世界中医药2025，Vol.20Issue(14)：2441-2447,7.DOI:10.3969/j.issn.1673-7202.2025.14.006
热炎宁颗粒干法制粒工艺优化及物理指纹图谱研究
Dry Granulation Process Optimization and Physical Fingerprint of Reyanning Granules
摘要
Abstract
Objective:To optimize the dry granulation process of Reyanning Granules and establish their physical fingerprint.Methods:Based on the concept of quality by design,the type and amount of excipients were screened using single-factor experi-ments.The dry granulation process of Reyanning Granules was optimized by combining multi-index comprehensive weighted scoring via AHP-CRITIC with orthogonal test design.Powder evaluation methods were used to comprehensively characterize the physical quality attributes of the granules,and a physical fingerprint was constructed.Similarity and cluster analyses were employed to assess the quality consistency of granules across different batches.Results:Dextrin was identified as the optimal excipient,with a drug-to-excipient ratio of 2∶1.The optimal process parameters obtained through single-factor investigation and orthogonal test optimization are as follows:roller pressure 8 MPa,vertical speed 30 r/min,and roller speed 12 r/min.Process verification showed a relative standard deviation(RSD)of 0.75％for the comprehensive score,indicating good repeatability and stability.The physical finger-print enabled rapid and comprehensive evaluation of quality consistency across batches.Similarity and cluster analyses demonstrated high consistency in the physical quality of 15 batches of Reyanning Granules,with clustering results largely consistent with similari-ty evaluations.Conclusion:The dry granulation process of Reyanning Granules was optimized,and a physical fingerprint was estab-lished,providing a scientific basis for quality control and production process improvement.关键词
热炎宁颗粒/成型工艺/优化/质量源于设计/正交试验设计/AHP-CRITIC法/物理指纹图谱/研究Key words
Reyanning Granules/Molding process/Optimization/Quality by design/Orthogonal experimental design/AHP-CRIT-IC method/Physical fingerprint/Study分类
医药卫生引用本文复制引用
史辞辞,赵月璇,赵梓先,刘建芳,崔兵,刘兴超..热炎宁颗粒干法制粒工艺优化及物理指纹图谱研究[J].世界中医药,2025,20(14):2441-2447,7.基金项目
国家自然科学基金项目(82404893) （82404893）
河北省中药制剂产业技术研究院专项(YJY2024011) （YJY2024011）
