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目的检验玫瑰油软胶囊的毒理学安全性。方法依据《保健食品检验与评价技术规范》(2003年版)对玫瑰油软胶囊进行安全性毒理学研究。结果(1)雌、雄大鼠的急性经口毒性试验(MTD)均大于10 g/kg BW,属实际无毒物,约相当于人体推荐量的750倍;(2)小鼠骨髓嗜多染红细胞微核试验、小鼠精子畸形试验(玫瑰油软胶囊剂量分别为2.5g,5.0 g,10 g/kg BW),Am es试验(玫瑰油软胶囊分别为0.008,0.04,0.2,1.0,5.0 mg/皿)结果均为阴性,无致突变作用;(3)30 d喂养试验各剂量组雄、雌性大鼠每日摄入玫瑰油软胶囊量分别为1.25 g,2.5 g,5.0 g/kg BW,相当于玫瑰油软胶囊人体推荐剂量的93,187,375倍;各剂量组大鼠生长情况良好;主要脏器绝对重量、脏体比、血常规检查、生化检查均在正常值范围内;高剂量组肝、脾、肾、胃、十二指肠、睾丸、卵巢与对照组比较均未见与受试物作用有关的组织病理学改变。结论玫瑰油软胶囊按上述剂量给予动物,对大、小鼠的各项观察指标未产生明显毒性作用,玫瑰油软胶囊作为保健食品是安全的。
Objective To examine the toxicological safety of rose oil soft capsule. Methods According to “health food testing and evaluation of technical specifications” (2003 edition) Rose oil soft capsule safety toxicology study. Results (1) The acute oral toxicity test (MTD) of both male and female rats was more than 10 g / kg BW, which was actually non-toxic, which was about 750 times of the recommended dose of human body. (2) Mice bone marrow polychromatic erythrocytes Micronucleus test, mice sperm abnormality test (rose oil soft capsule dosage was 2.5g, 5.0g, 10g / kg BW), Am es test (rose oil soft capsules were 0.008,0.04,0.2,1.0,5.0 mg / Dish) were negative, no mutagenic effect; (3) 30 d feeding test each dose male and female rats daily intake rose oil soft capsules were 1.25 g, 2.5 g, 5.0 g / kg BW , Equivalent to 93,187,375 times the recommended dose of rose oil soft capsule; the growth of rats in each dose group was good; the absolute weight, body weight ratio, blood routine examination and biochemical examination of major organs were within the normal range; There were no histopathological changes in the spleen, kidney, stomach, duodenum, testis and ovary compared with the control group. Conclusion Rose oil soft capsules according to the above doses to animals, the indicators of large and small mice did not produce significant toxic effects, rose oil soft capsule as a health food is safe.