壮药复方铁草胶囊毒理学研究  

Toxicologic Study on Fufang Tiecao Capsule

作　　者：钟鸣 周智 余胜民 吴植强 韦奇志 汤祖青 张赞 吴超权 

机构地区：[1]广西民族医药研究院,南宁530001 [2]广西食品药品检验所,南宁530021

出　　处：《中国实验方剂学杂志》2011年第1期173-177,共5页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：国家科技支撑计划项目课题(2006BAI06A17)

摘　　要：目的:观察动物ig复方铁草胶囊的急性毒性和长期毒性,确定无毒反应的剂量,以评估复方铁草胶囊长期用药的安全性。方法:以复方铁草胶囊浸膏24 h内分2次给小鼠灌胃投药;按原生药48,24,12 g.kg-1的剂量(临床拟用日剂量的75,37,19倍)分别给大鼠连续灌服复方铁草胶囊原生药浸膏6个月,分阶段观察大鼠的生长发育,摄食量,血液学及血液生化学指征,脏器系数及组织病理学检查。结果:小鼠1 d内2次ig复方铁草胶囊浸膏的最大给药量为原生药174.8 g.kg-1,未见出现明显的急性毒性反应。长期毒性试验48,24 g.kg-1剂量组出现红细胞(RBC),血红蛋白(HGB),红细胞平均血红蛋白浓度(MCHC)降低,网织红细胞(RET),平均红细胞体积(MCV),血常规指标(MCH),总胆红素(T-Bil)(主要是直接胆红素D-Bil)增高,肝脏和脾脏指数增高,个别肝脏枯否氏细胞增生伴较多含铁血黄素形成,较多的脾脏瘀血肿大伴含铁血黄素形成,这些现象在停药4周后基本消失。结论:ig复方铁草胶囊浸膏对小鼠无明显急性毒性反应。大鼠连续ig复方铁草胶囊浸膏6个月,在较大剂量时可能引起轻度红细胞破坏,停药后可消失;无其他明显的慢性毒性反应和延缓毒性反应。Objective： To observe the acute toxicity Fufang Tiecao capsule in rats and determine the safety dosage window. Therefore, we evaluated the safety of long-term prescription. Method： Given the extract of Fufang Tiecao capsule to the rats two times a day, and the extract of crude drug in whole was given to rats for six months at a dosage of 48,24,12 g. kg^-1（as the 75, 37 and 29 times of clinical use daily dose）. Moreover, observed the growth and development, food intake, the indication of hematology and blood biochemical analysis, organ coefficient and histopathology. Result： there was not appeared the obvious acute toxic reaction on the rats, which were given the most tolerance dose two times a day, the dose groups of 48, 24 g· kg^- 1 were found the reduction of PBC, HGB, MCHC, and the elevation of liver index, spleen index, RET, MCV, MCH and T-Bil（especially for the T-Bil）. Individual liver cell of kupffer appeared the hyperplasia and formed hemosiderin, however; the spleen appeared the congestion and tumefaction, the hemosiderin was formed. The above phenomenon almost disappeared after four weeks of stopping treatment. Conclusion： There was no obvious acute toxic reaction for the rats which were given the extract of Fufang Tiecao capsule. The higher drug dosage probably caused the mild destruction of rats erythrocytes in six months. It disappeared after the stopping treatment. There was no obvious chronic toxicity reaction and delay toxicity reaction on the rats.

关 键 词：复方铁草胶囊 毒理学研究 动物实验 

分 类 号：R282.7[医药卫生—中药学]