中文摘要 Minocycline為四環素類抗生素，是一種廣效型抗生素，且效果比一般四環素來得好，Minocycline對於一些已對四環素有抗藥性的病原菌，像是葡萄球菌、鏈球菌、大腸桿菌及流行性感冒嗜血桿菌等都有效。一般來說，Minocycline在胃腸道吸收快速，且食物對其吸收影響並不大。本實驗的目的是在評估兩種Minocycline HCl (100 mg) 膠囊劑：台灣氰胺公司生產的Minocin及永信藥廠生產的Borymycin，在14位國人健康男性受試者之生體可用率。 利用高效液相層析分析法(High performance liquid chromatography：HPLC)，分析血清中Minocycline HCl的濃度。其分析條件為：利用 Lichrospher RP- 18e管柱，4mm ×12.5 cm，移動相為 methanol- acetonitrile —1/1000 phosphoric acid (v/v)，8:8:84 v/v/v (pH 2.3)，流速 1.2 ml/min，Oxytetracycline為內部標準品，偵測波長UV 348 nm。 國人在服用Minocycline 膠囊劑 (劑量100 mg) 後，約1.57小時達到血中最高濃度1.78μg/ml左右，平均曲線下面積 (AUC0-∞) 約為34.7±5.6μg*hr/ml，平均排除半衰期約為19.7±4.0小時。 利用統計學方法two-way ANOVA比較二組產品的藥物動力學參數，包括：血中最高濃度 (Cmax)、Tmax、AUC0-∞、及AUC0-72等，結果發現並無統計學上的顯著差異 (p>0.05)，因此，可以認為Minocin膠囊劑和Borymycin膠囊劑是具有生體相等性的。; Abstract Minocyclins is a member of the tetracycline series antibiotics which has been shown to have addition activity against some of tetracyline-resistant microorganisms, including Staphylococci、Streptococci、E.coli and Haemophilus influenzae. Minocycline is rapidly absorbed from the gastrointestinal tract and is not significantly affected by the presence of food. The purpose of this study is to evaluate the bioavailability of two Minocycline HCl 100 mg capsules：Minocin capsules and Borymycin capsules, when they are administered to 14 healthy male volunteers by oral route. The Minocycline concentration in the serum were determined by a HPLC method. The chromatographic conditions were：Column, Lichrospher RP-18e, 4 mm ×12.5 cm；mobile phase, methanol- acetonitrile —1/1000 phosphoric acid (v/v), 8:8:84 v/v/v (pH 2.3) ; flow rate 1.2 ml/min；internal standard, Oxytetracycline. The chromatogram was monitored at UV 348 nm. After oral administration of Minocycline 100 mg capsules in Chinese health male subjects, the peak serum concentration of 1.78 μg/ml were achieved about 1.57 hrs, the mean area under the serum concentration curve (AUC0-∞) was 34.7±5.6μg*hr/ml, the mean terminal elimination half-life was 19.7±4.0 hrs. There are no significant statistic different between pharmacokinetic parameter (p>0.05) of the two products, including the peak sernm concentration (Cmax), time to peak level (Tmax) and area under the curve (AUC). It could be recommend that Minocin capsule and Borymycin capsule are bioequivalent.
