金莲花露毒理学安全性评价

Safety Assessment of Trollius Beverrage

目的对金莲花露毒理学安全性进行评价。方法清洁级昆明种小鼠、SD大鼠以金莲花露各按最大耐受量(MTD)等体积灌胃,记录中毒表现及死亡情况;采用平板掺入法,分加与不加S-9混合液两种;选清洁级昆明种小鼠,取胸骨骨髓制片,查其骨髓嗜多染红细胞微核发生率;选雄性小鼠,取附睾制片,查小鼠精子畸形率;30 d喂养实验,观察生长发育、食物利用率、血液学检查和生化学检查结果。结果雌雄性小、大鼠均未见明显的中毒症状及死亡;在加与不加S-9的情况下,均未呈现致突变作用;小鼠微核实验、小鼠精子畸形实验均呈阴性;30 d喂养大鼠,全部存活,且发育良好,选定各指标均未见异常。结论金莲花露对两种性别的大、小鼠的MTD均大于20000 mg/(kg.bw),说明该产品属实际无毒物;三项致突变实验结果阴性;大鼠30 d喂养实验各项指标均无明显异常。

Objective To assess the safety of Trollius Beverrage. Methods The experimental animals were Kunming mice and SD rats. Mice and rats were gastric infusion with MTD the same volume of Trollius Beverrage. Detoxification and death status were re- corded. Flat plate incorporating method was used with 2 kinds of mixture solutions which were added S -9 or not. The sternal bone marrow of clean Kunming mice was isolated and driven film producer. A living rate of mouse bone marrow polychromatic e- rythrocyte micronucleus test was checked. The epididymis of the double sides in female clean Kunming mice was driven film pro- ducer. The rate of sperm teratogenicity was observed. Perform the results of the growth and development, food utilization rate, the check of blood and biochemistry after the animals were fed to keep experiment for 30 days. Results The mice and rats were all not observed obvious poisoned symptom and death. Without adding S -9 condition, the mutation effect of all the animals didnt ap- pear. The micronucleus test and the sperm teratogenicity test in mice were negative. All rats survived after feeding for 30 days. Animals in each group growth were good. No abnormal phenomenon was observed. Conclusion The Trollius Beverrageg MTD of mice and rats was greater than 20000mg/（ kg. bw）. It was concluded that the product had no toxicity. The result of mutagenic test was negative and no abnormal phenomenon was observed after feeding for 30 days.