摘要
目的 :研究被试制剂国产盐酸氨溴索胶囊和标准参比制剂 (沐舒坦R○)的药动学和人体生物等效性。方法 :采用高效液相色谱法测定 12名健康受试者单剂量口服被试制剂或参比制剂 90mg后 ,血浆中盐酸氨溴索的浓度 ,经 3p97计算程序拟合 ,计算其药动学参数 ,比较其与标准参比制剂的人体生物等效性。结果 :经 3p97计算程序拟合 ,两者在体内的过程皆符合血管外给药一室模型 ,采用梯形法计算的两者AUC0 -t均值分别为 (2 42 1.2± 76 1.3) μg·h·L-1和 (2 485 .9± 80 3 .9) μg·h·L-1,实测Cmax均值分别为 (385 .5± 98.3) μg·L-1和 (378.9± 90 .3) μg·L-1,实测Tpeak均值分别为 (1.5± 0 .3)h和 (1.6± 0 .4)h。被试制剂的相对生物利用度为 (97.9± 6 .7) %。结论 :经统计学分析 。
OBJECTIVE:To study the relative bioequivalence between ambroxol capsules(test drug)and its standard tablets(reference drug)and pharmacokinetics in 12 healthy male volunteers.METHODS:A dose of 90 mg of domestic of imported ambroxol(test and reference preparation)was given according to a randonized 2 way cross over disign, blood samples were withdrawn up to 24 hours post administation,and plasma concentration of ambroxol was determined by high performance liquid chromatography(HPLC).RESULTS:The concentration time curves of two preparations fitted to a one compartment model.The peak plasma levels( C max )of ambroxol test drug and reference drug were(385.5±98.3)and(378.9±90.3) μg·L -1 respectively,the peak time( T max )were(1.5±0.3) h and (1.6±0.4) h, AUC 0 t were(2421.2±761.3)and (2485.9±803.9) μg·h·L -1 ,respectively. The relative bioavailability of the test drug was(97.9±6.7)%.CONCLUSIONS:The pharmacokinetics and relative bioavailability data obtained in the study furnished definite proof of bioequivalence of both domestic ambroxol capsules and imported ambroxol tablets. [
出处
《中国医院药学杂志》
CAS
CSCD
北大核心
2000年第12期709-712,共4页
Chinese Journal of Hospital Pharmacy
关键词
盐酸氨溴素
高产液相色谱法
生物等效性
祛痰药
ambroxol hydrochloride
high performance liquid chromatography(HPLC)
bioequivalence
