Comparative Bioavailability of Two Cephalexin Capsules in Chinese Healthy Volunteers.

• Main Authors: CHU,CHUN-YI, 朱純逸
• Other Authors: Cheng-Shiung Liu
• Format: Others
• Language: en_US
• Published: 2003
• Online Access: http://ndltd.ncl.edu.tw/handle/78389227269422567573

碩士 === 中國醫藥學院 === 藥物化學研究所 === 91 === Cephalexin is one of the first-generation of cephalosporin antibiotics given by oral route. Clinically , it is used in respiratory and urinary tract infections . In this study, the bioavailability of cephalexin from two capsule preparation in healthy Chinese male volunteers were evaluated. From calculated pharmacokinetic parameters, the possible bioequivalency of these two products were determined. Twelve healthy subjects received both products by randomized two-way crossover design. Within one day, each subject was administrated 250 mg doses before the test. The plasma and urine samples were collected all day. The concentrations of cephalexin in plasma samples were analyzed by high performance liquid chromatography (HPLC). The intra- and inter-day validation , limit of quantification and stability were reasonably with C.V. values less than 10%. The relative recovery was above 95%. The results showed Taiwan reaching peak concentration 10.99 ±1.93 μg/ml at about 0.86 hours. The mean half-life (T1/2) was about 1.23 hours. The mean area under the serum concentration curve (AUC0-∞) was about 19.34 ±3.65 μg · hr/ml. After analyzed by two-way ANOVA statistics, there are no significant statistic different between pharmacokinetic parameter (p＜0.05) of two products, including the plasma concentration (Cmax), time to peak level (Tmax), the mean half-life (T1/2), and area under the curve (AUC). It could be recommened that Keflex capsule and Cephanmycin capsule are bioequivalent. The result also evidenced that there are about 95 % of cephalexin excreted unchangely from the urine.