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本项实验在10名志愿受试者身上采用交叉设计法,以头孢羟氨苄胶囊为标准参比制剂,采用HPLC法对头孢羟氨苄颗粒剂进行了相对生物利用度试验。在常用生物等效性指标Cmax,Tmax,AuC0 ̄∞的基础上引入了MIC(最小抑菌浓度)以上的有效AUC(AUCeff)达到MIC的时间(To)和MIC以上浓度的持续时间(Te)。对这些参数进行生物等效性的评价的意义进行了探讨。传统的评价方法显示两制剂生物等效。AUCeff和Te的结果支持等效结论,而To的结果显示颗粒剂比胶囊早达到MIC。
This experiment in 10 volunteers who cross design method to cefadroxil capsule as a reference preparation, the use of HPLC cefadroxil granules relative bioavailability of the test. The effective AUC (AUCeff) above the MIC (To) and the duration (Te) of the MIC above the MIC were introduced on the basis of the commonly used bioequivalence indexes Cmax, Tmax and AuC0 ~ . The significance of bioequivalence assessment of these parameters was explored. Traditional evaluation methods show that both formulations are bioequivalent. The results of AUCeff and Te support the equivalent conclusion, whereas To’s results show that the granules reach the MIC earlier than the capsules.