中国中药杂志

2021, v.46(04) 792-800

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经典名方清胃散的物质基准量值传递分析
Analysis on quality value transfer of substance benchmarks of Qingwei San

黄嘉怡;张琦;杨艳玲;杨海菊;窦敏航;李花花;杜守颖;白洁;
HUANG Jia-yi;ZHANG Qi;YANG Yan-ling;YANG Hai-ju;DOU Min-hang;LI Hua-hua;DU Shou-ying;BAI Jie;School of Chinese Materia Medica,Beijing University of Chinese Medicine;

摘要(Abstract):

通过制备10批物质基准冻干粉,建立清胃散物质基准的特征图谱以及指标成分含量分析方法,确定其特征图谱的色谱峰归属及其相似度范围,异阿魏酸、巴马汀和丹皮酚的含量范围以及转移率范围,出膏率范围等各项评价指标,以阐明清胃散物质基准的关键质量属性。结果显示,10批清胃散物质基准特征图谱相似度良好(>0.90);进一步比对图谱信息可知,清胃散中共指认特征峰16个,其中5个特征峰来自升麻、5个特征峰来自黄连、2个特征峰来自当归、4个特征峰来自牡丹皮; 10批物质基准中异阿魏酸的质量分数为0.10%~0.18%,平均转移率为49.82%±4.02%;巴马汀的质量分数为0.17%~0.31%,平均转移率为15.84%±2.39%;丹皮酚的质量分数为0.41%~0.75%,平均转移率为23.41%±3.23%; 10批物质基准的出膏率控制在27%~33%,理论出膏率与实际出膏率之间传递率为86.59%±3.39%。该研究采用特征图谱、指标性成分含量及出膏率相结合的评价模式,对经典名方清胃散物质基准的量值传递过程进行分析,初步建立了科学稳定的物质基准质量评价方法,为经典名方清胃散的后续开发及相关制剂的质量控制提供依据。
By preparing 10 batches of substance benchmarks freeze-drying powder( lyophilized powder),the methodology of the characteristic spectrum and the content of index component for substance benchmarks of Qingwei San was established. The characteristic peaks and the similarity range of the characteristic spectrum,the contents and the transfer rate range of isoferulic acid,palmatine and paeonol,and the paste-forming rate range were determined to define key quality attributes of substance benchmarks of Qingwei San. In the10 batches of substance benchmarks of Qingwei San,the similarity of characteristic spectrum was higher than 0. 90. In further comparison of the characteristic peak information,a total of 16 characteristic peaks were identified,including 5 characteristic peaks from Cimicifugae Rhizoma,5 characteristic peaks from Coptidis Rhizoma,2 characteristic peaks from Angelicae Sinensis Radix and 4 characteristic peaks from Moutan Cortex. The content of isoferulic acid was 0. 10%-0. 18%,with the average transfer rate of 49. 82%±4. 02%. The content of palmatine was 0. 17%-0. 31%,with the average transfer rate of 15. 84% ±2. 39%. The content of paeonol was 0. 41%-0. 75%,with the average transfer rate of 23. 41%±3. 23%. The paste-forming rate of the 10 batches of substance benchmarks were controlled at 27%-33%,with the transfer rate between the theoretical paste-forming rate and the actual paste-forming rate was 86. 59%±3. 39%. In this study,the quality value transfer of substance benchmarks of Qingwei San was analyzed by the combination of characteristic spectrum,the content of index component and the paste-forming rate. A scientific and stable evaluation method was preliminarily established,so as to provide the basis for subsequent development and quality control of relevant preparations of Qingwei San.

关键词(KeyWords): 经典名方;清胃散;物质基准;特征图谱;量值传递
classical prescription;Qingwei San;substance benchmarks;characteristic spectrum;quality value transfer

Abstract:

Keywords:

基金项目(Foundation): 中央高校基本科研业务费专项(2020-JYB-ZDGG-031)

作者(Author): 黄嘉怡;张琦;杨艳玲;杨海菊;窦敏航;李花花;杜守颖;白洁;
HUANG Jia-yi;ZHANG Qi;YANG Yan-ling;YANG Hai-ju;DOU Min-hang;LI Hua-hua;DU Shou-ying;BAI Jie;School of Chinese Materia Medica,Beijing University of Chinese Medicine;

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DOI: 10.19540/j.cnki.cjcmm.20201102.301

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