不同药典中乳糖酸红霉素有关物质及含量测定方法的比较研究  

Comparison of assay and related substances of erythromycin lactobionate in the different pharmacopoeias

作　　者：黄晓春 刘琦 刘照振 刘祝月 刘海涛 寇晋萍 车宝泉 HUANG Xiaochun;LIU Qi;LIU Zhaozhen;LIU Zhuyue;LIU Haitao;KOU Jinping;CHE Baoquan(Beijing Institute for Drug Control,NMPA Key Laboratory for Research and Evaluation of Generic Drugs,Beijing Key Laboratory of Analysis and Evaluation of Chinese Medicine,Beijing 102206,China)

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：《中国药品标准》2024年第5期478-482,共5页Drug Standards of China

基　　金：2021年国家药品评价性抽验注射用乳糖酸红霉素项目(目录5)。

摘　　要：目的:对《中国药典》2020年版、USP 2023、JP 18、BP 2023及EP 11.0中乳糖酸红霉素含量及有关物质检测方法进行分析比较,通过试验考察不同药典标准检测注射用乳糖酸红霉素含量及有关物质结果的差异,为我国乳糖酸红霉素相关质量标准的修订和完善提供参考。方法:比较《中国药典》、USP、JP、BP及EP中乳糖酸红霉素含量及有关物质检测方法、限度标准方面的差异,基于《中国药典》和BP标准进行不同来源的注射用乳糖酸红霉素样品有关物质及含量测定。结果:《中国药典》、EP和BP标准中采用液相色谱方法进行乳糖酸红霉素有关物质检查,其中EP与BP方法相同;USP及JP该品种项下无有关物质检查项;《中国药典》和BP中有关物质检测的色谱方法差异大,限度控制方面BP中包含特定杂质7种,《中国药典》仅2种;且BP在特定杂质及单个未知杂质限度方面更严格。含量测定方法《中国药典》、USP及JP标准均采用抗生素微生物检定法,所用试验菌各异;EP与BP均采用液相色谱法中的外标法。采用《中国药典》和BP标准方法检测7批注射用乳糖酸红霉素样品有关物质及含量,测定的结果均符合标准规定;BP有关物质检查方法对特定杂质的检测效能及总杂质检出量明显高于《中国药典》方法。结论:乳糖酸红霉素及注射用乳糖酸红霉素有关物质检测的BP方法优于《中国药典》方法,BP采用的液相色谱法可替代《中国药典》的抗生素微生物检定法进行含量测定;BP有关物质及含量测定方法可为《中国药典》乳糖酸红霉素相关标准修订和完善提供重要参考。Objective:To compare the assay and related substance detection methods of erythromycin lactobionate in the Chinese Pharmacopoeia 2020(ChP),USP 2023(USP),JP 18(JP),BP 2023(BP)and EP 11.0(EP),investigate the differences between the test results obtained from 7 batches of erythromycin lactobionate for injection samples by using ChP and BP methods and thus provide a reference for the improvement of specification of erythromycin lactobionate.Methods:The differences of test methods and limits under the items of assay and related substances of erythromycin lactobionate in the above five pharmacopoeias were listed and compared.The related substances and contents of erythromycin lactobionate for injection samples from different manufactures were tested with methods stated in ChP and BP,and then compared and analyzed.Results:The items of related substances were determined by high performance liquid chromotographic methods in the ChP,EP and BP.The test methods and limits in the EP and BP were the same,which were different from that in ChP.The related substances were not determined in the USP and JP.There are obvious differences between the chromatographic methods and limits for the items of related substances in the ChP and BP,i.e.,BP contains 7 specific impurities,while ChP contains only 2 specific impurities.The limits for any other impurity and the total amount of impurities were lower in the BP than those in the ChP.The antibiotic microbiological assay was used as the test method for the item of assay in the ChP,USP and JP based on different bacterial strains,which was different from the chromatographic method used in the BP.Based on the different methods of the ChP and BP,the related substances and content determination results of 7 batches of erythromycin lactobionate for injection samples met the acceptance criteria.The detection efficiency of BP related substances inspection method for specific impurities and total impurities were significantly higher than that of the ChP method.Conclusion:The BP method is superior

关 键 词：乳糖酸红霉素 含量测定 有关物质 药典 比较研究 

分 类 号：R921.2[医药卫生—药学]