著者

下村 裕子 徳本 廣子 関田 節子 佐竹 元吉 徳川 斉正 徳川 眞木 合田 幸広

出版者

日本生薬学会

雑誌

生薬學雜誌 : shoyakugaku zasshi : the Japanese journal of pharmacognosy (ISSN:13499114)

巻号頁・発行日

vol.67, no.2, pp.41-58, 2013-08-20

参考文献数

79

---

The gallipot found as the heirloom of the Mito-Tokugawa family has the unclear label "Usaien" and contains a small amount of dry black preparation. It is historically clear that Ieyasu Tokugawa, who was the founder of the Edo Shogunate, used it. Fortunately, the "Korean Wazaikyokuho", which was a formulary of natural medicines, has been found as one of the valuable possessions of Kunozan Toshogu, where Ieyasu Tokugawa is enshrined and the formulary contains the "Usaien" formula. It is of interest to reveal the components of the preparation from the viewpoints of historiography and pharmacognosy. Therefore, by utilizing the "Usaien" formula as a clue, we started microscopic analyses to reveal the crude drug components of the historical dry black preparation. First we found this preparation contained a lot of pollens which were thought to be of multiple origins. This indicated the preparation was a kind of honey paste. Furthermore, the successive analyses on the basis of the morphological characteristics of elements of the crude drugs led to the identification of 52 crude drugs (herbal origins: 35, animal origins: 14 and minerals: 3) as the components. The reference formula in the "Korean Wazaikyokuho" consisted of 58 crude drugs and of them 2 volatile ones, 2 sarcous ones, mercury and calomel have remained unidentified, because of difficulty of confirmation by microscopic analyses or insufficient information the origin of their crude drugs. Since most of the crude drug components of the "Usaien" formula were identified in the dry black preparation, we thought the shogun, Ieyasu Tokugawa, used the formula for his health care.

著者

内山 奈穂子 鎌倉 浩之 政田 さやか 辻本 恭 細江 潤子 徳本 廣子 丸山 卓郎 合田 幸広 袴塚 高志

出版者

公益社団法人 日本薬学会

雑誌

YAKUGAKU ZASSHI (ISSN:00316903)

巻号頁・発行日

pp.17-00136, (Released:2017-07-19)

参考文献数

14

被引用文献数

2

---

In January 2017, counterfeits of the hepatitis C drug 'HARVONI® Combination Tablets' (HARVONI®) were found at a pharmacy chain through unlicensed suppliers in Japan. A total of five lots of counterfeit HARVONI® (samples 1-5) bottles were found, and the ingredients of the bottles were all in tablet form. Among them, two differently shaped tablets were present in two of the bottles (categorized as samples 2A, 2B, 4A, and 4B). We analyzed the total of seven samples by high-resolution LC-MS, GC-MS and NMR. In samples 2A, 3 and 4B, sofosbuvir, the active component of another hepatitis C drug, SOVARDI® Tablets 400 mg (SOVARDI®), was detected. In sample 4A, sofosbuvir and ledipasvir, the active components of HARVONI®, were found. A direct comparison of the four samples and genuine products showed that three samples (2A, 3, 4B) are apparently SOVARDI® and that sample 2A is HARVONI®. In samples 1 and 5, several vitamins but none of the active compounds usually found in HARVONI® (i.e., sofosbuvir and ledipasvir) were detected. Our additional investigation indicates that these two samples are likely to be a commercial vitamin supplement distributed in Japan. Sample 2B, looked entirely different from HARVONI® and contained several herbal constitutents (such as ephedrine and glycyrrhizin) that are used in Japanese Kampo formulations. A further analysis indicated that sample 2B is likely to be a Kampo extract tablet of Shoseiryuto which is distributed in Japan. Considering this case, it is important to be vigilant to prevent a recurrence of distribution of counterfeit drugs.

著者

柴田 寛子 野村 祐介 河上 強志 山本 栄一 安藤 大介 内山 奈穂子 徳本 廣子 小出 達夫 迫田 秀行 吉田 寛幸 阿部 康弘 袴塚 高志 五十嵐 良明 蓜島 由二 石井 明子 伊豆津 健一 本間 正充 合田 幸広

出版者

公益社団法人 日本薬学会

雑誌

YAKUGAKU ZASSHI (ISSN:00316903)

巻号頁・発行日

vol.142, no.8, pp.867-874, 2022-08-01 (Released:2022-08-01)

参考文献数

5

被引用文献数

1

---

Particular batches of Moderna mRNA Coronavirus Disease 2019 (COVID-19) vaccine were recalled after foreign particles were found in some vaccine vials at the vaccination site in Japan in August 2021. We investigated the foreign particles at the request of the Ministry of Health, Labour and Welfare. Energy dispersive X-ray spectroscopy analysis suggested that the foreign particles found in the vials recalled from the vaccination sites were from stainless steel SUS 316L, which was in line with the findings of the root cause investigation by the manufacturer. The sizes of the observed particles ranged from <50 μm to 548 μm in the major axis. Similar foreign particles were also detected in 2 of the 5 vaccine vials of the same lot stored by the manufacturer, indicating that the foreign particles have already been administered to some people via vaccine. Observation of the vials of the same lot by digital microscope found smaller particles those were not detected by visual inspection, suggesting that more vials were affected. Contrarily, visual inspection and subvisible particulate matter test indicated no foreign particles in the vials of normal lots. Possible root cause and strategies to prevent such a deviation were discussed from technical and regulatory aspects.