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目的:建立高效液相色谱荧光法(HPLC-FLU)测定人血浆中坎地沙坦浓度并对其口服制剂进行生物等效性研究。方法:采用随机自身对照双周期交叉实验设计,19名健康受试者口服受试制剂和参比制剂后,用HPLC-FLU法测定人血浆中坎地沙坦浓度,用非房室模型估算坎地沙坦的药动学参数。结果:受试制剂和参比制剂的药动学参数如下:AUC_(0～t)分别为(1378.86±293.90)和(1338.33±324.76)μg·h·L~(-1);AUC_(0～∞)分别为(1451.48±299.56)和(1398.80±338.82)μg·h·L~(-1);C_(max)分别为(139.01±36.56)和(141.17±36.69)μg·L~(-1);t_(max)分别为(3.03±0.82)和(3.26±1.63)h;t_(1/2)分别为(8.30±2.06)和(8.17±1.43)h。受试制剂的相对生物利用度为(104.20±11.90)%。结论:经统计学分析,两种国产坎地沙坦酯片剂具有生物等效性。
OBJECTIVE: To establish a HPLC-FLU method for the determination of candesartan in human plasma and to study the bioequivalence of its oral preparation. METHODS: Randomized self-controlled two-cycle crossover design was adopted. Nineteen healthy volunteers were given oral test formulation and reference formulation. The concentrations of candesartan in human plasma were determined by HPLC-FLU, and the non-compartmental model Losartan pharmacokinetic parameters. Results: The pharmacokinetic parameters of the test preparation and the reference preparation were as follows: AUC 0 ~ t were (1378.86 ± 293.90) and (1338.33 ± 324.76) μg · h · L -1; AUC 0 ~ ∞) were (1451.48 ± 299.56) and (1398.80 ± 338.82) μg · h · L -1, respectively; C max were (139.01 ± 36.56) and (141.17 ± 36.69) μg · L -1 ); t max were (3.03 ± 0.82) and (3.26 ± 1.63) h respectively; t 1/2 was 8.30 ± 2.06 and 8.17 ± 1.43 h respectively. The relative bioavailability of the test preparation was (104.20 ± 11.90)%. Conclusion: According to statistical analysis, the two domestic candesartan cilexetil tablets have bioequivalence.