This study aimed to assess the acute toxicity of Shizao decoction (SZD) in KM mice and its antitumor activity, offering insights into drug safety and antitumor efficacy. In experiments, specific pathogen-free (SPF) KM mice were administered either saline (as a blank control) or SZD, and the half-lethal dose (LD50) was determined. Additionally, SPF-grade SD rats were treated with SZD to produce SZD-medicated serum (SZD-MS). Assays, including the MTT method, lactic dehydrogenase (LDH) release, colony formation, and flow cytometry, were utilized to measure the inhibitory effects on cancer cell proliferation and induction of apoptosis. The toxicity tests revealed that none of the mice died after oral administration of SZD, rendering it impossible to establish an LD50 value. Notably, serum biochemistry results significantly diverged from those of the blank control group (P < 0.05). Histopathology, using hematoxylin and eosin (H&E) staining, unveiled that SZD exerted detectable damage on the liver and kidneys of the mice. In terms of antitumor activity, SZD-MS demonstrated a significant inhibition of proliferation in five tumor cell lines when compared to the vehicle control (P < 0.05, P < 0.01). This finding was further supported by the increased LDH release from H22 cells (P < 0.05), a reduction in colony formation (P < 0.05, P < 0.01), and an elevated apoptosis rate (P < 0.01). In conclusion, the study revealed that the maximum oral dosage of SZD, set at 0.8 mL/d for each mouse (roughly 120 times the standard adult daily dose), presented minimal toxicity. Moreover, it possessed promising anti-ascite tumor activity, suggesting its safety and therapeutic potential.
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