小儿定喘颗粒的急性毒性实验研究  

Acute Toxicity Testing of Pediatric Asthma-relieving Granules

作　　者：蔡壮 史俊祖 王雪峰[2] 杨建树 武瑞莉 CAI Zhuang;SHI Junzu;WANG Xuefeng;YANG Jianshu;WU Ruili(Liaoning University of Traditional Chinese Medicine,Shenyang 110847,Liaoning,China;The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine,Shenyang 110032,Liaoning,China)

机构地区：[1]辽宁中医药大学,辽宁沈阳110847 [2]辽宁中医药大学附属医院,辽宁沈阳110032

出　　处：《实用中医内科杂志》2024年第7期45-47,I0007,共4页Journal of Practical Traditional Chinese Internal Medicine

基　　金：国家自然科学基金项目(81973907);国家中医药管理局中医药循证能力建设项目(2019XZZX-LG006)。

摘　　要：目的观察小儿定喘颗粒对小鼠的急性毒性反应,为其临床安全应用提供实验依据。方法预试验分别灌胃给予Balb/c小鼠,剂量为655.2、491.4、327.6、163.8g/kg的小儿定喘颗粒水溶液,观察灌胃后各组小鼠的一般状态,根据小鼠死亡情况,计算半数致死量(LD50)。根据预实验结果进行最大耐受量试验:小儿定喘颗粒水溶液按照小鼠质量327.6g/kg进行灌胃,观察给药后小鼠外观、行为活动、分泌物、排泄物和体质量变化。给药14 d后取小鼠血清及脏器,进行组织病理学观察、血液生化指标检测。结果小鼠急性毒性预试验未获得半数致死量,最大耐受量实验观察期间无小鼠死亡,极量组外观、行为活动、分泌物、排泄物与空白对照组比较,差异均无统计学意义(P>0.05)。极量组小鼠脏器指数、体质量和血液生化指标与空白对照组比较,差异均无统计学意义(P>0.05)。结论小儿定喘颗粒小鼠灌胃给药最大耐受量为327.6 g/kg,为人临床用量的240倍,具有较高的临床用药安全性。Objective To observe the acute toxicity of pediatric asthma-relieving granules in mice,and to provide experimental basis for their clinical safety application.Method:Pre-test Balb/c mice were given gastric gavage at doses of 655.2,491.4,327.6 and 163.8g/kg in pediatric asthma-relieving granule aqueous solution,the general state of each group of mice after gavage was observed,and half of the lethal amount(LD50)was calculated according to the death of mice.According to the results of the pre-experiment,the maximum tolerance test was carried out:the aqueous solution of fixed asthma-relieving granules was gavaged according to the body weight of 327.6g/kg,and the appearance,behavioral activities,secretions,excretions and body weight changes of mice after administration were observed.After 14 days of administration,mouse serum and organs were taken for histopathological observation and blood biochemical index detection.Results Half of the lethal dose was not obtained in the acute toxicity pre-test of mice,no mice died during the observation period of the maximum tolerance experiment,and there was no significant difference in appearance,behavioral activity,secretion and excretion in the extreme group compared with the blank control group.There were no significant differences in organ index,body weight and blood biochemical indexes in the extreme group compared with the blank control group(P>0.05).Conclusion The maximum tolerated amount of gavage administration in children with asthma-relieving granules is 327.6 g/kg,which is 240 times the clinical dosage of humans,and has a high clinical drug safety.

关 键 词：小儿定喘颗粒 急性毒性 半数致死量 最大耐受量 

分 类 号：R287[医药卫生—中药学]