中国药房2013，Vol.24Issue(29)：2752-2754,3.DOI:10.6039/j.issn.1001-0408.2013.29.23
血液滤过置换液的细菌内毒素检查法研究
Study on Bacterial Endotoxin Test for Hemofiltration Replacement Fluid
魏霞 1韩梅 2韩瑶 3祝清芬1
作者信息
- 1. 山东省食品药品检验所,济南250101
- 2. 济南市中心医院急诊科,济南250013
- 3. 青岛华仁药业股份有限公司,山东青岛266101
- 折叠
摘要
Abstract
OBJECTIVE:To establish bacterial endotoxin test for hemofiltration replacement fluid.METHODS:The limit for bacterial endotoxin in this product was designed according to Chinese Pharmacopeia Ⅱ (2010 edition).The disturbance to bacterial endotoxins test from the samples was investigated by both gel-clot method and kinetic turbidimetric limulus test.RESULTS:Gel-clot method showed that this product neither inhibited nor enhanced the test.For kinetic turbidimetric limulus test,the absolute value of correlation was 0.984 8 (＞0.980),and the standard curve was valid.The recovery rates of bacterial endotoxin the sample solution were 50％-200％,which indicated that the sample solution neither inhibited nor enhanced the test.The contents of bacterial endotoxin in 3 batches of sample were lower than 0.03 EU/ml and all met the requirements for bacterial endotoxin test.Moreover,results of 2 methods were same to each other.CONCLUSIONS:Bacterial endotoxins test is suitable for this product instead of pyrogen test.The contents of bacterial endotoxin should be lower than 0.03 EU in 1 ml sample solution in quality criterion.关键词
血液滤过置换液/细菌内毒素检查/干扰试验/凝胶法/动态浊度法/定量测定Key words
Hemofiltration replacement fluid/Bacterial endotoxin test/Interference test/Gel-clot method/Kinetic turbidimetric limulus test/Quantitative determination分类
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魏霞,韩梅,韩瑶,祝清芬..血液滤过置换液的细菌内毒素检查法研究[J].中国药房,2013,24(29):2752-2754,3.
