黄芪多糖注射液生物活性检测的测量不确定度评定  

Evaluation of Uncertainty in Measurement of Bioactivity of Astragalus membranaceus Polysaccharide Injection

作　　者：郑玉连 冯学轩 王弋[1] 白建瑜 严家荣[1] 郭起岳[1] ZHENG Yulian;FENG Xuexuan;WANG Yi;BAI Jianyu;YAN Jiarong;GUO Qiyue(Guangdong Medical Laboratory Animal Center,Foshan 528248,China)

机构地区：[1]广东省医学实验动物中心,广东佛山528248

出　　处：《生物化工》2022年第6期100-102,106,共4页Biological Chemical Engineering

基　　金：广东省中医药局科研项目(20211056);广东省医学科学技术研究基金项目(A2021396)。

摘　　要：目的:按《中华人民共和国兽药典(2015年版)》二部黄芪多糖注射液的要求,测定黄芪多糖注射液的生物活性,通过分析不确定度来源建立不确定度评价的数学模型,从而对该实验的不确定度进行评定。方法:将120只BALB/c小鼠随机分为阴性对照组6组、给药组6组,10只/组,共12组,给药组小鼠腹腔注射黄芪多糖注射液,0.5 mL/只,阴性对照组给予等量的氯化钠注射液,1次/d,连续7 d。末次注射24 h后计算平均脾指数。并通过数学模型,从注射过程、动物称重、脾脏称重方面进行不确定度的分析与评定。结果:给药组与阴性对照组平均脾指数的差值Y=7.31±3.31,k=2,符合《中华人民共和国兽药典(2015年版)》二部黄芪多糖注射液生物活性中给药组与对照组平均脾指数差值应≥2的规定。结论:注射给药用注射器、动物体重和脾脏重量为不确定度主要来源。Objective:According to the requirements of astragalus polysaccharide injection Veterinary Pharmacopoeia of the People’s Republic of China(2015 edition)PartⅡ,determine the biological activity of Astragalus membranaceus polysaccharide injection,establish a mathematical model for uncertainty evaluation by analyzing the source of uncertainty,and then evaluate the uncertainty of the experiment.Methods:120 BALB/c mice are randomly divided into 6 groups of control group and 6 groups of administration group,10 mice/group,12 groups in total.The mice in the administration group are intraperitoneally injected with Astragalus membranaceus polysaccharide injection,0.5 mL/mouse,and the control group is given the same amount of sodium chloride injection,once a day,for 7 consecutive days.The average spleen index is calculated 24 hours after the last injection.Through the mathematical model,the uncertainty of the injection process,animal weighing and spleen weighing are analyzed and evaluated.Results:The difference between the mean spleen index of the administration group and the control group is Y=7.31±3.31,k=2,which is in accordance with the provisions of the Veterinary Pharmacopoeia of the People’s Republic of China(2015 edition)PartⅡthat the difference between the mean spleen index of the administered group and the control group in the biological activity of Astragalus membranaceus polysaccharide injection should be≥2.Conclusion:The syringe for injection administration,animal weight and spleen weight are the main sources of uncertainty.

关 键 词：黄芪多糖注射液 生物活性 不确定度 

分 类 号：R284[医药卫生—中药学]