利用溶液色差值与吸光度的相关性建立头孢西丁钠溶液颜色的仪器测定方法  

Establishment of an instrumental method for determination of the color of cefoxitin sodium solution by using the correlation between solution color difference and absorbance

作　　者：刘海涛 侯金凤 寇晋萍 刘琦 齐麟 Liu Hai-tao;Hou Jin-feng;Kou Jin-ping;Liu Qi;Qi Lin(Beijing Institute for Drug Control,NMPA Key Laboratory for Research and Evaluation of Generic Drugs,Beijing Key Laboratory of Analysis and Evaluation on Chinese Medicine,Beijing 102206)

机构地区：[1]北京市药品检验研究院、国家药品监督管理局仿制药研究与评价重点实验室、中药成分分析与生物评价北京市重点实验室,北京102206

出　　处：《中国抗生素杂志》2023年第3期338-342,共5页Chinese Journal of Antibiotics

摘　　要：目的建立一种客观量化的注射用头孢西丁钠溶液颜色的仪器测定方法。方法借助色差计考察色差值与溶液吸光度的相关性,选择相关性最强的波长作为检测波长,并在该波长下对注射用头孢西丁钠溶液颜色的药典标准进行限度转换。结果建立了在420 nm波长处测定注射用头孢西丁钠吸光度的溶液颜色仪器测定方法,吸光度限度规定为不得过0.17。结论该方法能够准确量化测定并表述注射用头孢西丁钠的溶液颜色,为更好的研究与控制药品质量提供了数据支持,也为其他药品的溶液颜色检查从粗略的目视法转变为精准量化的仪器法提供了参考。Objective To establish an objective quantified method for color determination of cefoxitin sodium solution for injection.Methods The correlation between the color difference value and the absorbance of the solution was investigated by the chromatic meter,and the wavelength with the strongest correlation was selected as the detection wavelength,and the color limit of cefoxitin sodium solution for injection was determined by investigating the absorbance value of the corresponding standard colorimetric solution at the selected detection wavelength.Results A method for the determination of the color of cefoxitin sodium solution for injection was established.The absorbance of the solution was determined at 450 nm wavelength and should not exceed 0.17.Conclusion This method can accurately quantify the solution color of cefoxitin sodium for injection,which provides data support for better research and control of drug quality,and also provides a reference for the transformation of solution color inspection of other drugs from rough visual methods to precise quantitative instrument methods.

关 键 词：注射用头孢西丁钠 色差计 溶液颜色检查法 相关性 限度转换 精准量化 

分 类 号：R978.1[医药卫生—药品]