Evaluating the regulatory effects of Icariin and Puerarin combination from shenge bushen capsules on renal-gonadal axis in beagle dogs

This study investigated the effects of shenge bushen capsules (SGBSC) with varying bioactive component mass fractions on renal-gonadal axis function in 56 Beagle dogs, via organ toxicity evaluation, toxicokinetics and urinalysis. Animals were assigned to three dose groups and one control group, receiving 9-month dosing followed by a 4-week recovery, then anesthetized, euthanized and subjectedc to post-mortem examination. SGBSC induced no drug-related renal-gonadal axis toxicity at any dose. Transient elevated urine protein positivity ( P ≤ 0.01) and reduced urinary pH ( P ≤ 0.05) were noted in the high-dose group, with no significant differences in organ coefficients or histopathology across groups ( P > 0.05). Puerarin and icariin plasma concentrations showed dose proportionality, without notable differences in tissue exposure or accumulation ( P > 0.05). SGBSC has a favorable renal-gonadal axis safety profile in Beagle dogs, supporting its clinical safety.