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目的:对自制丁香苦苷缓释片进行家兔体内的药动学及生物等效性评价。方法:6只健康家兔随机按照交叉试验方案设计,禁食12 h后单剂量口服缓释片剂(受试制剂T)和普通片剂(参比制剂R),于不同时间点在家兔耳缘静脉取血,处理后用高效液相色谱法检测血浆中丁香苦苷药物浓度,利用统计矩原理和可信区间法计算相关的药动学参数及判定两制剂是否生物等效。结果:受试制剂的相对生物利用度为132.6%,对比于受试制剂Tmax显著延长,峰形平缓;90%置信区间分别为AUC0-t:115.25%～144.44%,Cmax:51.33%～78.53%。结论:受试制剂与参比试剂做比较有良好的缓释效果。
OBJECTIVE: To evaluate the pharmacokinetics and bioequivalence of homemade syringin sustained release tablets in rabbits. Methods: Six healthy rabbits were randomized to a crossover trial. After a 12-hour fasting period, single-dose oral sustained-release tablets (test preparation T) and ordinary tablets (reference preparation R) were administered to rabbits at different time points The blood samples were taken from the veins of the ears. After treatment, the drug concentration of syringin in plasma was detected by HPLC. The relevant pharmacokinetic parameters were calculated by statistical moment theory and credible interval method and the bioequivalence of the two preparations was determined. Results: The relative bioavailability of the test preparation was 132.6%, which was significantly longer than that of the test preparation. The 90% confidence intervals were AUC0-t: 115.25% -144.44% and Cmax: 51.33% -78.53% . Conclusion: Compared with the reference preparation, the test preparation has a good sustained-release effect.