格列美脲片的人体相对生物利用度与药代动力学分析  

Human relative bioavailability and pharmacokinetic analysis of glimepiride tablets

作　　者：余长生 Yu Changsheng(Qingliu County Wenjiao Hospital,Sanming 365300,Fujian,China)

机构地区：[1]清流县温郊卫生院,福建三明365300

出　　处：《北方药学》2023年第7期5-7,共3页Journal of North Pharmacy

摘　　要：目的:观察格列美脲片的人体相对生物利用度与药代动力学情况。方法:选取2021—2022年健康志愿者15例为研究对象,自身交叉给药,分别服用国产、进口格列美脲片4mg,使用高效液相色谱法进行血药浓度测定,使用DrugAndStatistics(药物与统计,DAS)3.0.4软件进行药代动力学参数分析,使用SPSS 24.0软件分析数据。结果:健康志愿者服用国产、进口格列美脲片后血药浓度出现先升高后降低,血糖水平出现先降低后升高。国产格列美脲片Tmax(3.15±0.53)h、t1/2(7.35±1.67)h、Cmax(412.06±20.03)μg/L、AUC_(0~1)(2364.35±589.25)μg·h/L、AUC_(0~∞)(2598.33±592.21)μg·h/L同进口格列美脲片比较差异无统计学意义(P>0.05)。国产格列美脲片生物等效性分析结果显示AUC_(0~1)90%可信限为99.82%~118.74%;AUC_(0~∞)90%可信限为98.75%~116.87%落在参照片的80%~125%之间;进口格列美脲片AUC_(0~1)90%可信限为99.84%~118.09%;AUC_(0~∞)90%可信限为98.15%~117.96%落在参照片的80%~125%之间;两种药物制剂具有生物等效性。国产格列美脲片相对回收率100.45%,日内精密度6.28%,日间精密度8.71%,绝对回收率72.98%,生物利用度F108.98%。结论:国产、进口格列美脲片具有生物等效性,国产格列美脲片生物利用度较高,可改善血糖状态。Objective To observe the relative bioavailability and pharmacokinetics of glimepiride tablets in humans.Methods A total of 15 healthy volunteers from 2021 to 2022 were selected as the study subjects.They were cross-administered with domestic and imported glimepiide tablets 4mg respectively.The blood drug concentration was determined by high performance liquid chromatography(HPLC)and DrugAndStatistics(drug and statistics).DAS)3.0.4 software was used to analyze the pharmacokinetic parameters,and SPSS 24.0 software was used to analyze the data relationship.Results After taking domestic and imported glimepiide tablets,the blood concentration of healthy volunteers increased first and then decreased,and the blood glucose level decreased first and then increased.Domestic glimepiide tablets Tmax(3.15±0.53)h,t1/2(7.35±1.67)h,Cmax(412.06±20.03)μg/L,AUC_(0~1)(2364.35±589.25)μg·h/L,AUC_(0~∞)(2598.33±592.21)μg·h/L There was no significant difference between L and imported glimepiide tablets(P>0.05).The bioequivalence analysis results of glimepiide tablets showed that the AUC_(0~1)90%confidence limits were 99.82-118.74%.AUC_(0~∞)90%confidence limit is 98.75%~116.87%,which falls between 80%~125%of the reference film;The confidence limit of imported glimepiide tablets AUC_(0~1)90%was 99.84%~118.09%;AUC_(0~∞)90%confidence limit is 98.15%~117.96%,which falls between 80%~125%of the reference film;The two drug preparations are bioequivalent.The relative recovery was 100.45%,the intraday precision was 6.28%,the daytime precision was 8.71%,the absolute recovery was 72.98%,and the bioavailability was F108.98%.Conclusion Domestic and imported glimepiride tablets have bioequivalence,and domestic glimepiride tablets have high bioavailability,which can improve blood glucose status and is conducive to popularization.

关 键 词：格列美脲片 生物利用度 药代动力学 

分 类 号：R969.1[医药卫生—药理学]