Study on Bioavailability of Ashuangxilin Capsule
Xue Jiang
Abstract
Xue Jiang
Abstract
The pharmacokinetics and relative bioavailability of ashuangxilin capsules werestudied. Amoxicillin and dicloxacillin were determined after a single oral dose ofashuangxilin and compliscan. Two preparations were given respectively to 10 volunteersin an open randomized cross-over test. Amoxicillin and dicloxacillin concentration in plasmawas assayed by RP-HPLC method. After taking a single oral dose of 1.5g, two preparations,the AUC0→∞ of amoxicillin of test preparations and standard preparations, were 50.47±15.94mg·h·L-1 and 48.68±18.14mg·h·L-1, Tmax were 1.35±0.34 h and 1.25±0.26h, Cmax were 17.79±4.88 mg·L-1 and 17.54±7.88 mg· L-1, respectively. The AUC0→∞ ofdicloxacillin test preparations and standard preparations were 47.41±13.05 mg· h· L-1and 46.39±16.07 mg·h·L-1, were were 1.45±0.28 h and 1.45±0.37h, Cmax were14.7±5.13 mg·L-1 and 14.1±6.02 mg·L-1, respectively. The result of statistical analysisshowed that there were no significant differences the AUCo→∞, Tmax and Cmax of amoxicillinand dicloxacillin between the two formations and the two preparations were bioequivalent.
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The pharmacokinetics and relative bioavailability of ashuangxilin capsules werestudied. Amoxicillin and dicloxacillin were determined after a single oral dose ofashuangxilin and compliscan. Two preparations were given respectively to 10 volunteersin an open randomized cross-over test. Amoxicillin and dicloxacillin concentration in plasmawas assayed by RP-HPLC method. After taking a single oral dose of 1.5g, two preparations,the AUC0→∞ of amoxicillin of test preparations and standard preparations, were 50.47±15.94mg·h·L-1 and 48.68±18.14mg·h·L-1, Tmax were 1.35±0.34 h and 1.25±0.26h, Cmax were 17.79±4.88 mg·L-1 and 17.54±7.88 mg· L-1, respectively. The AUC0→∞ ofdicloxacillin test preparations and standard preparations were 47.41±13.05 mg· h· L-1and 46.39±16.07 mg·h·L-1, were were 1.45±0.28 h and 1.45±0.37h, Cmax were14.7±5.13 mg·L-1 and 14.1±6.02 mg·L-1, respectively. The result of statistical analysisshowed that there were no significant differences the AUCo→∞, Tmax and Cmax of amoxicillinand dicloxacillin between the two formations and the two preparations were bioequivalent.
Key concepts: Bioequivalence, Cmax, Bioavailability, Amoxicillin, Pharmacokinetics, Chemistry, Capsule, Pharmacology