CoQ10软胶囊在Beagle犬体内的相对生物利用度评价

Relative Bioavailability Assessment of Oral Coenzyme Q_(10) Formulations in Beagle Dogs

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 bioavailability of three coenzyme Q10 （CoQ10）formulations in Beagle dogs using an open, randomized, multiple-dose crossover design. Method： Formulations were evaluated in pairs, allowing a clean up period of 7 days prior to crossing over. Blood samples were collected from each animal prior to determine the endogenous plasma CoQ10 concentrations. Plasma concentration-time profiles were corrected for endogenous levels of CoQ10, and AUC were calculated using the linear trapezoidal rule from zero to the last plasma concentration. Result ：AUC0-1（ μg·h·mL^-1） for formulations A, B and C were 69. 31 ± 40. 49,62. 38 ± 59.05 and 104. 90 ± 64. 32, respectively. The relative bioavailability of the formulation A were found to be （ 144. 07 ± 79. 48 ） % and （78.60 ± 54. 28 ） % compared with the formulation B or C, respectively. Conclusion： Compared with the reference formulations, the relative bioavailability of the CoQ10 soft capsule was higher than the formulation B, but lower than the formulation C.