两种在线传感器评价中药配方颗粒溶化性研究  

Study on two online sensors for evaluation of solubility of Chinese medicine formula granules

作　　者：于佳琦 徐冰[1,2] 李婉婷 戴胜云 张志强 乔延江 YU Jia-qi;XU Bing;LI Wan-ting;DAI Sheng-yun;ZHANG Zhi-qiang;QIAO Yan-jiang(Department of Information of Traditional Chinese Medicine,Beijing University of Chinese Medicine,Beijing 102400,China;Beijing Key Laboratory for Production Process Control and Quality Evaluation of Traditional Chinese Medicine,Beijing Municipal Science&TechnoIogy Commission,Beijing 102400,China;National Institutes for Food and Drug Control,Beijing 100050,China;Beijing Tcmages Pharmaceutical Co.,LTD.,Beijing 101301,China;NationaI and Regional Joint Engineering Research Center for Key Technologies of Chinese Medicine Formula Granules,Tianjin 301700,China)

机构地区：[1]北京中医药大学中药信息学系,北京102400 [2]北京市科委中药生产过程控制与质量评价北京市重点实验室,北京102400 [3]中国食品药品检定研究院,北京100050 [4]北京康仁堂药业有限公司,北京101301 [5]中药配方颗粒关键技术国家地方联合工程研究中心,天津301700

出　　处：《中华中医药杂志》2020年第5期2395-2400,共6页China Journal of Traditional Chinese Medicine and Pharmacy

基　　金：中华中医药学会青年人才托举工程项目(No.2019-QNRC2-C11);北京中医药大学青年教师项目(No.2019-JYB-JS-015)。

摘　　要：目的:对中药配方颗粒的溶化性进行客观化评价并探究影响因素。方法:选择当归(2批)配方颗粒、广藿香配方颗粒、木蝴蝶配方颗粒、瞿麦配方颗粒、肉桂配方颗粒、乌药配方颗粒、益母草配方颗粒和炙甘草配方颗粒作为测试对象,涵盖根、茎、种子、皮等药用部位。采用在线浊度传感器和聚焦光束反射测量(FBRM)技术,分别实时动态监测中药配方颗粒溶化过程中浊度值和不同粒径区间内粒子数量随时间的变化,绘制溶化曲线,并对每种颗粒的溶化行为进行分析。结果:当归配方颗粒的溶化性能优于其他配方颗粒,溶化过程终点的浊度值大小受溶液中粒子数量和粒径的共同影响,其中,10~100μm粒径区间的粒子数量与溶液浊度呈强相关性(R2=0.9664)。结论:在线浊度传感器和FBRM传感器联用,可实现中药配方颗粒溶化性的量化评价,初步阐释颗粒溶化过程的机理机制,为中药配方颗粒质量改进提供依据。;Objective:To objectively evaluate the solubility of Chinese medicine formula granules and explore the influencing factors.Methods:Formula granules were selected as test subjects,including Angelicae sinensis radix(2 batches),Pogostemonis herba,Oroxyli semen,Dianthi herba,Cinnamomi cortex,Linderae radix,Leonuri herba,prepared radix licorice.These types covered roots,stems,seeds,skins and other medicinal parts.The online turbidity sensor and focused beam reflectance measurement(FBRM)technology were used to dynamically monitor the turbidity change during the dissolving of the Chinese medicinal formula granules and the change of the number of particles in different particle size ranges.The melting curve was drawn and the melting behavior of each particle was analyzed.Results:The results showed that the solubility of Angelicae sinensis radix granules was better than that of other granules,and the turbidity was affected by the number of particles and the size of the particles.Among them,the number of particles of 10-100μm was correlated strongly with the turbidity(R^2=0.9664).Conclusion:Online turbidity sensor combined with FBRM sensor can realize quantitative evaluation of particle solubility of Chinese medicine formula granules,which explains the mechanism of dissolving of Chinese medicine granules,and provides a basis for improving the quality of Chinese medicine formula granules.

关 键 词：中药配方颗粒 溶化性 浊度 在线传感器 聚焦光束反射测量 粒径 粒子数量 

分 类 号：R283.6[医药卫生—中药学]