養熱原兔專業戶的冬天要來了，MAT的春天來了。EP準備在5年內用MAT取代RPT，涉及59個章節。

Europen Pharmaceopeia to put an end to the rabbit pyrogen test

EP準備終結兔熱原試驗

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 月舉行的第 170 屆會議上，歐洲藥典委員會決定采取措施，最終將在大約 5 年內完全取代 EP 中的兔熱原試驗 (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熱原測試（通則 2.6.8）通過測量兔子通過靜脈注射待測物質的無菌溶液引起的體溫升高進行檢測。它于 1986 年首次在 EP 中發布。

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.

大多數熱原是細菌內毒素，可以使用 EP 通則 2.6.14 【細菌內毒素】和 2.6.32【使用重組因子 C 檢測細菌內毒素】中描述的細菌內毒素測試 (BET) 方法檢測這些熱原。然而，在某些情況下，也可能存在非內毒素熱原，而這些不會被 BET 檢測到。因此，需要進行涵蓋所有類型熱原的測試，以確認不存在非內毒素熱原。

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.

通則 2.6.30【單核細胞活化試驗 (MAT) 】于 2009 年增加至 EP 中，為 RPT 提供了一種體外替代方案，能夠檢測內毒素和非內毒素熱原。根據歐洲委員會的《歐洲保護用于實驗和其他科學目的的脊椎動物公約》，本章節的發布是動物福利方面向前邁出的重要一步。

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，盡管從那時起就鼓勵開發人員應用 MAT 而不是 RPT，兔子仍繼續被廣泛用于檢測致熱物質。

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（涵蓋各種主題，包括人用疫苗、血液制品、抗生素、放射性藥物和容器）涉及 RPT 并將受到影響。EP承諾對于所有這些章節采用合適的體外替代品代替熱原測試，最終消除所有 RPT。同時，積極鼓勵用戶尋找第 2.6.8 章的替代方案，最佳選擇是 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.

在整個過程中，用戶將有機會針對各案提出建議，因為每個相關章節都將通過 Pharmeuropa 公開征求意見。