拔毒生肌散中黄丹的含量测定方法研究  

Study on Quantitative Detection of Minium in Badu Shengji San

作　　者：李莉 彭韦楠 夏晶[2] 曹帅[2] 李丽敏[2] 季申 LI Li;PENG Weinan;XIA Jing;CAO Shuai;LI Limin;JI Shen(China State Institute of Pharmaceutical Industry,Shanghai 201203,China;Shanghai Institute for Food and Drug Control,NMPA Key Laboratory for Quality Control of Traditional Chinese Medicine,Shanghai 201203,China)

机构地区：[1]中国医药工业研究总院,上海201203 [2]上海市食品药品检验所,国家药品监督管理局中药质量控制重点实验室,上海201203

出　　处：《中药新药与临床药理》2020年第8期975-977,共3页Traditional Chinese Drug Research and Clinical Pharmacology

基　　金：国家科技部重点研发计划(2017YFC1700800);国家药典委员会中药材和饮片中重金属及有害元素限量标准研究(ZG2016);上海科委研发平台专项(18DZ2292200)。

摘　　要：目的建立拔毒生肌散中黄丹的含量测定方法,以完善其现有标准。方法基于铅含量表征黄丹含量的思路,采用HNO3-HCl酸体系消解样品,优化升温程序、样品取样量等条件,采用火焰原子吸收分光光度法测定拔毒生肌散中黄丹的铅含量。结果方法学考察结果均满足元素测定要求,不同批次拔毒生肌散中黄丹的含量测定结果为64.4~68.6 mg·g-1(以Pb计)。结论所建立的方法具有准确度高、专属性强、操作简单等优点,可用于拔毒生肌散中黄丹的质量控制。Objective To establish a method for determining the content of minium in Badu Shengji San and improve the existing standard of Badu Shengji San.Methods Based on the idea of using Pb content to present the content of minium,HNO3-HCl was used to digest samples;and the heating-up program,the sampling weight were optimized.The flame atomic absorption spectrophotometry(FAAS)was used to determine the Pb content so as to obtain the content of minium in Badu Shengji San.Results The results of the method validation all met the requirements of elemental determination.The contents of minium in different batches of samples were in the range of 64.4~68.6 mg·g-1(in terms of Pb).Conclusion The established method has the characteristics of high accuracy,strong specificity and simple operation.It can be used for the quality control of minium in Badu Shengji San.

关 键 词：拔毒生肌散 黄丹 铅 火焰原子吸收分光光度法 微波消解 

分 类 号：R284.1[医药卫生—中药学]