风湿骨痛片及其中间体的指纹图谱建立及指标成分含量测定  

Fingerprints of Fengshi Gutong tablets and intermediates and content determination of index components

作　　者：刘焕起 吴佩佩 吴海峰[3] 余世春[1,2] 许旭东 LIU Huan-qi;WU Pei-pei;WU Hai-feng;YU Shi-chun;XU Xu-dong(Anhui University of Traditional Chinese Medicine,Hefei 230011;Anhui Kechuang Pharmaceutical Research Institute Co.Ltd.,Hefei 230088;Institute of Medicinal Plant Development,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100093)

机构地区：[1]安徽中医药大学,合肥230011 [2]安徽科创药物研究所有限责任公司,合肥230088 [3]中国医学科学院药用植物研究所,北京100093

出　　处：《中南药学》2023年第11期3020-3024,共5页Central South Pharmacy

基　　金：国家重大新药创制-创新药物研究开发技术平台建设(No.2012ZX09301002-001)。

摘　　要：目的建立风湿骨痛片及其中间体的指纹图谱,并建立指标成分含量测定的高效液相色谱方法,为其质量控制提供参考。方法采用HPLC法建立风湿骨痛片中间体的指纹图谱,以对照品进行共有峰指认,通过相似度评价分析16批样品的质量差异,同时以盐酸麻黄碱、盐酸伪麻黄碱、绿原酸、甘草苷、苯甲酰新乌头原碱为指标性成分,建立其含量测定方法。结果建立了16批风湿骨痛片中间体的指纹图谱与对照图谱,各批次样品间相似度均大于0.90,标定出中间体中的12个共有峰、风湿骨痛片中的17个共有峰;5种成分在相应的质量浓度范围内与峰面积的线性关系良好(r≥0.999),加样回收率均在98.39%~101.09%。盐酸麻黄碱、盐酸伪麻黄碱、绿原酸、甘草苷、苯甲酰新乌头原碱含量平均值分别为3.51、2.50、0.36、2.48、2.05 mg·g^(-1)。结论所建立的指纹图谱及含量测定方法易行、可靠,可用于风湿骨痛片生产过程的跟踪控制,为建立更全面的质量控制标准提供依据。Objective To establish the fingerprints of Fengshi Gutong tablets and intermediates,develop an HPLC method to simultaneously determinate five components,and provide a reference for the quality control.Methods The fingerprints of Fengshi Gutong tablets and intermediates were established by HPLC method.The common peaks were identified with the reference substances.The quality difference of 16 batches of samples was analyzed by similarity evaluation.At the same time,ephedrine hydrochloride,pseudoephedrine hydrochloride,chlorogenic acid,glycyrrhizin and benzoylneaconitine were used as the index components and their content was determined.Results The similarity between the fingerprints of 16 batches of Fengshi Gutong tablets and intermediates and the control maps was greater than 0.90,with 12 common peaks identified in the intermediates and 17 common peaks identified in Fengshi Gutong tablets.The linearity between 5 components and the peak area was good(r≥0.999)in the corresponding concentration range,and the recoveries ranged 98.39%~101.09%.The average contents of ephedrine hydrochloride,pseudoephedrine hydrochloride,chlorogenic acid,liquiritin and benzoylneaconitine were 3.51,2.50,0.36,2.48,and 2.05 mg·g^(-1),respectively.Conclusion The established fingerprints and content determination method are easy and reliable,and can provide evidence for the quality control and evaluation of Fengshi Gutong tablets.

关 键 词：风湿骨痛片 中间体 高效液相色谱 指纹图谱 含量测定 

分 类 号：R284.3[医药卫生—中药学] R284.1[医药卫生—中医学]