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克方的急性毒性和长期毒性实验研究
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| 篇名： | 克方的急性毒性和长期毒性实验研究 |
| TITLE： | |
| 摘要： | 目的：考察克方的急性毒性和长期毒性，为其临床试验与合理用药提供参考。方法：将20只ICR小鼠随机分为克方组（350 g/kg）和正常对照组（饮用水），每组10只，每天ig给药2次（间隔8 h），连续14 d，进行急性毒性实验。将120只SD大鼠随机分为正常对照组（饮用水）和克方高、中、低剂量组[5、2.5、1.25 g（生药）/ml]，每组30只（♀♂各半），每天ig给药2次（间隔8 h），连续12周，进行长期毒性实验。结果：克方最大耐受量为350 g/kg，相当于临床人用量的140倍。与正常对照组比较，克方高剂量组大鼠体质量增长缓慢、摄食量减少（P＜0.05或P＜0.01）；雄性大鼠血中红细胞分布宽度、血红蛋白含量分布宽度、平均血红蛋白浓度降低，血小板平均体积、网织红细胞升高（P＜0.05或P＜0.01），但均在本实验室正常生理值范围内；克方高剂量组大鼠血中尿素氮、总胆红素、天冬氨酸转氨酶、丙氨酸转氨酶活性升高（P＜0.05或P＜0.01），恢复期大鼠未见异常；给药12周后，克方中、低剂量组大鼠凝血酶原时间缩短（P＜0.05或P＜0.01）；克方高剂量组发现8只大鼠膀胱黏膜上皮细胞轻、中度变性和坏死、脱落，恢复期无异常。结论：克方在临床140倍用量下对小鼠未见明显毒性作用。克方连续重复给药12周后，对大鼠肝脏、肾脏代谢有影响；具有一定的可逆性膀胱毒性；恢复期大鼠各项检查未见病变加深或迟发性病变。 |
| ABSTRACT： | OBJECTIVE： To investigate acute toxicity and long-term toxicity of Kefang （KF）， and to provide reference for clinical trial and rational drug use. METHODS： 20 ICR mice were randomly divided into KF group （350 g/kg） and normal control group （drinking water）， with 10 mice in each group； they were given relevant medicine intragastrically， twice a day （every 8 h）， for consecutive 14 d； acute toxicity test was conducted. 120 SD rats were randomly divided into normal control group （drinking water）， KF high-dose， medium-dose and low-dose groups [5， 2.5， 1.25 g （crude drug）/ml]， with 30 rats in each group （half male and half female）； treatment groups were given relevant medicine intragastrically twice a day （every 8 h）， for consecutive 12 weeks； long- term toxicity was conducted. RESULTS： The maximum tolerated dose of KF was 350 g/kg， which was equal to 140 times as clinical human dosage. Compared to normal control group， body weight of rats in KF high-dose group increased slowly and food intake decreased （P＜0.05 or P＜0.01）； red blood cell distribution width（RDW）， hemoglobin distribution width （HDW）， mean hemoglobin concentration（MCHC）of male rats were all decreased， while mean platelet volume （MPV） and reticulocyte （RET） were increased （P＜0.05 or P＜0.01）； these indicators were all in normal physiological range of our laboratory. BUN， TBIL， AST and ALT acitivies of KF high-dose groups increased （P＜0.05 or P＜0.01）， and no abnormal change was found during recovery period； 12 weeks after medication， prothrombin time of KF medium-dose and low-dose groups shortened （P＜0.05 or P＜0.01）； mild and middle degeneration and necrosis， denudation of bladder epithelial cells were found in 8 rats of KF high-dose group， no abnormality was found during recovery period. CONCLUSIONS： There was no obvious toxic effect on the mice in the dose of 140 times of the clinical dose. Continuous 12-week administration of KF will influence liver and renal metabolism of rats； KF shows reversibility toxicity to bladder. No deeper lesions or delayed lesions is found in rats during recovery period. |
| 期刊： | 2016年第27卷第34期 |
| 作者： | 张光际，杨凡，时乐，尹莲，徐立 |
| AUTHORS： | ZHANG Guangji，YANG Fan，SHI Le，YIN Lian，XU Li |
| 关键字： | 克方；急性毒性；长期毒性；大鼠；小鼠 |
| KEYWORDS： | Kefang； Acute toxicity； Long-term toxicity； Rat； Mice |
| 阅读数： | 346 次 |
| 本月下载数： | 4 次 |
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