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选用8名健康男性自愿受试者,随机交叉口服深圳海王药业有限公司生产的阿昔洛韦片剂及湖北省医药工业研究所科益制药厂生产的阿昔洛韦（参比制剂）片剂各400mg,采用高效液相色谱（HPLC）法测定血药浓度,进行相对生物利用度研究。结果表明,本品药代动力学过程符合线性—房室模型特征.受试片剂及参比片剂的达峰时间（Tmax）分别为（0.968±0.224）h和(1.157±O.336）h,峰浓度（Cmax）分别为（O.555±0.221)μg/ml和（O.496±0.149)μg/ml,消除半衰期（T_(1/2)kc）分别为（1.426±0.486）h和(1.630±0.405）h,药—时曲线下面积（AUC）分别为（1.844±0.535）μg/（ml·h）和（1.934±0.483)μg/（ml·h）,受试片剂与参比片剂比较的相对生物利用度为（95.18±12.48）%,变异系数:13.11％。两种口服片剂的达峰时间、峰浓度、消除半衰期和药—时曲线下面积说明两种片剂的吸收速度及吸收程度无明显统计学差异.表明该药品相对生物利用度符合临床应用的要求。
Eight healthy male volunteers were randomized to receive acyclovir tablets produced by Shenzhen Neptunus Pharmaceutical Co., Ltd. and acyclovir tablets (reference preparations) produced by Hubei Institute of Pharmaceutical Industry, Each 400mg, using high performance liquid chromatography (HPLC) method for the determination of plasma concentration, relative bioavailability studies. The results showed that the pharmacokinetics of this product met the linear-atrioventricular model.The peak time (Tmax) of the test tablets and the reference tablets were (0.968 ± 0.224) h and (1.157 ± 0.366) h and Cmax were (0.555 ± 0.221) μg / ml and (0.496 ± 0.149) μg / ml respectively, and the elimination half-life (T 1/2 kc) were 1.426 ± 0.486 h (1.630 ± 0.405) h, the area under the drug-time curve (AUC) were (1.844 ± 0.535) μg / (ml · h) and (1.934 ± 0.483) μg / (ml · h) The relative bioavailability of the reference tablets was (95.18 ± 12.48)%, the coefficient of variation was 13.11%. Peak time, peak concentration, elimination half-life and area under the drug-time curve of the two oral tablets showed no statistically significant differences in absorption rate and absorption between the two tablets, indicating that the relative bioavailability of the two tablets is clinically applicable Claim.