中药口服液体制剂物料流浸膏的性质表征体系构建与应用

Construction and application of characterization system of material liquid extract of oral liquid preparation of traditional Chinese medicine

目的:对流浸膏性质进行系统性研究,构建中药流浸膏物料性质表征体系。方法:搜集表征中药提取物流浸膏的相关性质构建物料性质表征体系,将其应用于示范品种蒲地蓝消炎口服液,对三味合提流浸膏和黄芩流浸膏性质进行测定并与制剂性质进行关联分析。结果:构建了包括空间结构、面性质、体性质、气味性质、理化性质和物质构成共6个层面、20项性质、41项性质指标的中药流浸膏物料性质表征体系;发现了与中药口服液体制剂的有效性、稳定性和口感密切相关的性质是溶解性、酸碱性和味道性质。结论:中药流浸膏物料性质表征体系的建立可以指导中药口服液体制剂的剂型改进与技术优化。

Objective:To study the properties of liquid extract systematically,and to establish a system for characterizing the properties of Chinese herbal extract.Methods:Collected the related properties of the extract of traditional Chinese medicine(TCM)to construct the characterization system of the extract of TCM,and applied it to the Pudilan Xiaoyan Oral Liquid,the properties of the three medicinal liquid extract and Scutellaria baicalensis liquid extract were determined and correlated with the properties of the preparation.Results:A system for characterizing the properties of Chinese medicinal herb extract was constructed,which consists of 6 levels,20 properties and 41 properties,including spatial structure,surface properties,body properties,odor properties,physical and chemical properties and material composition.It was found that the properties closely related to the effectiveness,stability and taste of oral liquid preparations of TCM were solubility,acidity and taste.Conclusion:The establishment of the characterization system can guide the improvement of dosage form and technology optimization of oral liquid preparation of TCM.