Abstract
The safety of herbal medicine products has been a widespread concern due to their complex chemical nature and lack of proper evaluation methods. We have adapted a sensitive and reproducible multiparametric cell-based high-content analysis assay to evaluate the hepatic-safety of four Chinese medicine injections and validated it with classical animal-based toxicity assays. Our results suggested that the reported hepatotoxicity by one of the drugs, Fufangkushen injection, could be attributed at least in part to the interference of mitochondrial function in human HepG2 cells by some of its constituents. This method should be useful for both preclinical screen in a drug discovery program and postclinical evaluation of herbal medicine preparations.
Highlights
Traditional Chinese medicine (TCM) injection is an innovative and quick-acting dosage form of herbal medicine products
Xiangdan injection (XDI) and Mailuoning injection (MLNI) were reported in adverse drug reaction (ADR) information bulletin by SFDA [8, 9]
The four TCM injections investigated in this study were widely used in clinical practice in China with large patient population
Summary
Traditional Chinese medicine (TCM) injection is an innovative and quick-acting dosage form of herbal medicine products. It plays a significant role in clinical treatment of acute, severe syndromes in China. The safety of TCM injection has been a long concern of the public, especially after consecutive reports of adverse drug reaction (ADR) recently. The ADR induced by TCM injection accounts for 77.2% of all the ADR induced by TCM in national ADR case report database [1]. Drug-induced hepatotoxicity accounts for one-half of cases of acute liver failure in America and Great Britain [3]. A more precise, rapid, and high-throughput method to evaluate the hepatotoxicity of drugs, especially for TCM injection, was needed
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