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为观察决明子乙醇提取物的亚慢性毒性 ,选用健康断乳Wistar大鼠 12 0只 ,随机分为 6组(1个阴性对照组和 5个剂量组 ) ,每组 2 0只 ,雌雄各半 ,分别以 5、15、2 5、35、4 5g生药量 kgBW 剂量掺入饲料 ,喂养大鼠 90d。结果表明 ,决明子乙醇提取物各剂量组均使大鼠肾 体比、肝 体比比值升高 ,肾、结肠、直肠、肠系膜淋巴结色素沉积 ,肠系膜淋巴结反应性增生。 15 0g kgBW 及以上剂量组脾 体比、白细胞计数升高 ,结肠浅表性粘膜炎。 2 5 0g kgBW 及以上剂量组动物体重增长缓慢 ,食物利用率下降 ,睾丸萎缩。作用靶器官 :肾、结肠、直肠、肠系膜淋巴结、睾丸。本实验条件下 ,决明子乙醇提取物最小毒副作用剂量为 5 0g kgBW,按 10 0倍安全系数计算 ,折合人体日摄入量为 3g ,小于药典规定的日最小摄入 9g的限量要求。本研究表明决明子作为保健食品原料长期大量摄入存在一定安全隐患 ,应限制使用剂量和服用期限 ,不宜列入“既是食品又是药品的物品名单”。
In order to observe the subchronic toxicity of ethanol extract of Semen Cassiae, 120 healthy weaned Wistar rats were randomly divided into 6 groups (1 negative control group and 5 dose groups), with 20 individuals in each group. 5,15,25,35,45 g of crude drug kgBW were mixed into the feed and the rats were fed for 90 days. The results showed that the ethanol extract of cassia seed in each dose group increased the ratio of rat kidney to liver, kidney, colon, rectum, mesenteric lymph node pigmentation, and mesenteric lymph node reactive hyperplasia. The spleen-to-body ratio and white blood cell count of the 150 g kgBW and above dose group increased, and the superficial mucositis of the colon was observed. The weight gain of the 250 g kgBW and above group animals was slow, the food utilization rate was decreased, and the testicles were atrophied. Target organs: kidney, colon, rectum, mesenteric lymph nodes, testis. Under the experimental conditions, the minimum toxic side effect dose of ethanol extract of cassia seed was 50 g kgBW. Calculated according to the safety factor of 100 times, it was equivalent to the daily human body intake of 3 g, which was less than the daily minimum intake of 9 g required by the Pharmacopoeia. This study shows that cassia seed as a health food raw material for a long period of time there is a certain number of potential safety hazards, should limit the use of dose and duration of intake, should not be included in the “both food and drug products list.”