更昔洛韦《国际药典》标准的制定  

Establishment of the"International Pharmacopoeia"standard for ganciclovir

作　　者：聂延君 吴敏 陈真 徐玉文 NIE Yan-jun;WU Min;CHEN Zhen;XU Yu-wen(l.NMPA Key Laboratory for Research and Evaluation of Generic Drugs,Shandong Research Center of Engineering and Technology for Consistency Evaluation of Generic Drugs,Shandong Institute for Food and Drug Control,Jinan 250101,China;Shandong Public Health Clinical Center,Jinan 250000,China)

机构地区：[1]山东省食品药品检验研究院,仿制药研究与评价重点实验室,山东省仿制药一致性评价工程技术研究中心,济南250101 [2]山东省公共卫生临床中心,济南250000

出　　处：《军事医学》2021年第8期620-625,共6页Military Medical Sciences

基　　金：国际药品标准编修项目(中检化药函[2012]997号)。

摘　　要：目的制定更昔洛韦符合第八版《国际药典》的质量标准。方法按照《国际药典》标准的制定要求,采用多种方法,对更昔洛韦的鉴别、溶液的澄清度与颜色、重金属、水分、有关物质检查和含量测定等进行考察和验证。结果制定了4种能有效鉴别更昔洛韦方法,以及溶液的澄清度与颜色、重金属和水分测定方法;制定了HPLC测定有关物质检查方法,有效分离6个已知杂质和其他未知杂质;采用非水滴定法测定更昔洛韦含量,结果与HPLC法基本一致。结论制定的质量标准简便可行、准确程度高,具有良好的可行性、试剂可及性以及方法灵敏性,可有效管控更昔洛韦质量。Objective To establish quality standards for ganciclovir in line with the"International Pharmacopoeia".Methods In accordance with the requirements of the"International Pharmacopoeia"standards,different methods were used to investigate and verify the identification of ganciclovir,solution clarity and color,heavy metals,water,related substances and content determination.Results Four identification methods were established to effectively identify the authenticity of ganciclovir.Methods for determining a solution’s clarity and color,heavy metals and water content were also made available.High performance liquid chromatography(HPLC)methods for related substances were established to effectively separate 6 impurities and other unknown impurities,and a non-aqueous titration method was used to determine the content of ganciclovir.The results were basically consistent with the HPLC method.Conclusion The established quality standards are simple,feasible,and highly accurate,with good feasibility,reagent accessibility,and sensitivity,which can effectively control the quality of ganciclovir.

关 键 词：更昔洛韦 《国际药典》 色谱法 薄层 色谱法 高效液相 非水滴定 

分 类 号：R921[医药卫生—药学]