Objective To observe the acute toxicity of Huangqi Yangxue Tiaojing formula (HYTF) in SD rats and evaluate its safety, and to provide evidence for clinical medication and subsequent research.

Methods A total of 20 SPF-grade SD rats (half male and half female) were randomly divided into HYTF administration group and blank control group, with 10 rats in each group. Rats in the HYTF administration group were administered the maximum feasible dose by intragastric gavage, while the blank control group received an equal volume of normal saline. Rats were observed continuously for 14 days, during which the general condition, body weight, food intake and estrous cycles of female rats were recorded daily. After the experiment, serum biochemical indicators of hepatic and renal function were measured; the main organs were weighed to calculate organ coefficients, and histopathological examination (HE staining) counting of ovarian follicles at various developmental stages were performed.

Results No death or obvious toxic reactions were observed in rats of both groups during administration. There were no intergroup differences in body weight and estrous cycle. The food intake of the HYTF administration group was significantly lower than that of the control group only on days 1-3 after administration (P < 0.01), and returned to normal in the following period. Organ and biochemical tests showed that the uterine organ coefficient in the HYTF administration group increased significantly (P < 0.05), while no statistically significant differences were found in other organ coefficients and hepatic and renal function indicators between groups (P > 0.05). No organic lesions were detected in organ pathological sections in either groups. HE staining of ovaries revealed that the number of preantral follicles in the HYTF administration group was markedly increased with richer follicle reserve.

Conclusion At the maximum feasible dose administered by intragastric gavage, HYTF showed no obvious acute toxicity, indicating reliable safety for medication. HYTF can increase the uterine organ coefficient and ovarian preantral follicle reserve in rats, exerting beneficial regulatory effects on the female reproductive system.

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