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Simultaneous Evaluation of Dissolution and Absorption Study of Compound Danshen Tablets and Capsules Based on Cellular Electrical Sensing Model

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Abstract

This study explores the dissolution mechanism and absorption process of compound Danshen tablets (CDTs) and compound Danshen capsules (CDCs) in vitro. Taking the cell index as the evaluation index of dissolution and absorption of multi-component solid preparations of CDTs and CDCs, it breaks through the idea of traditional research. We used real-time cell-based assay (RTCA) to provide a new idea and method for the consistency evaluation of traditional Chinese medicine (TCM) compound preparations. The drug dissolution and absorption simulation system (DDASS) was established to obtain the dissolution and absorption samples of compound Danshen solid preparations at different time points. The cell index (CI) of the sample to H9C2 cells was detected by RTCA technology, and the dissolution and absorption percentage were calculated based on this index to obtain the dissolution and absorption kinetics model. Meanwhile, one batch of tablets and one batch of capsules (batch numbers ZKC1816 and 202101001) were selected to conduct the overall animal pharmacodynamic experiment to verify the feasibility of drug effect evaluation with cell index as an indicator. The best fitting model of dissolution curves of each batch of CDTs and CDCs is the Weibull model. There was a good correlation (r > 0.86) between the dissolution-absorption-pharmacodynamic curve. Based on RTCA technology, we have established the comprehensive evaluation method for cell biology of compound Danshen solid preparations in line with the overall concept of TCM and a synchronous evaluation system of dissolution and absorption in vitro of new TCM compound solid preparations.

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Funding

This research was funded by the National Nature Science Foundation of China (82074004, 81773910), National Key R&D Program of China (2019YFC1710603), Jiangsu Graduate Research and Practice Innovation Project in 2020 (SJCX20_0566), and “Blue Project” in Jiangsu Universities in 2020 and Jiangsu Students’ Platform for innovation and entrepreneurship training program (202110315025, 202110315068Z).

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Author notes

  1. Lixia Ma and Yue Zhou contributed equally to this work.

Authors and Affiliations

  1. School of Pharmacy, Jiangsu Engineering Research Center for Development and Application of External Drugs in TCM, Nanjing University of Chinese Medicine, Nanjing, 210023, China

    Lixia Ma, Yue Zhou, Jia Zhang, Xi Yuan, Yimeng Zhao, Wei Gu, Jinhuo Pan, Tulin Lu & Guojun Yan

  2. Department of Chemical and Biomolecular Engineering, The Ohio State University, Columbus, Ohio, USA

    Zhaogang Yang

  3. Department of Radiation Oncology, University of Texas Southwestern Medical Center, Dallas, Texas, USA

    Zhaogang Yang

Authors
  1. Lixia Ma
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  2. Yue Zhou
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  3. Jia Zhang
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  4. Xi Yuan
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  5. Yimeng Zhao
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  6. Wei Gu
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  7. Jinhuo Pan
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  8. Zhaogang Yang
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  9. Tulin Lu
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  10. Guojun Yan
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Contributions

LM and YZ designed and conceptualized the study. JZ analyzed the data and drafted the manuscript. XY carried out the statistical analysis and interpreted the data. YZ and WG carried out animal experiments. ZY was responsible for data collection and preliminary analysis. TL and GY reviewed experimental protocols and revised the manuscript. All authors contributed to the article and approved the submitted version.

Corresponding author

Correspondence to Guojun Yan.

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Ethics Approval

All the experimental procedures followed the Nanjing University of Chinese Medicine (Approval Number: 202104A007), Nanjing, China.

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The authors declare no competing interests.

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Ma, L., Zhou, Y., Zhang, J. et al. Simultaneous Evaluation of Dissolution and Absorption Study of Compound Danshen Tablets and Capsules Based on Cellular Electrical Sensing Model. AAPS PharmSciTech 23, 290 (2022). https://doi.org/10.1208/s12249-022-02441-3

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