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目的:比较在 Beagle 犬体内3种辅酶 Q_(10)(CoQ_(10))制剂的相对生物利用度。方法:采用三制剂三周期(3×3拉丁方)自身对照交叉多剂量口服给药方式,周期间清洗1周。用高效液相色谱法测定6条健康 Beagle 犬口服 CoQ_(10)软胶囊(受试制剂A)、CoQ_(10)普通胶囊(参比制剂 B)和进口 CoQ_(10)软胶囊(参比制剂 C)后不同时间点血浆中 CoQ_(10)的浓度,扣除内源性 CoQ_(10)本底,绘制血药浓度-时间曲线,计算相对生物利用度。结果:受试犬口服 CoQ_(10)60mg 的受试制剂(A)和参比制剂(B,C)后,血浆中 CoQ_(10)AUC_(0-t)(μg·h·mL~(-1))分别为69.31±40.49,62.38±59.05,104.90±64.32。与参比制剂 B 与 C 相比,受试制剂中的相对生物利用度平均为(144.07±79.48)%和(78.60±54.28)%。结论:CoQ_(10)受试制剂 A 生物利用度高于参比制剂 B 而低于参比制剂 C。
OBJECTIVE: To compare the relative bioavailability of three coenzyme Q_ (10) (CoQ_ (10)) formulations in Beagle dogs. Methods: A three-phase three-period (3 × 3 Latin square) self-control crossover multi-dose oral administration method was used. The contents of CoQ_ (10) softgel capsule (Test A), CoQ_ (10) normal capsule (B) and CoQ_ (10) soft capsule The concentration of CoQ_ (10) in plasma at different time points was deducted from the endogenous CoQ_ (10) background, and the plasma concentration-time curve was drawn to calculate the relative bioavailability. RESULTS: After oral administration of CoQ_ (10) 60 mg of test preparation (A) and reference preparation (B, C), CoQ_ (10) AUC_ (0-t) 1)) were 69.31 ± 40.49, 62.38 ± 59.05, 104.90 ± 64.32, respectively. The relative bioavailability in the tested formulations was (144.07 ± 79.48)% and (78.60 ± 54.28)% on average compared to the reference formulations B and C. Conclusion: The bioavailability of CoQ_ (10) A was higher than that of reference B and lower than that of reference C.