兽用中草药复方参麻散安全性研究

Study on the safety of veterinary herbal preparation compound Shenma San

研究复方参麻散在临床应用中的安全性。选取148只小白鼠,灌胃给药进行急性毒性及蓄积性毒性试验。急性毒性试验采用简化寇式法测定半数致死量(LD_(50)),结果给药量即使达到小白鼠最大生理承受能力,仍未测出其LD_(50),说明LD_(50)>60 g/kg。最大给药量试验采用16 h 4次给药法,每次1 g/20 g,总剂量200 g/kg,以临床治疗量(1.2 g/kg)的166.7倍进行灌胃给药时,小白鼠无死亡,未见毒性反应,表明该药安全无毒、耐受性较高;采用递增法灌胃给药进行蓄积性毒性试验,以蓄积系数评价蓄积毒性,并测定比较试验组与对照组血液生化指标、体质量、脏器系数变化,肉眼观察各脏器(心、肝、脾、肺、肾)颜色、形态等组织病变,结果试验组所有小白鼠全部健活,且生长良好,呼吸、活动、饮食和排便均正常,口、鼻、眼均无异常分泌物。对照组与试验组血液生化指标及体质量、脏器系数差异不显著(P>0.05),且心、肝、脾、肺、肾、胃和肠的形态、颜色、质地均未见异常。蓄积系数K>5,属弱蓄积性或基本无蓄积性,表明复方参麻散不易发生蓄积中毒,临床应用安全。

To study the safety of veterinary herbal preparation compound Shenma San in clinical treatment,148 mice were lavaged for acute toxicity and accumulative toxicity test. The median lethal dose for acute was measured using Karber’s method.The results showed that LD50 could not be measured when the raising dosage reached the maximum physical capacity of mice,which meant LD50〉60 g/kg. The maximum dose test was carried out using 4 times in 16 hours,each 1 g/20 g,and total dose of 200 g/kg. Data showed that no death and no toxic reaction were found in the test group even though 166.7 times of the clinical therapeutic dose（1.2 g/kg） was administered to the mice,which suggested that compound Shenma San was non-toxic and had higher tolerance. To evaluate the accumulative toxicity,accumulative coefficient（K）was measured by gradually increasing doses,the blood biochemical index,the body weights and organ（heart,liver,spleen,lung and kidney） coefficients between experimental group and control group were tested,and the changes of color and shape of the organs： heart,liver,spleen,lung,kidney,stomach and intestine were observed. The results showed that the mice in the experimental groups were all survived,who grew well and were normal in respiration,activity,diet and defecation. No abnormal secretions were observed in the mouth,nose and eyes. The differences between control group and the experimental group were not significant（P 〉 0.05）,and the K value was over 5,which meant lightly accumulation or almost no accumulation. In conclusion,compound Shenma San is clinical safe and could not cause accumulative toxicity.