【摘要】 目的建立反相高效液相色谱法测定兰索拉唑的血浆浓度,并研究其生物等效性。方法以AgilentC18(250 mm×5 mm,5μm)为色谱柱;流动相为乙腈-1‰三乙胺水溶液(pH=7.0)(30:70),流速1.0 mL.min-1,进样量为20μL,内标为奥美拉唑。血浆样品经乙酸乙酯提取后于285 nm紫外光检测。结果 20例健康受试者单次口服兰索拉唑片后,受试制剂与参比制剂的血浆中兰索拉唑的半衰期(t1/2)分别为(2.19±0.49)和(2.38±0.48)h,达峰时间(tmax)分别为(2.52±0.80)和(2.82±0.69)h,血药峰浓度(Cmax)分别为(854.82±249.70)和(813.22±289.59)ng.mL-1,血药浓度-时间曲线下面积(AUC0-12 h)分别为(3 513.00±742.25)和(3 779.90±1 191.52)μg.h.mL-1,AUC(0-∞)分别为(3 742.64±749.85)和(4 078.54±1 171.17)μg.h.mL-1。结论两种制剂的兰索拉唑片具有生物等效性。更多还原

【Abstract】 Objective To establish a simple and fast method for determing concentration of lansoprazole in human blood,and to estimate bioequivalence of two lansoprazole. Methods Chromatography was carried out on an Agilent C18(250 mm×5 mm,5 μm),with acetonitrile-water(contained 1‰ triethylamine)(pH=7.0)(30:70) as mobile phase,at a flow rate of 1.0 mL· min-1,at 285 nm of wavelength with the sample loaded at 20 μL. Results Twenty volunteers were randomly divided into 2 groups.A single oral dose of 10 mg of test or reference tablets was delivered to each volunteer in an open crossover test.The plasma concentration of bisoprolol hemifumarate was determined by HPLC-UV detection.Based on the parameters of pharmacokintic and relative bioavailability,the bioequivalance of bisoprolol hemifumarate was evaluated.The main pharmacokinetic parameters of the test prepartion were as follows: t1/2 were(2.19±0.49) and(2.38±0.48) h,tmax were(2.52±0.80) and(2.82±0.69) h,Cmax were(854.82±249.70) and(813.22±289.59) ng·mL-1,AUC(0-12 h)were(3 513.00±742.25) and(3 779.90±1 191.52) μg·h·mL-1,AUC(0-∞) were(3 742.64±749.85) and(4 078.54±1 171.17) μg·h·mL-1,respectively. Conclusion The preparations of test and reference are bioequivalent.更多还原