摘要
目的:观察大鼠和小鼠口服同仁牛黄清心丸的急性毒性及长期毒性作用,为临床试验设计人用安全剂量和主要观察指标提供参考。方法:以SPF级ICR小鼠测定最大给药量的急性毒性试验;用SPF级SD大鼠进行长期毒性试验,160只大鼠按性别与体重随机分为对照组和同仁牛黄清心丸高[3.06 g生药/(kg·d)]、中[1.53 g生药/(kg·d)]、低[0.77 g生药/(kg·d)]剂量组,每日按1.0 m L/100g灌胃给药1次,每周给药6 d,连续灌胃26周,并分别于给药13、26周和停药4周时分批处死动物,观察大鼠的一般行为、体重增长、食量消耗,进行血常规及血液生化学指标、尿常规检查、系统尸解及组织病理学诊断。结果:小鼠体重增长、摄食量及大体解剖与空白对照组比较均无明显差异,试验过程中未见动物死亡。长期毒性各给药组大鼠的外观体征、行为活动、粪便性状及摄食量等未见明显异常,各剂量组的血常规、生化学、脏器指数等指标与对照组比较均无明显差异;病理学检查对照组及给药组均有少数动物个别组织出现异常,但与对照组比较,各给药组均未出现相关毒性病理病变。结论:小鼠灌胃同仁牛黄清心丸允许的最大给药量为28.235 g生药/(kg·d),相当于人日用剂量的461倍;在本实验条件下大鼠口服同仁牛黄清心丸高[3.06 g生药/(kg·d)]、中[1.53 g生药/kg·d]、低[0.77 g生药/(kg·d)]剂量组26周均未见明显毒性反应,该剂量下同仁牛黄清心丸对SD大鼠无明显毒性作用。
Objective： To study the acute and chronic toxicity of Tongren Niuhuang Qingxin Pills （同仁牛黄清心丸, NHQX） and to provide the reference for clinical medication. Methods： The acute toxicity of NHQX was studied in ICR mice with the maximal dose： the 160 rats were randomized into high dosage group [3.06g/（kg·d）], moderate dosage group [1.53 g/（kg·d）], low dosage group [0.77 g/（kg·d）] and control group to observe the chronic toxicity of NHQX, following 26 weeks continuum oral administration at a dosage of 1.0 mL per 100 g body weight per day in rats, general status, parameters of hematology, blood biochemistry and histopathology observation were measured to evaluate the toxicity. Results： Compared with control group, No significant differences were observed in rat＇s behaviors, food intake and relative examination indexes, such as routine control of blood, blood biochemistry, and urinalysis and organ coefficient. Conclusion： The maximal dose is 28.235 g/（kg·d） with single ir- rigation of NHQX in mice, which was 461 times the recommended human dose in the clinic practice; Under these experimental conditions, the high dosage group [3.06 g/（kg·d）], moderate dosage group [1.53 g/（kg·d）] and low dosage group[0.77 g/（kg·d）] rats of NHQX were not observed side -effects in 26 weeks administration. This administration showed no obvious toxic effect in rats.
出处
《中医药导报》
2015年第5期38-41,共4页
Guiding Journal of Traditional Chinese Medicine and Pharmacy
关键词
同仁牛黄清心丸
急性毒性
长期毒性
Tongren Niuhuang Qingxin Pills （NHQX）
acute toxicity
chronic toxicity
