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OA

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.