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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 a method to evaluate the drug release characteristics of Tongmai Pellets. Methods: The UV-Vis spectrophotometry and HPLC were used to determine the similarities of dissolution profiles of each drug release unit. HPLC was used to evaluate the in vitro release characteristics of single drug release unit of multimodal drug delivery system and multiple drug release system. Drug release unit in vitro release of the degree of interaction. Results: The dissolution profiles of Pueraria flavonoids micro-pellets, Salvianolic pellets, Ligusticum chuanxiong Pill and Tanshinone pellets were similar by UV spectrophotometry and HPLC. The release characteristics of each unit showed no interaction. Conclusion: The single index component can be used to indicate the release of the components. The preliminary construction of the multimodal drug release system of Tongmai pellets can improve the dissolution of insoluble components, showing the combination of immediate release and sustained release. Meet the design requirements.