养热原兔专业户的冬天要来了，MAT的春天来了。EP准备在5年内用MAT取代RPT，涉及59个章节。

Europen Pharmaceopeia to put an end to the rabbit pyrogen test

EP准备终结兔热原试验

EUROPEAN PHARMACOPOEIA

ANIMAL TESTING

 NEWS

 28 JUNE 2021

At its 170th session in June 2021, the European Pharmacopoeia (Ph. Eur.) Commission took the decision to engage on a path that should ultimately lead to the complete replacement of the rabbit pyrogen test (RPT) in the Ph. Eur., within approximately 5 years.

在 2021 年 6 月举行的第 170 届会议上，欧洲药典委员会决定采取措施，最终将在大约 5 年内完全取代 EP 中的兔热原试验 (RPT)。

The Ph. Eur. test for pyrogens (general chapter 2.6.8) consists of measuring the rise in body temperature evoked in rabbits by the intravenous injection of a sterile solution of the substance to be examined. It was first published in the Ph. Eur. in 1986.

EP热原测试（通则 2.6.8）通过测量兔子通过静脉注射待测物质的无菌溶液引起的体温升高进行检测。它于 1986 年首次在 EP 中发布。

The majority of pyrogens are bacterial endotoxins and these can be detected using the bacterial endotoxins test (BET) described in Ph. Eur. general chapters 2.6.14. Bacterial endotoxins and 2.6.32. Test for bacterial endotoxins using recombinant factor C. However, in some cases, non-endotoxin pyrogens may also be present and these are not detected by the BET. A test covering all types of pyrogens is therefore required to confirm the absence of non-endotoxin pyrogens.

大多数热原是细菌内毒素，可以使用 EP 通则 2.6.14 【细菌内毒素】和 2.6.32【使用重组因子 C 检测细菌内毒素】中描述的细菌内毒素测试 (BET) 方法检测这些热原。然而，在某些情况下，也可能存在非内毒素热原，而这些不会被 BET 检测到。因此，需要进行涵盖所有类型热原的测试，以确认不存在非内毒素热原。

General chapter 2.6.30. Monocyte-activation test (MAT) was added to the Ph. Eur. in 2009, providing an in-vitro alternative to the RPT that is capable of detecting both endotoxin and non-endotoxin pyrogens. The publication of this chapter was a significant step forward in terms of animal welfare, in accordance with the Council of Europe’s European Convention for the Protection of Vertebrate Animals used for Experimental and Other Scientific Purposes.

通则 2.6.30【单核细胞活化试验 (MAT) 】于 2009 年增加至 EP 中，为 RPT 提供了一种体外替代方案，能够检测内毒素和非内毒素热原。根据欧洲委员会的《欧洲保护用于实验和其他科学目的的脊椎动物公约》，本章节的发布是动物福利方面向前迈出的重要一步。

However, despite multiple efforts since then to encourage developers to apply the MAT instead of the RPT, rabbits continue to be used extensively to detect pyrogenic substances.

然而，尽管从那时起就鼓励开发人员应用 MAT 而不是 RPT，兔子仍继续被广泛用于检测致热物质。

There are currently 59 Ph. Eur. texts – covering a variety of topics including vaccines for human use, blood products, antibiotics, radiopharmaceuticals and containers – that refer to the RPT and will be affected. The Ph. Eur. is committed, for all these texts, to replacing the test for pyrogens with a suitable in-vitro alternative, ultimately leading to the complete elimination of the RPT. In the meantime, users are actively encouraged to seek alternatives to chapter 2.6.8, the best option being the MAT.

目前有 59 篇 EP 正文（涵盖各种主题，包括人用疫苗、血液制品、抗生素、放射性药物和容器）涉及 RPT 并将受到影响。EP承诺对于所有这些章节采用合适的体外替代品代替热原测试，最终消除所有 RPT。同时，积极鼓励用户寻找第 2.6.8 章的替代方案，最佳选择是 MAT。

Throughout the process, users will have the opportunity to comment on a case-by-case basis, since each of the texts concerned will go through the standard public enquiry in Pharmeuropa.

在整个过程中，用户将有机会针对各案提出建议，因为每个相关章节都将通过 Pharmeuropa 公开征求意见。