摘要
目的:比较国产佐米曲普坦胶囊与进口佐米曲普坦片剂的人体生物等效性。方法:18名志愿者随机交叉单次口服佐米曲普坦胶囊或片剂10mg后,采用高效液相色谱法测定血药浓度,用3p97软件包计算二者的药动学参数和生物等效性。结果:胶囊与片剂的药-时曲线均为口服吸收一室摸型。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±13.36)%,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:佐米曲普坦胶囊与片剂具有生物等效性。
OBJECTIVE： To observe the bioavailability of domestic（capsule） and imported（tablet） zolmitriptan preparation.METHODS： A randomized crossover design was performed in 18 healthy volunteers, a single oral 10mg dose of either zolmitriptan 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 t 1/2ke 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, respectively.The relative bioavailability of zolmitriptan capsule was（96.86 ± 13.36） %, there was no significant difference between 2 formulations in each pharmacokinetic parameters analysed by ANOVA, two-one-sided t test confidence zone of（1-2 α）.CONCLUSIONS：2 kind of zolmitriptan formulations were bioequialence.
出处
《中国药房》
CAS
CSCD
北大核心
2006年第23期1792-1794,共3页
China Pharmacy
