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目的:评价国产盐酸伐昔洛韦片在20名男性健康志愿者体内的生物等效性。方法:采用高效液相色谱荧光检测法测定20名健康志愿者单剂量、交叉口服盐酸伐昔洛韦片300 mg后血浆中阿昔洛韦浓度。用DAS软件进行药动学参数计算及生物等效性评价。结果:试验制剂或参比制剂C_max分别为(1.919±0.416)μg·ml-1和(1.805±0.566)μg·ml-1,t1/2分别为(3.263±0.564)h和(3.067±0.476)h,tmax分别为(1.175±0.373)h和(1.275±0.499)h,AUC0→t,AUC0→∞平均值分别为(6.504±1.369)μg·ml-1·h和(6.176±1.504)μg·ml-1·h,相对生物利用度F0-tn%、F0-∞%分别为(99.568±29.316)%、(107.292±17.844)%。结论:两种盐酸伐昔洛韦片剂具有生物等效性。
Objective: To evaluate the bioequivalence of domestic valacyclovir hydrochloride tablet in 20 male healthy volunteers. Methods: The plasma concentration of acyclovir in 20 healthy volunteers was determined by HPLC with fluorescence detection after single oral dose of 300 mg of valacyclovir hydrochloride tablets. Pharmacokinetic parameters calculation and bioequivalence evaluation with DAS software. Results: The C_max of test or reference preparations were (1.919 ± 0.416) μg · ml-1 and (1.805 ± 0.566) μg · ml-1 respectively, and the values of t1 / 2 were (3.263 ± 0.564) h and (3.067 ± 0.476) h, tmax were (1.175 ± 0.373) h and (1.275 ± 0.499) h respectively, AUC0 → t and AUC0 → ∞ (6.504 ± 1.369) μg · ml-1 · h and (6.176 ± 1.504) μg · ml-1 · h, respectively. The relative bioavailabilities were F0-tn% and F0-∞% 99.568 ± 29.316)%, (107.292 ± 17.844)%. Conclusions: The two valacyclovir hydrochloride tablets are bioequivalent.