不确定度评定在六味地黄丸(浓缩丸)中丹皮酚含量测定中的应用  

Application of Uncertainty Evaluation in Determination of Paeonol in Liuwei Dihuang Pills(concentrated pills)

作　　者：赵玉泉 ZHAO Yu-quan(Kaifeng Center for Food and Drug Control,Kaifeng 475004,China)

机构地区：[1]开封市食品药品检验所,河南开封475004

出　　处：《江西中医药大学学报》2023年第2期85-88,共4页Journal of Jiangxi University of Chinese Medicine

摘　　要：目的:评定HPLC法测定六味地黄丸(浓缩丸)中丹皮酚含量的不确定度。方法:采用HPLC法测定六味地黄丸(浓缩丸)中丹皮酚含量,对不确定度来源进行分析,建立相应的数学模型,计算各个不确定度分量,最后得出扩展不确定度。结果:六味地黄丸(浓缩丸)每丸含丹皮酚0.412 mg,扩展不确定度为0.017 mg,丹皮酚的含量结果应表述为(0.412±0.017)mg/丸。结论:六味地黄丸(浓缩丸)中丹皮酚含量测定的不确定度主要来源于平均丸重和溶液配制过程,严格控制这些过程可以提高药品质量和检验结果的准确性。Objective:To establish a method for the evaluation of uncertainty in the determination of the content of Paeonol in Liuwei Dihuang Pills(concentrated pills)by HPLC.Methods:By establishing a HPLC mathematical model for determining the content of Paeonol in Liuwei Dihuang Pills(concentrated pills),the sources of uncertainty were analyzed,and evaluate each uncertainty component,then the extendeduncertainty is obtained.Results:The content of Paeonol in Liuwei Dihuang Pills(concentrated pills)was 0.412 mg.The expanded uncertainty was 0.017 mg,the measurement result can be expressed as(0.412±0.017)mg per pill.Conclusion:The uncertainty of the method is mainly the average pill weight and the solution preparation,strictly controlling these processes can improve the quality of drugs and the accuracy of results.

关 键 词：不确定度 高效液相色谱法 六味地黄丸(浓缩丸) 丹皮酚 含量测定 

分 类 号：R284.1[医药卫生—中药学]