欧洲药典注射剂专论，已通过修订

2020年9月17日，欧洲药品质量管理局（EDQM）表示，欧洲药典委员会通过了注射制剂剂型专论（0520）的修订版本，该版本对多种药品提出了强制性的质量要求。这是一个全面修订，原文本的许多部分都已进行了大的修改，变化涉及粒子检验、细菌内毒素-热原检验等，其实施日期为2021年7月1日。

At its 167th session in June 2020, the European Pharmacopoeia (Ph. Eur.) Commission adopted the revised version of the dosage form monograph on Parenteral preparations (0520) which gives mandatory quality requirements for a large number of medicinal products on the European market.

在2020年6月的第167届会议上，欧洲药典委员会通过了注射制剂剂型专论（0520）的修订版本，该版本对欧洲市场上的多种药品提出了强制性的质量要求。

The revised text now describes the tests on particulate contamination – for both visible and sub-visible particles – in the test section as release criteria. These tests apply to all liquid parenteral preparations intended for injection or infusion (including solutions, suspensions, emulsions or gels). A reference to general chapter 5.17.2 has been included for additional guidance. This non-mandatory general chapter describes considerations used in the field of visual inspection and in the control of visible particles in medicinal products and provides guidance on how users can establish that their product is practically free from particles.

对于修订后的专论，在“检验部分”中描述了粒子污染物检验（包括可见和不可例子），作为放行标准。这些检验适用于所有用于注射或输液的液体注射制剂（包括溶液、悬浮液、乳剂或凝胶剂）。专论引用了通则5.17.2，以包含其它相关指导。通则5.17.2是非强制性的，描述了目检领域、以及可见粒子控制的注意事项，并就如何确定其产品不含粒子，为用户提供了指导。

The test for visible particles has also been added to the production section to ensure that parenteral preparations are kept free from visible particles during manufacture.

用于可见粒子的检验也已添加到“生产部分”，以确保注射制剂在生产过程中不含可见粒子。

Following a number of stakeholder comments, the original text has been expanded to include a new sub-section on intravitreal preparations, to clarify that they are parenteral preparations and not eye preparations. In line with requirements for all parenteral preparations in Europe, the bacterial endotoxin–pyrogen tests have been transferred from subsections to the general test section while maintaining the existing exception for veterinary products. For animal welfare reasons, the 10 ml injection volume recommendation for the pyrogen test has been deleted. Other additions include the introduction of uniformity requirements into the section on implants.

在许多利益相关者的评论之后，已对原文本进行了扩展，以包括有关玻璃体内制剂的新小节，以阐明它们是注射制剂，而不是眼部制剂。为符合欧洲所有注射制剂的要求，细菌内毒素-热原检验已从小节转移到“通用检验部分”，同时保持了对兽药的现有例外情况。出于动物福利的考虑，删除了用于热原检验的10 ml注射量建议。其他增加内容包括将均匀性要求引入植入剂部分。

This was a general revision and many portions of the original text have been substantially overhauled. For example, the individual definition sections within the monograph have been modified and aligned with the relevant Standard Terms. As a result, injections are now clearly identified as liquid preparations that are usually administered as a bolus as opposed to infusions, which are administered slowly over a period of time. Further, in the section on injections, the term “clear” has been deleted to avoid any confusion with regard to opalescence or turbidity and the preparation method has been deleted to allow users greater freedom in their choice of method.

这是一个全面修订，原文本的许多部分都已进行了大的修改。例如：

专论中的定义部分已修改、并与相关标准条款保持一致。这种修改的结果是，现在已经清楚地将注射剂界定为以快速浓注形式给药的液体制剂，这与输液剂相对，后者是在一段时间内缓慢给药。
此外，在“注射部分”中，术语“透明”已被删除，以避免在乳光或浑浊方面造成任何混淆；并且制备方法已被删除，以使用户在选择方法时拥有更大的自由度。
The revised chapter will be published in Supplement 10.5 of the Ph. Eur. by 1 January 2021 with an implementation date of 1 July 2021.

2021年1月1日，修订后的章节将发布在欧洲药典增刊10.5中，而其实施日期为2021年7月1日。

       文章来源： PharmLink

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