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目的：研究阿昔洛韦新制剂分散片与国产阿昔洛韦片的相对生物利用度。方法：１０名健康志愿者５对交叉，单剂量口服阿昔洛韦片（Ｒ）和阿昔洛韦分散片（Ｔ）２００ｍｇ，用ＨＰＬＣ法测定血清中阿昔洛韦含量，经３Ｐ８７软件处理数据。结果：Ｒ和Ｔ的Ｔｍａｘ分别为（２．１±０．８）ｈ和（１．７±０．７）ｈ；Ｃｍａｘ分别为（６４４±２１６）ｍｇ／Ｌ和（７４７±２４４）ｍｇ／Ｌ；ｔ１／２Ｋｅ分别为（２．５７±０．９５）ｈ和（２．６９±１．１５）ｈ。Ｔ较Ｒ吸收更快，差异具有统计学意义（Ｐ＜０．０５）；Ｔ的吸收滞后时间也较Ｒ明显缩短（Ｐ＜０．０５）。服用Ｒ和Ｔ后，ＡＵＣ０～１２分别为２８１７（ｍｇ·ｈ）／Ｌ和２８９４（ｍｇ·ｈ）／Ｌ。Ｔ相对于Ｒ的Ｆ为１．０３，９５％的可信限为０．９４～１．１３。结论：两制剂具有等效性。
Objective: To study the relative bioavailability of acyclovir dispersible tablets and domestic acyclovir tablets. Methods: A total of 10 healthy volunteers were given 5 acyclovir tablets (A) and acyclovir dispersible tablets (T) in crossover and single doses. The content of acyclovir in serum was determined by HPLC, data. RESULTS: The Tmax of R and T were (2.1 ± 0.8) h and (1.7 ± 0.7) h, respectively; the Cmax were (644 ± 216) mg / L and (747 ± 244) mg / L; t1 / 2Ke were (2.57 ± 0.95) h and (2.69 ± 1.15) h, respectively. T was faster than R absorption, the difference was statistically significant (P <0.05); T absorption lag time was significantly shorter than R (P <0.05). After taking R and T, AUC0 ~ 12 were 2817 (mg · h) / L and 2894 (mg · h) / L, respectively. The F of T with respect to R is 1.03 and the 95% confidence limit is 0.94-1.13. Conclusion: The two preparations are equivalent.