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目的:观察金丝桃苷对大鼠的长期毒性反应,评价金丝桃苷的安全性,为临床剂量的拟定提供依据。方法:健康Wistar大鼠160只,雌雄各半。按体重随机分为对照组和低、中、高(30,175,1000 mg.kg-1.d-1)剂量组,每周给药6 d,连续给药6个月。停药后留取部分动物继续观察1个月。分阶段考察大鼠的一般症状、体重、耗料量、血液学指标、血清生化学指标,动物剖检,对主要脏器进行称重、计算脏器系数,进行组织病理学检查。结果:长期毒性实验中与同期对照组比较,金丝桃苷低、中、高3个剂量组动物行为活动、体重增长、耗料量等均未见明显异常,血液学指标、血液生化指标、脏器系数及病理组织学检查发现肾脏是可能的毒性靶器官,但肾脏损害是可逆的,停药后可以恢复正常。结论:金丝桃苷具有较好的安全性,肾脏是可能的毒性靶器官,但损害是可逆的,建议临床使用时定期进行血液学和肾功能指标监测。
OBJECTIVE: To observe the long-term toxicity of hyperoside to rats and evaluate the safety of hyperoside to provide the basis for the formulation of clinical dose. Methods: 160 healthy Wistar rats, half male and half female. The rats were randomly divided into control group and low, medium and high dose groups (30,175,1000 mg.kg-1.d-1) according to their body weight. They were given 6-week weekly for 6 months. After stopping taking some animals continue to observe 1 month. The symptoms, body weight, consumption amount, hematological indexes, serum biochemical indexes and animal autopsy of rats were investigated in stages. The main organs were weighed, the organ coefficients were calculated, and histopathological examination was performed. Results: Long-term toxicity test compared with the control group, hyperoside low, middle and high dose of three groups of animals behavioral activity, weight gain, consumption of materials were no significant abnormalities, hematological indicators, blood biochemical parameters, Organ coefficient and histopathological examination revealed that the kidney is a possible toxic target organ, but the renal damage is reversible and can resume normal after stopping. Conclusion: Hyperoside has good safety. Kidney is a possible toxic target organ, but the damage is reversible. It is recommended that hematology and renal function indicators should be monitored periodically during clinical use.