Journal of Dali University ›› 2025, Vol. 10 ›› Issue (8): 20-29.DOI: 10. 3969 / j. issn. 2096-2266. 2025. 08. 003

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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

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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