自动电位滴定法测定微球助悬剂中过氧化值  

Determination of peroxide value in microsphere suspending agents by automatic potentiometric titration

作　　者：段盼盼 吴姿 赵丽娟 苏日佳 王燕清 DUAN Panpan;WU Zi;ZHAO Lijuan;SU Rijia;WANG Yanqing(Livzon Pharmaceutical Group Inc.,Guangdong,Zhuhai 519000,China)

机构地区：[1]广东省珠海市丽珠微球科技有限公司,广东珠海519000

出　　处：《中国医药科学》2024年第17期75-78,共4页China Medicine And Pharmacy

基　　金：广东省珠海市产学研合作项目(ZH22017002210010PWC)。

摘　　要：目的建立测定微球注射剂用助悬剂中过氧化值的电位滴定方法。方法用磷酸调节助悬剂的pH值,加饱和碘化钾溶液振摇反应后,加碘滴定液(0.005 mol/L),用硫代硫酸钠滴定液(0.001 mol/L)滴定,用电位滴定仪测定过氧化值。结果方法在pH 4.0~5.0范围内耐用(RSD=2.23%),精密度良好(RSD=1.49%),回收率在88.46%~114.10%,准确度高,测得4批助悬剂过氧化物量为2.75~3.98μmol/100 ml。结论本方法绿色环保,灵敏度高,适用于微球助悬剂一类过氧化值极低的液体药物制剂中过氧化值的测定。Objective To establish a potentiometric titration method for the determination of peroxide value in suspending agents for microsphere injection.Methods The pH of suspending agents was adjusted with phosphoric acid,and after shaking reaction with saturated potassium iodide solution,iodine titration solution(0.005 mol/L)was added,titrated with sodium thiosulfate titration solution(0.001 mol/L),and the peroxide value was determined with potentiometric titrator.Results The method was durable(RSD=2.23%)in the range of pH 4.0-5.0,with good precision(RSD=1.49%),the recovery rate was 88.46%-114.10%,and the accuracy was high.The suspending agents peroxide content of four batches were 2.75-3.98μmol/100 ml.Conclusion This method is environmentally friendly and highly sensitive,and is suitable for the determination of peroxide value in liquid pharmaceutical preparations with extremely low peroxide value,such as microsphere suspending agents.

关 键 词：微球 助悬剂 过氧化值 电位滴定法 

分 类 号：R927.2[医药卫生—药学]