通脉微丸多元释药系统释药特性评价

Drug releasing characteristics evaluation to multi-drug delivery system of Tongmai pellets

目的:建立通脉微丸多元释药系统的释药特性评价方法。方法:考察紫外分光光度法与HPLC测定各释药单元溶出曲线的相似性;HPLC评价通脉微丸多元释药系统单个释药单元以及形成多元释药系统后的体外释药特性,同时评价各释药单元体外释放的相互影响程度。结果:通过紫外分光光度法和HPLC测定的葛根黄酮微丸、丹酚酸微丸、川芎酚酸微丸、丹参酮微丸4种释药单元的溶出度曲线具有相似性;HPLC测定多元释药系统的各释药特性表明各单元无相互影响。结论:可利用HPLC测定的单一指标成分来表示组分的释放,初步构建的通脉微丸多元释药系统改善了难溶性组分的溶出,整体上表现出速释和缓释结合的特征,符合设计的要求。

Objective： To establish the drug release method of multi-drug delivery system of Tongmai pellets. Method： The drug releasing characteristics were researched by HPLC and UV spectrophotometric method. The drug releasing characteristics of the multi-drug delivery system of Tongmai pellets between single unit and multiple drug delivery system were evaluated by HPLC. Result： The four pellets release unit isoflavones pellets, tanshinone pellets, Sal pellets, Chuanxiong acid by ultraviolet spectrophotometry and HPLC method of dissolution obtained similar curves, and the similarity factor f2 were 63.31, 81.59, 70. 93, 68.08. The release unit after the formation of multiple drug delivery system had no influence on single unit. Conclusion： Initial construction of multiple drug delivery system Tongmai pellets improved the dissolution of insoluble components, the overall performance of the combination of rapid release and sustained release characteristics, in line with the design requirements.