市售7种养阴清肺制剂质量均一性分析  

Quality Uniformity Analysis of 7 Commercially Available Yangyin Qingfei Preparations

作　　者：苏江敏 劳永真 陈莎[1] 章军[1] 郭丛[1] 赵桉熠 邸继鹏 刘安[1] 刘艳[1] SU Jiangmin;LAO Yongzhen;CHEN Sha;ZHANG Jun;GUO Cong;ZHAO Anyi;DI Jipeng;LIU An;LIU Yan(Institute of Chinese Materia Medica,China Academy of Chinese Medical Sciences,Beijing 100700,China;National Engineering Technology Research Center for Gelatin-based Traditional Chinese Medicine,Dong'e Ejiao Co.Ltd.,Liaocheng 252200,China)

机构地区：[1]中国中医科学院中药研究所,北京100700 [2]东阿阿胶股份有限公司,国家胶类中药工程技术研究中心,山东聊城252200

出　　处：《中国实验方剂学杂志》2024年第18期164-170,共7页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：中国中医科学院科技创新工程项目(CI2023E001TS,CI2021A04405)。

摘　　要：目的:建立市售7种养阴清肺制剂的指纹图谱,对其中指标成分进行定量分析,并结合多元统计分析对其质量均一性进行评估,探究不同剂型的质量差异。方法:采用高效液相色谱法(HPLC)对市售7种养阴清肺制剂共33批样品进行分析,建立指纹图谱并指认共有峰,选择芍药苷、毛蕊花糖苷、哈巴俄苷、甘草酸、丹皮酚作为质量属性指标,采用HPLC对33批养阴清肺制剂进行定量分析,根据7种养阴清肺制剂服用方法计算其日摄入量并绘制雷达图,结合聚类分析和主成分分析探究7种养阴清肺制剂的质量差异情况及同剂型不同批次间的质量均一性。结果:7种剂型指纹图谱相似度为0.248~0.956,提示不同剂型养阴清肺制剂间存在较大差异,共标定共有峰15个,其中峰7、峰8、峰11、峰13、峰15分别为芍药苷、毛蕊花糖苷、哈巴俄苷、甘草酸和丹皮酚;雷达图显示大蜜丸和水蜜丸平均总日摄入量最高,其中丸剂成分均一性较好;聚类分析将33批样品质量分为质量较差和优质2类;主成分分析显示不同剂型批间均一性和剂型差异明显,口服液离散程度最小质量均一性较好,5种指标成分中丹皮酚在不同剂型中含量差异较大,是养阴清肺制剂质量控制的关键成分。结论:7种养阴清肺制剂中以大蜜丸和水蜜丸为相对优选的剂型;不同制剂工艺对丹皮酚含量影响较大,生产时应重点关注其质量控制。该研究为中药方剂不同剂型的制剂产品质量比较提供科学方法,有助于不同方剂优选剂型的开发,并为临床高效用药提供参考。Objective To establish the fingerprint of seven commercially available Yangyin Qingfei preparations,to quantitatively analyze the index components,to evaluate their quality uniformity with multivariate statistical analysis,and to explore the quality differences among different dosage forms.Method A total of 33 batches of commercially available 7 kinds of Yangyin Qingfei preparations were analyzed by high performance liquid chromatography(HPLC),the fingerprints were established and the common peaks were identified.Paeoniflorin,verbascoside,harpagoside,glycyrrhizic acid and paeonol were selected as the indicators of quality attributes to quantitatively analyze 33 batches of preparations.Based on the administration methods of Yangyin Qingfei preparations,the daily intake was calculated and the radar charts were poltted,and cluster analysis and principal component analysis were used to explore the quality differences of 7 kinds of Yangyin Qingfei preparations and the quality uniformity among different batches of the same dosage form.Result The similarity of fingerprints of 7 dosage forms was 0.248-0.956,suggesting that there were significant differences among different dosage forms of Yangyin Qingfei preparations,and a total of 15 common peaks were calibrated,of which peak 7,peak 8,peak 11,peak 13 and peak 15 were paeoniflorin,verbascoside,harpagoside,glycyrrhizic acid and paeonol,respectively.The radar plots showed that the average total daily intake of large honeyed pills and water honeyed pills was the highest,and the uniformity of pill components was better.The quality of 33 batches of samples was divided into poor quality and high quality by cluster analysis.Principal component analysis showed that the uniformity and dosage form of different dosage forms were significantly different,the oral liquid had the best quality homogeneity with the minimum dispersion.And the content of paeonol in different dosage forms was significantly different,which was the key component of quality control of Yangyin Qingfei preparati

关 键 词：养阴清肺制剂 日摄入量 剂型差异 多元统计分析 质量均一性 高效液相色谱法(HPLC) 指纹图谱 

分 类 号：R22[医药卫生—中医基础理论] R943[医药卫生—中医学] R28[理学—分析化学] O657[理学—化学]