菖远胶囊给大鼠长期大剂量用药的安全性评价

目的：研究菖远胶囊对大鼠长期大量用药后的安全性影响。方法：通过对大鼠连续灌胃菖远胶囊13周、26周和停药4周,分别与正常对照组比较血液、生化、病理学检查结果。结果：①菖远胶囊各剂量组给药后5～30 min动物自主活动有所减弱,30 min后自主活动逐渐恢复正常,各剂量组大小便颜色偏深,高剂量组比较明显,停止给药后,上述症状均恢复正常;②大鼠血液细胞学、生化学指标中有个别指标在给药初期（13周）出现明显差异,继续给药至26周,未见明显异常,停止给药后恢复正常;高剂量组动物体重有一定降低,个别脏器质量及指数增大,停药4周后均能恢复正常;病理检查结果示,菖远胶囊各剂量组主要脏器未见由药物引起的病理学改变;整个实验期间各组动物未见死亡;③大鼠长期给予菖远胶囊的安全剂量为4.0 g/kg。结论：菖远胶囊对动物的毒性较低,是值得开发的一个中药新药。

Evaluation on the Safety of Changyuan Capsule on Rats with Large Dose and Long Term Administration

Objective： To observe the safety of Changyuan Capsule in rats after a long-term and large-dose administration. Methods： After Changyuan Capsules were fed to rats for 13 weeks, and 26 weeks, and a 4-weeks rest, we respectively compared the examination of blood, biochemical and pathological results with the control group. Remits： （1）The each dose trial group showed that rats spontaneous activity weakened after administration in 5-30 min, and spontaneous activity gradually returned to normal for each dose trial group after 30 min. The urination and defecation color for each dose trial group became deep, and high-dose group got more obvious. And after stopping administering, the above-mentioned symptoms returned to normal. （2）A few parameters in rat blood cytology and biochemistry showed significant differences after feeding for 13 weeks, but did not deteriorate continuing feeding from 13 weeks to 26 weeks, and these parameters returned to normal after stopping administration. The high dose （4.0 g/kg） group showed weight lessened, and the weight of individual organs and their indexes increased, and these returned to normal after stopping administration for 4 weeks. No pathological changes were observed to any key organs,nor was there any fatality of rats. （3）The long-term safety dose of Changyuan Capsule was 4.0 g/kg. Conclusion： Changyuan Capsules are little toxic to rats. Therefore, it is worthy of developing as a new kind of traditional Chinese medicine.