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目的评价依那普利滴丸与片剂2种制剂的生物等效性。方法20名健康男性受试者自身交叉单剂量口服依那普利滴丸和普通片20 mg,以HPLC-MS/MS法测定血浆中依那普利的代谢产物依那普利拉的浓度。采用DAS 2.0软件处理计算主要药动学参数,以方差分析与双向单侧t检验进行统计学分析。结果2种制剂血浆中依那普利拉的t_(1/2)分别为(7±s4)和(7±3)h,c_(max)分别为(61±19)和(64±27)μg·L~(-1),t_(max)分别为(4.1±0.8)和(3.9±0.7)h,AUC_(0～48)分别为(498±139)和(496±228)μg·h·L~(-1),AUC_(0～∞)分别为(515±145)和(520±241)μg·h·L~(-1),以依那普利拉计算的人体相对生物利用度为(114±38)%。结论2种制剂在健康人体内具有生物等效性。
Objective To evaluate the bioequivalence of enalapril dropping pills and tablets. Methods Twenty healthy male volunteers were randomized to receive oral enalapril and 20 mg of common tablets. The concentration of enalaprilat metabolite enalapril in plasma was determined by HPLC-MS / MS. The main pharmacokinetic parameters were calculated by DAS 2.0 software and analyzed by variance analysis and two-way unilateral t-test. Results The t_ (1/2) of enalaprilat in the plasma of the two preparations were (7 ± s4) and (7 ± 3) h, and the max was 61 ± 19 and 64 ± 27, μg · L -1 and t max respectively were (4.1 ± 0.8) and (3.9 ± 0.7) h and (498 ± 139) and (496 ± 228) μg · h · L -1 and AUC 0 ~ ∞ were (515 ± 145) and (520 ± 241) μg · h · L -1, respectively. The relative bioavailability of enalapril Degree was (114 ± 38)%. Conclusion The two preparations are bioequivalent in healthy volunteers.