摘要
目的:建立经典名方苓桂术甘汤物质基准的质量控制方法和标准。方法:结合苓桂术甘汤物质基准的化学成分研究,建立肉桂酸、桂皮醛、甘草苷、甘草酸的含量测定方法,对17批苓桂术甘汤物质基准进行测定与评价。建立苓桂术甘汤物质基准的HPLC指纹图谱,使用中药色谱指纹图谱相似度评价软件,对17批苓桂术甘汤物质基准相似度进行分析,对共有峰进行药味归属。结果:肉桂酸、桂皮醛、甘草苷、甘草酸的含量测定及指纹谱图方法学验证结果均符合要求;17批苓桂术甘汤物质基准中甘草苷、甘草酸、肉桂酸、桂皮醛的平均含量为0.45%,1.07%,0.059%,0.27%;17批苓桂术甘汤物质基准共得到16个共有峰,其中归属于桂枝4个,归属于白术2个,归属于甘草10个,按中药色谱指纹图谱相似度评价系统计算,相似度均大于0.90。结论:所建立方法可作为苓桂术甘汤物质基准的质量控制标准,为苓桂术甘汤复方制剂的研究提供参考。
Objective:To establish a method for the content determination and fingerprint of Lingguizhugan Decoction,in order to provide a reference for the establishment of the quality control standard of Lingguizhugan decoction.Methods:Method was established for the determination of the content of cinnamic acid,cinnamal dehyde,liquiritin and glycyrrhizic acid,and applied to the determination and evaluation of 17 batches of Lingguizhugan decoction according to the present study of the chemical constituents of the material reference sample.Besides,the HPLC fingerprints of 17 batches of Lingguizhugan decoction were established and evaluated by the Chinese medicine chromatographic fingerprint similarity evaluation system software(version 2012A),and the common peaks in Lingguizhugan decoction were identified and assigned.Results:The results of method validation of Lingguizhugan decoction are in line with the requirements of the Chinese Pharmacopoeia.The average content values of liquiritin,glycyrrhizic acid,cinnamic acid and cinnamal dehyde,in 17 batches of Lingguizhugan decoction were 0.045%,1.07%,0.059%,and 0.27%,respectively.A total of 16 common peaks were identified in 17 batches of Lingguishugan decoction,in which 4 peaks belonged to Cinnamomi Ramulus,2 peaks belonged to Atractylodis Macrocephalae Rhizoma,and 10 peaks belonged to Radix et Rhizoma Glycyrrhizae.The similarities were all greater than 0.9.Conclusion:The established method can be used for the quality evaluation and provide a reference for the quality control of Lingguizhugan decoction.
作者
闵会
徐斌
郑亚纯
王芳芳
金付文
姚建标
MIN Hui;XU Bin;ZHENG Yachun;WANG Fangfang;JIN Fuwen;YAO Jianbiao(Zhejiang CONBA Pharmaceutical Co.,Ltd.,Hangzhou 310052,China;Zhejiang Provincial Key Laboratory of Traditional Chinese Medicine Pharmaceutical Technology,Hangzhou 310052,China;Qianshan Guanzhuang Town Health Clinics,Anqing 246320,China)
出处
《中国药品标准》
CAS
2022年第6期587-595,共9页
Drug Standards of China
基金
国家药品监督管理局中成药质量评价重点实验室开放课题(GZYZZ2020002)。
关键词
经典名方
苓桂术甘汤
质量控制
含量测定
指纹图谱
classical herbal formulae
Lingguizhugan decoction
quality control
content determination
fingerprint
