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
Tablets
are 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:
