基于流浸膏物料性质的中药口服液体制剂剂型设计与优化关键技术研究  

Study on the Dosage Form Design and Optimization of Key Technology of Oral Liquid Preparation of Traditional Chinese Medicine Based on the Properties of Liquid Extract

作　　者：丁珂 李萱 孙娥[1] 刘俊 赵菁 李超 封亮 贾晓斌 DING Ke;LI Xuan;SUN E;LIU Jun;ZHAO Jing;LI Chao;FENG Liang;JIA Xiao-bin(Hospital of Integrative Chinese and Western Medicine Affiliated to Nanjing University of Chinese Medicine/Jiangsu Research Insti-tute of Traditional Chinese Medicine/Key Laboratory of Oral Chinese Medicine Delivery System,State Administration of Traditional Chi-nese 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 Medicine,China Pharmaceutical University,Nan-)

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,江苏南京210028 [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,江苏泰兴225400 [3]中国药科大学中药学院,江苏南京211198

出　　处：《中药材》2023年第8期1843-1849,共7页Journal of Chinese Medicinal Materials

基　　金：国家重点研发计划项目(2018YFC1706902);江苏省儿科中药与特色制剂重点实验室开放课题(BM2019011);江苏省科技成果转化专项资金(BA2020077);江苏省医学创新团队项目(CXTDB2017003);国家中医药管理局重点研究室能力提升项目(2022GJJZDYJS-01);江苏省研究生实践创新计划项目(SJCX21-0716)。

摘　　要：中药口服液体制剂具有显效迅速、服用方便等优点,但仍存在有效成分损失、澄明度降低和特殊患群(儿童)口服顺应性差的共性瓶颈问题。中药提取物流浸膏作为口服液体制剂生产过程的中间体,其部分性质很大程度上决定口服液体制剂的性质。该文构建中药流浸膏物料性质表征体系,挖掘出与制剂性质密切相关的物料性质:溶解性、酸碱性和味道,在此基础上,建立基于溶解性能的中药口服液体制剂有效性提升技术、基于酸碱性的稳定性提高技术以及基于味道性能的中药口服液体制剂口感改善技术,从而提升产品的内在品质。总结基于流浸膏物料性质的中药口服液体制剂剂型设计与优化技术的研究思路,以期为中药口服液体制剂的研究开发提供理论指导和技术支撑。The oral liquid preparation of traditional Chinese medicine(TCM)has the advantages of quick effect and convenience,but there are still some common bottlenecks such as loss of active ingredient,decrease of clarity and poor oral compliance in special patient groups(children).As an intermediate in the production process of oral liquid preparation,the properties of oral liquid preparation are largely determined by its partial properties.In this paper,a system for characterizing the properties of Chinese herbal medicine extract was established,and the properties of the extract,such as solubility,acidity,alkalinity and taste,which are closely related to the properties of preparation,were found out.On this basis,the technology of improving the effectiveness of TCM oral liquid preparation based on the solubility,the technology of improving the stability based on the acidity and alkalinity,and the technology of improving the taste of TCM oral liquid preparation based on the taste performance were established,so as to enhance the inherent quality of products.In this paper,the research ideas of the formulation design and optimization technology of TCM oral liquid preparations based on the properties of liquid extract materials were summarized,it is expected to provide theoretical guidance and technical support for the research and development of oral liquid preparations of TCM.

关 键 词：中药口服液体制剂 剂型设计与优化 流浸膏性质表征 有效性 稳定性 口感 

分 类 号：R944.64[医药卫生—药剂学] R283.6[医药卫生—药学]