关键词: 呼宁散; 小鼠; 急性毒性; 亚急性毒性; 遗传毒性

Abstract: 【Objective】 The aim of this study was to determine the toxicity and safety of Huning powder and provide scientific basis for its clinical application in the treatment of chicken respiratory disease syndrome.【Method】 In the acute toxicity test,24 mice were randomly divided into control group and Huning powder low,medium and high doses of groups.Mice in Huning powder low,medium and high dose groups were given 2.5,5 and 10 g/kg BW Huning powder once with 0.2 mL/10 g BW,respectively,while mice in control group were given equal volume of sterilized distilled water.The toxicity and death of the mice were observed for 7 days.In the maximum dose test,20 mice were randomly divided into control group and test group.Mice in test group were given 10 g/kg BW Huning powder with 0.2 mL/10 g BW for 4 times within 24 h,mice in control group were given equal volume of sterilized distilled water.On the 15th day of the trial,the body weight was recorded and the pathological changes of main organs were observed.In the subacute toxicity test,40 mice were randomly divided into control group and Huning powder low,medium and high doses of groups (2.5,5 and 10 g/kg BW),all mice were administered continuously for 28 days,at 12 h after the last administer,mice were weighed,blood was collected,dissected and the heart,liver,spleen,lung and kidney were collected,the change of body weight and organ coefficient of mice were calculated,the contents of tumor necrosis factor-α (TNF-α),interleukin-4 (IL-4) and IL-6 in serum of mice were determined and histopathological examination was performed for the heart,liver,spleen,lung and kidney.In the bone marrow micronucleus test,50 mice were randomly divided into control group,positive control group (cyclophosphamide 40 mg/kg BW) and Huning powder low,medium and high doses of groups (2.5,5 and 10 g/kg BW),mice in each group were administered 2 times (interval 24 h),at 6 h after the last administer,mice were sacrificed and bone marrow smears were made,the rate of micronucleus and PCE/NCE value were calculated.In the sperm abnormality test,25 male mice were randomly divided into control group,positive control group (cyclophosphamide 40 mg/kg BW) and Huning powder low,medium and high doses of groups (2.5,5 and 10 g/kg BW),administered once a day for 5 days,the mice were sacrificed on day 35 after first administer and sperm smears were made,the rate of sperm deformity was calculated.【Result】 In the acute toxicity test,all mice in each group were survived without any toxic symptoms,and the LD₅₀ of Huning powder was not obtained,the maximum tolerance of Huning powder in mice was 40 g/kg BW,indicating that the Huning powder was safe and had no acute toxicity.In the subacute toxicity test,compared with male mice in control group,the weight of mice in Huning powder low dose group were significantly increased on the 7th day of administration (P＜0.05),the weight of mice in Huning powder medium dose group were extremely significantly increased on the 28th day of administration (P＜0.01),and Huning powder had no significant effect on the main organ coefficients and cytokine contents of mice in each group (P＞0.05),necropsy and pathological examination showed no obvious abnormal changes,indicating that Huning powder had no subacute toxicity.In the bone marrow micronucleus test and sperm abnormality test,Huning powder did not affect the bone marrow micronucleus rate and sperm deformity rate of mice (P＞0.05),and the PCE/NCE values were all within the normal range,indicating that Huning powder had no genetic toxicity.【Conclusion】 Huning powder at the dose 10 g/kg BW and below was safe and nontoxic.

Key words: Huning powder; mice; acute toxity; subcaute toxicity; genetic toxicity