Chinese medicine preparation Pudilan anti-inflammatory oral liquid: Chemical constituents and developmental toxicity

Pudilan anti-inflammatory oral liquid (PDL) is a classical Chinese herbal formulation. Traditionally used to treat respiratory infections, sore throat, and mumps, it is widely administered in children and pregnant women due to its perceived safety. However, recent guidelines advise caution in these populations, raising concern about its developmental toxicity. This study investigates the chemical profile and embryotoxic effects of PDL to bridge traditional use with modern toxicological evaluation.

To identify the chemical constituents of PDL and evaluate its developmental toxicity, as well as elucidate potential toxicological mechanisms using a zebrafish embryo model.

The chemical composition of PDL was characterized using ultra-high performance liquid chromatography coupled with quadrupole time-of-flight mass spectrometry (UHPLC-QTOF-MS). Zebrafish (Danio rerio) embryos were exposed to various PDL concentrations. Developmental toxicity was assessed through mortality, malformation, hatching, heart rate, body length, spontaneous movement, and locomotor activity. Histological analysis, transcriptomic profiling, and qRT-PCR validation were conducted to explore underlying mechanisms.

Baicalin was identified as the dominant flavonoid, followed by baicalein and wogonin. PDL exposure induced dose-dependent developmental toxicity, including increased mortality, malformations, and impaired cardiac and behavioral functions. Transcriptomic analysis revealed dysregulation in cell cycle, DNA replication, and steroid biosynthesis pathways.

PDL exhibits significant embryotoxicity in zebrafish, potentially mediated by flavonoid-induced disruption of developmental pathways. These findings highlight the need for safety assessments of traditional formulations, particularly in vulnerable populations.