天然产物研究与开发 ›› 2022, Vol. 34 ›› Issue (增刊2): 87-93.

• 开发研究 • 上一篇    下一篇

3种降尿酸保健食品配方产品的功能及安全性初步评价

徐小玲1,2,吕晓君1,2,潘望平1,2,徐巾晶1,2,何开勇1,2*   

  1. 1湖北省药品监督检验研究院;2湖北省药品质量检测与控制工程技术研究中心,武汉 430064
  • 出版日期:2022-12-07 发布日期:2022-12-07
  • 基金资助:
    湖北省科技条件资源管理与服务专项(2019BFC593)

Evaluation of the function and safety of three formulas of urate-lowering health food products

XU Xiao-ling1,2,LYU Xiao-jun1,2,PAN Wang-ping1,2,XU Jin-jing1,2,HE Kai-yong1,2*   

  1. 1Hubei Institute for Drug Control;2Hubei Engineering Research Center for Drug Quality Control,Wuhan 430064,China
  • Online:2022-12-07 Published:2022-12-07

摘要: 用前期研究建立的稳定可靠的动物造模方法诱导大鼠高尿酸血症模型,对3种保健食品配方产品进行功能及安全性评价。采用最大耐受量法(MTD)进行小鼠的急性毒性研究。大鼠造模1周后选取90只大鼠按血清尿酸水平随机分成9组,分别为模型对照组、阳性对照组1、阳性对照组2和受试物1~3组(设高、低2个剂量),每组10只继续给予高嘌呤饲料,上午按200 mg/kg灌胃给予造模剂氧嗪酸钾,下午灌胃给予受试物,连续灌胃30天。同时设空白对照组和阴性对照组。阳性对照组在实验开始两周后给予别嘌呤醇和苯溴马隆,剂量分别为10 mg/kg和5 mg/kg。第30天测定各组大鼠的血尿酸值及其他生化指标,并进行肝、肾的组织病理学检查。急性毒性试验结果显示,3种受试物均属无毒级。酵母粉饲料+氧嗪酸钾造模7天,造模组大鼠的血尿酸值与空白对照组比较,明显升高,造模成功。受试物2高剂量组、受试物3高剂量组、低剂量组均可显著降低大鼠血尿酸值,降尿酸功能为阳性。受试物1高、低剂量组有降低大鼠血尿酸值的趋势,但与模型对照组比较无统计学意义。本研究的剂量条件下,3种受试物对大鼠的肝脏和肾脏均无明显毒性作用。

关键词: 保健食品, 高尿酸模型, 大鼠, 血尿酸, 急性毒性

Abstract:

To evaluate the function of three health food formula products on hyperuricemia rat model established by using the stable and reliable animal modeling method.The maximum tolerated dose (MTD) method was used to study the acute toxicity studies in mice.One week after the rats were modeled,90 rats were selected and randomly divided into 9 groups according to their serum uric acid levels,model control group,positive control group 1,positive control group 2 and test group 1-3(set high and low doses),10 rats in each group.200 mg/kg potassium oxazine was given by gavage in the morning,and the test substance or positive drug was given in the afternoon.Rats were intragastrically administered for 30 days.In addition,set up the blank control group and the negative control group.After a gavage period of two weeks,the positive control group was given 10 mg/kg of allopurinol and 5 mg/kg benzbromarone.The blood uric acid value and other biochemical indicators were measured on the 30th day,and the histopathological examination of liver and kidney was performed.The results of the acute toxicity test showed that three test substances are non-toxic.Yeast powder+potassium oxazine was used to build the model for 7 days,compared with the blank control group,the blood uric acid value of the model rats significantly increased,the asymptomatic hyperuricemia rat model were induced successfully.After a gavage period for 30 days,high-dose group of test substance 2,high-dose group and low-dose group of test substance 3 can significantly reduce the blood uric acid value in rats,and have showed positive effects in urate-lowering function.The high-dose group and low-dose group of test substance1 tend to reduce the blood uric acid value,but there is no statistical significance compared with the model control group.Under the dosage conditions of this study,the three test substances had no toxic effects on liver and kidney of rats.

Key words: health food, hyperuricemia model, rats, blood uric acid, acute toxicity

中图分类号:  R965.1