首页|保和丸HPLC指纹图谱方法研究及质量评价

保和丸HPLC指纹图谱方法研究及质量评价

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目的 建立保和丸指纹图谱的分析方法,为其有效质量控制及科学评价提供参考.方法 采用Kromasil C18(5 μm,4.6 mm×250 mm)色谱柱,以乙腈-0.5%冰醋酸溶液为流动相,梯度洗脱,流速 0.7 mL/min,检测波长320 nm,对指纹图谱进行共有峰标定,以橙皮苷为参照峰,采用 2012 年版中药色谱指纹图谱相似度评价系统软件对61个生产企业共244 批不同剂型的保和丸进行相似度评价.结果 建立的保和丸 HPLC 指纹图谱分析方法指认了7个共有峰,采用药材及化学对照品进行归属,分别为焦山楂(1、2号峰)、莱菔子(3、6号峰)、连翘(4号峰)、连翘酯苷A(5号峰)、橙皮苷(7号峰).水丸的39批供试品各共有峰的相似度均≥0.90,17批供试品各共有峰的相似度<0.90;大蜜丸的56批供试品各共有峰的相似度均≥0.90,25批供试品各共有峰的相似度<0.90;浓缩丸的56批供试品各共有峰的相似度均≥0.90,51批供试品各共有峰的相似度<0.90.结论 建立的HPLC指纹图谱,方法简单快捷,重现性好,能够表达保和丸中多组分的整体特征,为保和丸的质量控制提供了科学依据.
Research and quality evaluation on fingerprint of Baohe pills by HPLC
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.

Baohe pillsHPLCfingerprintsimilarity evaluationquality controlquality evaluation

杨艳、王爱娜、史宪海、申国华

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山西省检验检测中心药品检验技术研究所,太原 030031

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

2024

山西医科大学学报
山西医科大学

山西医科大学学报

CSTPCD
影响因子:0.931
ISSN:1007-6611
年,卷(期):2024.55(9)