摘要
目的 :研究阿昔洛韦片的药物动力学及相对生物利用度。方法 :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600mg 阿昔洛韦片供试品与标准参比制剂后 ,阿昔洛韦血药浓度变化情况 ,经3p87药动学程序处理。结果 :药 -时曲线下面积分别为 (5 31±0 75) μg/ (ml·h)与 (5 44±0 99) μg/ (ml·h) ,达峰时间分别为 (1 90±0 39)h与 (1 95±0 37)h ,峰浓度分别为(1 12±0 19) μg/ml与 (1 15±0 16) μg/ml。配对t检验与双单侧t检验结果表明 ,二者药 -时曲线下面积、峰浓度及达峰时间均无显著性差异 (P>0 05)。阿昔洛韦片供试品的相对生物利用度为 (98 62±10 09) %。结论 :阿昔洛韦片供试品与标准参比制剂为生物等效制剂。
AIM: The pharmacokinetics and relative bioavailabilities of Acyclovir tablets were studied METHODS:Blood concentrations of Acyclovir was determined by RP-HPLC after a single oral dose of two kinds of Acyclovir tablets was given separately to 10 volunteers in an open randomized cross-over test RESULTS:After taking a single oral dose of 600mg Acyclovir test tablets and reference tablets, the AUC0→∞ of Acyclovir of the two formulations were 5 31±0 75μg/ml×h and 5 44±0 99μg/ml×h; Tmax were (1 90±0 39)h and (1 95±0 37)h;Cmax were 1 12±0 19μg/ml and 1 15±0 16μg/ml respectively CONCLUSION:The results of statistical analysis showed that there were no significant differences in the AUC0→∞、Tmax and Cmax of Acyclovir between the two formulations(P>0 05) and two Acyclovir tablets were bioequivalent
出处
《中国药房》
CAS
CSCD
2000年第2期78-79,共2页
China Pharmacy
