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[名方开心散基准样品的关键质量属性]

[Key quality attributes of benchmark samples of famous classical formula Kaixin Powder].

作者信息

Shang Bing-Xian, Zhao Zhen-Xia, Zeng Qi, Su Jian, Xu Bing, Liu Yong-Li, Lei Hai-Min

机构信息

School of Chinese Materia Medica, Beijing University of Chinese Medicine Beijing 102400, China Hebei Institute for Drug Control Shijiazhuang 050299, China.

Hebei Institute for Drug Control Shijiazhuang 050299, China.

出版信息

Zhongguo Zhong Yao Za Zhi. 2023 Jan;48(2):382-389. doi: 10.19540/j.cnki.cjcmm.20220520.301.

DOI:10.19540/j.cnki.cjcmm.20220520.301
PMID:36725228
Abstract

We prepared 15 batches of Kaixin Powder benchmark samples with the decoction pieces of different batches. Further, we established the specific chromatograms and index component content determination method of Kaixin Powder benchmark samples and analyzed the peaks and similarity of the chromatograms. With sibiricose A5, sibiricose A6, polygalaxanthone Ⅲ, 3,6'-disinapoyl sucrose, ginsenoside Rb_1, β-asarone, α-asarone, and dehydropachymic acid as index components, the index component content determination method was established and 70%-130% of the mean content of each component was set as the range. The chromatograms of 15 batches of Kaixin Powder benchmark samples had a total of 22 characteristic peaks, among which 8 peaks were identified, which represented sibiricose A5, sibiricose A6, polygalaxanthone Ⅲ, 3,6'-disinapoyl sucrose, ginsenoside Rb_1, β-asarone, α-asarone, and dehydropachymic acid, respectively. The chromatograms shared the similarity of 0.992-0.999. The 15 batches of benchmark samples had sibiricose A5 of 0.34-0.55 mg·g(-1), sibiricose A6 of 0.43-0.57 mg·g(-1), polygalaxanthone Ⅲ of 0.12-0.19 mg·g(-1), 3,6'-disinapoyl sucrose of 1.08-1.78 mg·g(-1), ginsenoside Rb_1 of 0.33-0.62 mg·g(-1), β-asarone of 2.34-3.72 mg·g(-1), α-asarone of 0.11-0.22 mg·g(-1), and dehydropachymic acid of 0.053-0.079 mg·g(-1). This study established the specific chromatograms and index component content determination method of Kaixin Powder benchmark samples, and the method was simple, feasible, reproducible, and stable. This study provides a scientific basis for further research on the key chemical properties of the benchmark samples and preparations of Kaixin Powder.

摘要

我们用不同批次的饮片制备了15批开心散基准样品。进一步建立了开心散基准样品的特征图谱及指标成分含量测定方法,并对图谱的峰及相似度进行了分析。以西伯利亚远志糖A5、西伯利亚远志糖A6、多花黄精三醇、3,6'-二芥子酰蔗糖、人参皂苷Rb_1、β-细辛醚、α-细辛醚、去氢茯苓酸为指标成分,建立了指标成分含量测定方法,并将各成分平均含量的70%-130%设定为范围。15批开心散基准样品的图谱共有22个特征峰,其中8个峰被鉴定出来,分别代表西伯利亚远志糖A5、西伯利亚远志糖A6、多花黄精三醇、3,6'-二芥子酰蔗糖、人参皂苷Rb_1、β-细辛醚、α-细辛醚、去氢茯苓酸。图谱相似度为0.992-0.999。15批基准样品中,西伯利亚远志糖A5为0.34-0.55mg·g(-1),西伯利亚远志糖A6为0.43-0.57mg·g(-1),多花黄精三醇为0.12-0.19mg·g(-1),3,6'-二芥子酰蔗糖为1.08-1.78mg·g(-1),人参皂苷Rb_1为0.33-0.62mg·g(-1),β-细辛醚为2.34-3.72mg·g(-1),α-细辛醚为0.11-0.22mg·g(-1),去氢茯苓酸为0.053-0.079mg·g(-1)。本研究建立了开心散基准样品的特征图谱及指标成分含量测定方法,该方法简便、可行、重现性好、稳定性高。本研究为进一步研究开心散基准样品及制剂的关键化学性质提供了科学依据。

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