奈韦拉平片的药物动力学和人体相对生物利用度研究  

Pharmacokinetics and Relative Bioavailability of Nevirapine Tablets in Human

作　　者：仲珑瑾[1] 焦正[1] 李中东[1] 施孝金[1] 钟明康[1] 

机构地区：[1]复旦大学附属华山医院临床药学研究室,上海200040

出　　处：《中国医药工业杂志》2005年第12期763-765,共3页Chinese Journal of Pharmaceuticals

摘　　要：20名男性健康受试者交叉口服奈韦拉平的受试制剂与参比制剂,以RP-HPLC法测定人血浆中奈韦拉平的浓度。采用C8柱,流动相为乙腈-0.025mol/L磷酸二氢铵缓冲液(27∶73)。口服受试或参比制剂后的Cmax分别为(2.50±0.41)和(2.62±0.61)μg/ml,tmax分别为(3.15±1.14)和(2.72±1.25)h,AUC0→168分别为(162.86±26.05)与(164.14±27.14)μg·h·ml-1。受试制剂的相对利用度为(99.46±7.28)%。经方差分析和双单侧t检验,两种片剂具有生物等效性。The pharmacokinetics and relative bioavailability of test and reference tablets of nevirapine were investigated in 20 healthy male volunteers, according to a randomized crossover design. The concentrations of nevirapine in plasma were determined by RP-HPLC method. A C8 column was used with the mobile phase of acetonitrile- 0.025mol/L diammonium phosphate buffer solution （pH 4.7） （ 27 ： 73）. The pharmacokinetic parameters were Cmax （2.50 ±0.41） and （2.624±0.61）μg/ml, tmax （3.15±1.14） and （2.72±1.25） h, AUC0→168 （162.86±26.05） and （164.144±27.14） Bg·h·ml^-1 for test and reference tablets, repectively. The relative bioavailability was （99.46±7.28） %. The results of variance analysis and two one-side t test showed that two brands were bioequivalent.

关 键 词：奈韦拉平 药物动力学 生物等效性 高效液相色谱 

分 类 号：R979.9[医药卫生—药品] O657.72[医药卫生—药学]