Preclinical safety of a bionic tiger bone capsule in Sprague-Dawley rats and beagle dogs.

BACKGROUND: Jintiange capsule is composed of bionic tiger bone powder and has similar ingredients to natural tiger bone. OBJECTIVE: To characterize the subacute toxicities of Jintiange capsule in rats and beagle dogs for preclinical safety assessment. METHODS: Suspensions of Jintiange capsule were given via gastric lavage over a 26-week period at low (500 mg/kg), mid (1500 mg/kg) and high doses (4000 mg/kg) in SD rats. Beagles were given by gastric lavage of suspensions of Jintiange capsule once daily for 6 days per week for 39 weeks at low (300 mg/kg), mid (900 mg/kg) or high dose (2000 mg/kg). RESULTS: Repeated gastric lavages of suspensions of Jintiange capsule at doses from 500 to 4000 mg/kg over 26 weeks caused no significant toxicity (No Observed Adverse Effect Level, NOAEL) in rats. In addition, repeated gastric lavages of suspensions of Jintiange capsule at doses from 300 to 2000 mg/kg over 39 weeks caused NOAEL in beagles. CONCLUSIONS: Jintiange capsule was safe in rats at a dose 66.7 times the clinically recommended dose and in beagles at 33.3 times the clinically recommended dose. Our subacute toxicity studies in rats and beagles demonstrated no apparent overall toxicities including haematotoxicities, hepatotoxicities and renal toxicities.