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日本及び海外製サリドマイド製剤の溶出挙動及び血中濃度推移の比較
http://hdl.handle.net/10087/5621
http://hdl.handle.net/10087/5621ab23ef9f-09f3-4556-9546-60fbce16cc2b
| 名前 / ファイル | ライセンス | アクション |
|---|---|---|
110006935752.pdf (867.6 kB)
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| Item type | 学術雑誌論文 / Journal Article(1) | |||||
|---|---|---|---|---|---|---|
| 公開日 | 2010-08-04 | |||||
| タイトル | ||||||
| タイトル | 日本及び海外製サリドマイド製剤の溶出挙動及び血中濃度推移の比較 | |||||
| タイトル | ||||||
| タイトル | Comparison of Dissolution Profile and Plasma Concentration-time Profile of the Thalidomide Formulations Made by Japanese, Mexican and British Companies | |||||
| 言語 | en | |||||
| 言語 | ||||||
| 言語 | jpn | |||||
| その他のタイトル | ||||||
| その他のタイトル | Comparison of Dissolution Profile and Plasma Concentration-time Profile of the Thalidomide Formulations Made by Japanese, Mexican and British Companies | |||||
| キーワード | ||||||
| 主題Scheme | Other | |||||
| 主題 | thalidomide | |||||
| キーワード | ||||||
| 主題Scheme | Other | |||||
| 主題 | pharmacokinetics | |||||
| キーワード | ||||||
| 主題Scheme | Other | |||||
| 主題 | dissolution test | |||||
| キーワード | ||||||
| 主題Scheme | Other | |||||
| 主題 | bioequivalence | |||||
| キーワード | ||||||
| 主題Scheme | Other | |||||
| 主題 | adverse effect | |||||
| 資源タイプ | ||||||
| 資源タイプ識別子 | http://purl.org/coar/resource_type/c_6501 | |||||
| 資源タイプ | journal article | |||||
| 著者 |
藤田, 行代志
× 藤田, 行代志× 山本, 康次郎× 青森, 達× 村上, 博和× 堀内, 龍也 |
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| 抄録 | ||||||
| 内容記述タイプ | Abstract | |||||
| 内容記述 | Thalidomide is an important advance in the treatment of multiple myeloma. In Japan thalidomide is now on the approval step for the treatment of multiple myeloma. The drug has some bothersome side effects such as defect of organogenesis, neuropathy, constipation and fatigue, but is likely more effective than standard chemotherapy and is changing multiple myeloma treatment. At this moment, Japanese patients must import the thalidomide preparations from Mexico, Britain and elsewhere, but after approval, they patients will be able to get the new Japanese thalidomide capsules. In order to determine appropriate amounts of Japanese thalidomide capsules in the treatment of multiple myeloma, we compared the dissolution profile and plasma thalidomide concentrations of Japanese and British capsules and Mexican tablets. The dissolution test was performed according to the Japanese and the United States Pharmacopoeia. The pharmacokinetic data for Japanese capsules were obtained from the clinical trial in Japanese subjects and compared with those data published for other formulations. The dissolution rate of the Japanese capsule was the fastest, followed by British and Mexican formulations. The pharmacokinetic profiles of Japanese and British capsules were similar, while the 100mg Japanese thalidomide capsule demonstrated a 1.6-fold higher maximum plasma concentration than the 200mg Mexican thalidomide tablet (1.7vs. 1.1μg/ml), greatly shortened t_<max> (4.5 vs. 6.2h), and the apparent half life was only one-third of the Mexican tablet (4.8 vs. 13.5h). A comparison of the dissolution and the pharmacokinetic absorption profiles demonstrated a rank-order correlation. Physicians and pharmacists should be aware of the probable alteration in plasma thalidomide concentration when switching to the Japanese capsule, especially from the Mexican tablet, and should monitor clinical response carefully. | |||||
| 書誌情報 |
薬学雑誌 巻 128, 号 10, p. 1449-1457, 発行日 2008-10-01 |
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| ISSN | ||||||
| 収録物識別子タイプ | ISSN | |||||
| 収録物識別子 | 00316903 | |||||
| 書誌レコードID | ||||||
| 収録物識別子タイプ | NCID | |||||
| 収録物識別子 | AN00284903 | |||||
| 権利 | ||||||
| 権利情報 | 日本薬学会 | |||||
| 権利 | ||||||
| 権利情報 | 本文データは学協会の許諾に基づきCiNiiから複製したものである | |||||
| フォーマット | ||||||
| 内容記述タイプ | Other | |||||
| 内容記述 | application/pdf | |||||
| 著者版フラグ | ||||||
| 出版タイプ | VoR | |||||
| 出版タイプResource | http://purl.org/coar/version/c_970fb48d4fbd8a85 | |||||
| 出版者 | ||||||
| 出版者 | 日本薬学会 | |||||
| 資源タイプ | ||||||
| 内容記述タイプ | Other | |||||
| 内容記述 | Journal Article | |||||
| 更新日 | ||||||
| 日付 | 2017-03-27 | |||||
| 日付タイプ | Created | |||||
