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目的:肾炎灵片是在传统中药基础上的创新药,是一个合理的雷公藤、黄芪复方配伍剂。观察肾炎灵片对普通Beagle犬的在体作用(3个月给药),为进一步长期毒性试验奠定基础,也为临床应用提供安全性资料。方法:根据肾炎灵临床治疗剂量和急性毒性试验结果,16只普通成年Beagle犬(雌雄各半)分低剂量(0.25g/kg)、中剂量(1.00g/kg)、高剂量(4.00g/kg)和对照(0.00g/kg)4组,给予连续服用3个月。治疗结束后麻醉取血,检查各主要脏器,并做病理观察。结果:实验动物治疗3个月后一般情况良好,无1例死亡,体质量和食量与对照组无显著差异。血液细胞学、生物化学的各项指标均在正常范围内,各剂量组与对照组比较无显著性差异(P>0.05)。各动物的心电图无异常变化。高剂量组雄性犬附睾精子计数减少。主要脏器组织学检查,质量系数无明显差异,高剂量组的雄性犬睾丸和附睾管腔内精子分布稀疏,数量减少。病理检查未发现明显异常。结论:研究结果表明,肾炎灵片在0.25～4.00g/kg剂量内灌胃给药3个月,受试犬不产生明显的积蓄性毒性反应,但大剂量肾炎灵片有一定生殖毒性。
Objective: Nephritis is an innovative medicine based on the traditional Chinese medicine is a reasonable Tripterygium, Astragalus compound compatibility agent. To observe the in vivo effect of Shenyinling tablets on common Beagle dogs (3 months), to lay the foundation for further long-term toxicity test and also to provide safety information for clinical application. Methods: According to the clinical therapeutic dose of nephritis and acute toxicity test, 16 normal adult Beagle dogs (male and female) were divided into two groups: low dose (0.25g / kg), medium dose (1.00g / kg) and high dose (4.00g / kg) and control (0.00g / kg) 4 groups, given for 3 consecutive months. After the treatment of anesthesia blood, check the major organs, and pathological observation. Results: After three months of treatment, the animals were generally in good condition with none of them dead. There was no significant difference in body weight and appetite between the two groups. Blood cytology, biochemistry indicators were within the normal range, the dose group and the control group no significant difference (P> 0.05). The animals ECG abnormal changes. High dose group of male dogs reduced epididymal sperm count. Histological examination of major organs, the quality coefficient was no significant difference, high-dose group of male dogs testes and epididymis sparse intracavitary sperm distribution, the number decreased. No significant abnormalities were found in pathological examination. Conclusion: The results showed that Shenyinling tablets in the dose of 0.25 ~ 4.00g / kg intragastric administration for 3 months, the dogs did not produce significant accumulation of toxic reactions, but the high-dose nephritis spirit tablets have a certain reproductive toxicity.