摘要
目的研究国产和进口替米沙坦片相对生物等效性。方法24名健康志愿者随机、交叉单剂po80mg国产和进口替米沙坦片。用高效液相色谱-荧光法检测血浆中替米沙坦的药物浓度,计算试验制剂的药动学参数及相对生物利用度,并进行生物等效性评价。结果国产及进口制剂的实测tmax分别为:(0.82±0.33)和(0.81±0.20)h,ρmax分别为(560.94±229.23)和(602.75±212.71)μg·L-1,AUC0-t分别为(3231.42±1353.49)和(3304.46±1308.97)μg·h·L-1。替米沙坦试验制剂的相对生物利用度为(98.2±11.5)%。结论主要药动学参数经统计学分析,两种制剂具有生物等效性。
OBJECTIVE To study the bioavailability of domestic and imported telmisartan tablets and evaluate its bioequivalence in healthy volunteers, METHODS A single oral dose of 80 mg domestic and imported telmisartan tablets was given to 24 healthy male volunteers according to an open randomized 2 way crossover design. The plasma concentration of telmisartan was determined by a HPLC assay. RESULTS The pharmacokinetic parmneters of the two products were as follows： tmax（0.82 ± 0.33） and （0.81 ±0,20）h, ρmax（560.94 ± 229.23） and （602.75 ± 212.71）μg·L^-1 ,AUCo-t（3231.42 ± 1 353.49） and （3 304.46 ± 1 308.97）μg·h·L^-1,respectively.The relative bioavailability of domestic preduct was （98.2 ± 11.5） %. CONCLUSION Two preparations were bioequivalence.
出处
《中国药学杂志》
EI
CAS
CSCD
北大核心
2005年第15期1167-1169,共3页
Chinese Pharmaceutical Journal
