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采用单剂量随机双周期交叉试验设计,评价6只Beagle犬口服多巴丝肼胶囊(受试制剂)和多巴丝肼片剂(参比制剂,美多芭)的生物等效性,用HPLC-MS法测定血浆中的左旋多巴浓度。受试制剂和参比制剂的主要药动学参数为:t_(max)(0.41+0.09)和(0.49±0.20)h,c_(max)(39.00±6.00)和(39.96±8.63)μg/ml,t_(1/2)(0.59±0.08)和(0.62±0.09)h,AUC_(0-1)(51.29±11.60)和(49.13±14.95)μg·h·ml~(-1),AUC_(0-∞)(51.36±11.61)和(49.21+14.95)μg·h·ml~(-1)。受试制剂中左旋多巴的相对生物利用度为(109.13±27.50)%,结果显示:两制剂生物等效。
The bioequivalence of the six Beagle dogs oral dopahydrazide capsules (test formulations) and dobesilazin tablets (reference formulation, metoprolol) was evaluated using a single-dose, randomized, two-cycle crossover design with HPLC Determination of levodopa concentration in plasma by -MS method. The main pharmacokinetic parameters of test and reference preparations were: t max (0.41 + 0.09) and (0.49 ± 0.20) h, c max (39.00 ± 6.00) and (39.96 ± 8.63) μg / ml , t 1/2 (0.59 ± 0.08) and (0.62 ± 0.09) h, AUC 0-1 (51.29 ± 11.60) and (49.13 ± 14.95) μg · h · ml -1, AUC_ 0-∞) (51.36 ± 11.61) and (49.21 + 14.95) μg · h · ml -1, respectively. The relative bioavailability of levodopa in the test preparation was (109.13 ± 27.50)%. The results showed that the two preparations were bioequivalent.