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目的研究2种盐酸伐昔洛韦胶囊的生物等效性。方法24名健康受试者单剂量交叉口服600mg2种盐酸伐昔洛韦胶囊,采用HPLC-UV测定其体内代谢转化物阿昔洛韦的血药浓度。数据经DAS软件处理。结果盐酸伐昔洛韦供试制剂与参比制剂(胶囊)的主要药动学参数如下:AUC0→t分别为:(12.985±2.271),(12.306±3.260)mg·h·L-1;AUC0→∞分别为:(13.416±2.333),(12.748±3.394)mg·h·L-1;ρmax分别为:(3.897±1.065),(3.592±1.356)mg·L-1;tmax分别为:(1.354±0.561),(1.479±0.447)h;t1/2分别为:(2.889±0.518),(2.959±0.602)h。对口服供试制剂和参比制剂后的lnAUC0→t,lnAUC0→∞,lnρmax进行方差分析与双单侧t检验,tmax进行秩和检验,结果2者为生物等效制剂(P<0.05)。供试品的相对生物利用度为:(110.4±26.7)%。结论2种盐酸伐昔洛韦胶囊生物等效。
Objective To study the bioequivalence of two valacyclovir hydrochloride capsules. Methods Twenty-four healthy volunteers were dosed with 600mg of 2 kinds of valacyclovir hydrochloride single-dose crossover and their plasma concentration of acyclovir was determined by HPLC-UV. Data is processed by DAS software. Results The main pharmacokinetic parameters of valacyclovir hydrochloride preparation and reference preparation (capsule) were as follows: AUC0 → t were (12.985 ± 2.271) and (12.306 ± 3.260) mg · h · L -1 respectively; AUC0 → (∞) were: (13.416 ± 2.333) and (12.748 ± 3.394) mg · h · L-1, respectively; ρmax were (3.897 ± 1.065) and (3.592 ± 1.356) mg · L -1, respectively; 1.354 ± 0.561) and (1.479 ± 0.447) h, respectively; t1 / 2 were (2.889 ± 0.518) and (2.959 ± 0.602) h, respectively. Analysis of variance and double unilateral t-test and tmax for rank sum test for lnAUC0 → t, lnAUC0 → ∞ and lnρmax after oral administration of test preparation and reference preparation showed that the two preparations were bioequivalent preparations (P <0.05). The relative bioavailability of the test product: (110.4 ± 26.7)%. Conclusions Two kinds of valacyclovir hydrochloride capsules are bioequivalent.