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藥物食品檢驗局調查研究年報

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篇名 市售豆蔻類藥材之鑑別
卷期 23
並列篇名 Studies on Authenticity of Doukou in Taiwanese Market
作者 賴齡羅吉方張憲昌林哲輝
頁次 114-135
關鍵字 白豆蔻草豆蔻肉豆蔻草果紅豆蔻山薑鑑別DoukouAmomum kravanh pierre ex gagnepAlpinia katsumadai ha-yataMyristica fragran houttAlpinia galangaAmomum tsaoko crevost et lemaire and alpinia japonica IdentificationTSCI
出刊日期 200509

中文摘要

白豆蔻(Amomi Rotundus Fructus)基原為薑科植物白豆蔻Pierre ex Gagnep.或爪哇白豆蔻Soland ex Maton 的乾燥果實;草豆蔻(Alpiniae Katsumadai Semen)為同科植物草豆蔻Hayata 乾燥成熟種子團;肉豆蔻(Myristicae Semen)為肉豆蔻植物肉豆蔻Houtt.之乾燥種仁,三者為常用豆蔻類藥材,但易因名字相似而混淆,故為瞭解目前市售豆蔻類藥材之基原,本計劃採逢機取樣方式價購上述三種藥材各50 件,共計150 件檢體,蒐集白豆蔻、草豆蔻、肉豆蔻、草果、紅豆蔻、山薑等對照藥材以供比對,經性狀特徵、組織鏡檢、粉末鏡檢及理化鑑別並與對照藥材及文獻比對,結果顯示豆蔻類藥材可從外果皮、結晶型態、石細胞及薄層層析圖譜之不同區分。本調查結果市售50 件白豆蔻檢體未發現偽品;50 件肉豆蔻檢體中有1 件為草豆蔻,其餘為正品;50 件草豆蔻檢體中有5 件偽品,其中4 件為草果,1 件為肉豆蔻;顯示除了白豆蔻外,草豆蔻及肉豆蔻仍有誤用之情形。

英文摘要

The commercial VIAGRA(r) products have arisen a phenomenon. As aresult, many off Chinese
medicines and food supplements claimed to have treatment effects on male erectile dysfunction. From January 2002 to March 2003, Bureau of Food and Drug Agency (BFDA) received 22 samples in 17 different traded names that were marketed in China. All of the samples were found illegally adulterated with sildenafil or tadalafil. Among the 17 different branded samples, 3 were manufactured by An Wei San Tee Medicinal Health Company(安徽三體醫藥保健公司), the rest were manufactured by different companies. Sample powder was extracted with 50% methanol and analyzed by LC/MS/MS, detected by photodiode array and tandem mass detector with positive electron spray ionization (ESI+) method. The testing conditions were set as following: Column: Cosmosil 5C18-AR,Mobile phase:methanol:acetonitrile:1% acetic acid (25:17:58) for sildenafil analysis; and acetonitrile:water:1% acetic acid(50 : 45: 5)for tadalafil analysis; Flow rate: 0.5mL /min (1:1 split); Voltage of capillary tube:3KV; Voltage of sample cone and collision energy were 80V/25eV and 60V/18eV for sildenafil and tadalafil respectively. The source temperature was set on 120oC, and the solvent desolvation temperature on 350oC. The daughter ion scan was set at m/z 475 for sildenafil and m/z 390 for tadalafil to obtain a daughter ion spectrum. The result were then compared with the data library (NLFD3/LM) that was set up by the lab. The existence of the adulterants were confirmedwhen the ion peaks retention time of samples, as well as the UV and mass spectrum patterns of the samples matched with the sildenafil and tadalafil data as recorded in the library. The quantity of sildenafil and tadalafil were calculated by calibration curves. Both pair of parent and daughter ion (m/z 475>100 and m/z 390>268) were chosen and multiple reaction monitoring (MRM) was performed. The results were then referred to the calibration curves (γ2=0.9993 and 0.9985) to determinethe amount of sildenafil and tadalafil in samples.

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