桂花阿胶固体饮料基于动物毒理实验的安全性评价  

Study on safety evaluation test of osmanthus donkey-hide gelatin formula beverage

作　　者：任小平 王少颖 王杰 冯鑫 REN Xiaoping;WANG Shaoying;WANG Jie;FENG Xin(Shaanxi Kanghui Pharmaceutical Co. ,LTD,Xianyang 712046;Shaanxi Kangruibao Medical Technology Co. ,LTD,Xianyang 712046,China;Xi'an United Nations Quality Detection Research Co. ,LTD,Xi'an 712000;Xi'an United Nations Quality Detection Research Co. , LTD, Xi'an 712000, China)

机构地区：[1]陕西康惠制药股份有限公司,陕西咸阳712046 [2]陕西正晟康源生物医药有限公司,陕西咸阳712046 [3]陕西康瑞宝医药科技有限公司,陕西咸阳712046 [4]西安国联质量检测研究有限公司,陕西西安712000

出　　处：《国外医学（医学地理分册）》2019年第3期245-252,共8页Foreign Medical Sciences：Section of Medgeography

摘　　要：目的评价桂花阿胶固体饮料的安全性。方法急性经口毒性试验,采用限量法,将大鼠禁食(不禁水)16h后,经口灌胃给予受试物,剂量为20.0g/kg·BW,给药后观察14d;细菌回复突变试验,设5个剂量组,及空白、溶剂、阳性对照组,采用平板参入法,对组氨酸缺陷型4株鼠伤寒沙门氏菌突变型菌株TA97a、TA98、TA100和TA102进行回变菌落计数;哺乳动物红细胞微核试验,设三个剂量组,及环磷酰胺组、阴性对照组,试验采用30h灌胃法,两次灌胃间隔24h进行试验,计数骨髓嗜多染红细胞在总红细胞的比例及微核嗜多染红细胞的比率;28d经口毒性试验,设三个剂量组及一个空白对照组,经口灌胃28d,观察体质量、食物利用率、血液学指标、血液生化指标及病理检测。结果该样品急性经口毒性试验结果为无毒性,细菌回复突变试验、哺乳动物红细胞微核试验结果均为阴性,28d经口毒性试验各项指标与空白对照组比较差异无显著性。结论各项试验表明桂花阿胶固体饮料在一定剂量范围内通过系统的体内和体外试验证明其具有食用安全性。Objective To evaluate the safety of osmanthus donkey-hide gelatin formula beverage.MethodsAcute Toxicity test:used limited method,SD rats after fasting for 16 h(unlimited water),after given sample by oral in 20.0 g/kg·BW dose,observed 14 days.Ames test:Set up 5 dose groups,blank control group,solvent control group,positive control group.Used plate incorporation method,counted the number of reverse colonies with 5 kinds of histidine nutrition deficiency Strain TA97 a,TA98,TA100 and TA102.Mammalian Erythocyte Micronucleus test:Set up three dose groups,cyclophosphamide group and negative control group.Used the method of 30-hour Oral intragastric administration,The sample was given twice at an interval of 24 hours.calculated proportion of bone marrow polychromatic erythrocytes in total red blood cells.28-day oral toxicity test:Set up three dose groups and a solvent control group.Oral intragastric administration for 28 days,solvent control group was given pure water.Observed body weight,food utilization rate,blood routine,blood biochemical indexes and pathological examination.Results The result of Acute Toxicity test was Non-toxic,The result of ames text and mammalian erythocyte micronucleus test of osmanthus donkey-hide gelatin formula beverage was negative.There was no significant difference compared to blank control group about various index of 28-day oral toxicity test.Conclusion Osmanthus donkey-hide gelatin is confirmed edible safety by system tests in vivo and in vitro test at a certain dose range.

关 键 词：桂花阿胶 急毒 遗传毒性 28d经口毒性试验 

分 类 号：TS262[轻工技术与工程—发酵工程]