复方芦荟口服液的毒理学安全性与通便功效研究

Study on toxicological safety and embellish aperient bowel function of compound Aloe vera oral liquid

中文关键词:  低聚果糖  水苏糖  芦荟  安全性  通便功效

英文关键词:fructo oligosaccharide  stachyose  Aloe vera  safety  embellish aperient bowel function

中文摘要:

      目的 评价一种以低聚果糖、水苏糖、芦荟、黑木耳为原料的复方口服液的毒理学安全性和通便功效。方法 依据《保健食品检验与评价技术规范(2003年版)》, 进行急性/短期经口毒性、遗传毒性以及动物通便功效等试验。结果 该样品小鼠急性经口最大耐受剂量(maximum tolerable dose, MTD)>15.00 g/(kg?BW); 鼠伤寒沙门氏菌/哺乳动物微粒体酶试验(Salmonella typhimurium/mammalian microsomal enzyme test, Ames试验): 不论加S9与否, 样品各剂量组标准测试菌株TA97a、TA98、TA100和TA102的回变菌落数均未超过相应溶剂对照值的两倍; 小鼠骨髓细胞微核试验和精子畸形试验: 与溶剂对照相比, 样品各剂量组小鼠微核细胞率、精子畸变率未见显著性差异(P>0.05); 大鼠30 d灌胃毒性试验: 样品各剂量组雌、雄大鼠均活动、生长正常, 体质量、进食量、食物利用率以及肝、肾、脾、睾丸等脏器湿重及脏体比均无显著变化(P>0.05), 血液学、血生化指标检测值均在本实验室历史参考值范围内, 未发现与样品明显有关的组织病理学改变; 小鼠通便功效试验: 与便秘模型对照组相比, 样品各剂量组5 h内排便粒数均无显著性差异(P>0.05), 首次排黑便时间均提前(P<0.05或P<0.01), 1.0和3.0 mL/(kg?BW)剂量组墨汁推进率均提高(P<0.01), 3.0 mL/(kg?BW)剂量组5 h内粪便重量增加(P<0.05)。结论 该样品具有通便功效, 未见其急性毒性, 在以5 μL/皿和10.0 mL/(kg?BW)为最高剂量时, 未见其致突变性或遗传毒性, 其雌、雄大鼠短期经口毒性无可见有害作用剂量(no observed adverse effect level, NOAEL)值均为10.0 mL/(kg?BW)(相当于成人推荐摄入量的100倍)。

英文摘要:

      Objective To evaluate the toxicological safety and embellish aperient bowel function of a compound oral liquid with fructo oligosaccharide, stachyose, Aloe vera and Auricularia auricula as raw materials. Methods According to the Technical standards for testing & assessment of health food (2003 edition), tests of acute/short-term oral toxicity, genotoxicity and embellish aperient bowel function in animal were performed. Results The acute oral maximum tolerable dose (MTD) in mice was greater than 15.00 g/(kg?BW); Salmonella typhimurium/mammalian microsomal enzyme test (Ames test): No matter whether S9 was added or not, the revertants numbers of standard test strains TA97a, TA98, TA100 and TA102 in all test article concentrations did not exceed twice that in corresponding solvent control; mice bone marrow micronucleus test and sperm malformation test: Compared with the solvent control, the micronucleus frequency and abnormal sperm rate of mice in each dose group of the sample were not changed significantly (P>0.05); rats’ 30-day gastric perfusion toxicity test: The growth and development of female, male rats in all group generally performed well; no significant changes were observed in body weights, feed intakes, feed utilization rates, organ weights, as well as organ/body weight ratios of liver, kidney, spleen, testis, etc., hematological, biochemical parameters were all within the historical reference values of our laboratory, histopathological examinations showed no damage caused by the sample; compared with the constipation model control group, there was no significant difference in the number of stool within 5 h in each dose group (P>0.05), but the first black stool time were shorten (P<0.05, P<0.01), the ink propulsion rates in 1.0 and 3.0 mL/(kg?BW) groups and the fecal weight within 5 h in 3.0 mL/(kg?BW) group were increased (P<0.05 or P<0.01). Conclusion The sample has embellish aperient bowel function without acute toxicity, when exposed to the highest dose at 5 μL/dish or 10.0 mL/(kg?BW), no mutagenicity or genotoxicity is observed, the no observed adverse effect level (NOAEL) of male and female SD rats in 30-day gastric perfusion study for the sample are both 10.0 mL/(kg?BW) (as 100 times as the recommended dose in adults).