Abstract
Fingerprinting is widely and commonly used in the quality control of traditional Chinese medicine (TCM) injections. However, current studies informed that the fingerprint similarity evaluation was less sensitive and easily generated false positive results. For this reason, a novel and practical chromatographic “Fingerprint-ROC-SVM” strategy was established by using KuDieZi (KDZ) injection as a case study in the present article. Firstly, the chromatographic fingerprints of KDZ injection were obtained by UPLC and the common characteristic peaks were identified with UPLC/Q-TOF-MS under the same chromatographic conditions. Then, the receiver operating characteristic (ROC) curve was used to optimize common characteristic peaks by the AUCs value greater than 0.7. Finally, a support vector machine (SVM) model, with the accuracy of 97.06%, was established by the optimized characteristic peaks and applied to monitor the quality of KDZ injection. As a result, the established model could sensitively and accurately distinguish the qualified products (QPs) with the unqualified products (UPs), high-temperature processed samples (HTPs) and high-illumination processed samples (HIPs) of KDZ injection, and the prediction accuracy was 100.00%, 93.75% and 100.00%, respectively. Furthermore, through the comparison with other chemometrics methods, the superiority of the novel analytical strategy was more prominent. It indicated that the novel and practical chromatographic “Fingerprint-ROC-SVM” strategy could be further applied to facilitate the development of the quality analysis of TCM injections.
Highlights
Traditional Chinese medicine (TCM) injections had been regarded as a “double-edge sword” in recent years [1], because they cand provide quick efficacy, but have dramatic safety risks
On the basis that the fingerprint similarity evaluation could not distinguish between qualified products (QPs) and unqualified products (UPs) samples, the novel chemometrics method, combined receiver operating characteristic (ROC) and support vector machine (SVM), was used in the established analytical strategy
The characteristic peaks in fingerprints were optimized by AUCs value greater than 0.7 in the ROC curve; the optimized characteristic peaks were used to establish the SVM prediction model
Summary
Traditional Chinese medicine (TCM) injections had been regarded as a “double-edge sword” in recent years [1], because they cand provide quick efficacy, but have dramatic safety risks. The epidemic exploration has indicated that the adverse drug reactions (ADRs) of TCM injections occur frequently, which account for over 70% ADRs of TCM [2]. For the purpose of improving the safety of TCM injections, re-evaluation the safety of TCM injections (RESTI) was prescribed by the China Food. As the quality of TCM injections is the key guarantee of safety, the quality of TCM injections is(CFDA). As theimportant quality of TCM injections is the key guaranteeit isofwell known the control storage of condition of TCM injections is much more stringent than other. TCM injections is an extremely important component of RESTI. Itwhich is wellindicates known that thethe storage condition of TCM injections is much more stringent than preparations, that stability of quality is closely related to the safety
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