国产甲磺酸培氟沙星注射剂质量分析

发布时间：2018-04-16 18:29

本文选题：甲磺酸培氟沙星注射剂 + 质量分析　；参考：《中国抗生素杂志》2017年06期

【摘要】：目的通过对上市甲磺酸培氟沙星注射剂检验与研究,从安全性、有效性和质量可控性等方面对其进行全面质量分析评价。方法依据现行法定质量标准,对全国范围内的甲磺酸培氟沙星注射剂进行标准检验,运用多种统计学方法,分析国内甲磺酸培氟沙星注射剂的质量总体水平,比较不同生产企业产品质量;根据专题调研、文献检索和标准检验结果及分析等情况,开展了有关物质、甲磺酸烷基酯类杂质和安全性指标探索性研究。结果本次抽验中涉及8个生产企业的30批甲磺酸培氟沙星注射剂(注射粉针28批和注射液2批),按法定标准检验结果均符合规定,合格率100%。分别采用ChP2010和EP2013所收载的甲磺酸培氟沙星有关物质分析方法,对甲磺酸培氟沙星注射剂有关物质进行测定,结果显示ChP2010与EP2013方法液相色谱行为差别较大,2种方法测定甲磺酸培氟沙星的最大杂质和总杂质含量相当,ChP2010检出的杂质个数多于EP2013,系统分离度优于EP2013。建立了气相质谱的方法同时测定甲磺酸培氟沙星中甲磺酸甲酯(MMS),甲磺酸乙酯(EMS),甲磺酸异丙酯(IMS)含量的方法,经测定国产6批原料药及30批制剂中不含有甲磺酸酯类杂质。对甲磺酸培氟沙星全身主动过敏反应、降压物质检查、溶血与凝聚检查法进行考察,各项指标均呈阴性反应或符合规定。结论甲磺酸培氟沙星注射剂现行标准可行,质量状况较好。
[Abstract]:Objective to test and study the listed pefloxacin mesylate injection, from safety, makes a comprehensive analysis and evaluation on the quality of its effectiveness and quality control etc. methods according to the existing legal quality standard, the standard test of nationwide pefloxacin mesylate injection, using a variety of statistical methods to analysis the level of quality general domestic pefloxacin mesylate injection, comparison of different production enterprise product quality; according to the special investigation, literature retrieval and standard test results and analysis, carried out the related substances of methanesulfonic acid alkyl ester impurities and the safety index of exploratory research. The results of the tests involving 8 production enterprises in 30 batches pefloxacin mesylate injection (injection injection injection and the 28 batch of 2 batches), according to the legal standard of the test results are in conformity with the provisions, the qualified rate of 100%. respectively using ChP2010 and EP2013 Method of pefloxacin mesylate related substances contained the analysis of related substances of pefloxacin mesylate injection were determined. The results showed that the difference of ChP2010 and EP2013 method of liquid chromatographic behavior of large, the maximum equivalent content of impurities and total impurities determination of pefloxacin mesylate 2 methods, ChP2010 detection of impurity number more than EP2013 that is better than EP2013. method was established by gas chromatography mass spectrometry for simultaneous determination of pefloxacin mesylate in methyl separation system (MMS), ethyl methanesulfonate (EMS), isopropyl mesylate (IMS) content determination method, the 6 batch of domestic raw materials and 30 batch preparations containing a sulfonic acid ester impurities of pefloxacin mesylate active systemic anaphylaxis, antihypertensive substances, haemolysis and agglomeration method were investigated. The indexes were negative or compliance. Conclusion pefloxacin mesylate injection current standard Yes, the quality is good.

【作者单位】：辽宁省药品检验检测院;
【分类号】：R927.1

【相似文献】