丁香苦苷缓释片在家兔体内的药动学及生物等效性研究

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。

Study on Pharmacokinetics and Bioequivalence of Syingopicroside Sustained-release Tablets in Rabbits

Objective: To evaluate the pharmacokinetics and bioequivalence of syingopicroside self-sustained-release tablets in rabbits. Method: The blood concent ration of syingopicroside of 6 rabbits was determined by HPLC and the pharmacokinetic parameters were calculated with statistical moment and confidence interval after administered random crossover with single dose of self-sustained-release syingopicroside tablets (test pharmaceutics,T) or the self-common tablets (reference pharmaceutics, R). Result: The relative bioavailability of self-sustained-release syingopicroside tablets was 132.6%. In comparison with self-common tablets, the T_max extended significantly and the peak was prolonged gentle; the 90% confidence interval of AUC_0-t was 115.25%-144.44%; the 90% confidence interval of C_max was 51.33%-78.53%. Conclusion: A good slow-release effect was found when compared test formulation with the reference reagent.