Biological fingerprinting based on microcalorimetry.

Traditional Chinese medicine (TCM) injections have been used as valuable preparations of herbal medicines. However, minor quality variation of TCM injections in the storage and transportation often results in adverse drug reactions and adverse drug events. In this study, biothermal dynamic test combined with chemical analysis was applied to monitor the consistency and stability of TCM injections. Shuang- huang- lian freeze-dried powder for injection (SHLPI) was selected as a representative herbal injection. Ten batches of normal samples and nine batches of artificially abnormal samples were collected. High-performance liquid chromatography (HPLC) fingerprinting was frequently used to characterize the chemical composition of TCM injections. However, it could not monitor minor quality fluctuation of the samples under special conditions such as lighting, high temperature, and bacterial contamination. The biological activity of SHLPI on the growth of Staphylococcus aureus was detected and then analyzed with chemometric methods including similarity evaluation and partial least-squared discriminant analysis. The similarity of abnormal samples in HPLC fingerprinting was > 0.99, whereas most of the abnormal samples in biological fingerprinting was 0.943-0.652, demonstrating the greater discriminating ability of biological fingerprinting. Our study demonstrated that biological fingerprinting is effective to monitor the quality fluctuation of TCM injections and could improve the quality control of herbal medicines. [ABSTRACT FROM AUTHOR]