健康人口服羟乙膦酸钠胶囊剂的相对生物利用度试验

Relative bioavailability of disodium etidronate capsules in healthy volunteers

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 disodium etidronate capsules in healthy volunteers.METHODS:The disodium etidronate concentrations in plasma were determined by extraction of molybdate blue butylacetate and colorimetry following a single oral dose of disodium etidronate capsules and disodium etidronate tablets respectively given to 8 volunteers.RESULTS:The t 1/2Ke was (3.03±1.07)h and (3.46±0.73)h, AUC (8.18±1.99) and (8.14±1.94)μg·h·ml -1 , t max (0.88± 0.17 ) and (1.04±0.32)h, c max (2.05±0.56) and (1.79±0.60)μg·ml -1 of disodium etidronate capsules and disodium etidroante tablets,respectively.CONCLUSION:The results of statistical analysis showed that the two formulations were bioequivalent.The relative bioavailability of disodium etidronate capsules was (100.6±10.0)%.