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采用自身前后交叉对照试验方法以 12例男性健康自愿受试者 ,单剂量口服罗红霉素分散片和罗红霉素片 (对照药品 )进行人体生物利用度比较研究。应用高效液相色谱法 (HPL C)测定服药后 48h内的血清罗红霉素浓度。结果表明罗红霉素分散片和罗红霉素片的主要药动学参数达峰时间 Tmax分别为 1.6 7± 0 .6 0和2 .31± 0 .48h,峰值血药浓度 Cmax为 11.0 9± 1.6 8和 9.35± 1.31mg/L ,T1 / 2β分别为 19.5 9± 8.11和 17.70± 4.2 2 h。药时曲线下面积 AUC分别为 16 9.90± 6 6 .41和 142 .77± 40 .0 9mg.h/L ,经双单侧 t检验两者的 Tmax、T1 / 2β无显著性差异 (P>0 .0 5 )。罗红霉素分散片的 Cmax高于普通片 (P<0 .0 5 ) ,AUC略高于普通片 ,但无明显差异 (P=0 .2 386 )。罗红霉素分散片对罗红霉素片的平均相对生物利用度为 118.89% ,以上说明罗红霉素分散片的生物利用度略优于普通片。
A comparative study of bioavailability of human volunteers with 12 male volunteer volunteers, a single oral dose of roxithromycin dispersible tablets and roxithromycin tablets (control drug) was conducted using the cross-reference test method. Serum roxithromycin was measured within 48 hours after taking the drug by high performance liquid chromatography (HPL C). The results showed that the main pharmacokinetic parameters of roxithromycin dispersible tablets and roxithromycin tablets peak time Tmax were 1.6 7 ± 0.60 and 2.31 ± 0.48h, peak plasma concentration Cmax was 11.0 9 ± 1.6 8 and 9.35 ± 1.31 mg / L respectively, with T1 / 2β of 19.5 9 ± 8.11 and 17.70 ± 4.2 2 h, respectively. The area under the curve of AUC was 16.990 ± 6.61.41 and 142.77 ± 40.099mg.h / L, respectively. There was no significant difference in Tmax and T1 / 2β between two groups (P> 0 .0 5). The Cmax of roxithromycin dispersible tablets was higher than that of normal tablets (P <0.05), and the AUC was slightly higher than that of ordinary tablets, but no significant difference (P = 0.3838). The average relative bioavailability of roxithromycin dispersible tablets to roxithromycin tablets was 118.89%. The above shows that the bioavailability of roxithromycin dispersible tablets is slightly better than that of ordinary tablets.