【摘要】 目的 評價麻敏維C緩釋膠囊（每粒含鹽酸偽麻黃堿90 mg和馬來酸氯苯那敏4 mg）在人體的生物等效性。 方法 于2006年6月采用隨機交叉自身前后對照試驗設計，26例受試者分別單次和多次空腹口服麻敏維C緩釋膠囊（試驗制劑）和復方鹽酸偽麻黃堿緩釋膠囊（參比制劑），與不同時間點取血樣，采用液-質聯用（HPLC/MS）法測定人血漿中鹽酸偽麻黃堿和馬來酸氯苯那敏的濃度，以DAS軟件計算藥物代謝動力學參數，并進行生物等效性評價。 結果 單次給藥后，兩組分的主要藥物代謝動力學參數無統計學意義（P gt;0.05）。試驗制劑中馬來酸氯苯那敏和鹽酸偽麻黃堿生物利用度分別為104.31%和109.19%。多次給藥后，兩組分的主要藥物代謝動力學參數無統計學意義（P gt;0.05）。試驗制劑的馬來酸氯苯那敏和鹽酸偽麻黃堿的生物利用度分別為103.58%和99.37%。 結論 麻敏維C緩釋膠囊和復方鹽酸偽麻黃堿緩釋膠囊具有生物等效性。
【Abstract】 Objective To investigate the bioequivalence of delayed-release capsule of ephedrine-chlorphenamine-vitamin C. Methods In June 2006, 26 healthy volunteers were administrated with delayed-release capsule of ephedrine-chlorphenamine-vitamin C or delayed-release capsule of ephedrine-chlorphenamine in a randomized and two-way crossover design with single or multiple dosage. The plasma concentrations were determined by HPLC/MS method. The pharmacokinetic parameters and bioequivalence were calculated by DAS software. Results After single dose administration, no significant differences were found in tmax, Cmax, t1/2, and AUC0-t between the two preparations. The relative bioavailability of the test preparation was 104.31% in chlorphenamine and 109.19% in ephedrine, respectively. After multiple dose administration, no significant differences were found in tmax, Cmax, t1/2, and AUC0-t between the two preparations. The relative bioavailability of the test preparation was 103.58% in chlorphenamine and 99.37% in ephedrine, respectively. Conclusion Delayed-release capsule of ephedrine-chlophenamine-vitamin C is equivalent to the reference preparation.
引用本文： 沈奇,梁茂植,劉春濤,余勤,羅柱,南峰,吳松澤,秦永平,徐楠,鄭莉,馮萍,王穎. 麻敏維C緩釋膠囊人體生物等效性研究. 華西醫學, 2010, 25(12): 2225-2227. doi: 復制