欧洲药典在线----对细菌内毒素修订内容的建议

julia朱玉姣

GMP News
23/12/2015

Pharmeuropa - Comments concerning revisedtexts about Bacterial Endotoxins

欧洲药典在线----对细菌内毒素修订内容的建议

As mentioned in the GMP News "EDQM revises 5.1.10. Guidelines forusing the Test for Bacterial Endotoxins" from November 2014,the EDQM published a revised draft of that chapter which was open forcomments. Now the EDQM issued an overview with "Commentsconcerning revised texts published in Supplement 8.8" - amongstothers concerning the changes in chapter 5.1.10. The EDQM summarized as follows:

正如2014年11月的GMP新闻“EDQM修订5.1.10细菌内毒素测试使用指南”中所提到的，EDQM公布了修订草案公开征求意见。现在EDQM发布了“增补8.8中公布的修订内容的建议”回顾----其中有关于5.1.10变更意见。EDQM汇总建议如下：

"This general chapter has undergone a generalrevision with the following scope:

本通则经过了大量修订，包括

• In the context of the new bacterial endotoxins Ph. Eur. policy     approved by the European Pharmacopoeia Commission during its 149th     Session (June 2014), a section has been added (section 2-4) to include     aspects to be considered when establishing an endotoxin limit for a     specific substance or product; also, the text has been revised to reflect     the fact that an endotoxin limit is not always provided in a specific     monograph.
• 欧洲药典委员会第149次会议（2014年6月）中批准的新的细菌内毒素EP原则中，增加了一个部分（第2-4部分）以包括在为一个特定物质或制剂建立一个内毒素限度时需要考虑的问题。另外，修订也是为了反映内毒素限度并不总是在特定的各论中给出的事实。
• Reference is made to general chapter 2.6.30. Monocyte-activation test     as an alternative to the rabbit pyrogen test, and a recommendation is     given to perform a risk assessment when using the bacterial endotoxin test     as a pyrogenicity test, due to the potential for contamination by     non-endotoxin pyrogens. In this respect, the previous section 11     concerning the replacement of the rabbit pyrogen test by a test for     bacterial endotoxins has been substituted with a new text in agreement     with a strategy to be applied for testing of bacterial endotoxins or     non-endotoxin pyrogens. A distinction is made between replacement methods     already described in the Ph. Eur. and other alternative methods.
• 其中引用了通论2.6.30单核细胞激活试验替代兔热源测试，并建议在使用细菌内毒素测试作为热源测试时进行风险评估，因为可能会受到非内毒素热源污染。在此方面，之前的第11部分关于使用细菌内毒素测试取代兔热源测试的内容改成了与实施细菌内毒素测试或非内毒素热源中策略一致的内容。替代方法之间的区别已在欧洲药典和其它替代方法中进行了描述。
• Reference is made to the use of alternative reagents to the Limulus     amoebocyte lysate, such as recombinant factor C: this practice avoids the     use of animal species and can be considered in the context of the use of     an alternative method as described in the General Notices.
• 其中引用了使用试剂替代鲎试剂，例如重组因子C：这种做法能避免使用动物，在使用通则中所述替代方法时可以考虑。
  

A number of additional specific points have beenincluded in the revision:

在修订内容中增加了很多其它特定点：

• Method A is no longer declared as the reference method, and all     methods A to F of general chapter 2.6.14. Bacterial endotoxins can     be used. Where the method is stated in the monograph, the use of     another method must be validated.
• 方法A不再被作为参考方法，2.6.14细菌内毒素中从A到F的所有方法均可以使用。如果在各论中已指明了方法，则使用另一方法必须进行验证。
• The expression ‘threshold endotoxin concentration’ has been replaced     by the more appropriate expression ‘endotoxin limit concentration’ to     harmonise with general chapter 2.6.30. Monocyte-activation test.
• 使用更恰当的词语“内毒素限度浓度”来替代“内毒素浓度阈值”以保持与通则2.6.30“单核细胞激活试验”保持一致。
• A new entry has been included in Table 5.1.10.-1 for formulations     administered per square metre of body surface.
• 在表5.1.10-1中包括一个新的计算公式用于计算单位平方米体表面摄入量。
  

Finally, the structure of the general chapter has beenmodified to improve its clarity."

最后，通则的结构进行了修订，以让其更清晰。

Additionally they announced, that the chapter 2.6.8.now includes a reference to 2.6.30. Monocyteactivation test as a potentialreplacement of the test for pyrogens.

此外，他们宣布，2.6.8章节现在包括了对2.6.30“单核细胞激活试验”的引用作为热源测试可替代方法。

For the complete overview please see "Commentsconcerning revised texts published in Supplement 8.8". The online versioncan be accessed on the website of EDQM. Access tothe online version requires registration, but this is a free service.

完整的概览参见“增补8.8公布的修订内容意见”。在线版本可以从上述网址中获得。在线版本需要注册，但是免费的。

Please be aware of ECA's special activity relatedto the current issue of Endotoxin Masking - see the hands-on laboratory course"Low Endotoxin Recovery/Masking"on 10 and 11 February 2016 in Bernried near Munich, Germany.

ECA将于2016年2月10-11日举办“低内毒素发现/掩蔽”的课程活动。

charls

坐沙发了

syhorchid

学习一下

老鸟

求完整翻译稿，能共享下不？鲎试剂替代法很感兴趣