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该文分别以结构母核相近的黄酮类及生物碱类中药单体为乳膏所载药物,以稳定的山梨醇酐单硬脂酸酯(司盘60)-聚氧乙烯脱水山梨醇单油酸酯(吐温80)乳化体系为乳膏基质,采用近红外稳定性分析技术定量表征乳膏的物理稳定性,基于乳膏凝胶网状结构理论、溶度参数理论、双电层理论、界面膜理论,探寻中药单体对乳膏物理稳定性的影响机制。结果表明,延胡索乙素、苦参碱、柚皮素、氧化苦参碱中药单体与乳膏基质辅料具有接近的溶度参数,其制备的乳膏具有较高的Zeta电位值,较强的物理稳定性,且与基质乳膏具有较为接近的微观结构信息;而黄芩苷、小檗碱、黄藤素、黄芩素中药单体与乳膏基质辅料的溶度参数差异较大,其制备的乳膏具有较低的Zeta电位值,较差的物理稳定性,且与基质乳膏的微观结构信息差异较大。
In this paper, the main components of similar structure of the mother of the flavonoids and alkaloids of Chinese medicine for the cream contained in the drug, with a stable sorbitan monostearate (Span 60) - polyoxyethylene sorbitol single oil The esterification system (Tween 80) is a cream matrix. The physical stability of the cream is quantitatively characterized by near-infrared stability analysis. Based on the gel network structure theory, solubility parameter theory, electric double layer theory, Interface membrane theory, to explore the mechanism of traditional Chinese medicine monomer cream physical stability. The results showed that the tetrahydropalmatine, matrine, naringenin, oxymatrine traditional Chinese medicine monomer and cream matrix excipients have close solubility parameters, the preparation of the cream has a high Zeta potential value, strong Physical stability, and have close microstructure information with the matrix cream; and baicalin, berberine, palmatine, baicalein Chinese herbal monomer and cream matrix excipients solubility parameters vary greatly, the preparation of Creams have lower Zeta potential values, poorer physical stability, and greater differences from the microstructure information of matrix creams.