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目的探讨马来酸依那普利叶酸片与不同厂家马来酸依那普利片联用叶酸片的相对生物利用度。方法 20名健康人群按照以下三个组别:对照组口服马来酸依那普利叶酸片(含依那普利10 mg/叶酸0.8 mg)、试验1组口服马来酸依那普利片(悦宁定)10 mg和叶酸片0.8 mg、试验2组口服马来酸依那普利片(依苏)10 mg和叶酸片0.8 mg,单剂量口服,经过清洗期后交换组别,保证每名受试者都能经历三组试验,对三种用药方案进行生物等效性评价。结果 20名健康人群经三种用药方案治疗后,试验组与对照组的血药浓度及血药浓度-时间曲线相比差异无统计学意义(P>0.05)。结论马来酸依那普利叶酸片和马来酸依那普利片加叶酸片具有相同的血药浓度及药时曲线,具有生物等效性。
Objective To investigate the relative bioavailability of enalapril maleate folic acid tablets and enalapril maleate tablets with different manufacturers. Methods Twenty healthy people were enrolled in the following three groups: Control group, oral folic acid tablets of enalapril maleate (enalapril 10 mg / folic acid 0.8 mg), test group 1 oral enalapril maleate (Yue-ning Ding) 10 mg and folic acid tablets 0.8 mg, test group 2 oral enalapril maleate (Yi Su) 10 mg and folic acid tablets 0.8 mg, single-dose orally, after the wash group after the exchange, guarantee Each subject underwent three sets of trials to evaluate the bioequivalence of the three dosing regimens. Results There was no significant difference in the blood concentration and plasma concentration-time curve between the experimental group and the control group after treatment with the three drug regimens in 20 healthy subjects (P> 0.05). Conclusion The enalapril maleate folate tablets and enalapril maleate tablets plus folic acid tablets have the same plasma concentration and drug-time curve, with bioequivalence.