三交叉试验设计考察头孢克肟不同制剂生物等效性

目的:研究受试制剂头孢克肟干混悬剂(A)、胶囊剂(B)和参比制剂(C,头孢克肟胶囊,世福素)的人体生物等效性。方法:采用高效液相色谱法测定18名健康受试者三交叉单剂量口服受试制剂或参比制剂200mg后血浆中头孢克肟的浓度。结果:经BIO3程序拟合,A、B、C的AUC0-1分别为(18．54±6．31)、(16．10±5．51)、(17．16±5．96)mg·h-1·L-1,实测Cmax分别为(2．63±0．76)、(2．43±0．78)、(2．57±0．90)mg·L-1,实测tmax分别为(4．11±0．58)、(4．56±0．51)、(4．56±0．70)h,A、B与C的相对生物利用度分别为(108．8±12．3)％和(95．7±15．9)％。结论:受试制剂A与参比制剂C、受试制剂B与参比制剂C具有生物等效性。

Determination of Bioequivalence of Cefixime by Three - way Crossover Design

OBJECTIVE:To study the bioequivalence of suspension formulation of cefixime(A),capsule formulation of ce-fixime(B) and reference preparation(C: Cefixime Capsules or Cefspan) in human body.METHODS: The study was conducted as a 3- way crossover design in 18 healthy volunteers whose plasma concentrations of cefixime were determined by HPLC after receiving a single oral dose of 200 mg trial preparations or reference preparation.RESULTS:The main pharmacokinetics of the three preparations(A、B、C) were as follows after undergoing BIO3 program fitting:AUC0-1 were(18.54±6.31)mg·h-1·L-1, (16.10±5.51)mg·h-1·L-1 and (17.16±5.96)mg·h-1·L-1, Cmax were(2.63±0.76) mg·L-1, (2.43±0.78)mg·L-1 and (2.57±0.90)mg·L-1;tmax were(4.11±0.58)h,(4.56±0.51)h and (4.56±0.70)h,respectively .The relative bioavailability of cefixime suspensions(A) and cefixime capsules(B) were (108.8±12.3)% and (95.7±15.9)% ,respectively as against reference preparation(C) .CONCLUSION:The test formulations(A and B) were found bioequivalent to the reference formulation(C).