Quality control of Shuanghuanglian freeze-dried powder for injection based on its HPLC-ELSD fingerprints and biological profiles

This paper is aimed to provide the methods of quality control and bioassay of traditional Chinese medicine injections including bioassay method.  Shuanghuanglian freeze-dried powder for injection (SFPI)  was chosen as study object.  HPLC-ELSD fingerprints of SFPI had been established and the samples were   differentiated by similarity calculation.  Meanwhile, biological profiles of SFPI on Escherichia coli had been established by microcalorimetry.  The similarity values were calculated using the correlation coefficient, based

on quantitative thermo-kinetic parameters ( , T_j, I%).  The results indicated that HPLC-ELSD fingerprints,

which showed content changes of chemical components, could not monitor minimal variation of different   samples, especially that of biological pollutants, while biological profiles could sensitively detect antibiotic   activity alterations of the samples, which were kept under specific conditions.  In conclusion, characterized   by two-dimension, microcalorimetry could supply thermograms as biological profiles characterized to describe the bioactivity of drugs.  This study could clearly demonstrate that the correlative detection was proposed as an efficient strategy for quality control of SFPI, based on HPLC-ELSD fingerprints and biological profiles, which could detect quality fluctuation of samples early and quickly and predict the potential adverse drug events (ADE) for ensuring clinical safety.