摘要
本实验采用反相高效液相色谱法测定10名志愿受试者单剂量口服1．5g阿双西林胶囊供试品与克菌胶囊标准参比制剂后，阿莫西林和双氯西林血药浓度变化情况，经3P87药代动力学程序处理，两种制剂阿莫西林药时曲线下面积分别是：50．47±15.94mg·h·L-1与48．68±18．14mg·h·L-1，达峰时间分别为：1．35±0．34h与1．25±0．26h，峰浓度分别是：17．79±4．88mg·L-1与17．54±7．88mg·L－1。两种制剂双氯西林药时曲线下面积分别是：47．41±13．05mg·h·L－1与46．39±16．07mg·h·L-1，达峰时间分别为：1.45±0．28h与145±0．37h，峰浓度分别是：14．7±5.13mg·L-1与14.1±6．02mg·L-1。以两种制剂阿莫西林与双氯西林药时曲线下面积、峰浓度及达峰时间为指标，双单侧t检验进行生物等效性评价，阿双西林胶囊供试品与克菌胶囊标准参比制剂为生物等效制剂（双侧P＜0．05）。阿双西林胶囊供试品阿莫西林与双氯西林的相对生物利用度分别为：105．58％±7.52％和103.70％±10．04％。
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.
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2000年第3期198-201,共4页
The Chinese Journal of Clinical Pharmacology
