【摘要】 建立了同时测定人血浆中氧去甲右美沙芬及愈创木酚甘油醚浓度的高效液相色谱 紫外检测法 ,并初步研究了以上两种药物在人体内的药动学性质。运用此法对 18名健康男性受试者单剂量交叉口服愈美分散片 (受试制剂 )和速立糖浆 (参比制剂 )后的酶水解血浆进行测定 ,并绘制了血浆药物浓度 时间曲线。口服愈美分散片测得 :氧去甲右美沙芬Tmax为 (1 89± 0 5 3)h ,Cmax为 (892 6±315 0 )ng/mL ,AUC0 -t为 (4 15 3 2± 115 1 9)ng·h·mL-1;愈创木酚甘油醚Tmax为 (0 6 5± 0 2 7)h ,Cmax为 (15 45 1± 493 6 )ng/mL ,AUC0 -t为 (2 6 89 8± 72 8 2 )ng·h·mL-1。口服速立糖浆测得 :氧去甲右美沙芬Tmax为 (1 81± 0 2 5 )h ,Cmax为 (85 5 0± 2 0 7 6 )ng/mL ,AUC0 -t为 (4 0 0 1 8± 75 3 5 )ng·h·mL-1;愈创木酚甘油醚Tmax 为 (0 5 0± 0 2 1)h ,Cmax 为 (1942 4± 437 6 )ng/mL ,AUC0 -t为 (3382 8±85 6 5 )ng·h·mL-1。氧去甲右美沙芬的相对生物利用度平均为 (10 3 6± 19 3) % ,愈创木酚甘油醚的相对生物利用度平均为 (86 9± 13 4) %。统计结果表明 ,两种制剂生物等效更多还原

【Abstract】 A sensitive HPLC method was developed to determine dextrophan and guaifenesin simultaneously in the human plasma. The enzyme hydrolized plasma concentrations of dextrophan and guaifenesin in 18 healthy volunteers after oral doses of dissoluble tablets and syrup (containing 60 mg of dextromethorphan hydrobromide and 400 mg of guaifenesin) were determined and concentration time curves were drawn. Pharmacokinetic parameters of the two formulations were obtained as follows: dextrophan: T max were(189±053)and(181±025)h, C max were(8926±3150)and(8550± 2076)ng/mL ,AUC 0- t were(41532±11519)and(40018± 753 5)ng·mL -1 ·h ; guaifenesin: T max were(065±027)and(0 50± 021)h , C max were(15451±4936)and(19424± 4376)ng/mL ,AUC 0- t were(26898±728 2)and(33828± 8565)ng·mL -1 ·h ,respectively.The statistical analysis results showed that there was no significant difference for dextrophan and guaifenesin between the test and reference formulation.The two formulations were bioequivalent.更多还原