注射用盐酸多西环素质量评价  

Quality evaluation of doxycycline hyclate for injection

作　　者：傅小雅 刘月 Fu Xiaoya;Liu Yue(Hainan Provincial Institute of Inspection and Testing Drug Control,Haikou 570216)

机构地区：[1]海南省检验检测研究院药品检验所,海口570216

出　　处：《中国抗生素杂志》2024年第4期375-380,共6页Chinese Journal of Antibiotics

摘　　要：目的对国产注射用盐酸多西环素的质量现状进行评价。方法采用法定标准对86批抽检样品进行检验;结合注射剂一致性评价要求,利用参比制剂,通过对原料药精制工艺、维生素C质量控制、制剂处方工艺、包材、有关物质及血管刺激性试验和溶血试验等关键项目的比较研究,分析不同企业制剂的质量差异及现行标准的合理性。结果86批样品法定检验合格率为100%。探索性研究优化了有关物质测定方法,并对杂质来源进行了归属;建立了主要辅料维生素C的杂质和含量检测方法;发现使用未精制原料的企业,杂质含量明显高于使用精制原料的企业;国内仿制制剂与参比制剂在性状、灌装量、包材、有关物质及稳定性等方面存在差异;发现制剂使用与临床不良反应间的相关性。结论国内三家生产企业质量状况分别为“好、一般、差”,与参比制剂在一些质量属性方面存在差异,建议国内企业优化生产工艺尤其是冷冻干燥工艺及使用更好质量的包材以提升产品质量;现行标准可进一步提高。Objective The quality of domestic doxycycline hydrochloride for injection was evaluated.Methods A total of 86 batches of samples underwent testing in accordance with the prescribed regulatory criteria.According to the requirements of consistency evaluation of injections,the quality difference of preparations from different enterprises and the rationality of current standards were analyzed by comparing the refining process of apis,quality control of vitamin C,formulation process,packaging materials,related substances,vascular irritation test and hemolysis test with reference preparations.Results The qualified rate of 86 batches of samples was 100%.The method of determination of related substances was optimized and the source of impurities was attributed.The method of impurity and content determination of vitamin C was established.It was found that the impurity content of the enterprises using unrefined raw materials was obviously higher than that of the enterprises using refined raw materials.There were differences in properties,filling amount,packing materials,related substances and stability between the domestic generic preparation and the reference preparation.Associations were found between clinical use and adverse reactions.Conclusion The quality status of the three domestic production enterprises was“good,average and poor”respectively,and there were differences in some quality attributes with the reference preparations.It was recommended that domestic enterprises optimize the production process,especially the freeze-drying process and the use of better quality packaging materials toimprove product quality.Current standards could be further improved.

关 键 词：注射用盐酸多西环素 评价性抽验 质量评价 一致性评价 有关物质 维生素C 

分 类 号：R978.1[医药卫生—药品] R917[医药卫生—药学]