文章摘要
贾 云,张 军,储继红,谈恒山,蒋 萌,熊宁宁,居文政.灯盏花素分散片人体生物等效性研究[J].药学与临床研究,2010,18(4):347~349
灯盏花素分散片人体生物等效性研究
Bioequivalence Study of Breviscapine Dispersible Tablets in Chinese Healthy Volunteers
投稿时间:2010-04-12  修订日期:2010-05-11
DOI:
中文关键词: 灯盏花素分散片  高效液相-质谱联用法  药代动力学  生物等效性
英文关键词: Breviscapine dispersible tablets  LC-MS  Pharmacokinetics  Bioequivalence
基金项目:江苏省中医药领军人才项目(2009)
作者单位
贾 云 扬子江药业集团有限公司泰州 225321 
张 军 南京中医药大学附属医院临床药理科南京 210029 
储继红 南京中医药大学附属医院临床药理科南京 210029 
谈恒山 南京中医药大学附属医院临床药理科南京 210029 
蒋 萌 南京中医药大学附属医院临床药理科南京 210029 
熊宁宁 南京中医药大学附属医院临床药理科南京 210029 
居文政 南京中医药大学附属医院临床药理科南京 210029 
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中文摘要:
      目的:以灯盏花素普通片为对照,研究灯盏花素分散片在健康人体内的相对生物利用度和生物等效性。方法:20名健康成年男性志愿者采用随机分组、自身交叉对照试验设计,用LC-MS法测定血浆中灯盏乙素苷元,线性范围为0.013~3.32μg·mL-1;平均回收率89.7%~100.5%,日内和日间精密度均小于12.0%。结果:灯盏花素分散片和普通片的主要药动学参数:tmax:(7.1±2.2)h和(6.6±1.9)h;Cmax:(0.87±0.37)mg·L-1和(1.0±0.44)mg·L-1;AUC(0-24h):(4.68±1.53)mg·h·L-1和(5.08±1.50)mg·h·L-1;AUC(0-∞):(4.78±1.55)mg·h·L-1和(5.18±1.54)mg·h·L-1·h;t1/2:(4.36±2.07)h和(4.09±1.35)h。以AUC(0-24h)计算的受试制剂的相对生物利用度为(93.1±16.9)%。结论:两种制剂的Cmax和AUC(0-24h)经方差分析和双单侧t检验其结果生物等效。
英文摘要:
      Objective: To evaluate the relative bioavailability and bioequivalence of breviscapine dispersible tablets (test) to the normal tablets (reference) in Chinese healthy volunteers. Methods: Twenty male healthy volunteers were randomized to receive a single crossover oral dose of 120mg breviscapine tablets or dispersible tablets. The plasma concentration of scutellarin aglycone was determined by an LC-MS method with the linear range at 0.013~3.32μg·mL-1 and inter- and intra-day RSD less than 12%. The bioequivalence was analyzed using BAPP2.2 program. Results: The main pharmacokinetic parameters showed without significant differences between the tablets test vs. reference, and they were as follows: tmax: (7.1±2.2) vs. (6.6±1.9)h, Cmax: (0.87±0.37) vs. (1.0±0.44)mg·L-1, AUC(0-24h): (4.68±1.53) vs. (5.08±1.50)mg·L-1·h, AUC(0-∞): (4.78±1.55) vs. (5.18±1.54) mg·L-1·h , t1/2: (4.36±2.07) vs. (4.09±1.35)h, F0-24h was (93.1±16.9)%. The results of variance analysis and two-one sided t-test showed that there was no significant difference between the two formulations in the AUC or Cmax. Conclusion: The breviscapine dispersible tablets were bioequivalent to the reference tablets.
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