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目的：研究国产5－单硝酸异山梨醇酯（IS－5－MN）胶囊及进口IS－5－MN片剂在健康志愿者的药动学特征及其生物等效性。方法：随机双盲实验先后一次口服IS－5－MN胶囊和进口IS－5－MN参比片剂（20mg）后，以高效气相色谱法时检测其血药浓度，采用CAPP软件包计算药动学参数，并做生物等效性分析。结果：一次口服胶囊和片剂的药动学符合二室开放模型，其主要药动学参数Cmax分别为（477．7±103．9）μg／L和（468．1±107．8）μg／L，Tmax分别为（0．77±0．36）h和（0．84±0．24）h，t1／2β分别为（6．99±0．71）h和（7．02±0．51）h（P＞0．05）；胶囊的相对生物利用度为（106．1±10．1）％。结论：两种制剂生物等效。
OBJECTIVE: To study the pharmacokinetics and bioequivalence of domestic 5-isononitrate (IS-5-MN) capsules and imported IS-5-MN tablets in healthy volunteers. Methods: A randomized, double-blind, randomized, double-blind, one-time oral administration of IS-5-MN capsule followed by the importation of IS-5-MN reference tablets (20 mg) was performed on a high performance gas chromatography Learn parameters and do bioequivalence analysis. Results: The pharmacokinetics of oral capsules and tablets conformed to the two-compartment open model. The main pharmacokinetic parameters Cmax were (477.7 ± 103.9) μg / L and (468.1 ± 107.8) μg / L, Tmax were (0.77 ± 0.36) h and (0.84 ± 0.24) h respectively, and t1 / 2β were (6.99 ± 0.71) h and (7.02 ± 0 .51) h (P> 0.05). The relative bioavailability of capsules was (106.1 ± 10.1)%. Conclusions: Both formulations are bioequivalent.