湿润烧伤膏酸值的测量不确定度评定  

Evaluation of Measurement Uncertainty of Acid Value of Moist Exposed Burn Ointment

作　　者：王晓钰[1] 蔡欣耿 蔡灏 WANG Xiaoyu;CAI Xingeng;CAI Hao(Shantou Institute for Drug Control,Shantou,Guangdong 515041,China;Shantou MEBO Pharmaceutical Co.,Ltd,Shantou,Guangdong 515041,China)

机构地区：[1]汕头市药品检验所,广东汕头515041 [2]汕头市美宝制药有限公司,广东汕头515041

出　　处：《今日药学》2023年第4期273-277,共5页Pharmacy Today

摘　　要：目的 评定湿润烧伤膏酸值的测量不确定度,以保证测定结果的准确性。方法 本研究使用直接滴定法测量湿润烧伤膏的酸值,通过分析影响酸值测定结果的各个因素,建立数学模型,分析各不确定度分量,评定湿润烧伤膏酸值的测量不确定度,进而计算酸值的扩展不确定度。结果 湿润烧伤膏的酸值的扩展不确定度为0.092 mg·g^(-1)(k=2),酸值为(2.75±0.092)mg·g^(-1),其中滴定终点的判断是影响不确定度的主要因素。结论 该方法可用于湿润烧伤膏酸值的不确定度分析,使测定结果更加可靠,同时为含油脂类药物酸值质量控制中采用直接滴定法的酸值测量不确定度分析提供参考。OBJECTIVE To assess the measurement uncertainty of the acid value of Moist Exposed Burn Ointment(MEBO)and further to ensure the accuracy of the result.METHODS The direct titrimetric method was used to detect the acid value of MEBO.A model was established to analyse each uncertainty components in the detection process of acid value and the measurement uncertainty was evaluated.Furthermore,the expanded uncertainty of acid value was calculated.RESULTS The expanded uncertainty for the acid value of the MEBO was 0.092 mg·g^(-1)(k=2)and the acid value was(2.75±0.092)mg·g^(-1).The terminal point of titration was the main factor affecting the uncertainty.CONCLUSION The method can be used to analyse the acid value uncertainty of MEBO,which make the measurement result is more reliable.Meanwhile,it provides reference for the determination of acid value uncertainty via direct titrimetric method in the quality control of drugs containing lipid.

关 键 词：湿润烧伤膏 酸值 测量不确定度 

分 类 号：R96[医药卫生—药理学]