论文部分内容阅读
目的 研究盐酸二甲双胍胶囊在正常人体内的药物动力学和相对生物利用度。方法 10 例健康男性志愿者,随机分为两组,分别交叉口服盐酸二甲双胍胶囊和片剂采用通过反相 H P L C 法测定盐酸二甲双胍在体内的药物浓度。结果 口服1 000 mg 盐酸二甲双胍胶囊片剂的达峰时间( Tmax) 分别为183 h ±056 h 和183 h ±050 h ;峰浓度( Cmax) 分别为225 mg· L- 1 ±049 mg· L- 1 和224 mg· L- 1±050 mg· L- 1 ;消除半衰期( T1/2β) 分别为240 h ±023 h和240 h ±028 h ;药时曲线下面积( A U C) 分别为1341 mg·h - 1· L- 1 ±355 mg·h - 1· L- 1 和1299 mg·h - 1· L- 1 ±339mg·h - 1· L- 1 ,经t 检验,两种剂型的药代动力学参数无显著性差异;口服盐酸二甲双胍胶囊对其片剂的相对生物利用度为10324 % 。结论 两种制剂具有生物等效性。
Objective To study the pharmacokinetics and relative bioavailability of metformin hydrochloride capsules in normal human. Methods Ten healthy male volunteers were randomly divided into two groups. Metformin hydrochloride capsules and tablets were administered orally. The drug concentration of metformin hydrochloride in the body was determined by reversed-phase H PLC method. Results The peak time (Tmax) of 1 000 mg oral metformin hydrochloride capsules was 1.83 h ± 056 h and 183 h ± 050 h, respectively. The peak concentrations (Cmax) were 225 mg · L ± 1 ± 049 mg · L -1 and 224 mg · L -1 ± 050 mg · L -1; elimination half-life (T1 / 2β) were 240 h ± 023 h And 240 h ± 028 h respectively. The area under the curve (A U C) was 1341 mg · h -1 · 1 ± 355 mg · h -1 · L -1 and 12 respectively 99 mg · h - 1 · L- 1 ± 339 mg · h - 1 · L - 1. There was no significant difference in the pharmacokinetic parameters between the two formulations by t test. The oral administration of metformin hydrochloride capsule had no significant difference The relative bioavailability of 10324%. Conclusions Both formulations are bioequivalent.