TFDA開放食品原料 : (6S)5-MTHF glucosamine salt甲基四氫葉酸葡萄糖胺鹽

主旨：預告訂定「原料『(6S)-5-甲基四氫葉酸葡萄糖胺鹽』之使用限制」草案。 中華民國106年3月23日 衛授食字第1051303979號依據：行政程序法第一百五十四條第一項。公告事項：一、訂定機關：衛生福利部。二、訂定依據：食品安全衛生管理法第十五條之一。三、「原料『(6S)-5-甲基四氫葉酸葡萄糖胺鹽』之使用限制」草案總說明及逐點說明如附件。本案另載於本部網站（網址：http//www.mohw.gov.tw），「法令規章」下之「衛生福利法規檢索系統」中之「法規草案」項下，及衛生福利部食品藥物管理署網站（網址：http://www.fda.gov.tw）之「公告資訊」下之「本署公告」網頁。四、對於公告內容有任何意見或修正建議者，請於本公告刊登公報之隔日起60日內，至本部「衛生福利法規檢索系統」中之「法規草案」項下陳述意見或洽詢：(一)承辦單位：衛生福利部食品藥物管理署(二)地址：115-61台北市南港區昆陽街161-2號(三)電話：(02)2787-7318(四) 傳真：(02)2653-1062(五)電子郵件：yalanho@fda.gov.tw部長　陳時中

Enhanced oral bioavailability of a novel folate salt: comparison with folic acid and a calcium folate salt in a pharmacokinetic study in rats. Minerva Ginecol. 2016 Apr;68(2):99-105.Folates play an important role to prevent neurological disorders in embryo development and in cardiovascular diseases. Folate supplementation is suggested, particularly in females of childbearing age, for the prevention of embryonal NTDs during pregnancy. Folic acid and reduced folate ((6S)5-MTHF) are currently used in supplementation. The aim of this study was to compare the bioavailability of Quatrefolic®, a novel patented (6S)5-MTHF glucosamine salt, with (6S)5-MTHF calcium salt and folic acid in Sprague Dawley rats. METHODS: Fifty-four to fifty-five-day old male Sprague-Dawley rats were divided in 3 treatment groups, each comprising 6 animals, receiving folic acid, (6S)5-MTHF calcium salt or Quatrefolic® at the dose of 70 µg/kg of (6S)5-MTHF equivalents in a single oral administration. Folates were determined in plasma with a HPLC method employing fluorimetric detection. (6S)5-MTHF level was chosen as a convenient end point to evaluate folate absorption. The main pharmacokinetic parameters were calculated (Cmax, tmax, AUC). RESULTS: Quatrefolic® administration produced a plasmatic (6S)5-MTHF concentration peak (Cmax: 879.6±330.3 ng/mL) 1.8 times higher than (6S)5-MTHF Ca salt (486.8±184.1 ng/mL), and 3.1 times higher than folic acid supplementation (281.5±135.7 ng/mL), while tmax values were similar for the three folate forms. Quatrefolic® supplementation showed AUC8h (1123.9 ng/mL ∙ h) 9.7 times higher than folic acid (114.7 ng/mL ∙ h) and 1.12 times higher than (6S)5-MTHF Ca salt (997.6 ng/mL ∙ h). CONCLUSIONS: Quatrefolic® has demonstrated an enhanced oral bioavailability in comparison to other reduced folates and to folic acid in rats.