摘要
目的建立经典名方清胃散物质基准的HPLC特征图谱以及含量测定方法,控制其质量以保证后续制备。方法遵循古籍并结合前期制备工艺的考察,制备15批清胃散物质基准,采用HPLC建立物质基准特征图谱,使用中药色谱指纹图谱相似度评价系统(2012版)计算相似度;将5种药材中的7种指标性成分作为清胃散物质基准含量测定指标,建立其HPLC含量测定方法,并对15批样品进行含量测定。结果特征图谱相似度均≥0.975,标定了13个共有峰,对7个共有峰进行了化学成分指认,分别为梓醇(1号峰)、阿魏酸(5号峰)、异阿魏酸(6号峰)、盐酸小檗碱(7号峰)、盐酸巴马汀(8号峰)、丹皮酚(12号峰)、藁本内酯(13号峰)。建立了2套指标性成分含量测定方法,其一测定了梓醇、阿魏酸、异阿魏酸、丹皮酚的含量,规定了4种成分含量应分别在1.48~2.76、0.14~0.26、0.48~0.90、1.72~3.19 mg·g^(-1)之间;其二测定了盐酸黄连碱、盐酸巴马汀、盐酸小檗碱的含量,规定了3种成分含量应分别在0.65~1.21、0.57~1.07、1.86~3.45 mg·g^(-1)之间。结论通过清胃散物质基准特征图谱及含量测定方法建立了清胃散物质基准的质量控制方法,该方法简单可靠,为后续质量控制及制剂开发提供依据及基础。
OBJECTIVE To establish an HPLC characteristic spectrum and content determination method for the reference material of the classic formula Qingwei Powder,and control its quality to ensure subsequent preparation.METHODS Following ancient books and combining with the investigation of the previous preparation process,15 batches of Qingwei Powder material standards were prepared.HPLC was used to establish the material standard feature map,and the similarity was calculated using the Chinese medicine chromatographic fingerprint similarity evaluation system(2012 version);seven indicator components from five medicinal herbs were used as the reference content determination indicators for Qingwei Powder,and an HPLC content determination method was established for 15 batches of samples.RESULTS The similarity of the characteristic spectra was≥0.975;13 common peaks were calibrated;and 7 common peaks were identified for chemical composition,including catalpol(peak 1),ferulic acid(peak 5),isoferulic acid(peak 6),berberine hydrochloride(peak 7),palmatine hydrochloride(peak 8),paeonol(peak 12),and ligustilide(peak 13).Two sets of indicator component content determination methods have been established.Firstly,the contents of catalpol,ferulic acid,isoferulic acid,and paeonol were determined,and the four component contents were specified to be 1.48-2.76、0.14-0.26、0.48-0.90、1.72-3.19 mg·g^(-1),respectively;secondly,the contents of coptisine hydrochloride,palmatine hydrochloride,and berberine hydrochloride was determined,and it was specified that the content of the three components should be 0.65-1.21、0.57-1.07、1.86-3.45 mg·g^(-1),respectively.CONCLUSION A quality control method for the reference material of Qingwei Powder has been established through the characteristic spectrum and content determination method.This method is simple and reliable,providing a basis and foundation for subsequent quality control and formulation development.
作者
曹杰楠
李思
盛华
CAO Jienan;LI Si;SHENG Hua(School of Pharmacy,Nanjing University of Chinese Medicine,Nanjing 210023,China;Jiangyin Tianjiang Pharmaceutical Co.,Ltd.,Wuxi 214400,China;Jinling Hospital,Affiliated Hospital of Medical School of Nanjing University,Nanjing 210002,China)
出处
《南京中医药大学学报》
CAS
CSCD
北大核心
2024年第1期37-46,共10页
Journal of Nanjing University of Traditional Chinese Medicine
基金
经典名方清胃散的开发研究(012009026331)。
关键词
清胃散
物质基准
特征图谱
指标性成分
含量测定
Qingwei Power
substance benchmark
characteristic chromatogram
indicator components
content determination
