Background:
Zishen Tongguan (ZSTG) capsules were prepared at the Affiliated Hospital of Nanjing
University of Chinese Medicine and have been proven to be clinically effective for treating pyelonephritis and benign
prostatic hyperplasia. However, the quality standards are not ideal; a comprehensive study of the “quality markers”
(Q-markers), the chemicals inherent in traditional Chinese medicine and its preparations, has not been carried out.
Experimental Methods:
In this paper, a sensitive and specific ultra-high-performance liquid chromatographictandem
mass spectrometry (UHPLC-MS/MS) method was developed for the simultaneous determination of eight
potential Q-markers of ZSTG, including timosaponin A3, berberine, jatrorrhizine, phellodendrine, palmatine, mangiferin,
neomangiferin, and timosaponin BII. A Kromasil 100-3.5 C18 column was used with a mobile phase of 0.2%
formic acid with acetonitrile, and gradient elution at a flow rate of 0.2 mL/min was achieved in 13 minutes and used
for separation. Detection was performed in positive/negative mode with multiple reaction monitoring (MRM).
Results:
The analytical method was validated in terms of the sensitivity, linearity, accuracy, precision, repeatability,
stability and recovery. The method established here was successfully applied to study the potential Q-markers in 8
batches of commercial samples, which demonstrated its use in improving the quality control of ZSTG.
Conclusion:
The developed method had high repeatability and accuracy and was suitable for the simultaneous analysis
of multiple Q-markers, which may provide a new basis for the comprehensive assessment and overall quality
control of ZSTG.
A Strategy for Selecting “Q-Markers” of Chinese Medical Preparation via Components Transfer Process Analysis with Application to the Quality Control of Shengmai Injection