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日本的草药监管。

Regulation of herbal medicines in Japan.

作者信息

Saito H

机构信息

Department of Pharmacology, College of Pharmacy, Nihon University, Funabashi-shi, Chiba, Japan.

出版信息

Pharmacol Res. 2000 May;41(5):515-9. doi: 10.1006/phrs.1999.0645.

DOI:10.1006/phrs.1999.0645
PMID:10753549
Abstract

In Japan, two overlapping types of traditional herbal medicines coexisted for centuries. The first one was the traditional Japanese and Chinese medicine. These medical systems were damaged by the first Medical Care Law in 1874 that proclaimed the abrogation of traditional Japanese medicine. The second type of herbal medicine used in Japan originated in Europe and south-east Asia and became popular after the law in 1874 was announced. Some of those products are still used today as prescription drugs. Although the renaissance of the traditional medicines has been on the rise since approximately 1960, the confusion and decline of the traditional Japanese medicines was further strengthened by introduction of dietary supplements. Regulation of herbal medicines, except 'Kampo' formulas is the same as the approval for both prescription and OTC drugs. Typical characteristics of the Japanese herbal medicines is the existence of Japanese traditional medicines, 'Kampo' formulas and combinations of the traditional medicines with vitamins and pharmaceuticals. Regulation of quality standards of those herbal products was established in Japanese Pharmacopoeia for more than 90% of them.

摘要

在日本,两种相互重叠的传统草药医学共存了几个世纪。第一种是传统的日本和中国医学。这些医学体系在1874年第一部《医疗法》颁布时受到了损害,该法律宣布废除传统日本医学。日本使用的第二种草药医学起源于欧洲和东南亚,在1874年法律颁布后开始流行。其中一些产品至今仍作为处方药使用。尽管自大约1960年以来传统医学的复兴一直在兴起,但膳食补充剂的引入进一步加剧了传统日本医学的混乱和衰落。除“汉方”配方外,草药的监管与处方药和非处方药的批准相同。日本草药医学的典型特征是存在日本传统医学、“汉方”配方以及传统医学与维生素和药物的组合。这些草药产品90%以上的质量标准在《日本药局方》中已有规定。

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