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目的:评价吗替麦考酚酯胶囊在18名男性健康志愿者体内的生物等效性。方法:受试者随机、双交叉、单剂量口服试验药和对照药1 000 mg。血浆药物浓度采用HPLC法测定,色谱柱为Agilent Zorbax SB C18,流动相为乙腈:水:三乙胺磷酸溶液(35:45:30,v／v),紫外检测波长为250 nm,4-乙基苯甲酸为内标;药动学参数采用DAS软件处理获得。结果:试验药和参比药t1／2 ke分别为(17．56±19．23)和(21．55±28．36)h,Cmax分别为(45．34±16．99)和(45．11±13．78)mg·L-1,tmax分别为(0．69±0．29)和(0．74±0．33)h,AUC0-36分别为(88．92±22．32)和(90．61±21．54)mg·h·L-1。试验药相对生物利用度为99％±18％。经双单侧t检验和方差分析,两制剂符合生物等效标准。结论:试验药和参比药具有生物等效性。
Objective: To evaluate the bioequivalence of mycophenolate mofetil in 18 male volunteers. METHODS: Subjects were randomized, double-crossover, single-dose oral test drug and control drug 1 000 mg. The concentration of plasma drug was determined by HPLC. The column was Agilent Zorbax SB C18 with the mobile phase of acetonitrile: water: triethylamine phosphoric acid (35:45:30, v / v), the UV detection wavelength was 250 nm, Benzyl benzoate as internal standard; Pharmacokinetic parameters were obtained by DAS software. Results: The t1 / 2 ke of test drug and reference drug were (17.56 ± 19.23) and (21.55 ± 28.36) h, respectively, and the Cmax were (45.34 ± 16.99) and .11 ± 13.78) mg · L-1, tmax were (0.69 ± 0.29) and (0.74 ± 0.33) h respectively, AUC0-36 were (88.92 ± 22.32 ) And (90.61 ± 21.54) mg · h · L-1. The relative bioavailability of the test drug was 99% ± 18%. By double unilateral t test and analysis of variance, the two formulations meet the bioequivalence criteria. Conclusion: The test drugs and reference drugs are bioequivalent.