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经典名方清胃散物质基准特征图谱及指标成分含量测定研究

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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。
Characteristic Chromatogram and Index Component Contents of Substance Benchmark of Classic Formula Qingwei Power
OBJECTIVE To establish an HPLC characteristic spectrum and content determination method for the reference mate-rial 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 ber-berine 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.

Qingwei Powersubstance benchmarkcharacteristic chromatogramindicator componentscontent determination

曹杰楠、李思、盛华

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南京中医药大学药学院,江苏 南京 210023

江阴天江药业有限公司,江苏 无锡 214400

南京大学医学院附属金陵医院,江苏 南京 210002

清胃散 物质基准 特征图谱 指标性成分 含量测定

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012009026331

2024

南京中医药大学学报
南京中医药大学

南京中医药大学学报

CSTPCD北大核心
影响因子:1.658
ISSN:1672-0482
年,卷(期):2024.40(1)
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