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。
Objective Based on the test and the research of pefloxacin mesilate for injection, analyzed and evaluated the quality including the safety, the effectiveness and the controllability. Methods The nationwide pefloxacin mesilate for injection was tested according to the official quality standards. The quality was analyzed by using multiple statistical methods. The products from different manufacturing enterprises were compared. We performed an exploratory research on related substances, alkyl sulfonic acid ester impurities and safety factors. Results Thirty batches of samples from eight manufacturing enterprises were tested; the pass rate is 100%. Methods in Chinese Pharmacopoeia 2010 and European Pharmacopoeia 2013 were used for detecting related substances of pefloxacin mesylate for injection, respectively. The content of the main impurity and the total impurity determined by the two methods above were equivalent. The number of the impurities detected using the ChP2010 method was more than that using the EP2013 method. The resolution was better than EP2013＇s. The determination method for methylmethanesulfonate （MMS）, ethyl methanesulfonate （EMS） and isopropyl methanesulfonate （IMS） in pefloxacin mesilate by GC-MS was established. None of the methanesulfonic acid ester impurities were detected in six batches of the materials and thirty batches of the injections. The active allergic reactions, antihypertensive substances, hemolysis and coagulation of pefloxacin mesylate for injection were investigated. The results were negative or conform to regulations. Conclusion The official quality standards of pefloxacin mesilate injections are effective to control the quality. Therefore, the quality was all right in general.
出处
《中国抗生素杂志》
CAS
CSCD
北大核心
2017年第6期491-495,共5页
Chinese Journal of Antibiotics
