Safety studies of Nexrutine, bark extract of Phellodendron amurense through repeated oral exposure to rats for 28 days.

Abstract Nexrutine (NX), a marketable herbal extract from a traditional Chinese herbal plant, Phellodendron amurense, is majorly used for the resolution of inflammation, gastroenteritis, and some tissue-specific cancer. Strategies for the identification of the safety of anticancer solutions of plant origin are an important area of study. The present investigation assesses the single and repeated dose (28 days) toxicity of NX following OECD guidelines 425 and 407, respectively. Briefly, to identify acute toxic properties of NX, a dose of 2000 mg/kg b. wt was administered once orally. Simultaneously, repeated dose toxicity was evaluated through daily administration of the three different doses (250, 500, 750 mg/kg b. wt) of NX for 28days. The single administration of NX showed no signs of toxicity and morbidity, suggesting LD50 of NX more than 2000 mg/kg b. wt. Furthermore, repeated dose exposure of NX for 28 days did not show any sign of toxicity. Hematology, serum biochemistry, and histopathological analysis also did not show any significant abnormalities. However, a marginal decrease in triglyceride, cholesterol, and glucose levels along with mild tubular degeneration in the kidney was also noticed in the high dose NX treatment group. Overall, the findings of the study suggest that NX is safe for use up to 500 mg/kg b.wt.