重庆医科大学学报
重慶醫科大學學報
중경의과대학학보
UNIVERSITATIS SCIENTIAE MEDICINAE CHONGQING
2001年
1期
78-79,82
,共3页
吴妍%罗大林%吕立明%何海霞%姚高琼%雷自强%朱治本%周远大
吳妍%囉大林%呂立明%何海霞%姚高瓊%雷自彊%硃治本%週遠大
오연%라대림%려립명%하해하%요고경%뢰자강%주치본%주원대
尼莫地平%生物利用度%高效液相色谱法
尼莫地平%生物利用度%高效液相色譜法
니막지평%생물이용도%고효액상색보법
目的：研究尼莫地平软胶囊的人体相对生物利用度。方法：10名健康男性志愿者随机交叉单剂量口服国产尼莫地平软胶囊和进口尼莫通片后，用HPLC法测定血浆中尼莫地平的浓度变化情况。结果：两种制剂的体内药时数据符合二室模型，Cmax分别为27.15±9.77ng/ml，38.02±14.83ng/ml；Tmax为1.04±0.41h，0.77±0.25h；AUC(0～12)为107.79±38.56μg/h/L，111.22±47.63 μg/h/L。两种制剂的相对生物利用度比较，其生物利用度为99.92％。结论：表明国产尼莫地平软胶囊与进口尼莫通片属生物等效制剂。
目的：研究尼莫地平軟膠囊的人體相對生物利用度。方法：10名健康男性誌願者隨機交扠單劑量口服國產尼莫地平軟膠囊和進口尼莫通片後，用HPLC法測定血漿中尼莫地平的濃度變化情況。結果：兩種製劑的體內藥時數據符閤二室模型，Cmax分彆為27.15±9.77ng/ml，38.02±14.83ng/ml；Tmax為1.04±0.41h，0.77±0.25h；AUC(0～12)為107.79±38.56μg/h/L，111.22±47.63 μg/h/L。兩種製劑的相對生物利用度比較，其生物利用度為99.92％。結論：錶明國產尼莫地平軟膠囊與進口尼莫通片屬生物等效製劑。
목적：연구니막지평연효낭적인체상대생물이용도。방법：10명건강남성지원자수궤교차단제량구복국산니막지평연효낭화진구니막통편후，용HPLC법측정혈장중니막지평적농도변화정황。결과：량충제제적체내약시수거부합이실모형，Cmax분별위27.15±9.77ng/ml，38.02±14.83ng/ml；Tmax위1.04±0.41h，0.77±0.25h；AUC(0～12)위107.79±38.56μg/h/L，111.22±47.63 μg/h/L。량충제제적상대생물이용도비교，기생물이용도위99.92％。결론：표명국산니막지평연효낭여진구니막통편속생물등효제제。
Objective: A single oral dose of domestic and imported nimodipine soft capsules or nimotop tablets was given to 10 healthy volunteers in a randomized crossover study. Methods: Plasma level was determined by HPLC. Results: The results showed that the plasma level-time curve of the two preparations were two compartment model. The Cmax of nimodipine soft capsules and tablets were 27.15±9.77 ng/ml and 38.02±14.83ng/ml; Tmax were 1.04±0.41h and 0.77±0.25h; AUC(0-12) were 107.79±38.56μg/h/L and 111.22±47.63μg/h/L, respectively. Conclusion:The relative bioavailability of domestic nimodipine to imported was 99.92%. The results indicated that the two formulations were bioequivalent.
