α-熊果苷纯度标准物质的研制  

Development of Alpha-Arbutin Certified Reference Material

作　　者：李硕 张楠[1] 刘喆 李庆武[1] 李莉[2] 王海燕[2] 孙磊[2] 张正东[1] LI Shuo;ZHANG Nan;LIU Zhe;LI Qingwu;LI Li;WANG Haiyan;SUN Lei;ZHANG Zhengdong(National Institute of Metrology,Beijing 100029,China;National Institutes for Food and Drug Control,Beijing 100050,China)

机构地区：[1]中国计量科学研究院,北京100029 [2]中国食品药品检定研究院,北京100050

出　　处：《计量科学与技术》2022年第8期7-12,共6页Metrology Science and Technology

摘　　要：以α-熊果苷高纯试剂为原料,通过质谱、红外光谱、紫外-可见光谱、核磁共振谱、熔点、旋光度等对标准物质进行了鉴别和确证。采用高效液相色谱-荧光检测法测定标准物质的色谱纯度,参照《中国药典》2020年版四部通则中方法分别对标准物质的水分和炽灼残渣进行测定,参照《化妆品安全技术规范》对标准物质的溶剂残留进行测定。采用质量平衡法定值,定值结果为99.87%,不确定度为2.46%(k=2)。通过高效液相色谱-荧光检测法对分装后的α-熊果苷标准物质进行了均匀性和短期稳定性考察。结果表明,本研究工作研制的α-熊果苷标准物质具有纯度高、量值准确、稳定性好等特点,可用于控制产品质量,满足化妆品质量安全检测的要求。Using high purityα-arbutin reagent as raw material,the reference material was further identified and confirmed by MS/MS,IR,UV-vis,nuclear magnetic resonance,melting point,optical rotation,etc..The chromatographic purity ofα-arbutin reference material was determined by High-Performance Liquid Chromatography (HPLC) coupled with fluorescence detector (FLD).Moisture and ignition residue determination was carried out according to the guideline specified in Volume IV of the Pharmacopoeia of the People’s Republic of China 2020 Edition.The residual solvents were determined according to the procedure specified in the Safety and Technical Standards for Cosmetics.The purity ofα-arbutin reference material was then calculated by the mass balance method and the certified value ofα-arbutin is 99.87%with an expanded uncertainty of 2.46%(k=2).The homogeneity and short-term stability tests were carried out with HPLC-FLD after packaging.The results showed that theα-arbutin reference material has the characteristics of high purity,accurate value,and stability,which can provide technical support to cosmetics quality and safety tests in China.

关 键 词：α-熊果苷 标准物质 化妆品 质量平衡法 液相色谱 

分 类 号：TQ658[化学工程—精细化工] O652[理学—分析化学]