八珍益母丸中芍药苷的HPLC法测定结果的不确定度评价  

Uncertainty Evaluation on Paeoniflorin Content Determination of Bazhen Yimu Pills by HPLC

作　　者：马晓静[1] 崔业波[1] 高楠楠[1] 

机构地区：[1]四平市食品药品检验所,吉林四平136000

出　　处：《中国现代中药》2017年第12期1754-1757,共4页Modern Chinese Medicine

摘　　要：目的:对八珍益母丸中芍药苷的HPLC法测定结果的不确定度进行分析,找出影响不确定度的因素。方法:参照《中华人民共和国药典》2015版一部八珍益母丸含量测定方法,对测定过程和步骤进行量化分析,计算合成不确定度,并确定测量结果在95%置信区间下的扩展不确定度。结果:采用HPLC法测定八珍益母丸中芍药苷含量的扩展不确定度为每丸0.20 mg。结论:对照品的称量是本次实验不确定度的主要来源,对称量过程的严格控制有利于提高检测结果的可靠性、准确性。Objective： To analyze the uncertainty of determination of paeoniflorin in Bazhen Yimu Pillls by HPLC and find out the effect factors of uncertainty. Methods： The content determination method for Bazhen Yimu Pills in Chinese Pharmacopoeia（CP）2015 was applied for the study. The determination process and procedures were analyzed, and the combined uncertainty was calculated and finally the extended uncertainty were obtained in 95% confidence intervals. Results： The expanded uncertainty for the HPLC determination of paeoniflorin is 0. 20 mg in each pill. Conclusion： The uncertainty of the experiment is mainly caused by the weight of standard, strict control of the weighing process will help to improve reliability and accuracy of test results.

关 键 词：八珍益母丸 芍药苷 含量测定 不确定度 高效液相色谱法 

分 类 号：R287.4[医药卫生—中药学]