2种佐米曲普坦制剂的人体生物等效性研究

Bioequivalence of 2 Kinds of Zolmitriptan Agents in Human

目的:研究佐米曲普坦分散片与佐米曲普坦片在人体内的生物等效性。方法:18名健康志愿者随机交叉单剂量口服佐米曲普坦分散片(受试制剂)或普通片(参比制剂)10mg后,用高效液相色谱(HPLC)法测定血药浓度,用3p97软件计算二者的药动学参数,并评价其生物等效性。结果:受试制剂与参比制剂的药-时曲线均为口服吸收一室摸型,t1/2ke分别为(2.79±1.15)、(3.01±1.12)h,tmax分别为(1.89±0.84)、(1.76±0.60)h,Cmax分别为(16.74±11.44)、(16.65±13.16)ng·mL-1,AUC0～10分别为(65.37±60.08)、(68.42±64.53)ng·h·mL-1。经方差分析、双单侧t检验及(1-2α)置信区间法统计分析,各药动学参数无显著性差异(P>0.05)。佐米曲普坦分散片的相对生物利用度为(95.54±10.99)%,结论:佐米曲普坦分散片与普通片具有生物等效性。

OBJECTIVE： To study the bioequivalence of Zolmitriptan dispersible tablet and Zolmitriptan general tablet in human. METHODS： In randomized crossover design test, 18 healthy volunteers were given a single dose of 10 mg Zolmitriptan dispersible tablet（test agent） and 10 mg Zolmitriptan general tablet （reference agent）. Plasma concentration of zolmitriptan was measured by HPLC. The pharmacokinetic parameters as well as relative bioavailability were measured by 3p97 software. RESULTS： The plasma concentration-time curves of dispersible tablet and general tablet were both one-compartment model. The main pharma- cokinetic parameters of test vs. reference agent were as follows： t1/2ke（2.79 ± 1.15）h vs. （3.01±1.12）h, tmax（1.89 ± 0.84）h vs. （1.76 ± 0.60）h, Cmax（16.74 ± 11.44）ng·mL^-1 vs. （16.65 ± 13.16）ng·mL^-1, AUC0-10（65.37 ± 60.08）ng·h·mL^-1 vs. （68.4± 64.53）ng.h. mL^-1, respectively. Results of variance analysis, two one-side t test, （1-2a）confidence interval method showed there was no significant difference between the two agents in pharmacokinetic parameters （P〉0.05）. The relative bioavailability of Zolmitriptan dis- persible tablet was （95.54 ± 10.99）%. CONCLUSION： Zolmitriptan dispersible tablet and Zolmitriptan general tablet were bioequivalent.