摘要
目的:评价2种不同厂家盐酸美金刚片的生物等效性。方法:采用标准二阶段交叉设计自身对照试验方案,将20名健康男性受试者随机分为2组,分别单剂量口服盐酸美金刚片受试制剂(国产)或参比制剂(进口)10mg后,用液-质联用(LC-MS)法测定血浆中美金刚浓度,以DAS2.0软件计算药动学参数。结果:20名健康受试者单剂量口服受试制剂或参比制剂后,药动学参数分别为:t1/2(69.77±14.61)、(76.06±17.92)h,tmax(5.15±1.18)、(5.05±1.36)h,cmax(13.64±3.28)、(13.34±4.18)μg·mL-1,AUC0～240h(857.73±164.45)、(888.16±316.00)μg·h·mL-1,AUC0～∞(940.00±180.70)、(999.00±346.40)μg·h·mL-1。与参比制剂比较,受试制剂的生物利用度为104.2%。结论:2种盐酸美金刚片生物等效。
OBJECTIVE：To evaluate the relative bioavailability and bioequivalence of 2 kinds of Memantine tablets from different manufacturers.METHODS：In standard two step cross-design self-controlled trials,20 healthy male volunteers were randomly divided into 2 groups.2 groups orally took a single dose of 10 mg tablets of the test preparation （domestic tablet） and reference preparation （imported tablet）.The plasma concentration of memantine was determined by LC-MS,and pharmacokinetic parameters were calculated by using DAS 2.0 software.RESULTS：The pharmacokinetic parameters of reference and test preparations were as follows：t1/2 were （69.77±14.61）h vs.（76.06±17.92）h;tmax（5.15±1.18）h vs.（5.05±1.36）h;cmax（13.64±3.28）μg·mL-1 vs.（13.34±4.18）μg·mL-1;AUC0～240 h（857.73±164.45）μg·h·mL-1 vs.（888.16±316） μg·h·mL-1;AUC0～∞（940.00±180.70）μg·h·mL-1 vs.（999.00±346.40）μg·h·mL-1,respectively.The relative bioavailability of test preparation was 104.2%,compared with reference preparation.CONCLUSION：2 kinds of Memantine tablets are bioequivalent.
出处
《中国药房》
CAS
CSCD
2012年第22期2047-2050,共4页
China Pharmacy
