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目的;评价贝氏和博莱盐酸二甲双胍片生物等效性。方法:将20名健康男性志愿者随机分为两组,分别交叉口服两种盐酸二甲双胍片剂,用高效液相色谱法测定血清中药物浓度;用3p97软件计算药代动力学参数;用方差分析和单双侧t检验及（1-2α）置信区间法分析两种盐酸二甲双胍片剂是否等效。结果:分别单剂口服1000mg贝氏或博莱盐酸二甲双孤片剂的Tmax为（2.42±1.03）h和（2.50±1.08）h;Cmax分别为（2.22±0.60）μg/ml和（2.12±0.47）μg/ml;AUC0-24分别为（16.69±5.70）mg/（h·L）和（16.98±6.38）mg/（h·L）。经3种方法的统计分析,两者无显著性差异（P>0.05）。结论:贝氏盐酸二甲双胍片与博莱盐酸二甲双胍片的相对生物利用度为（98.29±11.98）％,两种盐酸二甲双胍片剂具有生物等效性。
Objectives; To evaluate the bioequivalence of Bethesda and Bolaley’s metformin hydrochloride tablets. Methods: Twenty healthy male volunteers were randomly divided into two groups. Two kinds of metformin hydrochloride tablets were orally administered orally. Serum concentrations of the drugs were determined by high performance liquid chromatography (HPLC). Pharmacokinetic parameters were calculated by 3p97 software. And single-sided t-test and (1-2α) confidence interval analysis of two metformin hydrochloride tablets is equivalent. Results: The Tmax was (2.42 ± 1.03) h and (2.50 ± 1.08) h in single-dose orally administered 1000 mg Bupleurum or Bolazeprazide respectively; the Cmax were (2.22 ± 0.60) μg / ml and ± 0.47) μg / ml; AUC0-24 was (16.69 ± 5.70) mg / (h · L) and (16.98 ± 6.38) mg / (h · L), respectively. There was no significant difference between the three methods (P> 0.05). Conclusion: The relative bioavailability of metformin hydrochloride tablets and metformin hydrochloride tablets is (98.29 ± 11.98)%, and the two metformin hydrochloride tablets are bioequivalent.