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

作　　者：丁珂 杨挡 孙娥[1] 李超 朱法根 邵建国 熊志伟 封亮 贾晓斌 DING Ke;YANG Dang;SUN E;LI Chao;ZHU Fagen;SHAO Jianguo;XIONG Zhiwei;FENG Liang;JIA Xiaobin(Affiliated Hospital of Integrated Traditional Chinese Western Medicine,Nanjing University of Chinese Medicine,Jiangsu Research Institute of Traditional Chinese Medicine,Key Laboratory of Oral Chinese Medicine Delivery System,National Administration of Traditional Chinese Medicine,Nanjing 210028,China;Jumpcan Pharmaceutical Group Co.,Ltd.,Key Laboratory of Pediatric Chinese Medicine and Specialty Preparations,Taixing 225400,China;School of Traditional Chinese Pharmacy,China Pharmaceutical University,Nanjing 211198,China)

机构地区：[1]南京中医药大学附属中西医结合医院,江苏省中医药研究院,国家中医药管理局中药口服释药系统重点研究室,南京210028 [2]济川药业集团有限公司,江苏省儿科中药与特色制剂重点实验室,泰兴225400 [3]中国药科大学中药学院,南京211198

出　　处：《中华中医药杂志》2024年第1期119-124,共6页China Journal of Traditional Chinese Medicine and Pharmacy

基　　金：国家重点研发计划(No.2018YFC1706902);江苏省儿科中药与特色制剂重点实验室开放课题(No.BM2019011);江苏省科技成果转化专项资金(No.BA2020077);江苏省医学创新团队项目(No.CXTDB2017003);国家中医药管理局2022年中央财政转移支付地方项目(No.2022GJJZDYJS-01);江苏省研究生实践创新计划项目(No.SJCX21-0716)。

摘　　要：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.

关 键 词：中药口服液体制剂 流浸膏 物料性质表征体系 蒲地蓝消炎口服液 溶解性 酸碱性 味道 

分 类 号：R283.6[医药卫生—中药学]