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題 名 | Detection and Determination of Phenformin in Chinese Medicinal Capsules by GC-MS and HPLC=應用氣相層析質譜儀及高效液相層析儀分析中藥製劑摻加Phenformin西藥成分之研究 |
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作 者 | 林美智; 林哲輝; 溫國慶; | 書刊名 | 藥物食品分析 |
卷 期 | 9:3 2001.09[民90.09] |
頁 次 | 頁139-144 |
分類號 | 418.43 |
關鍵詞 | 中藥摻加西藥; 氣相層析質譜儀; 高效液相層析法; Phenformin; Traditional Chinese medicine; GC-MS; High performance liquid chromatography; |
語 文 | 英文(English) |
中文摘要 | 治療糖尿病之phenformin (芬法敏)由於使用後會造成乳酸中毒,行政院衛生署雖 已於民國 67 年即禁用,然卻於某大陸藥品中檢出,因而引起我們研究的興趣。本研究係以 氣相層析質譜儀定該成分,續以高效液相層析儀分析其含量。氣相層析質譜儀設定條件如下 :HP-5MS 毛細氣相層析管, 以 70eV 離子電能作電子撞擊式 (EI mode) 分析, 起始溫度 100 ℃維持 3 分鐘,再以每分鐘 10 ℃之升溫速率,至 280 ℃並維持 15 分鐘。高效液相 層析分析條件如下:Cosmosil 5C18 AR (5 cm × 4.6 mm) 及μ Bondpak phenyl (30cm × 3.9 mm) 為分析之管柱, 使用移動相為磷酸二氫鉀 (pH 6.55): 乙�� (40:60)。 流速 1 mL/min,偵測波長 235 nm。以 metformin 為內部標準品。分析結果如下:同日間及異日間 之測試,其相對標準偏差在 1.6 %以下。偵測極限及最低檢出量分別為 0.065 μ g/mL 及 0.20 μ g/mL,添加回收率 102.7 %,檢體中平均含量為 3.45mg ╱膠囊。 |
英文摘要 | Phenformin was prohibited by the ROC Department of Health in 1978. In this investigation, a GC-MS was used for the detection of phenformin in herbal preparation produced in Mainland China followed by determination by HPLC. For GC-MS, a HP-5MS capillary column was used. The initial column temperature was at 100 ℃ for 2 min, ramping 10 ℃ /min to 280 ℃, then holding at 280 ℃ for 15 min. Ionization source temperature was at 230 ℃, and 70 eV electron impact mode was employed. HPLC was performed on a Cosmsil 5C18 AR (5 cm × 4.6 mm), and a μ Bondpak phenyl (30 cm × 3.9 mm)column using 0.01M potassium dihydrogenphosphate (pH 6.55)-ace- tonitrile (60:40, v/v) as eluent, with flow rate at 1.0 mL/min and detection wavelength set at 235 nm. Metformin was used as the internal standard. The interday and intraday precisions were less than 1.6%. The limit of detection and the limit of quantitation were 0.065 μ g/mL and 0.20 μ g/mL, respectively, The spike recovery was 102.7%. The average content of phenformin in the preparation was 3.45 mag per capsule. |
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