CAJ | 학술논문

目的：研究双氯芬酸钾胶囊在正常人体内的药代动力学与相对生物利用度。方法：采用HPLC法测定10名健康男性志愿者随机自身交叉单剂量口服50mg双氯芬酸钾胶囊和进口双氯芬酸钾片后的血药浓度，计算两者的药代动力学参数及相对生物利用度，并以AUC（0～6）、Tmax、Cmax为指标，用配对t检验法分析国产胶囊与进口片的生物等效性。结果：国产与进口双氯芬酸钾制剂的药－时曲线符合口服吸收一房室模型。AUC（0 ～6）分别为（183452±71106）μg/（h·L）、（189119±85 908）μg/（h·L）；Tmax分别为（115±077）h、（130±0 97）h；Cmax分别为（152229±106387）ng/ml、（150854±89 244）ng/ml。配对t检验结果表明，AUC（0～6）Tmax、Cmax均无显著性差异（P>005）。结论：国产双氯芬酸钾胶囊对进口片的相对生物利用度为（10080±1659）％，国产与进口两种双氯芬酸钾制剂具有生物等效性。
목적：연구쌍록분산갑효낭재정상인체내적약대동력 학여상대생물이용도。방법：채용HPLC법측정10명건강남성지 원자수궤자신교차단제량구복50mg쌍록분산갑효낭화진구쌍록 분산갑편후적혈약농도，계산량자적약대동역학삼수급상대생 물이용도，병이AUC（0～6）、Tmax、Cmax위지표，용배대t검험법 분석국산효낭여진구편적생물등효성。결과：국산여진구쌍 록분산갑제제적약－시곡선부합구복흡수일방실모형。AUC（0 ～6）분별위（183452±71106）μg/（h·L）、（189119±85 908）μg/（h·L）；Tmax분별위（115±077）h、（130±0 97）h；Cmax분별위（152229±106387）ng/ml、（150854±89 244）ng/ml。배대t검험결과표명，AUC（0～6）Tmax、Cmax균무현 저성차이（P>005）。결론：국산쌍록분산갑효낭대진구편적 상대생물이용도위（10080±1659）％，국산여진구량충쌍록 분산갑제제구유생물등효성。
OBJECTIVE:To study the pharmacokinetics and relative bioavailability of diclofenac potassium capsules in normal volunteers.METHODS:A single oral 50mg dose of domestic diclofenac potassium capsules or imported diclofenac potassium tablets were given to 10 healthy male volunteers in an open randomized crossover study.Diclofenac potassium concentration in plasma were determined by HPLC.The pharmacokinetic parameters as well as relative bioavailability were measured.RESULTS:The concentration－ time curves of domestic diclofenac potassium capsules and imported diclofenac potassium tablets were conformed to one compartment open model.The AUC(0～ 6)was (1 834.52± 711 06） μ g/（ h· L） and (1 891.19± 859.08)μ g/（ h· L）， Tmax(1.15± 0.77)h and (1.30± 0.97)h,Cmax(1 522.29± 1 063.87)ng/ml and (1 508.54± 892.44)ng/ml respectively.There were no significant differences between the two formulations in the AUC(0～ 6),Tmax,Cmax.CONCLUSION:The relative bioavailability of domestic diclofenac potassium capsule was(100.80± 16 59)％ compared with the imported tablet.The result of the statistical analysis showed that the two formations were bioequivalent.