头孢地尼分散片的人体生物等效性研究

目的:研究头孢地尼分散片在健康人体中的药动学和生物等效性。方法:采用微生物法测定20名健康志愿者单剂量交叉口服400mg头孢地尼分散片(受试制剂)和头孢地尼胶囊(参比制剂)后不同时间血清中的药物浓度。结果:受试制剂与参比制剂药-时曲线均符合一房室开放模型,tmax分别为(3.48±0.53)、(3.60±0.48)h,Cmax分别为(2.10±0.32)、(2.15±0.26)mg·L-1;t1/2ke分别为(2.41±0.39)、(2.33±0.41)h,AUC0~12分别为(9.51±1.65)、(10.05±1.72)mg·h·L-1,AUC0~∞分别为(10.43±1.62)、(11.01±1.81)mg·h·L-1。受试制剂相对于参比制剂的生物利用度为(96.03±14.89)%。结论:两种制剂具有生物等效性。

Bioequivalence of Cefdinir Dispersible Tablets in Healthy Volunteers

OBJECTIVE:To study the pharmacokinetics and the bioequivalence of cefdinir dispersible tablets in healthy volunteers.METHODS:Microbiological assay method was used to determine the plasma concentration at different time in 20 healthy volunteers after oral administration of single dose of 400mg of cefdinir dispersible tablets(test preparation) and cefdinir capsule(reference preparation) by cross-over way.RESUTLS:The concentration-time curves of test preparation and reference preparation of cefdinir fitted one compartment open model.The pharmacokinetic parameters of the test preparation vs.the reference preparation were as follows:tmax(3.48±0.53)h vs.(3.60±0.48)h,Cmax(2.10±0.32)mg·L-1 vs.(2.15±0.26)mg·L-1.t1/2ke(2.41±0.39)h vs.(2.33±0.41)h,AUC0～12(9.51±1.65)mg·h·L-1 vs.(10.05±1.72)mg·h·L-1,AUC0～∞(10.43±1.62)mg·h·L-1 vs.(11.01±1.81)mg·h·L-1,respectively.The relative bioavailability of cefdinir dispersible tablet as against its reference preparation was(96.03±14.89)%.CONCLUSION:The two preparations of cefdinir were proved to be bioequivalent.