藥品安全監(jiān)管日益嚴(yán)格，雜質(zhì)檢測(cè)設(shè)備的作用日益突出 - 北京華儀通泰環(huán)?？萍加邢薰?/title> <meta name="keywords" content="藥品安全監(jiān)管日益嚴(yán)格，雜質(zhì)檢測(cè)設(shè)備的作用日益突出" /> <meta name="description" content="　藥與生活息息相關(guān)。確保藥品質(zhì)量和公共用藥*全不僅關(guān)系到患者的健康和*全，也有助于進(jìn)一步完善藥品全生命周期的質(zhì)量管理。眾所周知，藥物中往往存在沒有療效或影響藥物療效和穩(wěn)定性的雜質(zhì)，這些雜質(zhì)甚至可能對(duì)人體健康造成危害。因此，為了保證藥品*全，企業(yè)需要對(duì)藥品雜質(zhì)進(jìn)行分析，控制藥品中的雜質(zhì)含量。" /> <link href="/Public/CSS/w/base.css" rel="stylesheet"> <link href="/Public/CSS/w/style.css" rel="stylesheet"> <script src="/Public/JS/w/config.js"></script> <script src="/Public/JS/w/jquery.min.js"></script> <script src="/Public/JS/w/common.js"></script> <script src="/Public/JS/w/jquery.SuperSlide.js"></script> <script src="/Public/JS/w/app.js"></script> <script type="text/javascript"> // GoMobile('http:///'); // var searchid = 5; </script> <script> var _hmt = _hmt || []; (function() { var hm = document.createElement("script"); hm.src = 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class="news-detail-title"> <h1>藥品安全監(jiān)管日益嚴(yán)格，雜質(zhì)檢測(cè)設(shè)備的作用日益突出</h1> <p> <span>瀏覽量：625</span>  <span>發(fā)布時(shí)間：2020-10-12 14:08:48</span> </p> </div> <div id="i8pjzty" class="news-detail-view"> <p>　　藥與生活息息相關(guān)。確保藥品質(zhì)量和公共用藥*全不僅關(guān)系到患者的健康和*全，也有助于進(jìn)一步完善藥品全生命周期的質(zhì)量管理。眾所周知，藥物中往往存在沒有療效或影響藥物療效和穩(wěn)定性的雜質(zhì)，這些雜質(zhì)甚至可能對(duì)人體健康造成危害。因此，為了保證藥品*全，企業(yè)需要對(duì)藥品雜質(zhì)進(jìn)行分析，控制藥品中的雜質(zhì)含量。</p><p style="text-align: center;"><img src="/Public/Uploads/image/20201012/1602482895747573.png" title="1602482895747573.png" alt="雜質(zhì)檢測(cè)儀.png"/></p><p>　　藥物雜質(zhì)是活性藥物成分(API、原料藥)或藥物制劑中不希望有的化學(xué)成分。原料藥中的雜質(zhì)可能來自其他來源，如合成過程或原料、中間體、溶劑、催化劑和反應(yīng)副產(chǎn)物。</p><p>　　藥物中的雜質(zhì)按性質(zhì)可分為信號(hào)雜質(zhì)和有害雜質(zhì)，其中信號(hào)雜質(zhì)一般無害，但其含量可以反映藥物的純度水平，而有害雜質(zhì)對(duì)人體有害，在質(zhì)量標(biāo)準(zhǔn)上應(yīng)嚴(yán)格控制。</p><p>　　在藥物開發(fā)過程中，原料成分不穩(wěn)定，與輔料不相容，或者與包裝材料發(fā)生反應(yīng)，都可能造成雜質(zhì)。藥物中的雜質(zhì)含量會(huì)影響藥物的*全性。因此，雜質(zhì)的識(shí)別、定量、表征和控制成為藥物開發(fā)過程中的關(guān)鍵組成部分。</p><p>　　根據(jù)行業(yè)規(guī)定，藥典規(guī)定的各種雜質(zhì)檢查項(xiàng)目是指在藥品生產(chǎn)和正常儲(chǔ)存過程中，按照既定工藝可能含有或產(chǎn)生的，需要控制的雜質(zhì)。藥典沒有規(guī)定檢查的雜質(zhì)一般不需要檢查。但*須嚴(yán)格控制危害人體健康和影響藥物穩(wěn)定性的雜質(zhì)限量。</p><p>　　據(jù)了解，為了更好地保證用藥*全，相關(guān)的藥物雜質(zhì)分析檢測(cè)設(shè)備不斷誕生，技術(shù)也越來越精良。比如某企業(yè)研發(fā)生產(chǎn)的ZW-3紫外分析儀，可以在藥品生產(chǎn)和研究中用于檢查激素、生物堿、維生素等能產(chǎn)生熒光的藥物的質(zhì)量。再比如*效液相色譜法，可以有效地將待測(cè)中藥的成分或組分與其他雜質(zhì)分離，從而達(dá)到鑒別、檢測(cè)和含量測(cè)定的目的。近年來，*效液相色譜法在中藥檢驗(yàn)中得到廣泛應(yīng)用。</p><p>　　隨著技術(shù)的不斷發(fā)展，這些用于檢測(cè)雜質(zhì)的儀器在藥品質(zhì)量控制中發(fā)揮著重要作用。此外，近年來，隨著智能技術(shù)的不斷發(fā)展，智能技術(shù)也在這些儀器領(lǐng)域得到了應(yīng)用。如企業(yè)研發(fā)的藥物雜質(zhì)異物檢測(cè)儀采用智能識(shí)別技術(shù)，具有自學(xué)習(xí)和記憶功能，能夠自動(dòng)識(shí)別和記憶產(chǎn)品特征，有效消除各種“產(chǎn)品效應(yīng)”帶來的干擾。</p><p>　　雜質(zhì)的識(shí)別、定量、表征和控制對(duì)藥品的質(zhì)量和*全控制具有重要意義。作者了解到，許多監(jiān)管機(jī)構(gòu)，如ICH、USFDA、EMA、加拿大藥品和健康管理局、日本藥品和醫(yī)療器械管理局(PMDA)和澳大利亞健康和老化治療產(chǎn)品部，都關(guān)注雜質(zhì)控制。此外，英國藥典(BP)、美國藥典(USP)、日本藥典(JP)和歐洲藥典(EP)等多部藥典對(duì)原料藥和藥物制劑中雜質(zhì)的限量水平增加了越來越多的規(guī)定。與2015年版相比，2020年版《中國藥典》在化學(xué)雜質(zhì)檢測(cè)方面有了更大程度的修訂和增加。根據(jù)行業(yè)情況，新版《中國藥典》總體上更接近國際標(biāo)準(zhǔn)，更適合行業(yè)發(fā)展需要，在藥品*全監(jiān)管方面更為嚴(yán)格。</p><p><br/></p> 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