Preliminary Study on the Quality Consistency Evaluation of the Classic Prescription Danggui Buxue Tang based on DASS-RTCA Method
OBJECTIVE To establish a quality consistency evaluation method reflecting the overall pharmacodynamic characteris-tics 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 characteris-tic 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 reflec-ted that the quality of different batches of DBT has high consistency.CONCLUSION The quality consistency evaluation method es-tablished 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.
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万方数据
