红景天配方颗粒水分和浸出物测定的不确定度评定  

Evaluation of Uncertainty for Determination of Moisture and Extract of Rhodiola Dispensing Granules

作　　者：田树兴 丁艳谱 周崇富 刘红光 李军山 TIAN Shu-Xing;DING Yan-pu;ZHOU Chong-Fu;LIU Hong-guang;LI Jun-shan(Yunnan Shineway Spirin Pharmaceutical Co.Ltd.,Chuxiong 675000,China;Chuxiong Shineway Spirin Pharmaceutical Research Co.Ltd.,Chuxiong 675000,China;Shineway Pharmaceutical Group Ltd.,Shijiazhuang 051430,China)

机构地区：[1]云南神威施普瑞药业有限公司,云南楚雄675000 [2]楚雄神威施普瑞药物研究有限公司,云南楚雄675000 [3]神威药业集团有限公司,河北石家庄051430

出　　处：《海峡药学》2021年第11期92-96,共5页Strait Pharmaceutical Journal

基　　金：云南省重大科技专项(生物医药项目,项目编号:2019ZF008)。

摘　　要：目的建立红景天配方颗粒水分和浸出物测定的不确定度评定。方法采用《中华人民共和国药典》2020年版四部要求的方法,测定出红景天配方颗粒中水分及浸出物的含量。依据根据JJF 1059.1-2012《测量不确定度评定与表示》的要求,对红景天配方颗粒中水分及浸出物含量测定的不确定度进行评定。结果通过评定分析,水分含量的相对标准不确定度u_(c)(C)=0.028%,扩展不确定度U=0.056%;浸出物含量的相对标准不确定度u_(c)(Y)=0.21%,扩展不确定度U=0.42%。结论在水分含量测定的不确定度评定中,主要贡献为重复性实验引入的不确定度及称量瓶和试样干燥后的质量M 2引入的不确定度,当称量瓶和试样干燥后恒重差异越小,其引入的不确定越小;浸出物含量测定的不确定度评定中,重复性实验引入的不确定度贡献较大;同时,在水分和浸出物测定时增加一定的平行样品亦可减小重复性实验引入的不确定度。OBJECTIVE To establish the uncertainty evaluation for the determination of moisture and extract of Rhodiola dispensing granules.METHODS The content of water and extract in Rhodiola dispensing granules was determined by the method required in the fourth part of Pharmacopoeia of the people′s Republic of China(2020 Edition).According to the requirements of JJF 1059.1-2012 evaluation and expression of measurement uncertainty,the uncertainty of determination of water and extract content in Rhodiola dispensing granules was evaluated.RESULTS Through evaluation and analysis,the relative standard uncertainty of moisture content u_(c)(C)=0.028%,expanded uncertainty U=0.056%;Relative standard uncertainty of extract content u_(c)(Y)=0.21%,expanded uncertainty U=0.42%.CONCLUSION In the uncertainty evaluation of moisture content determination,the main contribution is the uncertainty introduced by repeatability experiment and the mass M_(2) of weighing bottle and sample after drying.When the difference of constant weight between weighing bottle and sample is smaller,the uncertainty introduced is smaller;in the uncertainty evaluation of determination of extract content,the uncertainty introduced by repeatability experiment is larger.In addition,the uncertainty introduced by the repeatability experiment can also be reduced by adding certain parallel samples in the determination of moisture and extract.

关 键 词：配方颗粒 不确定度 浸出物 水分 

分 类 号：R969.4[医药卫生—药理学]