CAJ | 학술논문

目的探讨正清风痛宁肠溶片在Beagle犬体内药动学和生物等效性.方法选用10只Beagle犬单剂量随机交叉口服正清风痛宁肠溶片受试制剂或参比制剂10 mg?kg-1,用高效液相色谱法测定血药浓度,3p97软件计算药动学参数和生物等效性评价.结果受试制剂与参比制剂的药-时曲线呈一室模型,主要药动学参数Tmax分别为(86.25±10.61)min和(75.00±16.04)min,Cmax分别为(0.18±0.038)μg?mL-1和(0.18±0.042)μg?mL-1,t1/2ke分别为(78.34±15.21)min和(88.77±30.90)min,AUC0-T分别为30.31±7.82μg?min?mL-1和(32.09±8.61)μg?min?mL-1,受试制剂相对生物利用度为(94.45±5.49)%.结论经方差分析、单双侧t检验和非参数统计检验,表明受试制剂与参比制剂具有生物等效性.
목적탐토정청풍통저장용편재Beagle견체내약동학화생물등효성.방법선용10지Beagle견단제량수궤교차구복정청풍통저장용편수시제제혹삼비제제10 mg?kg-1,용고효액상색보법측정혈약농도,3p97연건계산약동학삼수화생물등효성평개.결과수시제제여삼비제제적약-시곡선정일실모형,주요약동학삼수Tmax분별위(86.25±10.61)min화(75.00±16.04)min,Cmax분별위(0.18±0.038)μg?mL-1화(0.18±0.042)μg?mL-1,t1/2ke분별위(78.34±15.21)min화(88.77±30.90)min,AUC0-T분별위30.31±7.82μg?min?mL-1화(32.09±8.61)μg?min?mL-1,수시제제상대생물이용도위(94.45±5.49)%.결론경방차분석、단쌍측t검험화비삼수통계검험,표명수시제제여삼비제제구유생물등효성.
Objective To investigate the pharmacokinetics and bioequivalence of Zheng Qing Feng Tong Ning enteric tablets in beagle dogs. Methods Accorging to a randominzed two-period crossover desing, ten beagle dogs were administred po 10mg?kg-1 of reference tablet or test preparation with a 7 days washoul. Drug concentrations of plasma were detemined by HPLC. The pharmacokinetic parmeters and bioequivalence were calculated by 3p97 pharmacokinetic program.Result The concentration-tine curves of reference or test prenaration fitted to one compartment model in beagle dogs. The Tmax, Cmax, t1/2 and AUC0-T was (86.25±10.61)min and(75.00±16.04)min,(0.18±0.038)μg?mL-1 and (0.18±0.042)μg?mL-1,(78.34±15.21)min and(88.77±30.90)min,(30.31±7.82 )μg?min?mL-1 and(32.09±8.61)μg?min?mL-1, respectively. There was no significant difference between the two formulations in the Tmax, Cmax, AUC(0-T). The relative bioavailability of test preparation was(94.45±5.49)% compared with reference tablet. Conclusion The result of the statistical analysis showed that the two formulations were bioequialent.