摘要
目的评价伐昔洛韦两种片剂的生物等效性。方法将18名健康男性志愿者随机分为两组,分别交叉口服两种伐昔洛韦片,用高效液相色谱法测定其血浆中阿昔洛韦浓度,用3P97软件计算药代动力学参数,用方差分析和单双侧t检验及(1-2α)置信区间法分析两种伐昔洛韦片是否等效,达峰时间(T_(max))用非参数统计Wilcoxo法进行检验。结果分别单剂量口服600 mg上海臣邦医药科技有限公司或丽珠制药厂生产的伐昔洛韦片的T_(max)分别为(1．39±0．21)h和(1．39±0．27)h,峰浓度(C_(max))分别为(3．49±0．80)μg/mL和(3．6l±0．85)μg/mL; 0～12 h药时曲线下面积(AUC_(0-12))分别为(12．33±2．70)mg·h/L和(13．01±2．00)mg·h/L。经3种方法的统计分析,两者无显著差异(P＞0．05)。结论伐昔洛韦受试片和伐昔洛韦参比片的相对生物利用度为(94．4±12．2)%,两种伐昔洛韦片具有生物等效性。
Objective To evaluate the bioequivalence （BE） of two kinds of famciclovir tablets. Methods Eighteen healthy male volunteers were divided into two groups randomly and two kinds of tablets were given to each volunteer in the cross way. Plasma concentrations of famciclovir were measured by high performance liquid chromatography （HPLC）, and the 3P97 software was employed to calculate the parameter of metabolic dynamics of drugs. Statistical differences between means were analyzed by using square analysis, two one- side t test and （1-2α） believe-intervals. Tmax, was tested by nonparametric statistics Wilcoxo. Results A single dosage of 600 mg of the testing tablet or the reference tablet was taken orally. The pharmacokinetic parameters of famciclovir in the testing tablets and the reference tablet were as follows： Tmax （1.39±0.21）h and （1.39±0.27）h; Cmax（3.49±0.80）ug/mL and （3.61±0.85）ug/mL; AUC0-12：（12.33± 2.70）mg· h/L and （13.01 ± 2.00）mg· h/L, respectively. By three means of statistic analysis, two kinds of tablets had no significant difference （P 〉 0. 05 ）. Conclusion The relative bioavailability of the testing tablets is （94. 4 ± 12.2）%, the two kinds of famciclovir tablets have bioequiavalent.
出处
《中国药业》
CAS
2007年第6期27-29,共3页
China Pharmaceuticals
