强力镇痫丸的药物毒性研究及临床观察

目的观察强力镇痫丸的药物毒性。方法测定小白鼠LD50,观察其急性毒性反应。大鼠连续给药6个月并停药30天(恢复期)后分别采血,进行血常规以及肝肾功能检查;处死动物,取心、肝、脾、肺、肾、胃、十二指肠组织检查,观察大鼠的长期毒性反应以及毒性反应的可逆程度和可能出现的延迟性反应。并对患者进行长时间的临床观察。结果强力镇痫丸急性毒性和长期毒性试验,对动物的器官组织检查,未发现有毒性损害,脏器组织病理形态学无明显变化,血常规和肝、肾功能的各项检查指标与对照组比较,均无显著性差异(P>0.05)。临床观察,患者血常规和肝功能无异常变化,各组指标数值均在生理值范围内,均无显著性差异(P>0.05)。结论实验证明:强力镇痫丸大剂量(成人临床常用剂量的100倍、50倍)、长时间服用毒性低、安全可靠;临床常用剂量经患者服用,未发现毒副作用,对造血系统及肝功能无异常改变。

Study and clinical observation on toxicity of Qianglizhenxian pill

OBJECTIVE To observe the drug toxicity of Qianglizhenxian pill.METHODS LD_(50) was determined in mice.The drug had been given continuously for 6 months,and after 30 days the blood routine,liver and kidney function of the mice were test respectively,and the long-term toxic reaction,reversibility of them and the possible delayed reaction were test by examining the heart,liver,spleen,lung,kidney,stomach and duodenum of the executed animals.A long-term clinical observation also made on patients using the drug.RESULTS There are no acute and long-term toxic damage and obvious pathomorphologic changes in the organic tissue of the animals using the drug;also there is no significant difference in blood routine,liver and kidney function test between test group and the control group(P>0.05).Blood routine liver function index in patients using the drug are in the normal range,the difference was no signifficant(P>0.05).CONLUSION It was confimed that there was low toxicity after large dose of Qianglizhenxian pill(seperately 100 and 50 times of common dose).Also there was no side effect and abnormal changes in hematopoietic system and liver function patients taking common dose of the drug.