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

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

Key words:  Compound Sodium Chloride injection  ICP-MS  production pipeline  migration measurement

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5 mm；冷却气流速14 L·min^-1；辅助气流速0.800 0 L·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。

Abstract:

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.