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《北欧药典》的作用与功能。

Role and functions of the Nordic Pharmacopoeia.

作者信息

Fors M

出版信息

Ann Ist Super Sanita. 1975;11(3-4):220-7.

PMID:1234724
Abstract

It was proposed as early as in 1860 that a common pharmacopoeia should be worked out in the Nordic countries but it took more than a hundred years before such a pharmacopoeia was published and put into force. Ever since that early date the Nordic countries have, however, been striving for common regulations in the drug field with more or less intensity. The accomplishment of the common pharmacopoeia is therefore to be regarded only as a milestone on the long way to complete conformity of the different national drug regulations. The Nordic Pharmacopoeia has definitely broken through the borderlines of the earlier national pharmacopoeias, which were designed for the activities of the pharmacies, and has obtained recognition as a work on drug standards possible to apply in the manufacture and control of drugs no matter where they are produced or controlled. The Nordic Pharmacopoeia thus has wider functions and a greater responsibility than the earlier pharmacopoeias. This depends partly on the pharmacopoeia itself, partly on the development in the field of drug control. On the other hand the Nordic Pharmacopoeia has left some of the tasks of the earlier pharmacopoeias to different national formularies, manuals and other sources of information. This applies especially to galenical preparations. As expected the Nordic Pharmacopoeia has facilitated drug trade in the Nordic countries to a certain extent and it is no doubt of greatest value in the different control activities of the national health authorities. It is also a guide-book and a reference work for manufacturers and control laboratories of different kinds. But this is what it should be, what it is intended to serve as. In addition to that the Nordic Pharmacopoeia has played an essential role in many other respects; not least as initiator of different progressive work and drawer of guide-lines for future development in the drug field.

摘要

早在1860年就有人提议北欧国家应制定一部通用药典,但直到一百多年后这样一部药典才得以出版并生效。然而,从那个早期开始,北欧国家就或多或少地积极致力于在药品领域制定共同法规。因此,通用药典的完成只能被视为在不同国家药品法规完全统一的漫长道路上的一个里程碑。《北欧药典》无疑突破了早期为药房活动设计的国家药典的界限,并已获得认可,成为一部可应用于药品生产和控制的药品标准著作,无论药品在何处生产或控制。因此,《北欧药典》比早期的药典具有更广泛的功能和更大的责任。这部分取决于药典本身,部分取决于药品控制领域的发展。另一方面,《北欧药典》已将早期药典的一些任务留给了不同的国家处方集、手册和其他信息来源。这尤其适用于草药制剂。不出所料,《北欧药典》在一定程度上促进了北欧国家的药品贸易,并且毫无疑问在国家卫生当局的不同控制活动中具有最大价值。它也是各类制造商和控制实验室的指南和参考著作。但这正是它应该的样子,它就是为此而设计的。除此之外,《北欧药典》在许多其他方面也发挥了重要作用;尤其是作为不同进步工作的发起者和药品领域未来发展指导方针的制定者。

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