Abstract
Quality control of Chinese medicine injections remains a challenge due to our poor knowledge of their complex chemical profile. This study aims to investigate the chemical composition of one of the best-selling injections, Shenqi Fuzheng (SQ) injection (SQI), via a full component quantitative analysis. A total of 15 representative small molecular components of SQI were simultaneously determined using ultra-high performance liquid chromatography (UHPLC) coupled with quadrupole tandem time-of-flight mass spectrometry (Q-TOF-MS); saccharide composition of SQI was also quantitatively determined by high performance liquid chromatography (HPLC) with evaporative light scattering detector (ELSD) on an amino column before and after acid hydrolysis. The existence of polysaccharides was also examined on a gel permeation chromatography column. The method was well validated in terms of linearity, sensitivity, precision, accuracy and stability, and was successfully applied to analyze 13 SQI samples. The results demonstrate that up to 94.69% (w/w) of this injection product are quantitatively determined, in which small molecules and monosaccharide/sucrose account for 0.18%–0.21%, and 53.49%–58.2%, respectively. The quantitative information contributes to accumulating scientific evidence to better understand the therapy efficacy and safety of complex Chinese medicine injections.
Highlights
Quality control of herbal injection remains a challenge
In recent years, many herbal injection products have been licensed and marketed, whereas many medicine-injury incidents regarding adverse reactions caused by herbal injection have been reported
The established method demonstrated acceptable accuracy with spike recovery of 94.97%–106.59% for all analytes; and the RSDs of the peak areas for 15 analytes detected within 24 h were lower than 4.73%. These results suggested that the developed Ultra-Performance Liquid-Chromatography Tandem Mass Spectrometry (UPLC-MS) method was accurate and reliable for simultaneous quantitative determination of the 15 investigated compounds in Shenqi Fuzheng injection (SQI) injection
Summary
Quality control of herbal injection remains a challenge. Different from traditional Chinese patent drugs, herbal injection has a very short history. Born in the army hospital during war time [1], the first herbal injection (bupleurum injection) was initially created for the heavily injured soldiers when penicillin was severely short of supply. As both a great invention and a crazy risk, herbal injection has received a great deal of recognition and criticism over the past decades. Compared to other drug preparations, injection has more strict criteria for quality control. Qualitative and Molecules 2016, 21, 1092; doi:10.3390/molecules21081092 www.mdpi.com/journal/molecules
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