第 52 卷第 2 期 Vol. 52 No. 2 2022 年 4 月 Apr 2022

所属栏目：分析与测试 动态浊度法测定乳酸钠林格注射液中细菌内毒素含量的研究

姜艳玲1，李 婵2，赵 敏1 （1.西安万隆制药股份有限公司，陕西 杨凌 712100；2.陕西省药品和疫苗检查中心，陕西 西安 710065）

摘　要：采用细菌内毒素检测仪，基于动态浊度法测定了乳酸钠林格注射液在不同生产阶段中细菌内毒素的含量。细菌内毒素含量在0.003 906~1.000 0 EU/mL范围，∣r∣=0.991 0（≥0.980 0），标准曲线回归方程为：y=-0.229 8x+2.894 9，线性回归关系良好，标准曲线可靠；乳酸钠林格注射液的浓配、稀配、灌装及成品2倍稀释时，回收率99%~135%，符合50%~200%的要求，实验无干扰作用，3批不同阶段样品结果均小于0.50 EU/mL。该方法无干扰、检测灵敏度及准确度高、数据可靠，适用于乳酸钠林格注射液生产过程中细菌内毒素含量的测定。

关键词：动态浊度法；乳酸钠林格注射液；细菌内毒素

中图分类号：TQ423　　文献标识码：A　　文章编号：1009-9212（2022）02-0077-04

Dynamic Turbidimetric Determination of Bacterial Endotoxin in Sodium Lactate Ringer Injection

JIANG Yan-ling1, LI Chan2, ZHAO Min1 (1. Xi'an WanLong Pharmaceutical Co.,Ltd., Yangling 712100, China; 2. Shaanxi Center for Drug and Vaccine inspection, Xi'an 710065, China)

Abstract：The dynamic turbidimetric method was used to determine the bacterial endotoxin content of Sodium Lactate Ringer Injection in different production stages using bacterial endotoxin detector. The results showed that with a bacterial endotoxin content range of 0.003 906~1.000 0 EU/mL， ∣r∣=0.991 0(≥0.980 0), The standard curve regression equation is as following: y=-0.229 8x+2.894 9. The linear regression relationship was good, and the standard curve was reliable. In the stage of thick blending, thin blending, filling and finished for Sodium Lactate Ringer Injection at 2 times dilution, the recovery rates were 99%~135%, which meet the requirements of 50%~200%, the test had no interference effect, and the test results of 3 batches in the different stages of samples were less than 0.50 EU/mL. This established method has no interference with high detection sensitivity and accuracy, and the data were reliable. This method is suitable for the determination of bacterial endotoxin content in Sodium Lactate Ringer Injection.

Key words：dynamic turbidity method; Sodium Lactate Ringer Injection; bacterial endotoxin

作者简介：姜艳玲（1978—），女，陕西西安人，执业药师，研究方向：药物分析和药品质量管理工作。

收稿日期：2021-10-20