欧洲药典新章节草案“预混辅料”公布 - 药群论坛

20151111 ECA新闻：欧洲药典新章节草案“预混辅料”公布

A draft of a new Ph. Eur. chapter "Co-Processed Excipients" has been published in Pharmeuropa 27.4 withdeadline for comments on December 31, 2015.

新的EP章节草案“预混辅料”在27.4中公布，征求意见截止日期为2015年12月31日。

In the proposed chapter aco-processed excipient is defined as "any combination of two or moreexcipients obtained by physical co-processing that does not lead to theformation of covalent bonds".

在拟定的章节中，预混辅料定义为“两种或更多种辅料通过物理预混获得的混合物，其中不含有分子键”。

The individual components of aco-processed excipient have to comply with the requirements of anycorresponding individual Ph. Eur monograph and of the general Ph. Eur.monograph Substances for pharmaceutical use. Additionally,the co-processed excipients comply with the requirements of the generalPh. Eur. monograph Substances for pharmaceutical use.

用于预混的单个辅料必须符合欧洲药典中相应的各论要求，以及药用物质的通论要求。另外，预混辅料还要符合药用物质通论的要求。

Co-processed excipients can be producedby processings that produce only a physical interaction between the componentslike for example co-drying, spray drying, granulation, extrusion, andhigh-shear dispersion. They may be batch or continuous processes.

预混辅料可以通过只会发生物理反应的工艺过程制得，例如，共同干燥，喷雾干燥，制粒，挤出和高剪切分散。这些工艺可以是间歇生产也可以是连续工艺。

The proposed monograph includes sectionson Characters, Identification, Tests, Assay, Labelling, andFunctionality-Related Characteristics.

所拟的各论包括部分为属性、鉴别、测试、含量、标签和功能性相关特性。

The section on "Tests"proposes that "specifications are defined for the final co-processedmaterial as a whole" and "if the co-processed excipient includesimpurities not controlled by the monographs of the individual components, thesemust be specified and suitably controlled".

在“测试”部分提议“为最终预混物料整体质量定义质量标准”，“如果预混辅料包括了单成分各论中未受控的杂质，则必须指明并进行适当控制”。

Following your registration on thePharmeuropa website you can get to the complete Draft Chapter "Co-Processed Excipients".