山西医科大学学报2024，Vol.55Issue(9)：1214-1218,5.DOI:10.13753/j.issn.1007-6611.2024.09.016
保和丸HPLC指纹图谱方法研究及质量评价
Research and quality evaluation on fingerprint of Baohe pills by HPLC
杨艳 1王爱娜 1史宪海 1申国华1
作者信息
- 1. 山西省检验检测中心药品检验技术研究所,太原 030031
- 折叠
摘要
Abstract
Objective To establish a fingerprint of Baohe pills for providing references in the effective quality control and the scien-tific evaluation.Methods The common peaks of the fingerprint spectrum were calibrated on Kromasil C18 column(4.6 mm×250 mm,5 μm)with Acetonitrile and 0.5%glacial acetic acid as the mobile phase for gradient elution at a flow rate of 0.7 mL/min at the detection wavelength of 320 nm.Taking hesperidin as the reference peak,the similarity of 244 batches of different dosage forms of Baohe pills from 61 production managements was evaluated by the software of Similarity Evaluation System for Chromatographic Fingerprint of TCM(version 2012).Results A total of 7 common peaks were identified by the established HPLC fingerprint of Baohe pills,including charred fructus crataegi(peaks 1,2),radish seed(peaks 3,6),forsythia(peak 4),forsynoidide A(peak 5)and hesperidin(peak 7).The similarity of common peaks of 39 batches of water pills was above or equal to 0.90,and that of 17 batches was below 0.90.The simi-larity of the common peaks of 56 batches of big honeyed pills was above or equal to 0.90,and that of 25 batches of samples was below 0.90.The similarity of common peaks in 56 batches of concentrated pills was above or equal to 0.90,and that of 51 batches was below 0.90.Conclusion The established HPLC fingerprint method is simple and fast,with good reproducibility,and can exhibit the overall characteristics of multiple components in Baohe pills,which provides a scientific basis for the quality control of Baohe pills.关键词
保和丸/高效液相色谱法/指纹图谱/相似度评价/质量控制/质量评价Key words
Baohe pills/HPLC/fingerprint/similarity evaluation/quality control/quality evaluation分类
医药卫生引用本文复制引用
杨艳,王爱娜,史宪海,申国华..保和丸HPLC指纹图谱方法研究及质量评价[J].山西医科大学学报,2024,55(9):1214-1218,5.
