Quality fluctuation detection of an herbal injection based on biological fingerprint combined with chemical fingerprint

Abstract

Herbal injection is one of the most important preparations of traditional Chinese medicine. More than 130 types of herbal injections are used clinically for 400 million patients annually with total sales of over four billion US dollars per year. However, the current quality control (QC) methods relying mainly on chemical fingerprints (CF) can hardly ensure quality and safety of the herbal injections with complex chemical composition and have resulted in an increase in serious adverse drug reactions. In this study, a comprehensive approach for the QC of a controversial herbal injection Shuang-Huang-Lian lyophilized powder (SHL) was established based on the quality fluctuation detection by a combination of CF and biological fingerprint (BF). High-performance liquid chromatography and the impedance-based xCELLigence system were applied to establish the CF and BF, respectively. In addition, multivariate analysis was performed to evaluate the discriminant ability of the two methods. The results showed that being subjected to environmental influence like oxygen/air, high temperature, and extreme illumination could lead to quality fluctuation of SHL. The combination of chemical and biological fingerprint method is a more powerful tool for the QC of SHL because it can clearly discriminate different groups of abnormal samples. This method can be used for the detection of quality fluctuation of SHL and can provide reference for the quality control of other herbal injections.

A multiple biomarker assay for quality assessment of botanical drugs using a versatile microfluidic chip

“…Consequently, there is rising interest in introducing biological assays that reflect the drug’s known or intended mechanism of action as a complement to chemical analysis 8 . These approaches can be separated into two primary categories: those that evaluate the biological consistency by similarity analysis of gene/protein expression profiling 9 – 11 or biofingerprinting 12 , 13 ; and those that directly measure bioactivity of a drug on enzymes, cells, microorganisms or animals using a single biological parameter 14 – 17 . However, bioassays addressing a single pharmacological activity may not fully account for the efficacy of botanical drugs.…”

Quality consistency evaluation of commercial transfer factor injections by chromatographic fingerprint combined with multivariate statistical analysis

“…Fingerprinting can be carried out using both chromatographic and spectroscopic techniques, and the chromatographic approach, especially HPLC, is regarded as one of the most potential and reliable means. It has been internationally acknowledged as one of the most efficient methods for the quality control and batch-to-batch consistency of complex matrices [23][24][25][26][27]. Consequently, the method might be more valid and efficient than the current quality control standards in quality evaluation of multicomponent biochemical injections.…”

UPLC-QTOF/MSE and Bioassay Are Available Approaches for Identifying Quality Fluctuation of Xueshuantong Lyophilized Powder in Clinic

“…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 ). Currently, more than 130 types of herbal injections are applied clinically among about 400 million patients per year, generating approximately annual sales of four billion US dollars (Zhang et al, 2014 ). However, 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 ).…”