EP各论中溶出度和崩解度测试的新政策 20201210.pdf

New policy for dissolution and disintegrationtesting in Ph. Eur. Monographs EP 各论中溶出度和崩解度测试的新政策 European Pharmacopoeia Monograph News 10 December 2020 Strasbourg, France Over the last few years, the European Pharmacopoeia(Ph. Eur.) has been elaborating monographs on medicinal productscontaining chemically defined active substances, applicable toimmediate-release solid dosage forms (tablets, capsules) . 在过去的几年中，欧洲药典一直在撰写含有明确化学成分的速释固体制剂 （片剂，胶囊剂）的各论。 These monographs include a mandatory test fordissolution or disintegration. However, in justified and authorised cases,manufacturers may propose another procedure and/or, where appropriate,different acceptance criteria as part of their marketing authorisationapplication. This is indicated in the monographs by the sentence : 这些各论包括关于溶解或崩解的强制性测试。但是，在合理的情况下，制 造商可以提议另一种方法和/ 或在适当时提出不同的接受标准，作为其上市 许可申报的一部分。这在各论中中用以下句子表示： The tablets comply with the test and the acceptance criterion describedbelow, unless otherwise justified and authorised . 这些片剂应符合以下所述的测试和接受标准，另有说明和批准者除外，。 Since the result of the dissolution test may beaffected by the formulation and/or the manufacturing process, the Ph. Eur.Commission launched a substantive examination of users’ expectations withregard to this test in medicinal product monographs . 由于溶出度测试的结果可能会受到配方和/或生产过程的影响，因此，欧洲 药典委员会对药品各论中的使用者对该测试的期望进行了实质性检查。 Users in the pharmaceutical industry, the licensingauthorities, national pharmacopoeias and OMCLs, for example, were thereforeinvited to participate in a survey in January 2019 . 因此，制药行业的用户，如药监当局、国家药典和 OMCL 被邀请参加了 2019 年 1 月的调查。 Three options were proposed: 期间提出了三种方案： 1. keep a mandatory dissolution test in the monographs ; 在各论中保留强制检测溶出度 2. include a dissolution test as an example in the monographs ; 在各论中加入一种溶出度检测作为例子 3. do not include a dissolution test since the dosage form monographs on Tablets (0478) and Capsules (0016) contai