Disintegration Test of Health Food Products Containing Ginkgo Biloba L. or Vitex Agnus-Castus L. in the Japanese Market

Medicines

Naoko Sato-Masumoto³  Sayaka Masada³  Satoshi Takahashi²  Sachiko Terasaki²  Yoichi Yokota²  Takashi Hakamatsuka³  Yukihiro Goda¹ 

[1] Division of Drugs, National Institute of Health Sciences, 1-18-1 Kamiyoga, Setagaya-ku, Tokyo 158-8501, Japan;Toyama Prefectural Institute for Pharmaceutical Research, 17-1, Nakataikoyama, Imizu-shi, Toyama 939-0363, Japan; E-Mails:;Division of Pharmacognosy, Phytochemistry and Narcotics, National Institute of Health Sciences, 1-18-1 Kamiyoga, Setagaya-ku, Tokyo 158-8501, Japan; E-Mails:

关键词: OTC crude drug product;    health food;    ginkgo leaf;    chaste tree fruit;    disintegration test;    Western herb;   

DOI  :  10.3390/medicines2020047

来源: mdpi

【 摘 要 】

For many years now, a number of Western herbs have been widely used in health food products in Japan and as pharmaceuticals in Europe. There are few or no mandated criteria concerning the quality of these herbal health food products, thus clarification is warranted. Here, we performed disintegration tests of 26 pharmaceutical and health food products containing the Western herbs ginkgo leaf and chaste tree fruit, in accord with the Japanese Pharmacopoeia. All eight pharmaceutical herbal products found in the European market completely disintegrated within the defined test time, and 11 of the 18 tested herbal products distributed as health foods in Japan disintegrated. Among the incompatible products identified in the Pharmacopoeia test, some products remained intact after incubation in water for 60 min. To ensure the efficacy of Western herbal products sold as health food in Japan, quality control, including disintegration, is therefore recommended, even though these products are not regulated under the Pharmaceutical Affairs Law.

【 授权许可】

CC BY   
© 2015 by the authors; licensee MDPI, Basel, Switzerland.