肾炎灵片对正常Beagle犬的在体作用

Effects of Shenyanling Tablet on Normal Beagle Dogs:in vivo Study

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：Shenyanling tablet, as an innovative drug based on Chinese traditional medicine, is a reasonable compatibility agent of tripterygium wilfordii and radix astragali. To observe the in vivo effects of Shenyanling tablets on normal Beagle dogs with administration for 3 months, lay foundations for further long-term toxicity test, and provide security data for clinical application. Methods： According to the clinical dose and results of acute toxicity test of Shenyanling, 16 adult Beagle dogs （8 males and 8 females） were divided into four groups： low dose （0.25 g/kg）, middle dose （1.00 g/kg）, high dose （4.00 g/kg） and the control groups. The dogs of these 3 study groups were administered with Shenyanling for 3 months. Blood samples were collected after treatment, and main organs were examined with pathological observation. Results： The general states of all dogs after treatment were fine with no cases of death. Compared with the control group, there were no statistical differences of body weights and food intakes. Parameters of blood cytology and biochemistry were within the normal range, with no significant differences among each study group and the control group （P〉0.05）. There were no abnormal ECG changes among each dog, and no significant differences were showed in quality coefficient during the histological examinations of main organs. While sperm count reduced significantly in male dogs of the high d.ose group （P〈0.05）, with sparse distribution of sperms in testis and epididymis. Conclusion： The results show that no evident accumulated-toxicity reactions will be induced by administration of Shenyanling for 3 months within 0.25-4.00 g/kg, while high dose of Shenyanling tablets may have certain reproductive toxicities.