无糖型强力枇杷露的安全性评价研究  

Safety Evaluation of Sugar-free Qiangli Pipa Syrup

作　　者：陈昕昕 邵田莉 黄秋平[1] 张晓洁[1] 蔡溢 谌红献[1] CHEN Xinxin;SHAO Tianli;HUANG Qiuping;ZHANG Xiaojie;CAI Yi;SHEN Hongxian(Mental health Institute,The Second Xiangya Hospital of Central South University,Changsha 410011;Department of Psychiatry,Kangning Hospital of Shenzhen,Shenzhen 518000)

机构地区：[1]中南大学湘雅二医院精神卫生研究所,湖南长沙410011 [2]深圳市康宁医院精神科,广东深圳518000

出　　处：《中国药物滥用防治杂志》2021年第3期280-284,共5页Chinese Journal of Drug Abuse Prevention and Treatment

基　　金：横向课题“无糖型强力枇杷露的成瘾性评价实验”。

摘　　要：目的:研究无糖型强力枇杷露对雌性Sprague Dawley(SD)大鼠的急性毒副作用,测出半数致死量(Median Lethal Dose,LD50),并对该药物进行安全性评价,为临床使用的安全性提供实验证据。方法:选取健康未孕的成年雌性SD大鼠,实验组予以10倍浓缩无糖型强力枇杷露,对照组则予以10倍浓缩的溶媒试剂,用序贯法测得药物LD50。在实验过程中观察实验组和对照组SD大鼠的行为变化,实验结束后予以解剖,观察各器官的结构变化并予以记录。结果:雌性SD大鼠无糖型强力枇杷露的LD50约为1122 mL·kg^(-1),与对照组相比,实验组SD大鼠腹部隆起,可触及肠型,行为反射出现抑制。解剖死亡的实验组SD大鼠,发现肺叶萎缩,胃肠道有药液滞留,膀胱充盈,对照组及存活的实验组SD大鼠解剖后未见上述组织器官表现。结论:无糖型强力枇杷露的LD50约为1122 mL·kg^(-1),毒性分级为低毒等级,过量的无糖型强力枇杷露会引起呼吸抑制、胃肠蠕动减慢和尿潴留。临床使用时要严格根据使用说明书及医嘱服药。Objective:To explore the acute toxic and side effects of Sugar-free Qiangli Pipa syrup on Sprague Dawley(SD)rats,measure the median lethal dose(LD50),evaluate the safety of the medicine,and provide experience and evidence for the safety of clinical use.Methods:Healthy adult female SD rats were selected,the experimental group was given 10 times concentrated sugar-free Qiangli Pipa syrup,while the control group was given 10 times concentrated menstruum.The LD50 of the drug was measured by up-and-down procedure.The changes of SD rats were observed during the experiment;and these SD rats were dissected after the experiment,and the changes of each organ were recorded.Results:The LD50 of Sugarfree Qiangli Pipa syrup is about 1122 mL·kg^(-1).Compared with the control group,SD rats in the experimental group were found abdominal bulge,palpable intestinal type and inhibition of behavioral reflex.After dissecting the dead SD rats in the experimental group,it was found that the lung lobes were atrophied,the gastrointestinal tract was stagnated,and the bladder was filled.The above findings were not found in the surviving SD rats.Conclusion:The LD50 of the Sugar-free Qiangli Pipa syrup is about 1122 mL·kg^(-1),and the toxicity is classified as low toxicity.Gastrointestinal peristalsis,respiration,urinary tract and behavioral reflex of SD rats were suppressed after drinking high-dose medicine.Clinical use should be in strict accordance with the instructions and doctor’s advice.

关 键 词：无糖型强力枇杷露 序贯法 安全性 半数致死量 

分 类 号：R285.5[医药卫生—中药学]