翻译： JULIA  来源：Julia法规翻译

24.08.2017

Revised Ph. Eur. Chapter Tablets

修订后的欧洲药典片剂章节

The revised European Pharmacopoeia (Ph. Eur.)Monograph Tablets (0478) has been published in Ph. Eur. Supplement 9.3.New and revised texts of Supplement 9.3 will be implemented on January 1, 2018(unless otherwise indicated). Additionally, from the 9th Edition,corrections are to be taken into account as soon as possible and not later thanthe end of the month following the month of publication (i.e. August 31,2017, for Supplement 9.3).

修订后的欧洲药典各论片剂（0478）已在EP9.3中发布。新的以及修订后的EP9.3将于2018年1月1日生效（另有说明者除外）。此外，自第9版开始，所有纠错内容将在第一时间考虑，不会迟于发布日次月月底（即，增补9.3于2017年8月31日）。

The details of the revised Monograph Tabletsare the following:

修订后的各论“片剂”章节详细内容如下：

• Subdivision of tablets: Break-marks must be functional, either to ease the     intake of the medicinal product or to deliver fractional doses; in cases     where fractions of tablets are necessary to deliver the intended dose     stated in the labelling, the efficacy of the breakmark is assessed with     respect to uniformity of mass of the subdivided parts. The tests have to     be performed during product development or for validation purposes using     the test provided in the monograph in section Production.

• 片剂分割：刻痕必须是功能性的，要么易于服用，要么是服用整片的一部分剂量。如果必须使用片剂的一部分来满足标签所陈述的给药剂量，则刻痕的有效性要评估分割部分的质量均一性。检测必须在产品的研发期间，或者是使用各论生产部分中所提供的测试进行验证。

• Tests:     Wording clarified for dissolution test: Unless otherwise justified and     authorized, a suitable test is carried out, for example one of the tests     described in Ph. Eur. general chapter 2.9.3. Dissolution test for solid     dosage forms.

• 检测：溶出度澄清用词：除另有论证和批准外，要执行适当的检测，例如EP通则2.9.3“固体制剂溶出度检测”中所述的测试之一。

• Gastro-resistant tablets: Dissolution test deleted as already listed in     general Tests section; Definition amended: Usually they are prepared by     covering tablets with a gastro-resistant coating or from granules or     particles already covered with a gastro-resistant coating (previous     definition: "Usually they are prepared from granules or particles     already covered with a gastro-resistant coating, in certain cases they are     prepared by covering tablets with a gastro-resistant coating); Production     section deleted as covered by dissolution test in general Tests section.

• 肠溶片：溶出测试删除，在通用测试部分列出。定义修订：通常采用肠溶包衣液包片，或已覆盖肠溶包衣的颗粒制成（之前的定义：“通常其采用已覆盖肠溶包衣的颗粒制成，特定情形下由肠溶包衣液包片制成）。生产部分删除，在通用检测部分溶出度测试中包括。

• Modified-release tablets: Production section deleted as covered by     dissolution test in general Tests section.

• 缓释片剂：生产部分删除，在通用测试溶出检测部分包括。

• Tablets for use in the mouth: Section deleted as it is within the scope of Oromucosal     preparations (1807).

• 含片：删除，包括在“口腔粘膜制剂”（1807）范围中。

• Oral lyophilisates: Definition amended: Oral lyophilisates are solid single-dose     preparations made by freeze-drying of a liquid or semi-solid     preparation. These fast-releasing preparations are intended to be placed     in the mouth where their contents are released in saliva and swallowed or,     alternatively, are intended to be dissolved or dispersed in water before     oral administration.

• 口服冻干：定义修订：口服冻干为固体一次性制剂，使用液体或半固体冻干制备。这些快速释放的制剂服用时在放在口中，其成分释放于唾液后吞咽，或溶于或分散于水中后口服。

For further information please go to the online version of the Ph. Eur. (Log in-data required).

更多信息参见EP在线。