中国中药杂志

2008, (10) 1168-1170

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犬血浆中牡荆素鼠李糖苷的测定及益心酮缓释片药动学研究
Determination of vitexin-rhamnoside in Beagle dog plasma and preliminary pharmacokinetics of Yixintong sustained release tablets

曲璐;郑杭生;冯年平;李淞明;
QU Lu,ZHENG Hang-sheng,FENG Nian-ping,LI Song-ming(Department of Pharmaceutics,Shanghai University of Traditional Chinese Medicine,Shanghai,201203,China)

摘要(Abstract):

目的:建立测定犬血浆中牡荆素鼠李糖苷的HPLC法,初步研究益心酮缓释片在Beagle犬体内的药动学。方法:应用自身对照设计实验法,用反相高效液相色谱法测定单剂量口服益心酮缓释片(2片×288 mg/片)和市售普通片(4片×144 mg/片)后,Beagle犬血浆中牡荆素鼠李糖苷的浓度,应用非隔室模型统计矩方法和3p87程序对药动学参数进行分析。结果:益心酮缓释片和普通片口服后在Beagle犬体内过程可分别用单室和双室模型描述;药动学参数为:口服普通片:T1/2=8.94 h,Tmax=1 h,AUC0-∞=5 880.4 ng.h.mL-1,MRT=6.1 h;口服缓释片:T1/2=5.22 h,Tmax=4 h,AUC0-∞=6 792.75 ng.h.mL-1,MRT=8.4 h,相对生物利用度为115.5%。结论:自制缓释片在犬体内表现出了缓释特性。
Objective:To develop an HPLC method to determine vitexin-rhamnoside in plasma of Beagle dogs and study the pharmacokinetics and bioavailability of Yixintong sustained release tablets in Beagle dogs.Method:A newly-developed HPLC method using C18 column and methanol-acetonitrile-tetrahydrogenfuran-0.5% acetic acid(1∶1∶19.4∶78.6) as mobile phase was validated,and then was employed to determine vitexin-rhamnoside in plasma of Beagle dogs after oral administration of Yixintong sustained release tablets and general tablets.The main pharmacokinetic parameters were estimated by pharmacokinetic program 3p87.The non-compartmental pharmacokinetic parameters were also calculated on basis of the statistic moment theory.Result:The pharmacokinetic profiles of Yixintong sustained release tablets and the general tablets were fitted to a one-and two-compartment open model,respectively.The T1/2,Tmax,AUC0-∞ and MRT for Yixintong sustained release tablets were 5.22 h,4.0 h,6 792.75 ng·h·mL-1 and 8.4 h,respectively,compared with 8.94 h,1.0 h,5 880.4 ng·h·mL-1 and 6.1 h for the general tablets.The relative bioavailability of the Yixintong sustained release tablets was 115.5% in Beagle dogs.Conclusion:The sustained-release characteristic of Yixintong sustained release tablets were confirmed by pharmacokinetic study.

关键词(KeyWords): 益心酮;牡荆素鼠李糖苷;缓释片;药动学
Yixintong;vitexin-rhamnoside;sustained release tablets;pharmacokinetics

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基金项目(Foundation): 上海市教委资助项目(03CK01);; 上海市教委重点学科建设项目(J50302)

作者(Author): 曲璐;郑杭生;冯年平;李淞明;
QU Lu,ZHENG Hang-sheng,FENG Nian-ping,LI Song-ming(Department of Pharmaceutics,Shanghai University of Traditional Chinese Medicine,Shanghai,201203,China)

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