决明子乙醇提取物的亚慢性毒性研究

A 90-day subchronic toxicity study on Semen Cassiae ethanol extract

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”。

A study was conducted in rats to observe the subchronic toxicity of ethanol extract of Semen Cassiae. 120 Wistar rats were randomly divided into 6 groups (i.e. the negative control group and five treatment groups), and each group consisted of 10 males and 10 females. The animals were given the extract mixed into the fodder of the concentration of 5, 15, 25, 35, 45 g crude herbal medicine/kg BW for 90 days. The results showed that the ethanol extract of Semen Cassiae increased the ratio of kidney/body weight and liver/body weight, made pigment sediment in kidney, colon, rectum, mesenteric lymph nodes and testicle, and reactive hyperplasia of mesenteric lymph nodes. In 15 0 g/kg BW and above dose groups, The increases of spleen/body weight ratio and the number of WBC, and superficially catarrh in colon were found. In the 25 0 g/kg BW and higher groups, the body weight increased slowly, the food efficiency declined and the testicle shrinked. The target organ were kidney, colon, rectum, mesenteric lymph nodes and testicle. The results indicated that the observed adverse effect level of Semen Cassiae ethanol extract was 5 0 g crude herbal medicine/kg BW, and ADI is less than 3 0 g/kg if deduced from rats to human, according to 100 times safety coefficient .This ADI was far below the 9 0 g of suggested dose agreed by codex. When the Semen Cassiae, was used as a component of health food, the dose and term of taking Semen Cassiae should be restricted due to its safety risk ,and it may be irrational to list Semen Cassiae on the materials of health food.