Study on the Acute Toxicity and Effect of an Anti-tumor Traditional Chinese Medicine Compound Formulations on the Blood Physiological and Biochemical Indexes of Mice

PurposeTo study the safety of a traditional Chinese medicine compound formulation, and to provide a reference for clinical treatment of human tumor.

MethodThe acute toxicity, the maximum tolerated dose and the 28 d oral toxicity of the compound formulations were studied. The mice were given a dose of 0.2, 0.6, 1.8, 5.4, 16.2 g/kg (bw) at the same time for oral acute toxicity test. The maximum tolerated test extract with the concentrations of 1.25, 1.00, 0.80, 0.64, 0.51 g/mL 0.04 mL/g (bw) was administered orally to the mice in each group within 3 hours, and the mice were continuously observed for 7 days. Forty mice were randomly divided into high, medium, low and control dose group. In the control group, the compound preparations of different concentrations 15, 7.5, 3.75, 0 g/kg (bw) were administered for 28 days, and the blood physiological and biochemical indexes of the mice were determined.

ResultThe results of acute toxicity showed that the crude extract of the compound preparation had an oral tolerance of LD₅₀>5 g/kg (bw), and the maximum tolerance of the mice was 150 g/kg (bw), and the maximum tolerated dose was 1 050 times of the human dose. The body weight and blood physiological indexes of the mice in each group were not significantly different (P>0.05). The blood biochemical parameters only showed significant difference between the LDH and the control, low and high dose groups (P<0.05), and there were no significant differences in GPT, GOT, Cr and BUN (P>0.05).

ConclusionThe compound preparation has no toxic effect, has no effect on blood physiological and biochemical indexes, and is safe for clinical use.