养血祛风止痛颗粒急性毒性检测及安全性评价

Acute toxicity testing and safety evaluation of Yangxue Qufeng Zhitong granules

目的:对ICR小鼠进行养血祛风止痛颗粒急性毒性试验并进行安全性评价。方法:本实验选用体重(18.0~20.0)g的ICR品系小鼠共40只,随机数字表法随机分成空白对照组(n=20)及实验组(n=20)。养血祛风止痛颗粒最大给药量耐受实验采用急性毒性实验限量法,实验组每只小鼠给予以3.6g生药/mL浓度、0.4mL/10(g·BW)体积灌胃给药,1日内灌注给药2次,日累积剂量为288g生药(kg·BW)(临床人日用最高剂量为1.07g生药/(kg·BW),相当于临床人日用最高剂量的270倍),空白对照组给同体积去离子水,持续灌注7d。观察动物反应、死亡率、外观、四肢活动、摄食、饮水、排泄等表现,连续观察7日后断颈法处死大鼠,对全部大鼠进行解剖和组织形态学观察。结果:实验小鼠全部健康存活,较治疗前体重显著增加,实验完成后,实验组与空白对照组比较差异未见统计学意义(P>0.05)。所有实验小鼠外观、四肢活动、摄食、饮水、排泄等方面未见到异常,未观察到显著急性中毒反应及小鼠死亡。与对照组相比,实验组心、肺、气管、肾、膀胱、肾上腺、大脑、小脑、脑干、脾、胸腺、睾丸、附睾、卵巢、食管、胃、小肠、大肠、肝、颌下腺、胰腺、甲状腺组织未见明显病理组织学差异。结论:养血祛风止痛颗粒经口灌胃半数致死量高于2.88×10^(5)mg/(kg·BW),提示其大剂量应用不具备明显毒性,养血祛风止痛颗粒实际为无毒化合物。

Objective:To conduct acute toxicity experiments and safety evaluations of Yangxue Qufeng Zhitong granules on ICR mice.Method:A total of 40 ICR strain mice weighing(18.0-2.0)g were selected for this experiment.They were randomLy divided into a blank control group(n=20)and an experimental group(n=20)using a random number table method.The maximum dose tolerance test of Yangxue Qufeng Zhitong Granules was conducted using the acute toxicity test limit method.Each mouse in the experimental group was given 3.6g of raw medicine/mL concentration and 0.4mL/10(g.BW)volume by gavage.The drug was administered twice a day with a daily cumulative dose of 288g of raw medicine/(kg·BW)(the highest daily dose for clinical people is 1.07g of raw medicine/(kg·BW),which is 270 times the highest daily dose for clinical people),while the blank control group was given the same volume of deionized water for 7 days.Observe animal reactions,mortality rate,appearance,limb movement,feeding,drinking,excretion,and other manifestations.After 7 consecutive days of observation,the rats were euthanized using the neck cutting method,and all rats were subjected to anatomical and histological observation.Result:All experimental mice survived healthy and significantly increased in weight compared to before treatment.After the experiment,there was no significant statistical difference between the experimental group and the blank control group(P>0.05).No abnormalities were observed in the appearance,limb movement,feeding,drinking water,and excretion of all experimental mice,and no significant acute toxic reactions or mouse deaths were observed.Compared with the control group,there were no significant histopathological differences observed in the heart,lungs,trachea,kidneys,bladder,adrenal gland,brain,cerebellum,brainstem,spleen,thymus,testes,epididymis,ovaries,esophagus,stomach,small intestine,large intestine,liver,submandibular gland,pancreas,and thyroid tissues of the experimental group.Conclusion:The median lethal dose of Yangxue Qufeng Zhitong Granules orally administered by gavage is higher than 2.88×10^(5)mg/(kg·BW),indicating that its high-dose application does not have significant toxicity.Yangxue Qufeng Zhitong Granules are actually non-toxic compounds.