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１２名健康志愿者采用交叉给药方法，分别单剂量口服５ｍｇ国产盐酸阿呋唑嗪片及进口盐酸阿呋唑嗪片，进行两种制剂的生物等效性研究。采用ＨＰＬＣ荧光检测法测定血浆中阿味唑嗪的浓度，血药浓度－时间数据经３ｐ９７生物利用度计算程序处理拟合，符合血管外给药二室开放模型，试验结果表明：单次口服５ｍｇ国产盐酸阿呋唑嗪片和进口盐酸阿呋唑嗪片后，达峰时间分别为１４６ ± ０．５４ｈ和１．４２ ±０．２９ ｈ，峰浓度分别为 ３９．７９ ± ５，２９ μ ｇ· Ｌ~（－１）和 ４０．０５ ± ５．８８ μ ｇ· Ｌ~（－１），０－ ２４ｈ的药时曲线下面积分别为２２５．４０ ± ２６．６６μｇ·ｈ· Ｌ~（－１）和２３５．０４±２４．１３ μ ｇ·ｈ· Ｌ~（－１）、其主要药代动力学参数经方差分析和双单侧ｔ检验，无显著性差异（Ｐ＞０．０５），两种制剂具有生物等效性。国产盐酸阿呋唑嗪片的相对生物利用度为９６．９０／±１５．８％。
Twelve healthy volunteers were given oral administration of oral administration of 5mg domestic alfaconazole hydrochloride tablets and imported alfuzosin hydrochloride tablets, respectively, to study the bioequivalence of the two preparations. The concentration of arsenazosin in plasma was determined by HPLC fluorescence detection method. The plasma concentration-time data were fitted and processed by 3p97 bioavailability calculation program, which was in accordance with the two-compartment open model of extravascular administration. The results showed that a single oral dose of 5mg The results showed that the peak time was 146 ± 0.54h and 1.42 ± 0.29 h respectively after the domestic made of avermectin hydrochloride tablets and the import of afuzosin hydrochloride tablets, the peak concentrations were 39.79 ± 5,29 μ g · The area under the curve of drug concentration at L -1 and 40.05 ± 5.88 μg · L -1 and 0-24 h were 225.40 ± 26.66 μg · h · L ~ 1) and 235.04 ± 24.13 μg · h · L ~ (-1), respectively. The main pharmacokinetic parameters showed no significant difference (P> 0.05) by analysis of variance and double unilateral t test, Both formulations are bioequivalent. The relative bioavailability of domestic afuzosin tablets was 96.90 / ± 15.8%.