秦七风湿方组分中药制剂前的理化性质研究

Pre-formulation physicochemical properties of component-based Chinese medicine of Qinqi Fengshi Fang

开展秦七风湿方组分中药制剂前的理化性质研究,为秦七风湿方组分中药的剂型设计提供研究基础。采用大孔树脂吸附精制技术分别制备秦七风湿方处方中秦艽、珠子参、山茱萸等3味中药的有效总苷组分提取物;研究各总苷组分的溶解性、润湿性、吸湿性、平衡溶解度、油水分配系数、稳定性等理化性质。结果显示,秦艽总苷、珠子参总苷、山茱萸总苷均具有良好的溶解性、润湿性,各总苷组分的溶解性指数均大于85%,吸水性指数均大于50%。在pH 2.0~7.4,各总苷组分平衡溶解度均随溶液pH的增大而增大,且各总苷组分间溶解度变化趋势具有良好的一致性。各总苷组分均具有适宜的亲疏水性且较为相似。各总苷组分稳定性整体上较好,但吸湿性较强,其吸湿性强弱程度顺序为:秦艽总苷>珠子参总苷>山茱萸总苷。因此,在秦七风湿方组分制剂制备过程中需考虑药物的吸湿性问题,可通过筛选适宜的辅料与包装材料,以降低制剂的吸湿性。该研究为秦七风湿方组分中药的剂型设计提供了参考借鉴。

Pre-formulation physicochemical properties of the component-based Chinese medicine of Qinqi Fengshi Fang were investigated to provide a research basis for the design of the dosage form for component-based Chinese medicine of Qinqi Fengshi Fang.The macroporous resin adsorption and refining technology was used to prepare the total glycosides extract of Gentianae Macrophyllae Radix,Panacis Majoris Rhizome and Corni Fructus respectively in the prescription of Qinqi Fengshi Fang.Their physicochemical properties were investigated,including solubility,wettability,hygroscopicity,equilibrium solubility,oil-water partition coefficient,and stability.The results showed that the total glycosides of Gentianae Macrophyllae Radix,Panacis Majoris Rhizome and Corni Fructus all had good solubility and wettability.The solubility index of each total glycoside component was greater than 85%,and the water absorption index was greater than 50%.In the range of pH 2.0-7.4,the equilibrium solubility of three kinds of total glycosides all increased with the increase of pH,showing a consistent change trend of solubility.The hydrophilicity was also suitable and similar.Overall,three kinds of total glycosides showed good stability,but strong hygroscopicity.The degree of hygroscopicity was as follows:total glycosides of Gen-tianae Macrophyllae Radix>total glycosides of Corni Fructus>total glycosides of Panacis Majoris Rhizome.Therefore,the hygroscopi-city needed to be considered in the preparation of the component-based Chinese medicine of Qinqi Fengshi Fang.The excipients and packaging materials can be properly selected to reduce the hygroscopicity of the preparation.This study provides a reference for the dosage form design of the component-based Chinese medicine of Qinqi Fengshi Fang.