时珍国医国药2026，Vol.37Issue(13)：2471-2477,7.DOI:10.70976/j.1008-0805.SZGYGY-2026-1310
基于指纹图谱和多成分定量的陈皮破壁饮片生产过程量值传递规律研究
Investigating quality attribute transmission in the manufacturing of Pericarpium Citri Reticu-latae decoction pieces with cell-broken technology using chemical fingerprinting and multi-component quantitative analysis
摘要
Abstract
Objective To investigate the quality attribute transmission of index components during the preparation of Pericarpium Citri Reticulatae decoction pieces with cell-broken technology,providing guidance for process optimization and improvement.Methods According to the content determination method in Pharmacopoeia of the People's Republic of China(中华人民共和国药典,2020 edi-tion)and standard fingerprint methodology,the index components(including hesperidin,nobiletin,and tangeretin)and HPLC finger-print of Pericarpium Citri Reticulatae medicinal materials,coarse powder,cell-broken powder,and final cell-broken decoction pieces(CBDP)were systematically evaluated during the preparation of CBDP.Rotary granulation and dry granulation were respectively employed to prepare CBDP.The effects of different granulation processes on the content of index components and physical properties were systematically investigated by comparing with conventional production samples,and the corresponding physical fingerprint radar chart was established.Results Throughout the manufacturing stages of CBDP(from medicinal materials to coarse powder,then to cell-broken powder to CBDP),the mean transfer rates of the index components were quantified as follows:hesperidin 100.9%,nobiletin 102.0%,and tangeretin 101.8%,with HPLC fingerprint similarity(calculated by the vector cosine method)all exceeding 0.95.Sig-nificant differences were detected in particle size distribution,bulk density,friability,chromaticity values(CIE LAB color space:L*,a*,b*),and hardness between CBDP prepared by different granulation processes,and physical fingerprints showed significant differ-ences in profile characteristics.Conclusion During the production process,the index components and HPLC fingerprint of CBDP main-tain good stability.While both granulation methods are fundamentally feasible and result in comparable chemical contents,marked dif-ferences in physical properties exist,particularly in hardness,friability,and L* and b* chromaticity values,which should serve as criti-cal process control indicators.This study provides reliable foundational data for optimizing the preparation technology and lays a theoreti-cal foundation for subsequent process refinement and quality control.关键词
陈皮/生产过程控制/指纹图谱/干法制粒/物理性质评价Key words
Pericarpium Citri Reticulatae(陈皮)/Production process control/Fingerprint/Dry granulation/Physical prop-erty evaluation分类
医药卫生引用本文复制引用
张前亮,邓雯,史军杰,梁荣炬,陈炜璇,彭丽华,乔卫林..基于指纹图谱和多成分定量的陈皮破壁饮片生产过程量值传递规律研究[J].时珍国医国药,2026,37(13):2471-2477,7.基金项目
国家企业技术中心项目(发改高技[2020]1918号) （发改高技[2020]1918号）
中药破壁饮片国家地方联合工程研究中心项目(发改办高技[2019]180号) （发改办高技[2019]180号）
广东省中药破壁饮片工程实验室项目(粤发改创新函[2018]3149号) （粤发改创新函[2018]3149号）
