维生素C Na胶囊与维生素C片剂的相对生物利用度比较

COMPARISON OF BIOAVAILABILITY BETWEEN SODIUM VITAMIN-C CAPSULE AND TABLET IN HEALTHY SUBJECTS

用高效液相色谱法测定人血中Vc,对10名健康志愿者po Vc Na胶囊的相对生物利用度及其药物动力学进行研究.结果受试药Vc Na胶囊和对照药Vc片的C_(max)为(67.71±24.13)和(74.33±17.50)μmol/L;T_(1/2)为(7.44±2.00)和(7.69±3.07)h;AUC为(746.4±411.4)和(785.4±428.8)μmol·h/L.各参数经配对t检验均无显著性差异,显示两种制剂体内吸收、分布和消除基本一致.Vc-Na胶囊人体相对生物利用度为(95.1±9.1)%.提示Vc Na胶囊可作为Vc在临床上应用.

The relative bioavailability and pharmacokinetics between vitamin-C tablet (standard drug )and sodium vitamin-C capsule (test drug) was studied in 10 male subjects, plasma concentration of vitamin-C was determined by high-performance liquid chromatogra-phy(HPLC). The peak plasma levels (Cmax) of vitamin-C in standard drug and test drug were (67. 71±24.13) and (74. 33±17.50) umol/L respectively,elimination half-lives (T1/2β)were (7. 44±2. 00) and (7.69±3. 07)h respectively,and AUC were (746. 4±411.4 )and (785.4±428. 8)μmol·h/L respectively. The pharmacokinetic parameters in sodium vitamin-C capsule were not significantly different from that in vitamin-C tablet. Therefore,the disposition of two drugs was similar. The relative bioavailability of sodium vitamin-C capsule was (95.1±9.1)%.The results suggested that sodiun vitamin-C capsule be taken to clinical applica-tion.