Abstract
Xueshuantong Lyophilized Powder (XST), consisting of a series of saponins extracted from Panax notoginseng, is widely applied to treat acute cerebral infarction, stroke, and coronary heart disease in China. However, most adverse drug reactions (ADR) in clinic are caused by quality problems of XST. In this study, six batches of certainly abnormal, four batches of possibly abnormal XST, and eight batches of normal XST were obtained from the clinical practice. Their quality fluctuations were identified by ultra-performance liquid chromatography coupled with an electrospray ionization quadrupole time-of-flight mass spectrometry operating in MSE mode (UPLC-QTOF/MSE) and bioassays including antithrombin and proplasmin assay. Fourteen potential components responsible for clinical ADR were identified by UPLC-QTOF/MSE, especially ginsenoside Rg1, Rg3, Rb1 and notoginsenoside R1. In addition, 83.3% (5/6) and 50.0% (3/6) certainly abnormal samples could be identified by UPLC-QTOF/MSE and bioassay, respectively. Interestingly, further integration of the two methods could entirely identify all the certainly abnormal samples and inferred that all the possibly abnormal samples were closely related to their quality fluctuation. It indicates that it is advisable to combine UPLC-QTOF/MSE and bioassay for identifying quality fluctuation of XST, and thus reduce its ADR in clinic.
Highlights
Herbal injections are one kind of the modern preparations derived from traditional Chinese medicine
Data from China Food and Drug Administration (CFDA) showed that 127 thousand cases of adverse drug reactions (ADR) were induced by herbal injections, and it is estimated to account for 53.7% of ADR induced by traditional Chinese medicine (China Food and Drug Administration, 2016)
The MSE data of Xueshuantong Lyophilized Powder (XST) samples in negative mode was chosen to be processed by Progenesis QI, because more comprehensive compound ions in XST samples could be detected in negative ionization, which had been proved to have higher sensitivity than positive mode (Wang et al, 2015)
Summary
Herbal injections are one kind of the modern preparations derived from traditional Chinese medicine. With their powerful and rapid therapeutic effects on specific diseases (e.g., cardiovascular disease, cancer), herbal injections are attracting more and more attention in mainland China, Hong Kong, and Taiwan (Normile, 2003; Luo et al, 2015). The Chinese Government is deeply concerned about the considerable number of ADR caused by the quality problem of herbal injections and has made an announcement to improve their quality standards (General Office of the State Council of the People’s Republic of China, 2017; Xu et al, 2018). It is important to develop the quality standards of herbal injections to ensure their clinical safety
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