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目的通过青藏高原特有珍稀油料植物微孔草籽油与中成药配伍得到一种具有缓解视疲劳作用的软胶囊,为评价该软胶囊的毒理学安全性,对该样品进行30d大鼠喂养实验。方法将受试样品分别按0.9、1.8、3.6g/Kg.BW剂量(分别相当于人群日摄入量的54、108、216倍)对SPF级Wistar大鼠连续经口灌胃30d,观察大鼠中毒症状和死亡情况。结果各实验组大鼠体重、进食量、食物利用率、血常规、血液生化指标、脏体比及病理组织学观察等各项指标与阴性对照相比较差异均无统计学意义。结论 30d大鼠喂养实验表明该受试样品未发现明显毒性作用。
OBJECTIVE To evaluate the toxicological safety of Soft Gelatin Capsules by combining the micro-porous rapeseed oil with the proprietary rare plant oil of Qinghai-Tibet Plateau and traditional Chinese patent medicines. Methods The SPF Wistar rats were orally gavaged with 0.9, 1.8, 3.6 g / Kg.BW doses (54,108,216 times of daily intake respectively) for 30 days. Rat poisoning symptoms and deaths. Results The body weight, food intake, food utilization rate, blood routine, blood biochemical indexes, visceral ratio and histopathological examination of rats in each experimental group showed no significant difference compared with negative control. Conclusion The experiment of feeding rats for 30 days showed that no obvious toxic effect was found in the tested samples.