阿魏酸钠胶囊与片剂在健康人体的生物等效性研究(1)
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[摘要] 目的：研究阿魏酸钠胶囊和阿魏酸钠片在健康志愿受试者中的药动学和人体生物等效性。方法：20名健康志愿者随机交叉单次口服受试制剂阿魏酸钠胶囊和参比制剂阿魏酸钠片，均100 mg，采用HPLC-UV检测方法，测定血浆中阿魏酸钠浓度，采用Das2.1程序计算其药动学参数，评价两种制剂的人体生物等效性。结果：受试制剂及参比制剂主要药动学参数分别为：Cmax(1.021±0.286) μg/ml和(1.066±0.397) μg/ml，tmax(0.388±0.078) h和(0.371±0.083) h，t1/2(0.887±0.431) h和(0.824±0.404) h，AUC(0~t)(0.613±0.172) μg·h/ml和(0.614±0.235) μg·h/ml。结论：受试制剂阿魏酸钠胶囊和参比制剂阿魏酸钠片具有生物等效性。
[关键词] 阿魏酸钠；生物等效性；高效液相-紫外检测法
[中图分类号] R969.1 [文献标识码] A [文章编号] 1673-7210(2011)11(c)-037-03
Bioequivalence of Sodium Ferulate Capsules and Tablets in healthy volunteers
YANG Ting1, YU Bin1, SONG Xin2, LIU Liping1
1.Department of Pharmacy, the Second Affiliated Hospital of Anhui Medical University, Anhui Province, Hefei 230601, China; 2.College of Pharmacy, Anhui College of Traditional Chinese Medicine, Anhui Province, Hefei 230038, China
[Abstract] Objective: To study the pharmacokinetic characteristics of Sodium Ferulate Capsules and Tablets in healthy volunteers and to evaluate the bioequivalence of them. Methods: In a randomized, crossover and self-control study, 20 healthy volunteers were orally administrated Sodium Ferulate Capsules and Tablets (100 mg respectively). The plasma concentrations were determined by the HPLC-UV. Pharmacokinetic parmeters were calculated and the bioequivalences were evaluated by DAS2.1 software. Results: The main pharmacokinetic parameters of Sodium Ferulate were as follows: Cmax (1.021±0.286) μg/ml and (1.066±0.397) μg/ml, tmax (0.388±0.078) h and (0.371±0.083) h, t1/2 (0.887±0.431) h and (0.824±0.404) h, AUC(0-t) (0.613±0.172) μg·h/ml and (0.614±0.235) μg·h/ml. Conclusion: The test and reference sodium ferulate are bioequivalent.
[Key words] Sodium Ferulate; Bioequivalence; HPLC-UV
阿魏酸(Ferulic Acid)的化学名称为4-羟基-3-甲氧基-肉桂酸，是桂皮酸的衍生物之一，最初在植物的种子和叶子中发现，是一种广泛存在于植物中的酚酸，在细胞壁中与多糖和蛋白质结合成为细胞壁的骨架。它在阿魏、当归、川芎仁等中药材中的含量较高，是这些中药的有效成分之一。阿魏酸钠(Sodium Ferulate)是阿魏酸的钠盐，具有抑制血小板聚集、松弛血管平滑肌、清除氧自由基、提高膜稳定性、保护血管内皮[1]、增强免疫功能等功效，并具有一定的镇痛、解痉作用[2]。临床上主要用于冠心病[3]、脑血管病[4]、肾小球疾病[5]、肺动脉高压、糖尿病性血管病变[6]、脉管炎等血管性病症的辅助治疗，亦可用于偏头痛、血管性头痛的治疗[7] ......
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