摘要
目的建立白英药材饮片的质量标准及指纹图谱。方法按2020年版《中国药典(四部)》浸出物测定法项下醇溶性浸出物测定法测定样品的浸出物含量。采用超高效液相色谱(UPLC)法测定样品中绿原酸的含量。以绿原酸峰为参照峰绘制15批样品的UPLC指纹图谱。采用中药色谱指纹图谱相似度评价系统(2012A版)进行相似度评价。结果15批样品的浸出物含量为7.51%~13.37%,平均9.63%。绿原酸质量浓度在1.6114~48.3421 mg/L范围内与峰面积线性关系良好(R2=0.9999,n=6);精密度、稳定性、重复性试验结果的RSD均小于2.0%;平均加样回收率为100.01%,RSD为2.03%(n=9)。15批样品的指纹图谱有8个共有峰,指认了其中3个化学成分,分别为新绿原酸、绿原酸、隐绿原酸,有10批的指纹图谱相似度大于0.9。结论初步拟订白英药材饮片的浸出物含量不得低于8%,绿原酸含量不得低于0.040%,指纹图谱相似度不得低于0.9。所建立的标准可用于白英药材饮片的质量控制。
Objective To establish the quality standard and fingerprint of Herba Solani Lyrati Decoction Pieces.Methods The content of extract in samples was determined based on the determination of alcohol-soluble extract under the extract determination of the Chinese Pharmacopoeia(2020 Edition,volumeⅣ).The content of chlorogenic acid in samples was determined by the ultra-high-performance liquid chromatography(UPLC)method.The UPLC fingerprint of 15 batches of samples was drawn with the peak of chlorogenic acid as the reference.The Similarity Evaluation System for Chromatographic Fingerprint of Traditional Chinese Medicine(Version 2012A)was used for similarity evaluation.Results The extract content of 15 batches of samples was in the range of 7.51%-13.37%,with an average content of 9.63%.The linear range of chlorogenic acid was 1.6114-48.3421 mg/L(R2=0.9999,n=6).The RSDs of precision,stability and repeatability tests were all lower than 2.0%.The average recovery rate of chlorogenic acid was 100.01%with an RSD of 2.03%(n=9).There were eight common peaks in the fingerprint of 15 batches of samples,of which three chemical components were identified,including neochlorogenic acid,chlorogenic acid and cryptochlorogenic acid.There were 10 batches of samples with the similarity of fingerprint greater than 0.9.Conclusion The proposed standard is as follows:the extract content of Herba Solani Lyrati Decoction Pieces should not be lower than 8%,the content of chlorogenic acid should not be lower than 0.040%,and the similarity of the fingerprint should not be lower than 0.9.The established standard can be used for the quality control of Herba Solani Lyrati Decoction Pieces.
作者
万丽娟
黄茜茜
林露
胡辉
龙林
瞿彩丽
WAN Lijuan;HUANG Qianqian;LIN Lu;HU Hui;LONG Lin;QU Caili(Jing Brand Chizhengtang Pharmaceutical Co.,Ltd.,Huangshi,Hubei,China 435000;Hubei Traditional Chinese Medicine Formula Granule Engineering Technology Research Center,Huangshi,Hubei,China 435000;Hubei Provincial Key Laboratory for Quality and Safety of Traditional Chinese Medicine Health Food,Huangshi,Hubei,China 435000)
出处
《中国药业》
CAS
2023年第14期73-77,共5页
China Pharmaceuticals
基金
湖北省科技重大专项课题[2020ACA007-03]。
关键词
白英
药材饮片
质量标准
绿原酸
超高效液相色谱
指纹图谱
Herba Solani Lyrati
decoction pieces
quality standard
chlorogenic acid
UPLC
fingerprint
