痛风颗粒成型工艺研究及其物理指纹图谱建立  

Research on Tongfeng Granules Preparation Technology and its Physical Fingerprint Map Establishment

作　　者：张强 杨仁惠 柯媛媛 周训蓉 Zhang Qiang;Yang Renhui;Ke Yuanyuan;Zhou Xunrong(College of Pharmacy,Guizhou University of Traditional Chinese Medicine,Guiyang 550025,China;Department of Pharmacy,The Second Hospital Affiliated to Guizhou University of TraditionalChinese Medicine,Guiyang 550003,China)

机构地区：[1]贵州中医药大学药学院,贵州贵阳550025 [2]贵州中医药大学第二附属医院药学部,贵州贵阳550003

出　　处：《亚太传统医药》2025年第1期38-44,共7页Asia-Pacific Traditional Medicine

基　　金：贵州省中医药、民族医药重点学科建设项目(QZYYZDXK(JS)-2023-04)。

摘　　要：目的:优选痛风颗粒的成型工艺并建立其物理指纹图谱。方法:在单因素试验的基础上,以稠膏与辅料的比例、可溶性淀粉与微晶纤维素(MCC)的比例、稠膏与胶态二氧化硅的比例为考察因素,以成型率、休止角、吸湿率及软材性状的综合评分为评价指标,利用响应面法优选最佳成型工艺。采用物理指纹图谱对痛风颗粒的均一性、流动性、稳定性等物理属性指标进行综合表征,评价不同批次颗粒的质量一致性。结果:最佳成型工艺为稠膏与辅料比例为1∶0.99,可溶性淀粉与微晶纤维素(MCC)的比例为7∶2,稠膏与胶态二氧化硅的比例为1∶0.09,12批颗粒物理指纹图谱的相似度均高于0.9。结论:该工艺稳定可行,生产出的颗粒性质稳定,符合痛风颗粒实际大生产要求。Objective:To optimize the molding process of Tongfeng Granules and establish its physical fingerprint.Methods:On the basis of single-factor test,the ratio of thick paste and excipients,the ratio of soluble starch and microcrystalline cellulose(MCC),the ratio of thick paste and colloidal silica,the comprehensive score of molding rate,resting Angle,hygroscopic rate and soft material properties are taken as the evaluation index,and the best molding process is selected by the response surface method.Physical fingerprint mapping was used to comprehensively characterize the physical properties of uniformity,fluidity and stability of Tongfeng Granules to evaluate the quality consistency of different batches of particles.Results:The optimal molding process is that the ratio of thick paste and excipients is 1∶0.99,the ratio of soluble starch to microcrystalline cellulose(MCC)is 7∶2,the ratio of thick paste to colloidal silica is 1∶0.09,and the similarity of physical fingerprint of 12 batches of particles is higher than 0.9.Conclusion:The process is stable and feasible,and the particles produced are stable,which meets the actual large production requirements of Tongfeng Granules.

关 键 词：痛风颗粒 成型工艺 响应面法 物理指纹图谱 湿法制粒 

分 类 号：R284[医药卫生—中药学]