EP增补版10.6：制剂专论和通则变更

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2月4日，欧洲药典（EP）发布EP增补版10.6的相关信息。2020年11月第168届会议上，欧洲药典委员会通过了三份制剂专论和两篇相关通则的修订版、以及一篇新的通则。修订后的章节涵盖了许多药品，包括所有的眼用和耳用制剂、以及所有大于18 mm的口服片剂和胶囊；而新的通则“微粒污染：非注射液体制剂中的不溶性微粒（2.9.53）”，主要适用于某些眼用制剂。

对制剂专论的主要变化，以下作了简要说明：

眼用制剂（1163）

Eye preparations (1163) – New requirements concerning the test for sub-visible particle contamination have been added for eye drops and eye lotions. These requirements apply specifically for preparations used in a surgical setting or for the treatment of the injured eye. Where ophthalmic inserts are concerned, the text now stipulates that a suitable test to demonstrate the appropriate release of the active substances must be performed.

滴眼液和眼用液体制剂已添加了有关不溶性微粒污染检验的新要求。这些要求专门适用于外科手术环境中、或眼睛受伤治疗中的制剂。在涉及眼用嵌入剂的情况下，本章现规定必须进行适当的试验，以证明活性物质的适当释放。

耳用制剂（0652）

Ear preparations (0652) – A new section on ear sprays has been created in order to specify clearly the tests to carry out for this category of ear preparations. Thus, uniformity of delivered dose (intra-container testing), number of deliveries per container and, for pressurised preparations, the leak rate test have been included as requirements for metered-dose ear sprays that are supplied in multidose containers.

EP已建立了有关耳用喷雾剂的新内容，以明确规定要针对此类耳用制剂进行的检验。因此，作为多剂量容器中对于定量耳喷雾剂的要求，已经包括的检验项目包括：给药剂量的均匀性（容器内的检验）、每个容器的给药次数，以及对于加压制剂的泄漏率。

药用泡沫剂（1105）

Foams, medicated (1105) – The sterility test and the labelling section have been deleted in order to avoid duplication of information from the dosage form monographs that refer to this text.

药用泡沫剂已删除无菌检验和标签部分，以避免重复使用引用制剂专论中的信息。

通则的主要变更是：

片剂和胶囊的崩解（2.9.1）

Disintegration of tablets and capsules (2.9.1) – The section concerning Test B applicable for tablets and capsules larger than 18 mm has been revised. Test B is currently specific to the European Pharmacopoeia and, unlike Test A, is not harmonised with either the Japanese Pharmacopoeia (JP) or the US Pharmacopeia (USP). The wording of Test B has been aligned with that of the harmonised text and, again in accordance with the latter, staged testing is now described.

检验B的部分，适用于大于18毫米的片剂和胶囊，已进行了修订。目前，检验B特定于欧洲药典，与检验A不同，它与日本药典（JP）或美国药典（USP）均未进行统一。检验B的措词现已与检验A的措词保持一致，且根据检验A描述了分阶段检验。

The Ph. Eur., JP and USP will continue their efforts to further harmonise Test B within the Pharmacopoeial Discussion Group (PDG).

EP、JP和USP将继续努力，在药典讨论小组（PDG）框架下，进一步统一的检验B。

多剂量容器中给药剂量的均匀性和准确性（2.9.27）

Uniformity and accuracy of delivered doses from multidose containers (2.9.27) – The revised text makes it possible to conduct the test based on volume measurements.

修订后的文本使得可以基于体积测量进行检验。

ll these texts will be published in July 2021 in Supplement 10.6 of the European Pharmacopeia and will become legally binding in the member states of the European Pharmacopoeia on 1 January 2022.

所有这些章节将于2021年7月在EP增补版10.6中发布，并将于2022年1月1日在成员国中具有法律约束力。

Ref.: Ph. Eur. Supplement 10.6: updated dosage form monographs and general chapters. 04 FEBRUARY 2021. EDQM.

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