapid determination of calcium chloride injection.Methods:An automatic refractometer was used to establish a linear regression equation with refraction rate(x)as the abscissa and corresponding calcium chloride injection content(y)as the ordinate under the conditions of wavelength of 589 nm and sample pool temperature of 20℃.The linear range of the equation was studied,and its repeatability,stability and accuracy were verified.Results:Under the experimental conditions,the linear equation was y=0.000026x+1.332960(R^(2)=0.9999)when the concentration of calcium chloride was 12-60 mmol·L^(-1).The RSD of repeatability was 0.34%,and 4 d content detection was stable.The average recovery was 100.58%±0.61%with RSD of 0.60%.For refractometry and EDTA titration method in the Pharmacopoeia,the obtained content results of calcium chloride injection were not significantly different,and RSD values(n=6)of the same product determined by two methods were 0.34%and 1.2%,respectively.Conclusion:The method can be used for calcium chloride injection content.

关 键 词：折射仪法 氯化钙注射液 氯化钙含量 折光率 方法学验证 

分 类 号：R921.2[医药卫生—药学]