丹参多组分渗透泵片在Beagle犬体内的药动学研究  

Pharmacokinetics of Danshen multi-component osmotic pump tablets in Beagle dogs

作　　者：周琳[1] 刘宪英[1] 郑金凤[1] 吴清[1] 杜守颖[1] 

机构地区：[1]北京中医药大学中药学院,北京100102

出　　处：《中国中药杂志》2012年第12期1761-1764,共4页China Journal of Chinese Materia Medica

基　　金：国家自然科学基金项目(81073059);国家高技术研究发展计划(863)项目(2009AA043201);国家重点实验室开放基金项目(SKL2010Z0304);北京中医药大学自主课题(2011JYBZZ-XS039);北京中医药大学复方中药制药研究创新团队

摘　　要：目的:以丹参普通片为参比制剂,研究Beagle犬口服丹参多组分渗透泵片后药物在血浆中的浓度变化,评价丹参多组分渗透泵片的缓释行为。方法:采用HPLC测定,日本岛津ODS-SP色谱柱(4.6 mm×150 mm,5μm),流速1 mL.min-1,柱温30℃。丹参酮ⅡA和丹酚酸B的血浆样品分别以乙酸乙酯萃取和丙酮沉淀的方法除去蛋白,根据测定结果求算药代动力学参数。结果:2种极性不同的成分的方法学考察均符合要求,与丹参普通片相比,Beagle犬口服丹参多组分渗透泵片后,Cmax降低,Tmax延长。结论:与丹参普通片相比,丹参多组分渗透泵片具有良好的缓释效果。Objective： To study the variation in plasma concentration after oral administration of Danshen multi-component os- motic pump tablets in Beagle dogs with conventional Danshen tablets as the control preparation, in order to assess the sustained release of Danshen multi-component osmotic pump tablets. Method： HPLC was adopted for determination, with Shimadzu＇s ODS-SP column （4.6mm×150mm,5μm） , flow rate of 1 mL ·min^-1 , and column temperature of 30℃. Protein in plasma samples of tanshinone II A and salvianolic acid B was removed by ethyl acetate extract and acetone precipitation method respectively. Their pharmacokinetic parameters were calculated based on determination results. Result： The methodology study on the two constituents with different polarity showed conformity to the requirements. Compared with conventional Danshen tablets, Danshen multi-component osmotic pump tab- lets showed decrease in Cmax and extension in Tmax after oral administration in Beagle dogs. Conclusion： Danshen multi-component os- motic pump tablet has a good sustained-release effect compared with conventional Danshen tablets.

关 键 词：丹参 中药多组分渗透泵片 药代动力学 生物半衰期 BEAGLE犬 

分 类 号：R285.5[医药卫生—中药学]