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目的 :研究羟乙膦酸钠胶囊在正常人体内的相对生物利用度。方法 :采用钼蓝 乙酸丁酯萃取比色法测定 8名志愿者单剂量 po 40 0mg羟乙膦酸钠胶囊和羟乙膦酸钠片剂后的血药浓度变化情况 ,计算二者的相对生物利用度。用双单侧t检验法分析两种制剂的生物等效性。结果 :两种制剂的消除相半衰期分别为 (3.0 3± 1 .0 7)h和 (3.46± 0 .73)h ;血药浓度曲线下面积分别为 (8.1 8± 1 .99)和 (8.1 4± 1 .94) μg·h·ml-1,其达峰浓度分别为 (0 .88± 0 .1 7)和 (1 .0 4± 0 .32 )h ,达峰浓度分别为 (2 .0 5±0 .5 6 )和 (1 .79± 0 .6 0 ) μg·ml-1。结论 :羟乙膦酸钠胶囊与羟乙膦酸钠片剂为生物等效制剂 ,羟乙膦酸钠胶囊的相对生物利用度为 (1 0 0 .6± 1 0 .0 ) %。
Objective: To study the relative bioavailability of etidronate sodium capsule in normal human. Methods: The change of plasma concentration of eight volunteers with single dose of po 40 0 mg sodium etidronate and sodium etidronate tablets was measured by molybdenum blue butyl acetate extraction colorimetric method, and the relative biological Utilization. Bioequivalence of the two formulations was analyzed using the double unilateral t-test. RESULTS: The elimination half-lives of the two preparations were (3.03 ± 1.07) h and (3.46 ± 0.73) h, respectively. The area under the plasma concentration curve was (8.18 ± 1.99) and (8.1 4 ± 1 .94) μg · h · ml-1, the peak concentrations were (0.88 ± 0.17) and (1.40 ± 0.32) h, respectively. The peak concentrations were (2 .0 5 ± 0.56) and (1.79 ± 0.60) μg · ml-1. CONCLUSION: Etidronate sodium capsules and etidronate tablets are bioequivalent formulations, and the relative bioavailability of etidronate sodium capsules is (100 ± 6 ± 10)%.