国产阿昔洛韦咀嚼片人体生物等效性研究

目的 比较国产阿昔洛韦咀嚼片与片剂的人体相对生物利用度。方法 8 名健康受试者进行随机交叉试验设计, 分别先后单次口服800 mg 阿昔洛韦片剂或咀嚼片, 采用高效液相色谱法测定血浆中阿昔洛韦浓度。结果 咀嚼片与参比片剂的AUC_0~t分别为4.19 和4.00 μg·h·ml^-1, 相对生物利用度为(105.8 ±13.1) % 。结论 阿昔洛韦咀嚼片与片剂AUC 具有等效性。

Study on bioavailability of domestic acyclovir chewable tablets

Aim To compare the relative bioavailabilities of domestic acyclovir chewable tablets and normal tablets. Methods A single oral dose of 800 mg acyclovir chew able tablets or normal tablets was given to 8 volunteers respectively in a randomized, cross-over study, acyclovir serum concentration was determined by high performance liquid chromatography. Results The AUC of chewable nd normal tablets was respectively 0.42 and 0.40μg·ml·h^-1, and the relative bioavailability of acyclovir chewable tablets was (105.8±13.1) %. Conclusion The chewable tablets and reference tablets is bioequivalent in AUC.