Kószeginé S H, Török I, Lipták J, Paál T
Országos Gyógyszerészeti Intézet, Budapest, Zrínyi u.3.-1051.
Acta Pharm Hung. 2001;71(1):99-103.
The authors give an overview on the present role of the 7th Edition of the Hungarian Pharmacopoeia in the assurance of the good quality of medicines in Hungary. The reasons for the more and more limited applicability of the pharmacopoeia conflicting with its legal validity are shown for the most important groups of medicines. The authors, members of the presidium of the Hungarian Pharmacopoeia Commission, outline the future face and the timing of the publication of the 8th edition of the Hungarian Pharmacopoeia, which is intended to consist of the translations of the general chapters and monographs of the 3rd and 4th Editions of European Pharmacopoeia as well as of the so called national volume with monographs not included in the EP but harmonized with its general chapters. The impact of the new pharmacopoeia on the different fields of pharmacy and the necessary measures to be taken to make the switch-over from Ph. Hg. VII to Ph. Hg. VIII as smooth as possible are also summarised in the paper.
作者概述了《匈牙利药典》第7版在确保匈牙利药品质量方面的当前作用。针对最重要的药品类别,展示了药典适用性越来越有限但仍具法律效力的原因。作为匈牙利药典委员会主席团成员,作者概述了《匈牙利药典》第8版的未来面貌和出版时间,该版旨在收录《欧洲药典》第3版和第4版的通则和各论的译文,以及所谓的国家卷,其中包含未纳入《欧洲药典》但与通则协调一致的各论。本文还总结了新药典对药学不同领域的影响以及为使从《匈牙利药典》第7版平稳过渡到第8版而需采取的必要措施。