Abstract: Objective To evaluate the safety of Bushen Bitong Wan and provide a reference for the dosage design of safe clinical medications via acute and long-term toxicity tests in SD rats. Methods In the acute toxicity test, SD rats were administered with tolerated doses up to 12.0 g·kg^-1 by gavage twice daily. The rats were closely observed for toxic reactions. In the long-term toxicity test, 160 SD rats were divided into high-dose (6.0 g·kg^-1), medium-dose (3.0 g·kg^-1), low-dose (1.5 g·kg^-1) groups and a control group, with 40 rats in each. The rats were given the drug for 26 weeks, followed by 4 weeks of recovery. The test indicators involved body weight, feed consumption, hematological parameters, serum biochemistry, blood coagulation, urine parameters, and histopathological examination. Results In the acute toxicity test, the maximum tolerated dose of Bushen Bitong Wan in SD rats exceeded 12.0 g·kg^-1, equivalent to 94.38 times the intended clinical dose, but no obvious toxic or side effects were observed. In the long-term toxicity test, SD rats were given the extract powder of Bushen Bitong Wan by gavage for 26 weeks. The non-toxic response dose was 6.0 g (crude drug)·kg^-1, which was 47.19 times the intended clinical dose. Conclusion Under the conditions used in this test, Bushen Bitong Wan produces no obvious toxicity in the tested animals. Long-term oral administration is safe within the intended clinical dosage range and courses of treatment.

Key words: Bushen Bitong Wan, Acute Toxicity Test, Long-Term Toxicity Test, Non-Clinical Safety Evaluation, Rats