摘要
目的:建立一快速、灵敏的尼莫地平(NM)血药测定方法,并将其应用于NM片生物利用度的研究.方法:以尼群地平为内标,采用固相萃取的HPLC分析法.取样1.0ml.志愿者双交叉po测试品或对照品120mg.用三因素方差分析和双单侧检验其药物动力学参数.结果:NM最低检测浓度为2.00ng/ml,最低检测量为1.00ng.线性范围为5～300ng/ml.方法回收率均接近100%,RSD<5%,日内、日间重现性均<8%.结论:本分析方法快速、灵敏.重现性好.符台NM片剂生物利用度研究的要求.双单侧检验表明两种NM片剂不等效.测试品的相对生物利用度约为对照品的141.8%.
AIM: To develop a new high performance liquid chromatography (HPLC) method for determination of nimodipine in human plasma,and apply to the study of relative bioavailability of nimodipine. METHODS :Nitrendipine was used as internal standard. Plasma (1 ml) was extracted by a C2 solid phase extraction (SPE) HPLC method. One hundred and twenty mg test or control tablet was administered by each volunteer in a randomized, crossover way. Data was calculated by three-factor analysis of variance in a randomized, crossover way and two one-side test. RESULTS: The lower limit of concentration of ni-modipine was 2 ng/ml and the concentration range of standard curve was 5-300 ng/ml. Re-coveries of the method were almost 100% ,with RSD<5%. The intra-day variance and inter-day variance were <8%. CONCLUSION:This method can be applied to study the relative bioavailability of nimodipine. There are not bioequivalent between the 2 tablets.
出处
《中国临床药学杂志》
CAS
1999年第S1期36-39,共4页
Chinese Journal of Clinical Pharmacy
关键词
尼莫地平
高效液相色谱法
生物利用度
nimodipine
high performance liquid chromatography
bioavailability
