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Open AccessArticle

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

1
Division of Pharmacognosy, Phytochemistry and Narcotics, National Institute of Health Sciences, 1-18-1 Kamiyoga, Setagaya-ku, Tokyo 158-8501, Japan
2
Toyama Prefectural Institute for Pharmaceutical Research, 17-1, Nakataikoyama, Imizu-shi, Toyama 939-0363, Japan
3
Division of Drugs, National Institute of Health Sciences, 1-18-1 Kamiyoga, Setagaya-ku, Tokyo 158-8501, Japan
*
Author to whom correspondence should be addressed.
Academic Editor: Il-Moo Chang
Medicines 2015, 2(2), 47-54; https://doi.org/10.3390/medicines2020047
Received: 9 March 2015 / Revised: 9 April 2015 / Accepted: 17 April 2015 / Published: 23 April 2015
(This article belongs to the Special Issue Safety of Herbal Materials)
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. View Full-Text
Keywords: OTC crude drug product; health food; ginkgo leaf; chaste tree fruit; disintegration test; Western herb OTC crude drug product; health food; ginkgo leaf; chaste tree fruit; disintegration test; Western herb
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Sato-Masumoto, N.; Masada, S.; Takahashi, S.; Terasaki, S.; Yokota, Y.; Hakamatsuka, T.; Goda, Y. Disintegration Test of Health Food Products Containing Ginkgo Biloba L. or Vitex Agnus-Castus L. in the Japanese Market. Medicines 2015, 2, 47-54.

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