| 李文淑1 刘树红2 孙斌1 郭晓东1 魏振满1.孟鲁斯特钠咀嚼片在健康人体内药动学和生物等效性[J].,2012,12(2):337-340 |
| 孟鲁斯特钠咀嚼片在健康人体内药动学和生物等效性 |
| Study On Bioavailability of Montelukast Sodium Chewable Tablets |
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| DOI： |
| 中文关键词: 孟鲁司特钠咀嚼片 高效液相色谱 药动学 生物等效性 |
| 英文关键词: Montelukast sodium chewable tablets HPLC Pharmacokinetics Bioequivalence |
| 基金项目: |
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| 中文摘要: |
| 目的：研究两种(仿制新药与市售)孟鲁司特钠咀嚼片在人体内生物等效性。方法：采用单中心、随机、开放、双周期自身交叉
试验设计，20 名健康男性志愿者分2 周期分别口服受试制剂和参比制剂各10 mg，HPLC 法测定血浆中孟鲁司特钠咀嚼片的浓
度，用DAS2.1.1 软件计算人体药动学参数并进行生物等效性评价。结果：受试制剂和参比制剂两药的主要药代动力学参数AUC0-t
分别为(17.94±6.19)μg h/ml 和(17.37±4.73)μg h/ml，AUC0-∞
分别为(18.26±6.16)μg h/ml 和(17.64±4.66)μg h/ml，Cmax 分别为
(5.58±1.95)μg/ml 和(5.54±1.65)μg/ml，Tmax 分别为(2.03±0.97)h 和(1.93±0.69)h， t1/2 分别为(1.20±0.17)h 和(1.19±0.13)h。受试制
剂的平均相对生物利用度为(101.5±6.56)%。结论：受试制剂和参比制剂具有生物等效性。 |
| 英文摘要: |
| Objective: To study the bioavailability in two kinds of Montelukast sodium chewable tablets. Methods: In a
randomized crossover study, 20 healthy male volunteers were given a single oral dose of 10 mg test and reference formulations. The
plasma concent ration of Montelukast sodium was determined by an HPLC method. The pharmacokinetic parameters were calculated and
the bioequivalence of two formulations were evaluated by DAS 2.1.1 software. Results: The main pharmacokinetic parameters in the test
and reference praperations of cefalexin were as follow: AUC0-t were (17.94±6.19)μg h/ml and (17.37±4.73)μg h/ml, AUC0-∞ were
(18.26±6.16)μg h/ml and (17.64±4.66)μg h/ml, Cmax were (5.58±1.95)μg/ml and (5.54±1.65)μg/ml, Tmax were (2.03±0.97)h and
(1.93±0.69)h, t1/2 were (1.20±0.17)h and (1.19±0.13)h. The relative bioavailability o f the test tablets was (101.5±6.56)%. Concluion:
The test and reference preparations are bioequivalent. |
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