<p>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 (<i>P</i> ≤ 0.01) and reduced urinary pH (<i>P</i> ≤ 0.05) were noted in the high-dose group, with no significant differences in organ coefficients or histopathology across groups (<i>P</i> &gt; 0.05). <i>Puerarin</i> and <i>icariin</i> plasma concentrations showed dose proportionality, without notable differences in tissue exposure or accumulation (<i>P</i> &gt; 0.05). SGBSC has a favorable renal-gonadal axis safety profile in Beagle dogs, supporting its clinical safety.</p>

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

  • Zhaojun Yang,
  • Chong Zhang,
  • Huijuan Dong,
  • Changbing Pu,
  • Juan Hao,
  • Xiaoli Zhang

摘要

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.