【摘要】 目的研究美索巴莫胶囊(肌松药)在健康人体的药代动力学及其生物等效性。方法按两制剂双周期自身对照交叉试验设计,18名男性健康志愿者分别单剂量口服2种国产美索巴莫胶囊(参比制剂)和(受试制剂),用RP-HPLC法测定血药浓度,计算药代动力学参数,并评价2制剂的生物等效性。结果口服美索巴莫胶囊参比制剂和受试制剂750mg后的主要药代动力学参数:Cmax分别为(13.87±2.44)和(14.34±2.99)μg.mL-1;tmax分别为(0.82±0.21)和(0.80±0.23)h;AUC0-12分别为(32.79±10.03)和(33.90±8.40)μg.h.mL-1;AUC0-∞分别为(33.91±9.89)和(35.00±8.79)μg.mL-1;t1/2Ke分别为(1.91±0.58)和(1.79±0.59)h;美索巴莫的相对生物利用度F0-12平均为(105.0±11.2)%,F0-∞平均为(104.3±10.2)%。结论2种美索巴莫胶囊制剂生物等效。更多还原

【Abstract】 Objective To study the pharmacokinetics and bioequivalence of methocarbamol capsule in healthy volunteers. Methods A single dose 750 mg of reference and test methocarbamol capsules was given to 18 healthy volunteers in randomized 2-way cross-over study. The pharmacokinetics as well as relative bioavailability was measured by RP-HPLC.Results The main pharmacokinetic paranceters of the reference and test capsules were as follow: Cmax were (13.87±2.44) and (14.34±2.99) μg · mL-1;tmax were (0.82±0.21) and (0.80±0.23) h;AUC0-12 were (32.79±10.03) and (33.90±8.40) μg ·h · mL-1;AUC0-∞ were(33.91±9.89)and(35.00±8.79)μg · h · mL-1;t1/2Ke were (1.91±0.58) and (1.79±0.59) h.The relative bioavailability of AUC0-12 was (105.0±11.2 )% and AUC0-∞ was (104.3±10.2)%,respectively.Conclusion The reference and test methocarbamol capsules were bioequivalence.更多还原