| 李文淑1 刘树红2 孙斌1 郭晓东1 魏振满1.头孢氨苄胶囊制剂人体生物等效性研究[J].,2012,12(3):547-550 |
| 头孢氨苄胶囊制剂人体生物等效性研究 |
| Study on Bioequiavailability of a Newly Prepared-Cefalexin Capsule |
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| DOI： |
| 中文关键词: 头孢氨苄 高效液相色谱 药动学 生物等效性 |
| 英文关键词: Cefalexin HPLC Pharmacokinetics Bioequiavailability |
| 基金项目: |
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| 中文摘要: |
| 目的：研究新仿制的头孢羟氨苄胶囊制剂与市场在售的同类制剂在健康人体内的生物等效性。方法：采用随机交叉试验设
计，20 名健康男性志愿者分别口服受试制剂与参比制剂500 mg，HPLC 法测定血浆中头孢氨苄的浓度，用DAS 2.0 软件计算药动
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，Cmax 分别为（18.12±3.17）μg/ml 和
(21.28±3.77)μg/ml，Tmax 分别为(1.09±0.37)h 和(1.04±0.33)h，t1/2 分别为(1.15±0.22)h 和(1.14±0.20)h，AUC0-t 分别为(35.43±
5.39)μg h/ml 和(37.27±4.76)μg h/ml，AUC0-∞ 分别为(36.68±6.06)μg h/ml 和(38.62±5.48)μg h/ml，受试制剂的平均相对生物
利用度为(96.50±7.2)%。结论：受试制剂和参比制剂具有良好的生物等效性。 |
| 英文摘要: |
| Objective: To compare a newly prepared Cefalexin capsule with a commercial one in bioavailability. Methods: In a
randomized crossover study, 20 healthy male volunteers were given a single oral dose of 500 mg test and reference formulations. The
plasma concentration of Cefadroxil was determined by using an HPLC method. The pharmacokinetic parameters were calculated and the
bioequivalence of two formulations were evaluated by DAS 2.0 software. Results: The main pharmacokinetic parameters in the test and
the reference preparation of Cefalexin were as follows: Cmax were (18.12±3.17) μg/ml and (21.28±3.77) μg/ml, Tmax were (1.09±
0.37)h and (1.04±0.33)h, t1/2 were (1.15±0.22)h and (1.14±0.20)h, AUC0-t were (35.43±5.39) μg h/ml and (37.27±4.76)μg h/ml,
AUC0-∞were (36.68±6.06)μg h/ml and (38.62±5.48) μg h/ml. The relative bioavailability o f the test tablets was (96.50±7.2)%. |
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