摘要
目的评价国产阿托伐他汀钙胶囊与进口阿托伐汀钙片剂(立普妥片)的生物等效性。方法22名男性健康志愿者,采用随机、单剂量、自身交叉对照试验设计,空腹口服国产阿托伐他汀钙胶囊和立普妥片20mg,分别于服药前及服药后各时间点采集血样,用LC/MS/MS法测定血浆中阿托伐他汀的浓度,并计算Cmax、Tmax、T1/2、AUC(0-t)、AUC(0-∞)等相关参数,利用方差分析及双单侧t检验判断2种制剂是否具有生物等效性。结果口服阿托伐他汀钙受试及参比制剂后,血浆中阿托伐他汀的Cmax分别为7.98±3.25、8.47±3.36μg·L-1;Tmax分别为1.37±0.64、1.20±1.01h;T1/2分别为10.64±3.21、10.01±1.81h;AUC(0-t)分别为52.70±13.79、51.83±17.52μg·L-1·h;AUC(0-∞)分别为55.45±14.66、54.09±17.79μg·L-1·h;2组参数均无统计学差异(P>0.05);受试制剂的相对生物利用度为(106.0±23.8)%。结论国产阿托伐他汀钙胶囊与进口立普妥片剂具有生物等效性。
Aim To study the relative bioavailability of atorvastatin calcium capsules and imported lipitor tablets in healthy volunteers. Methods In a randomized two - way crossever design, a single oral dose of 20mg atorvastatin calcium capsules（A） and lipitor tablets （B） were given to 22 male healthy volunteers. The plasma atorvastatin concentrations within 48h after administration were determined with LC/MS/MS and parameters Cmax Tmax, T 1/2, AUC（0- t）, AUC（0-∞） were obtained and analyed with two - one side t test. Results The main pharmacokinetic parameters of domestic atorvastatin calcium capsule and imported lipitor tablet were as follows： C max were 7.98 ± 3.25 and 8.47 ± 3.36μg·L^-1, respectively; Tmax were 1.37±0.64 and 1.20±1.01h,respectively; T1/2β were 10.64±3.21 and 10.01 ± 1.81h,respectively; AUC（0-t） were 52.70±13.79 and 51.83 ±17.52μg·L^-1·h,AUC（0-∞） were 55.45 ± 14.66 and 54.09 ±17.79μg·L^-1. h, respectively. There is no statistically significant difference between these two test groups. The relative bioavailability of the test capsule was （106.0±23.8）%. Conclusions The atorvastatin calcium capsules and lipitor tablets are bioequivalent.
出处
《解放军药学学报》
CAS
2005年第4期262-265,共4页
Pharmaceutical Journal of Chinese People's Liberation Army
