中国中药杂志2025，Vol.50Issue(23)：6528-6538,11.DOI:10.19540/j.cnki.cjcmm.20250905.301
丹参酮组分"液态自微乳-固态分散微片"复合载药系统的构建与应用
Construction and application of composite drug delivery system combining liquid self-microemulsifying and solid dispersed micro-tablets for tanshinone components
摘要
Abstract
The low water solubility of tanshinone components(TSC)limits their quality and functionality.This study innovatively constructed a composite drug-loading system of TSC self-microemulsifying dispersed micro-tablets by integrating the solubilization advantages of self-microemulsions with the stability characteristics of solid preparations.First,based on solubility tests,compatibility experiments,and pseudo-ternary phase diagram analysis,a ternary self-microemulsion system composed of ethyl oleate,polyoxyethylene castor oil,and absolute ethanol was established,and the self-microemulsion formation process was optimized using a central composite design-response surface methodology.Under the optimal self-microemulsifying conditions,the equilibrium solubility of TSC increased to(58.65±0.18)mg·mL-1,exhibiting excellent centrifugation and dilution stability.In vitro drug release studies demonstrated that the TSC self-microemulsifying system significantly improved drug release,achieving complete release within 48 h in HCl medium.Subsequently,the matrix formulation of the dispersed micro-tablets was determined through single-factor screening.The resulting micro-tablets exhibited good mechanical properties and rapid dispersion characteristics,while particle size distribution after dissolution and transmission electron microscopy images confirmed effective maintenance of the self-microemulsion structure.Fourier transform near-infrared spectroscopy,X-ray diffraction,and simultaneous thermal analysis indicated that TSC was successfully encapsulated within the self-microemulsifying dispersed micro-tablets,while also highlighting the need for temperature protection during production.This study successfully established a novel"liquid self-microemulsifying-solid dispersed micro-tablet"composite drug-loading system,providing a new approach for improving the bioaccessibility of TSC.关键词
丹参酮组分/三元自微乳体系/星点设计-响应面法/分散微片Key words
tanshinone components/ternary self-microemulsion system/central composite design-response surface methodology/dispersed micro-tablets引用本文复制引用
MA Xiao-yan,DAI Jiang-dong,HU Shu-qi,LI Ben-hong,ZHAO Xi-chao,SUN Lu,XIONG Zhi-wei,FENG Liang..丹参酮组分"液态自微乳-固态分散微片"复合载药系统的构建与应用[J].中国中药杂志,2025,50(23):6528-6538,11.基金项目
中国博士后科学基金项目(2023M743904) （2023M743904）
江苏省博士后科研计划项目(2023ZB824) （2023ZB824）
