对市售蛇类抗蛇毒血清的分析表明，一些产品的内毒素含量很高

IF 3.6 Q2 TOXICOLOGY

Toxicon: X Pub Date : 2024-02-15 DOI:10.1016/j.toxcx.2024.100187

Gabriela Solano , Stuart Ainsworth , Adriana Sánchez , Mauren Villalta , Paola Sánchez , Gina Durán , José María Gutiérrez , Guillermo León

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引用次数: 0

摘要

作为注射治疗药物，蛇类抗蛇毒血清必须符合内毒素含量规范。我们使用鹅卵石红细胞裂解液（LAL）测试法来评估几种已上市并用于临床的抗蛇毒血清中的内毒素含量。结果发现，一些产品的内毒素含量高于这些污染物的公认限值。这些结果表明，生产商和监管机构有必要将内毒素测定作为抗蛇毒血清常规评估的一部分。

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Analysis of commercially available snake antivenoms reveals high contents of endotoxins in some products

As injectable therapeutics, snake antivenoms must meet specifications for endotoxin content. The Limulus amebocyte lysate (LAL) test was used to evaluate the endotoxin content in several commercially available antivenoms released for clinical use. It was found that some products have endotoxin concentrations higher than the accepted limit for these contaminants. These results emphasize the need to include endotoxin determination as part of the routine evaluation of antivenoms by manufacturers and regulatory agencies.

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来源期刊

Toxicon: X Pharmacology, Toxicology and Pharmaceutics-Toxicology

CiteScore

6.50

自引率

0.00%

发文量

审稿时长

14 weeks