前维生素D相对校正因子的研究及测定  

Investigation and determination of relativecorrection factor of pre-vitamin D

作　　者：施洁明[1] 王珵[1] 张立雯[1] 董顺玲[1] 乐健 袁松[3] 陆益红 王丹丹 徐万魁 郑淑凤 SHI Jieming;WANG Cheng;ZHANG Liwen;DONG Shunling;LE Jian;YUAN Song;LU Yihong;WANG Dandan;XU Wankui;ZHENG Shufeng(Guangzhou Institute for Drug Control,Guangzhou 510160,China;Shanghai Institute for Food and Drug Control,Shanghai 201203,China;National Institutes for Food and Drug Control,Beijing 102629,China;Jiangsu Institute for Food and Drug Control,Nanjing 210019,China;Zhejiang Institute for Food and Drug Control,Hangzhou 310052,China;Liaoning Institute for Drug Control,Shenyang 110036,China;Xiamen Institute for Food and Drug Control,Xiamen 361013,China)

机构地区：[1]广州市药品检验所,广州510160 [2]上海市食品药品检验研究院,上海201203 [3]中国食品药品检定研究院,北京102629 [4]江苏省食品药品监督检验研究院,南京210019 [5]浙江省食品药品检验研究院,杭州310052 [6]辽宁省药品检验检测院,沈阳110036 [7]厦门市食品药品质量检验研究院,福建厦门361013

出　　处：《中国药品标准》2024年第2期147-153,共7页Drug Standards of China

基　　金：国家药典委员会2021年国家药品标准提高通用技术方法类补充课题(2021H02);广州市市场监督管理局科技项目(2022kj32)。

摘　　要：目的:测定前维生素D相对校正因子,简化维生素D含量测定的计算方法。方法:通过对各国药品标准中维生素D含量计算方法的研究,采用HPLC法测定前维生素D相对校正因子,并对测定的影响因素进行了考察。结果:统计了国内7家实验室的前维生素D相对校正因子的测定结果,确定了254 nm和265 nm 2个波长下的前维生素D相对校正因子。结论:采用前维生素D相对校正因子法计算维生素D的总量,简化了实验步骤,避免了随机操作误差。该方法快速、准确,为进一步提高维生素D制剂标准奠定了基础。Objective:To determine the relative correction factor of pre-vitamin D and simplify the calculation method of vitamin D assay.Methods:By studying the calculation method of vitamin D content in drug standards of various countries,HPLC was used to determine the relative correction factor of pre-vitamin D,and the influencing factors of determination were investigated.Results:The relative correction factors of pre-vitamin D at 254 nm and 265nm wavelength were determined by statistical analysis of 7 laboratories in China.Conclusion:Using the pre-vitamin D relative correction factor method to calculate the total amount of vitamin D simplified the experimental steps can be simplified by the pre-vitamin D relative correction factor method to calculate the total amount of vitamin D and the random operating errors can be avoided.The method is rapid and accurate,and lay a solid foundation for further improving the standard of vitamin D preparations.

关 键 词：维生素D 前维生素D 相对校正因子 影响因素 高效液相色谱 外标法 

分 类 号：R921.2[医药卫生—药学]