复方氯化钠注射液生产管道中15种元素迁移量测定  

Determination of Migration of 15 Elements in Production Pipeline of Compound Sodium Chloride Injection

作　　者：聂蕾 白桦芳 张欢 刘颖玲 陈水廷 NIE Lei;BAI Huafang;ZHANG Huan;LIU Yingling;CHEN Shuiting(Yunnan Province Medical Instrument Testing Research Institute,Kunming 650106,China;Kunming Medical University,Kunming 650504,China)

机构地区：[1]云南省医疗器械检验研究院,昆明650106 [2]昆明医科大学,昆明650504

出　　处：《中国现代应用药学》2020年第17期2109-2113,共5页Chinese Journal of Modern Applied Pharmacy

摘　　要：目的研究复方氯化钠注射液生产管道中Pt,Fe,Mn,Cr,Mo,Cd,Pb,As,Hg,Co,Ni,V,Cu,Sb,P共15种元素迁移量的测定方法并评价其安全性。方法采用ICP-MS测定,射频功率1 550 W;蠕动泵泵转速40 r×min^-1;雾化室温度2.7℃;采样深度5mm;冷却气流速14L·min^-1;辅助气流速0.800 0L·min^-1。结果各元素线性系数r为0.998 8~0.999 9,加样回收率为75%~120%,仪器精密度RSD为1.3%~8.5%,重复性RSD为2.2%~15.0%。15种元素实际每日摄入量均小于每日允许暴露量(permitted daily exposure, PDE)。结论建立的方法操作简便、结果可靠,可用于复方氯化钠注射液生产管道中15种元素迁移量测定。OBJECTIVE To study the migration of 15 elements(Pt, Fe, Mn, Cr, Mo, Cd, Pb, As, Hg, Co, Ni, V, Cu, Sb and P) in the Compound Sodium Chloride injection from its production pipeline and to evaluate its safety. METHODS ICP-MS was used to perform the analysis. The radio frequency power was 1 550 W;the speed of the peristaltic pump was 40 r×min^-1;the temperature of the atomization chamber was 2.7 ℃;the sampling depth was 5 mm;the cooling airflow speed was 14 L·min^-1 and the auxiliary airflow velocity was 0.800 0 L·min^-1. RESULTS The r of 15 elements was 0.998 8-0.999 9;the recovery rate was 75%-120%;the RSD of the precision experiment of instrument was 1.3%-8.5%;the RSD of the repetitive experiment was 2.2%-15%;and the daily intake of 15 elements in the determination of 3 batches of sample migration was lower than their corresponding permitted daily exposure(PDE). CONCLUSION The method is simple and reliable. It can be used to determine the migration of 15 elements in the Compound Sodium Chloride injection from its production pipeline.

关 键 词：复方氯化钠注射液 电感耦合等离子体质谱 生产管道 迁移量测定 

分 类 号：R917.101[医药卫生—药物分析学]