【摘要】 目的 :研究盐酸二甲双胍片的人体生物等效性。方法 :20名健康男性志愿者单剂量随机、交叉口服盐酸二甲双胍参比制剂或受试制剂1000mg ,采用高效液相色谱法测定血浆中药物浓度。结果 :受试制剂和参比制剂的Cmax 分别为 (2 59±0 62)、(2 60±0 62) μg/ml,Tmax 分别为 (2 0±0 5)、(1 9±0 5)h ,T1/2 分别为 (3 01±0 54)、(2 90±0 50)h ,AUC0～12 分别为(13 21±3 28)、(12 99±2 98) (μg·h)/ml,AUC0～∞分别为 (14 29±3 44)、(13 91±3 23) (μg·h)/ml。受试制剂的相对生物利用度为 (101 6±7 9) %。结论 :受试制剂与参比制剂具有生物等效性。更多还原

【Abstract】 OJBECTIVE:To study the bioequivalence of metformin hydrochloride tablets.METHODS:A single oral dose of1000mg metformin tablet was given to20healthy male volunteers in an open randomized cross-over test.The plasma levels of metformin were determined by HPLC with ultraviolet detection.RESULTS:The pharmacokinetic parameters of tested and metformin tablets were as follows,C max was(2.59±0.62)μg/ml and(2.60±0.62)μg/ml,T max was(2.0±0.5)h and(1.9± 0.5)h,T 1/2ke was(3.01±0.54)h and(2.90±0.50)h,AUC 0～12 was(13.21±3.28)(μg·h)/ml and(12.99±2.98)(μg·h)/ml,AUC 0～∞ was(14.29±3.44)(μg·h)/ml and(13.91±3.23)(μg·h)/ml,respectively.The relative bioavailability of metformin tablet was(101.6±7.9)%.CONCLUSION:This study shows that the two kinds of preparations are bioequivaˉlent.更多还原