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目的考察国产异丁司特缓释胶囊的人体相对生物利用度。方法12名男性健康受试者随机分为3组 ,分别口服单剂量日本产异丁司特缓释胶囊20mg、国产异丁司特缓释胶囊20mg、异丁司特原料药10mg,交叉自身对照。于服药后取静脉血 ,用HPLC法测定血清异丁司特浓度。结果三种制剂的Cmax 分别为 (54.9±9.7)、(60.7±9.1)、(62.2±11.5) μg·L-1,tmax 分别为 (3.8±0.8)、(3.9±0.8)、(1.75±0.34)h ,t1/2(ke)为(11.5±1.4)、(12.1±1.0)、(3.5±0.5)h ,AUC(0～t) 为(618.1±57.7)、(588.2±66.6)、(233.0±46.4)μg·h·L-1。以日本杏林公司产品作为参比制剂 ,国产异丁司特缓释胶囊的人体相对生物利用度为(95.6±11.0) %。结论经双向单侧t检验 ,国产和进口缓释胶囊具有生物等效性 ,与原料药相比具有明显的缓释特性
Objective To investigate the relative bioavailability of domestic ibudilast sustained-release capsules. Methods Twelve male healthy volunteers were randomly divided into 3 groups: oral administration of a single dose of ibudilast 20 mg Japanese sustained-release capsules, imatinib sustained release capsules 20 mg, ibuprofen 10 mg, cross-self control . Venous blood was taken after taking medicine and the concentration of ibudilast was measured by HPLC. Results The Cmax of the three preparations were (54.9 ± 9.7), (60.7 ± 9.1), (62.2 ± 11.5) μg · L-1, respectively, and the tmax were (3.8 ± 0.8), (3.9 ± 0.8), (1.75 ± 0.34 ), t1 / 2 (ke) were (11.5 ± 1.4), (12.1 ± 1.0), (3.5 ± 0.5) h and AUC (0 ~ t) were (618.1 ± 57.7), (588.2 ± 66.6) ± 46.4) μg · h · L-1. The relative bioavailability of domestic sustained release capsules of ibuprofen was (95.6 ± 11.0)%. Conclusion The two-way one-sided t test, domestic and imported sustained-release capsules with bioequivalence, compared with the raw material drug has obvious sustained-release properties