硫酸庆大霉素注射液质量评价  

Quality Evaluation of Sulfate Gentamicin Injection

作　　者：李少杰[1] 姚永青[1] 刘英[1] 赵静[2] 陈卓[1] 王立萍[1] 杨淑先[1] 

机构地区：[1]河南省食品药品检验所,郑州450003 [2]郑州大学药学院

出　　处：《中国药事》2014年第11期1231-1240,共10页Chinese Pharmaceutical Affairs

摘　　要：目的通过对抽验结果数据进行统计分析,评价国产硫酸庆大霉素注射液的质量现状。方法依据现行法定质量标准,对全国范围内的硫酸庆大霉素注射液进行法定标准检验,运用多种统计学方法,分析国内硫酸庆大霉素注射液的质量总体水平,比较不同生产企业产品质量;根据专题调研、文献检索和检验结果及分析等情况,开展了杂质谱、组分纯度和离子色谱法测定有关物质等探索性研究,探讨了有关物质、组分纯度和效价的关系。结果本次抽验中涉及的318批次样品标准检验,其中,2批溶液的颜色超标,8批有关物质不符合规定,1批含量不符合规定。杂质谱研究结果显示,各企业杂质谱基本固定,原料和对应制剂杂质个数和杂质含量均一致;解决了用高效液相色谱法测定庆大霉素组分纯度的问题。结论目前绝大部分国产硫酸庆大霉素注射液生产工艺成熟,质量状况较好;杂质谱研究有助于产品的质量控制,进而促进产品质量的提高;新建组分纯度测定方法可更直观地反映产品的质量状况。Objective To evaluate the quality condition of sulfate gentamicin injection at present,through the statistical analysis of the results of sampling inspection data.Methods According to the current quality standard,the nationwide sulfate gentamicin injection examination was conducted. Multiple statistical methods were used to analyze the overall quality of the domestic sulfate gentamicin injection and the product quality of different manufacturing enterprises was compared.Based on the results of special investigation,literature search and analysis of testing results,exploratory study was carried out covering impurity profiling,component purity and determination of related substances with ion chromatography.The relationship among related substances,component purity and potency was discussed.Results According to the current standard,among the 318 batches of samples tested,2batches failed because of solution colour,8batches failed because of impurity and 1batch failed because of content.The impurity profiling results showed that the impurity profiles of the enterprises were essentially fixed,and the impurity species and contents in the raw materials and the corresponding preparation were the same.The gentamicin component purity could be determined by high performance liquid chromatography.Conclusion At the moment,the majority of the domestic sulfate gentamicin injection products have mature production technology,and relatively high quality.The impurity profiling could help to control and improve the product quality.The new component purity determination method could reflect the product quality more directly.

关 键 词：硫酸庆大霉素 评价性抽验 质量评价 杂质谱 有关物质 效价 组分纯度 离子色谱 

分 类 号：R927.11[医药卫生—药学]