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Preliminary Study on the Quality Consistency Evaluation of the Classic Prescription Danggui Buxue Tang based on DASS-RTCA Method
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Wufeng GAO1, 2, Jia ZHANG1, 2, Haiwen BIAN1, 2, Yue JIANG1, 2, Yali QI1, 2, Dezhi SHI1, 3, Lei BI4, Ling GU4, Guojun YAN1, 2, 3, *
Chinese Pharmaceutical Journal | 2024, 59(12) : 1110 - 1119
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Chinese Pharmaceutical Journal | 2024, 59(12): 1110-1119
Preliminary Study on the Quality Consistency Evaluation of the Classic Prescription Danggui Buxue Tang based on DASS-RTCA Method
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Wufeng GAO1, 2, Jia ZHANG1, 2, Haiwen BIAN1, 2, Yue JIANG1, 2, Yali QI1, 2, Dezhi SHI1, 3, Lei BI4, Ling GU4, Guojun YAN1, 2, 3, *
Affiliations
  • 1 School of Pharmacy, Nanjing University of Chinese Medicine, Nanjing 210023, China
  • 2 Jiangsu Provincial Engineering Research Center of Traditional Chinese Medicine External Medication Development and Application, Nanjing 210023, China
  • 3 Jiangsu Provincial Engineering Research Center of Classical Formula, Nanjing 210023, China
  • 4 School of Integrated Chinese and Western Medicine, Nanjing University of Chinese Medicine, Nanjing 210023, China
Published: 2024-06-22 doi: 10.11669/cpj.2024.12.006
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OBJECTIVE To establish a quality consistency evaluation method reflecting the overall pharmacodynamic characteristics of multi-batch Chinese medicine compound preparations. METHODS Establish a drug absorption simulating system(DASS) standardized absorption biomimetic system module using a flipped intestinal sac model, and prepare intestinal absorption samples of Danggui buxue tang from different sources and batches; Drawing on the concept of consistency evaluation of biopharmaceuticals, a cell biological effect characterization module was established using Real-time cell analysis(RTCA) to monitor the cell response curves of 15 batches of Danggui buxue tang samples. RESULTS The combination of DASS-RTCA was used to extract the characteristic parameters of time-dependent cell response patterns (TCRPs) maps from 15 batches of Danggui buxue tang samples. The RSD of each characteristic parameter was less than 5.1%, indicating that the differences in cell effect characterization of Danggui buxue tang (DBT) were small and the similarity of TCRPs maps was high. Through similarity analysis, cluster analysis, radar chart analysis, etc., it is reflected that the quality of different batches of DBT has high consistency. CONCLUSION The quality consistency evaluation method established by DASS-RTCA can reflect the overall quality of the preparations and provide new ideas and methods for the evaluation of batch-to-batch quality consistency of traditional Chinese medicines.

Danggui buxue tang  /  drug absorption simulating system  /  real time cell analysis  /  biological evaluation  /  consistency evaluation
Wufeng GAO, Jia ZHANG, Haiwen BIAN, Yue JIANG, Yali QI, Dezhi SHI, Lei BI, Ling GU, Guojun YAN. Preliminary Study on the Quality Consistency Evaluation of the Classic Prescription Danggui Buxue Tang based on DASS-RTCA Method[J]. Chinese Pharmaceutical Journal, 2024 , 59 (12) : 1110 -1119 . DOI: 10.11669/cpj.2024.12.006
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Year 2024 volume 59 Issue 12
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Article Info
doi: 10.11669/cpj.2024.12.006
  • Receive Date：2024-02-26
  • Online Date：2025-11-25
  • Published：2024-06-22
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  • Received：2024-02-26
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Affiliations
    1 School of Pharmacy, Nanjing University of Chinese Medicine, Nanjing 210023, China
    2 Jiangsu Provincial Engineering Research Center of Traditional Chinese Medicine External Medication Development and Application, Nanjing 210023, China
    3 Jiangsu Provincial Engineering Research Center of Classical Formula, Nanjing 210023, China
    4 School of Integrated Chinese and Western Medicine, Nanjing University of Chinese Medicine, Nanjing 210023, China
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表12种不同金属材料的力学参数
科
Family		 属数
Number of
genus		 种数
Number of
species		 占总种数比例
Percentage of
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Genus		 种数
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鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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