摘要
目的 :建立反相HPLC测定人体中阿尼西坦血药浓度的方法。方法 :12名健康志愿者单剂量口服阿尼西坦 40 0mg后 ,用反相HPLC研究血中对甲氧基苯甲酰氨基丁酸 (PNBA)的浓度及代谢动力学过程 ,经 3P87软件处理数据。结果 :该方法经线性、精密性和准确度验证 ,日内变异系数 (n =5 )及日间变异系数 (n =6 )均在 10 %以内 ,检测限量为 0 .1μg/ml,Cmax达 17.5 μg/ml,Tmax为 2 3min ,AUC为 72 7(μg·min) /ml。 结论 :此方法的可靠性较好 ,比直接测定阿尼西坦浓度更方便 ,有实际意义。
OBJECTIVE: A convenient and accurate method, reverse phase HPLC method is established to detect the concentration of aniracetam metabolite, N anisoyl GABA (II) (PNBA). METHODS: After oral administrate of aniracetam to humans, it is rapidly, extensively and mainly metabolized to active metabolite, N anisoyl GABA, with very low concentration of aniracetam in plasma. It is reasonable to evaluated the bioavailability of aniracetam formulations by measuring PNBA and to analyze the plasma samples of twelve healthy volunteers. RESULTS: The method was validated by linerity, precision and accuracy tests. The limit of quantitation was 0.1μg/ml. The RSD was <10% in intra day and day by day tests. The result of C max was 17.5μg/ml, T max 23min and AUC 727 (μg·min)/ml.CONCLUSIONS: It is indirect, true and convenient to study the aniracetam metabolite by this method. It is more reliable than other direct methods.
出处
《中国新药杂志》
CAS
CSCD
2000年第4期249-251,共3页
Chinese Journal of New Drugs
