欧洲药典在线----对细菌内毒素修订内容的建议

20151223 ECA新闻：欧洲药典在线----对细菌内毒素修订内容的建议  

GMP News
23/12/2015

Pharmeuropa - Comments concerningrevised texts 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 revises5.1.10. Guidelines for using the Test for Bacterial Endotoxins"from November 2014, the EDQM published a revised draft of that chapterwhich was open for comments. Now the EDQM issued anoverview with "Comments concerning revised texts published inSupplement 8.8" - amongst others concerning the changes in chapter5.1.10. 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 undergonea general revision 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 149thSession (June 2014), a section has been added (section 2-4) to include aspectsto be considered when establishing an endotoxin limit for a specific substanceor product; also, the text has been revised to reflect the fact that anendotoxin 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 arecommendation is given to perform a risk assessment when using the bacterialendotoxin test as a pyrogenicity test, due to the potential for contaminationby non-endotoxin pyrogens. In this respect, the previous section 11 concerningthe replacement of the rabbit pyrogen test by a test for bacterial endotoxinshas been substituted with a new text in agreement with a strategy to be appliedfor testing of bacterial endotoxins or non-endotoxin pyrogens. A distinction ismade between replacement methods already described in the Ph. Eur. and otheralternative 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 tothe Limulus amoebocyte lysate, such as recombinant factor C: this practiceavoids the use of animal species and can be considered in the context of theuse 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 pointshave been included 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 canbe used. Where the method is stated in the monograph, the use of anothermethod 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’ hasbeen replaced by the more appropriate expression ‘endotoxin limitconcentration’ to harmonise with general chapter 2.6.30. Monocyte-activationtest.

·        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 forformulations 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 generalchapter has been modified 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 thechapter 2.6.8. now includes a reference to 2.6.30. Monocyteactivation test as apotential replacement 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"Comments concerning revised texts published in Supplement 8.8". Theonline version can be accessed on the website of EDQM. Access to the online versionrequires 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 specialactivity related to the current issue of Endotoxin Masking - see the hands-onlaboratory course "Low EndotoxinRecovery/Masking" on 10 and 11 February 2016 in Bernried nearMunich, 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。

来源：http://zhuyujiao1972.blog.163.com/blog/static/986947272015112405820863/