發(fā)布時(shí)間：2018-04-16 18:29

  本文選題：甲磺酸培氟沙星注射劑 + 質(zhì)量分析�。� 參考：《中國抗生素雜志》2017年06期

【摘要】：目的通過對(duì)上市甲磺酸培氟沙星注射劑檢驗(yàn)與研究,從安全性、有效性和質(zhì)量可控性等方面對(duì)其進(jìn)行全面質(zhì)量分析評(píng)價(jià)。方法依據(jù)現(xiàn)行法定質(zhì)量標(biāo)準(zhǔn),對(duì)全國范圍內(nèi)的甲磺酸培氟沙星注射劑進(jìn)行標(biāo)準(zhǔn)檢驗(yàn),運(yùn)用多種統(tǒng)計(jì)學(xué)方法,分析國內(nèi)甲磺酸培氟沙星注射劑的質(zhì)量總體水平,比較不同生產(chǎn)企業(yè)產(chǎn)品質(zhì)量;根據(jù)專題調(diào)研、文獻(xiàn)檢索和標(biāo)準(zhǔn)檢驗(yàn)結(jié)果及分析等情況,開展了有關(guān)物質(zhì)、甲磺酸烷基酯類雜質(zhì)和安全性指標(biāo)探索性研究。結(jié)果本次抽驗(yàn)中涉及8個(gè)生產(chǎn)企業(yè)的30批甲磺酸培氟沙星注射劑(注射粉針28批和注射液2批),按法定標(biāo)準(zhǔn)檢驗(yàn)結(jié)果均符合規(guī)定,合格率100%。分別采用ChP2010和EP2013所收載的甲磺酸培氟沙星有關(guān)物質(zhì)分析方法,對(duì)甲磺酸培氟沙星注射劑有關(guān)物質(zhì)進(jìn)行測(cè)定,結(jié)果顯示ChP2010與EP2013方法液相色譜行為差別較大,2種方法測(cè)定甲磺酸培氟沙星的最大雜質(zhì)和總雜質(zhì)含量相當(dāng),ChP2010檢出的雜質(zhì)個(gè)數(shù)多于EP2013,系統(tǒng)分離度優(yōu)于EP2013。建立了氣相質(zhì)譜的方法同時(shí)測(cè)定甲磺酸培氟沙星中甲磺酸甲酯(MMS),甲磺酸乙酯(EMS),甲磺酸異丙酯(IMS)含量的方法,經(jīng)測(cè)定國產(chǎn)6批原料藥及30批制劑中不含有甲磺酸酯類雜質(zhì)。對(duì)甲磺酸培氟沙星全身主動(dòng)過敏反應(yīng)、降壓物質(zhì)檢查、溶血與凝聚檢查法進(jìn)行考察,各項(xiàng)指標(biāo)均呈陰性反應(yīng)或符合規(guī)定。結(jié)論甲磺酸培氟沙星注射劑現(xiàn)行標(biāo)準(zhǔn)可行,質(zhì)量狀況較好。
[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.

【作者單位】： 遼寧省藥品檢驗(yàn)檢測(cè)院;
【分類號(hào)】：R927.1

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