CAJ | 학술논문

目的比较国产佐米曲普坦胶囊与进口佐米曲普坦片在健康人体内的药代动力学过程,并评价其生物等效性。方法18名健康男性志愿者随机双交叉单剂量口服佐米曲普坦胶囊或片剂10mg,用高效液相色谱法测定血药浓度，3p97软件包计算二者的药动学参数和生物等效性。结果单剂量口服佐米曲普坦胶囊与片剂的药-时曲线均为口服吸收一室模型。t1/2ke分别为(3.72±1.77)、(3.81±1.44)h,tmax分别为(1.42±0.35)、(1.33±0.51)h,cmax分别为(21.68±8.67)、(21.86±10.38)μg/L,AUC(0→t)分别为(75.94±31.34)、(78.40±28.21)(μg?h)/L。佐米曲普坦胶囊的相对生物利用度为(96.86±3.36)%,经方差分析、双单侧t检验及(1-2α)置信区间法统计分析,2种制剂药动学参数无显著性差异(P>0.05)。结论国产佐米曲普坦胶囊与进口佐米曲普坦片剂具有生物等效性。
목적비교국산좌미곡보탄효낭여진구좌미곡보탄편재건강인체내적약대동역학과정,병평개기생물등효성。방법18명건강남성지원자수궤쌍교차단제량구복좌미곡보탄효낭혹편제10mg,용고효액상색보법측정혈약농도，3p97연건포계산이자적약동학삼수화생물등효성。결과단제량구복좌미곡보탄효낭여편제적약-시곡선균위구복흡수일실모형。t1/2ke분별위(3.72±1.77)、(3.81±1.44)h,tmax분별위(1.42±0.35)、(1.33±0.51)h,cmax분별위(21.68±8.67)、(21.86±10.38)μg/L,AUC(0→t)분별위(75.94±31.34)、(78.40±28.21)(μg?h)/L。좌미곡보탄효낭적상대생물이용도위(96.86±3.36)%,경방차분석、쌍단측t검험급(1-2α)치신구간법통계분석,2충제제약동학삼수무현저성차이(P>0.05)。결론국산좌미곡보탄효낭여진구좌미곡보탄편제구유생물등효성。
Objective To observe the bioavailability of domestic(capsule) and imported(tablet) zolmitriptan preparation. Methods A randomized crossover design w as perform ed in 18 healthy volunteers, a single oral 10mg dose of eitherzolmitript an capsule or tablet was administered to each volunteers in different time, plasma concentration of zolmitriptan were measured by HPLC, the pharmacokinetic parameters as well as relative bioavailability were measured by 3p97. Results The concentration- time curves of domestic capsule and imported tablet were a one compartment open model, the t1/2ke were (3.72±1.77) and (3.81±1.44) h, tmax (1.42±0.35) and (1.33±0.51) h, cmax (21.68±8.67) and (21.86±10.38) μg/L, AUC (0→t) (75.94±31.34) and (78.40±28.21)(μg?h)/L, respect ively. The relative bioavailability of zolmitriptan capsule was(96.86±13.36) %,there was no significant difference between 2 formulations in each pharm acokinetic parameters analysed by ANOVA, two-one-sided t test confidence zone of (1~2α). Conclusions 2 kind of zolmitriptan formulations were bioequivalence.