改进的高效液相色谱法测定舒林酸血药浓度及人体生物利用度  

Study on bioequivalence of sulindac tablets

作　　者：马霖[1] 韩志武[1] 李静[1] 沙丽颖[1] 孙伟[1] 

机构地区：[1]青岛大学医学院附属医院,山东青岛266003

出　　处：《中国医院药学杂志》2004年第9期544-545,共2页Chinese Journal of Hospital Pharmacy

摘　　要：目的 :以舒达宁片为对照品对舒林酸片进行生物等效性评价。方法 :18名男性健康受试者 ,采用单剂量随机自身交叉对照试验设计 ,空腹口服 2 0 0mg单剂量试验和参比制剂并采集 12h内动态血标本 ,用改进的HPLC法测定血清药物浓度并计算相关参数 ,并进行双单侧t检验以判断两制剂是否生物等效。结果 :试验制剂舒林酸片剂和参比制剂舒达宁片剂的AUC0 -t分别为 18.2 1,18.0 0mg·h·L-1,Cmax分别为 8.0 7,7.4 4mg·L-1,Tmax分别为 1.86 ,1.86h ,T1/ 2 分别为 2 .80 ,2 .36h ,AUC0 -∞ 分别为 18.97,18.6 1mg·h·L-1。两组各参数均无统计学差异 (P >0 .0 5 )。AUC0 -t、AUC0 -∞ 和Cmax经双单侧t检验 ,差异无显著性。结论 :舒林酸片的相对生物利用度为 10 1.15 % 。OBJECTIVE To study the bioequivalence of sulindac tablets in healthy volunteers. METHODS A rapid and sensitive RP-HPLC assay was modified for determination of the drug levels in serum. In a randomized two-way crossover design,200 mg single dose po sulindac tablets (A) and shu da ning (B),respectively, were given to 18 male healthy volunteers. The parameters were estimated by the non-compartment model with a statistic analysis of ANOVA and two one-sided t test. RESULTS The T _max,C _max, AUC _0-t and AUC _0-∞ of A and B groups were _1.86 and _1.86 h, _8.07 and _7.44 mg·L_-1,_18.21 and _18.00 mg·h·L_-1, _18.97 and _18.61 mg·h·L_-1, respectively. The mean relative bioavailibility of product A group vs. reference B group was _101.15%. There was no significant difference between the two products. CONCLUSION The result suggests that these two products are bioequivalent.

关 键 词：舒林酸 药动学 生物等效性 高效液相色谱法 

分 类 号：R969.1[医药卫生—药理学]