丙戊酸钠缓释片的人体生物等效性研究

目的 评价两种丙戊酸钠缓释片的生物等效性.方法 采用开放,随机交叉试验设计,20名健康男性志愿者单剂量口服丙戊酸钠缓释片参比制剂和受试制剂各1000mg,用高效液相-荧光色谱法测定不同时间血清中丙戊酸钠的浓度并计算其主要的药代动力学参数.结果 单剂量口服两种丙戊酸钠缓释片主要药代动力学参数:Cmax分别为115.34±12.24和109.34±11.84μg·mL-1;tmax分别为0.91±0.74和0.98±0.68h;AUC0-∞分别为1.92±0.58和1.91±0.64mg·h·mL-1;利用方差分析及双单侧t检验对两种丙戊酸钠缓释片的生物等效性进行评价.结论 两种厂家生产的丙戊酸钠缓释片具有生物等效性.

Studies on Bioequivalence of Sodium Valproic Sustained-Release compound tablets in healthy volunteers

OBJECTIVE To evaluate relative bioavailability of valproic sustained-release compound from Two different company tablets in healthy volunteers.METHODS A single and a multi oral administration of 1000 mg sodium valproic sustained-release compound tablets were given to 20 healthy male volunteers in randomized crossover study respectively.The concentration of sodium valproate were determined by HPLC-fluoresence method.RESULTS The pharmacokinetics parameters after a single oral administration of 1000mg valproic sustained-release compound from Two different company were as follows:Cmax 115.34±12.24 and 109.34±11.84μg·mL-1;tmax 0.91±0.74 and 0.98±0.68h;AUC0-∞ 1.92±0.58 and 1.91±0.64mg·h·mL-1.CONCLUSION The results of statistical analysis showed that the two preparations were bioequivalence.