如意珍宝丸对KM小鼠的急毒试验研究  

Research on Acute Toxicity Test of Ruyi Zhenbao Pill in Mice

作　　者：李啟恩 袁发荣 窦勤 郭肖 Li Qien;Yuan Farong;Dou Qin;Guo Xiao(Tibetan Medical Research Center,Qinghai University,Xining 810016,China;Tibetan Medical College,Qinghai University,Xining 810016,China;Arura Tibetan Medicine Co.,Ltd.,Xining 810016,China;Xinjiang Institute of Traditional Uyghur Medicine,Urumqi 830001,China)

机构地区：[1]青海大学藏医药研究中心,西宁810016 [2]青海大学藏医学院,西宁810016 [3]金诃藏药股份有限公司,西宁810016 [4]新疆维吾尔自治区维吾尔医药研究所,乌鲁木齐830001

出　　处：《青海科技》2023年第1期67-72,共6页Qinghai Science and Technology

基　　金：青海省重大科技专项“重点藏药品种有效性研究与安全性评价”(2020-SF-A3-2)。

摘　　要：目的:开展如意珍宝丸经口给予小鼠的急性毒性试验,观察其在最大浓度、最大给药量下所产生的毒性反应及其严重程度、潜伏期及持续时间,以及死亡情况,以期阐明如意珍宝丸经口给予小鼠急性毒性试验的毒性作用,为长期毒性试验的剂量设计和临床用药提供参考。方法:如意珍宝丸以最大配制浓度29.4%、最大给药体积40 ml/Kg,1日2次,累加剂量23.5 g生药/Kg,经口给予KM小鼠,进行急性毒性观察。结果:整个试验期间,对照(CN)组和如意珍宝丸(RY)组小鼠均未发生死亡。RY组小鼠第1次和第2次给药后出现0.5 h左右的腹卧,之后慢慢开始活动和进食。CN组和RY组小鼠的行为活动未见其他异常。与CN组比较,RY组小鼠的体重和摄食量均未见明显改变,解剖观察未见脏器明显异常。结论:如意珍宝丸以最大配制浓度29.4%、最大给药体积40 ml/Kg,1日2次,累加剂量为23.5 g生药/Kg的前提下,经口给予KM小鼠14天后,未出现明显的毒性反应,其对小鼠的最大无毒性剂量为23.5 g生药/Kg,为临床量的294倍。Objective:Observe the toxicity,severity,incubation period,duration and death of Ruyi Zhenbao Pill at the maximum concentration and dosage.The purpose of this study is to clarify the toxicity of Ruyi Zhenbao Pill in the acute toxicity test of mice by oral administration,and to provide reference for the dose design of long-term toxicity test and clinical medication.Methods:Ruyi Zhenbao Pill was orally administered to KM mice twice a day with the maximum concentration of 29.4%and the maximum dose volume of 40 ml/Kg,the cumulative dose of 23.5g crude drug/Kg,for acute toxicity observation.Results:During the whole test period,no death occurred in the control(CN)and Ruyi Zhenbao Pill(RY)groups.The mice in RY group were prone to abdominal lying for about 0.5 h after the first and second administration,and then slowly began to move and eat.There was no other abnormality in the behavior of mice in CN and RY groups.Compared with the CN group,there was no significant change in body weight and food intake.Anatomical observation showed no obvious abnormality of organs.Conclusion:Ruyi Zhenbao Pill has no obvious toxic reaction after 14 days of oral administration to KM mice at the maximum concentration of 29.4%,the maximum administration volume of 40ml/Kg,twice a day,and the cumulative dose of 23.5g/Kg.The maximum non-toxic dose of Ruyi Zhenbao Pill to mice is 23.5g/Kg,which is 294 times of the clinical dose.

关 键 词：藏药 如意珍宝丸 急性毒性试验 单次给药毒性 安全性评价 

分 类 号：R285.5[医药卫生—中药学]