细菌内毒素检查法在肠外药物中的应用

Y Ogawa
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引用次数: 0

摘要

鲎试验是JP XII中采用的细菌内毒素检测方法,利用鲎(Limulus polyphemus, Tachypleus tridentatus等)的血球提取物(鲎鲎鲎溶解液,LAL)检测或定量革兰氏阴性细菌来源的内毒素。它可以通过凝胶凝块或分光光度法(浊度法和比色法)技术进行,前者是基于由于内毒素激活LAL而形成的凝胶。浊度法是基于凝胶形成过程中LAL浊度的变化和LAL中肽水解酶活化的比色法技术。鲎试验作为一种简便、高灵敏度的方法,已被非正式地用于兔体内热原试验中测定肠外药物中的内毒素。JP XII细菌内毒素检查仅采用凝胶凝块技术,该技术仅允许注射使用。虽然大多数肠外药物在实践中表现出抑制或增强作用,但通过用水稀释不超过最大有效稀释倍数(MVD)来消除干扰效应,可以最容易地进行该试验。由于MVD取决于应用方法的灵敏度,比浊法和比色法技术比凝胶凝块技术更敏感,具有明显的优势。JP作为细菌内毒素检测国际统一的主要药典,提出了“细菌内毒素检测国际统一草案”,其主要目的是引入补充浊度法和比色法技术。在这种情况下,本文讨论了以下问题:(1)为了实现药典技术要求的国际统一,建议将浊度法和比色法与凝胶凝块法同时纳入药典;(2)JP、USP和EP现行细菌内毒素检查法规定的检测原则和/或条件的差异;(3)世界各国内毒素参考标准的情况。
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[Application of a bacterial endotoxin test for parenteral drugs].

The Limulus test, which has been adopted as the Test for Bacterial Endotoxins in the JP XII, can detect or quantitate endotoxins of Gram-negative bacterial origin using blood corpuscle extracts (Limulus amebocyte lysate, LAL) of horseshoe crabs (Limulus polyphemus, Tachypleus tridentatus, etc.). It may be conducted by the gel-clot or spectrophotometric (turbidimetric and colorimetric) techniques, the former being based on gel formation due to the activation of LAL by endotoxins. The turbidimetric technique is based on the LAL turbidity change during the gel formation and the colorimetric technique on activation of peptide hydrolytic enzymes in LAL. The Limulus test has been unofficially utilized as a simple and highly sensitive method for the determination of endotoxins in parenteral drugs in lieu of the in vivo Pyrogen Test using rabbits. For the Bacterial Endotoxins Test of the JP XII, the gel-clot technique alone was adopted, the technique being only allowed for Injection. Although most parenteral drugs show inhibition or enhancement in practice, this test can be most easily conducted by eliminating interfering effects through dilution of specimens by a factor not exceeding the maximum valid dilution (MVD) with water. Since MVD is dependent on the sensitivity of applied methodology, the turbidimetric and colorimetric techniques, which are more sensitive than the gel-clot technique, have a distinct advantage. The JP, as the leading Pharmacopoeia for the international harmonization of Bacterial Endotoxins Testing, has presented a "Draft towards International Harmonization of Bacterial Endotoxins Test", whose main purpose is the introduction of supplementary turbidimetric and colorimetric techniques. Under these circumstances the following subjects are discussed: (1) the proposal that, with a view towards international harmonization of the technical requirements of Pharmacopoeias, both the turbidimetric and colorimetic techniques should be included together with the gel-clot technique, (2) the differences in the testing principles and/or conditions prescribed in the current Bacterial Endotoxins Test of JP, USP and EP, and (3) the worldwide situation for Endotoxin Reference Standards.

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