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目的研究甲钴胺软胶囊在健康人体内的药物动力学及相对生物利用度。方法 20例男性健康受试者采用自身交叉单剂量口服给药对照法服用药物,以微生物比浊法测定受试者服药后72 h内血浆中甲钴胺浓度,计算甲钴胺的药动学参数和生物等效性。结果口服单剂量给药药动学参数计算结果显示,血浆中受试制剂和参比制剂的tmax分别为(7.3±2.6)h和(6.8±2.5)h,ρmax分别为(426.7±165.2)ng·L-1和(420.7±188.6)ng·L-1t,1/2分别为(23.6±8.4)h和(28.5±7.0)h,AUC0-t分别为(9 568±3 265)ng·h.L-1和(9 398±3 733)ng·h.L-1,AUC0-∞分别为(11 245±3 676)ng·h.L-1和(11 333±4 138)ng·h.L-1。以AUC0-t计算,甲钴胺软胶囊的平均相对生物利用度为(105.0±19.3)%。结论两种制剂在人体内具有生物等效性。
Objective To study the pharmacokinetics and relative bioavailability of mecobalamin capsules in healthy volunteers. Methods Twenty healthy male volunteers were given oral cross-over oral administration of the drug, and the concentration of mecobalamin in the plasma was measured by the turbidimetric method within 72 hours. The pharmacokinetics of mecobalamin Parameters and bioequivalence. Results The results of single-dose oral administration showed that tmax was (7.3 ± 2.6) h and (6.8 ± 2.5) h in test and reference preparations respectively, and pmax was (426.7 ± 165.2) ng The mean AUC0-t were (9 568 ± 3 265) ng · hL for L-1 and 420.7 ± 188.6 ng · L-1t, respectively, with 1/2 of 23.6 ± 8.4 and 28.5 ± 7.0, respectively -1 and (9 398 ± 3 733) ng · hL-1 and AUC0-∞ were 11 245 ± 3676 ng · hL-1 and 11 333 ± 4 138 ng · hL-1, respectively. The average relative bioavailability of mecobalamin soft capsules was (105.0 ± 19.3)% based on AUC0-t. Conclusion Both formulations are bioequivalent in humans.