烟酸缓释片在健康人体的生物等效性  

Bioequivalence of nicotinic acid sustained-release tablets in healthy volunteers

作　　者：葛苗苗[1] 卫乐乐[1] 方凯[1] 黄露[1] 黎维勇[1] 

机构地区：[1]华中科技大学附属协和医院临床药学研究室,武汉430022

出　　处：《中国临床药理学杂志》2011年第2期118-120,共3页The Chinese Journal of Clinical Pharmacology

摘　　要：目的研究烟酸缓释片(广谱调血脂药)在健康人体的药代动力学,并评价其生物等效性。方法 30名男性健康志愿者随机交叉单剂量口服试验制剂或参比制剂1.5 g,用高效液相色谱-串联质谱法测定血浆中烟酸浓度。结果单剂量口服烟酸试验制剂或参比制剂1.5 g,药代动力学参数如下:AUC0-t分别为(20.05±16.29),(21.61±18.06)μg.h.mL-1;AUC0-∞分别为(20.81±16.30),(22.81±18.47)μg.h.mL-1;Cmax分别为(8.72±6.81),(9.57±8.22)μg.mL-1;tmax分别为(4.41±1.34),(4.31±1.29)h;t1/2分别为(4.00±4.90),(2.91±3.39)h,烟酸缓释片的相对生物利用度为(96.6±30.9)%。结论受试制剂与参比制剂生物等效。Objective To study the pharmacokinetics of nicotinic acid sustained-release tablets in healthy volunteers and evaluate the bioequivalence.Methods Single oral dose（1.5 g of test and reference formulations）were given to 30 volunteers in an open randomized crossover way.The concentrations of nicotinic acid in plasma were determined by HPLC-MS/MS.The pharmacokinetic parameters were calculated and the bioequivalence of two formulations were evaluated by DAS program.Results The main pharmacokinetic parameters of test and reference preparations obtained from single oral dose were as follows： AUC0-t were（20.05±16.29）,（21.61±18.06）μg·h·mL^-1;AUC0-∞ were（20.81±16.30）,（22.81±18.47）μg·h·mL^-1;Cmax were（8.72±6.81）,（9.57±8.22）μg·mL^-1;tmax were（4.41±1.34）,（4.31±1.29）h;t1/2 were（4.00±4.90）,（2.91±3.39）h.Conclusion The two preparations were bioequivalent.

关 键 词：烟酸缓释片 生物利用度 生物等效性 高效液相色谱-串联质谱 

分 类 号：R969.1[医药卫生—药理学] R972.6[医药卫生—药学]