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目的:研究不同厂家泛昔洛韦片的人体相对生物利用度和生物等效性。方法:健康志愿者18名,随机双交叉单剂量口服试验制剂和参比制剂各0.5 g,剂间间隔为1周。分别于服药后12 h内多点抽取静脉血;用HPLC法测定血浆中喷昔洛韦的浓度。用DAS程序计算相对生物利用度并评价两种制剂生物等效性。结果:单剂量口服试验制剂和参比制剂后血浆中的喷昔洛韦的Cmax分别为(3.05±0.73)和(3.16±0.99)mg.L-1,Tmax分别为(1.03±0.47)和(1.15±0.62)h,AUC0~12分别为(9.11±2.75)和(9.53±2.68)mg.h.L-1,AUC0~inf分别为(9.49±2.98)和(9.89±2.76)mg.h.L-1。AUC0~12,AUC0~inf和Cmax的90%可信区间分别为87.7%~103.7%,87.9%~103.8%和91.4%~106.4%。结论:试验制剂与参比制剂的人体相对生物利用度为(97.9±22.6)%,两种制剂具有生物等效性。
OBJECTIVE: To study the relative bioavailability and bioequivalence of famciclovir tablets from different manufacturers. Methods: Eighteen healthy volunteers were randomized double crossover single oral dose of 0.5 g of test preparation and reference preparation with interval of 1 week. Venous blood samples were taken at multiple points within 12 h after taking the drug. The concentration of penciclovir in plasma was determined by HPLC. Relative bioavailability was calculated using the DAS program and the bioequivalence of both formulations was evaluated. Results: The Cmax values of penciclovir in plasma after single-dose oral test and reference preparation were (3.05 ± 0.73) and (3.16 ± 0.99) mg.L-1, respectively, and the Tmax were (1.03 ± 0.47) and 1.15 ± 0.62) h, AUC0 ~ 12 were (9.11 ± 2.75) and (9.53 ± 2.68) mg.hL-1, respectively. The AUC0 ~ inf were (9.49 ± 2.98) and (9.89 ± 2.76) mg.hL- The 90% confidence intervals of AUC0 ~ 12, AUC0 ~ inf and Cmax were 87.7% ~ 103.7%, 87.9% ~ 103.8% and 91.4% ~ 106.4%, respectively. Conclusion: The relative bioavailability of the test preparation to the reference preparation is (97.9 ± 22.6)%, and both preparations are bioequivalent.