摘要
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 test toxicological safety of rose oil elastic capsule. Methods The toxicological safety of rose oil was studied according to "Technical Standards For Testing & Assessment of Health Food" (2003 Edition ). Results 1. Acute toxicity test by mouth ( MTD ) was over 10 g/kg BW in male and female rats, which was 750 times of recommending dosage for human. It was of no poison actually. 2. The results of micronucleus test, teratospermia test ( the dosage of rose oil elastic capsule was 2.5 g, 5.0 g, 10 g/kg BW, respectively ) and Ames test ( the dosage of rose oil elastic capsule was 0.008, 0. 04, 0.2, 1.0, 5.0 mg / dish, respectively ) in rats were all negative, and there was no mutagenic action. 3. The intake dosages of rose oil elastic capsule fed on rats for 30 days were 1.25 g, 2.5 g, 5.0 g/kg BW, respectively, that was the recommended dosages for human of 93 times, 187 times and 375 times. The rats in each dosage group grew well. Absolute weight of main organs, ratio of organ and body weight, blood routine examination, biochemistry examination were all normal. Compared with the rats in control group, there was no histopathology change related to the capsule in liver, spleen, kidney, stomach, cuodenum, didymus and ovaries of rats in high -dosage group. Conclusions According to the dosage given to the experimental rats, the rose oil elastic capsule can produce no overt toxicity to rats and mice. As health food, the capsule is safe.
出处
《地方病通报》
2007年第6期22-24,共3页
Endemic Diseases Bulletin
关键词
玫瑰油
月见草油
毒性观察
Rose oil
Evening primrose oil
Observation, toxicity