大理大学学报 ›› 2025, Vol. 10 ›› Issue (8): 20-29.DOI: 10. 3969 / j. issn. 2096-2266. 2025. 08. 003

• 药学 • 上一篇    下一篇

累积中药指纹图谱用于决明子脐贴累积释放度的评价与验证

鄢海燕,黄 莉,邹纯才*   

  1. (皖南医学院药学院,安徽芜湖 241002)
  • 收稿日期:2024-05-20 修回日期:2024-07-19 出版日期:2025-08-15 发布日期:2025-09-06
  • 通讯作者: 邹纯才,教授,E-mail:zouchc@163.com。
  • 作者简介:鄢海燕,教授,主要从事药物制剂及其质量控制研究。
  • 基金资助:
    安徽高校省级自然科学研究重大项目(KJ2016SD60);皖南医学院药剂学一流本科课程(2019ylkc017);安徽省
    省级质量工程项目药剂学专项(2019kfkc084)

Evaluation and Validation of Cumulative Release Rate of Transdermal Patches Containing Cassia Seed#br# Extract Using Cumulative Fingerprint of Traditional Chinese Medicine

Yan Haiyan, Huang Li, Zou Chuncai*   

  1. (Pharmacy School of Wannan Medical College, Wuhu, Anhui 241002, China)
  • Received:2024-05-20 Revised:2024-07-19 Online:2025-08-15 Published:2025-09-06

摘要: 目的:应用累积中药指纹图谱对决明子脐贴累积释放度进行评价并验证。方法:基于《中药指纹图谱及其数字化》理
论,提出累积中药指纹图谱的概念、原理及计算公式,以决明子脐贴透皮累积释放度的计算为例,与《中华人民共和国药典》
2020年版四部通则0931项下溶出度和释放度的数据处理结果进行比较。结果:决明子脐贴各成分在第24小时的累积释放度
存在差异,有14种成分超过80.0%,1种成分低于10.0%。累积中药指纹图谱与《中华人民共和国药典》2020年版规定方法不同
取样时间点累积释放度计算结果比较,误差均值绝对值均小于2.3%。结论:累积中药指纹图谱可用于中药制剂累积释放度的
评价,结果准确、操作简便,为中药制剂的质量控制和检查提供了新的方向。

关键词: 累积中药指纹图谱, 决明子脐贴, 释放度, 验证

Abstract: Objective: To evaluate and validate the cumulative release rate of transdermal patches containing Cassia seed extract
using cumulative traditional Chinese medicine fingerprint(TCM fingerprint). Methods: Based on the theory in Fingerprint of
Traditional Chinese Medicine and Its Digitization, the concept, principle, and calculation formula of cumulative TCM fingerprint were
established. Taking the transdermal cumulative release rate of transdermal patches containing Cassia seed extract as an example, the
results were compared with the data processing outcomes of dissolution rate and release tests rate specified under item 0931 in General
Chapter of Chinese Pharmacopoeia (ChP) 2020 Edition. Results: The cumulative release rate of components in transdermal patches
containing Cassia seed extract varied at 24 hours: 14 components exceeded 80.0%, while 1 component was below 10.0%. When
comparing cumulative TCM fingerprint with the cumulative release rate results at different sampling time points specified in ChP 2020,
the absolute values of the mean error were all below 2.3%. Conclusion: The cumulative TCM fingerprint can be applied to evaluate the
cumulative release rate of TCM preparations, with accurate results and simple operation, offering a new approach for quality control and
inspection of TCM preparations.

Key words: cumulative TCM fingerprint, transdermal patches containing Cassia seed extract, release rate, validation

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