提高制药品质辐射灭菌技术优势突出_制药工业,制药设备,灭菌器-制药网

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class="icon-message"></i></a> </div> </div> </div> <div class="contentRight"> <div class="contentText">　<strong>　【中国制药网编辑视点】</strong>随着我国制药装备行业的发展，国内的灭菌设备</a>不论是技术还是品质方面都有了长足的进步。灭菌设备种类更加齐全，分类更加细化。笔者获悉，辐射灭菌技术具有、节能、无残留、无污染等优势，能较少影响药品品质;此外加工操作简便快捷、机械化自动化程度高，是非热加工的物理保险技术。<br /><br /><div style="text-align: center"><br />辐射灭菌（图片来源于百度图片）</div><br />　　辐射灭菌法指将灭菌产品置于适宜放射源辐射的γ射线或适宜的电子加速器发生的电子束中进行电离辐射而达到杀灭微生物的方法。本法常用的为60Co-γ射线辐射灭菌。医疗器械、容器、生产辅助用品、不受辐射破坏的原料药</a>及成品等均可用。<br /><br />　　采用辐射灭菌法灭菌的无菌产品其SAL应≤10-6。γ射线辐射灭菌所控的参数主要是辐射剂量(指灭菌物品的吸收剂量)。该剂量的制定应根据考虑产品灭菌物品的适应性和及产品可能污染的微生物大数量及强抗辐射力，所使用的剂量事先应验证其有效性及安全性。常用的辐射灭菌吸收剂量为25kGy。对终产品、原料药、某些医疗器材应尽可能采用低辐射剂量灭菌。灭菌前，应对待被灭菌物品微生物污染的数量和抗辐射强度进行测定，以评价灭菌过程赋予该灭菌物品的无菌保证水平。<br /><br />　　灭菌时，应采用适当的化学或物理方法对灭菌物品吸收的辐射剂量进行监控，以充分证实灭菌物品吸收的剂量是在规定的限度内。如采用与灭菌物品一起被辐射的放射性剂量计，剂量计要置于规定的部位。在初安装时计量剂量计应用标准源进行校正，并定期进行再校正。<br /><br />　　辐照灭菌是一种利用高能射线作用于微生物的一种灭菌方法，同传统的环氧乙烷灭菌相比，具有灭菌速度快、灭菌彻底，无化学残留无环境污染等优点。根据蒙特利公约中规定，发达国家在2005年前，发展中国家在2015年前，需要彻底禁用传统制冷剂溴甲烷，这对我国冷冻冷藏保存的传统方法提出了挑战，同时也为我国当前辐照市场提供了发展机遇。<br /><br />　　相较环氧乙烷灭菌等方法，辐照灭菌具有诸多的优点，但是有专家也指出，过量辐照会影响药材安全。据悉，许多医药企业为图方便，不顾标准规定，擅自将自己的复方制剂而不是单位药材送去辐照。但由于复方制剂药材品种多、成分复杂，出事染菌量较大，辐照部门无法针对每一种单位药材进行有针对性的辐照，为使灭菌一次合格，往往只能大剂量超标准辐照。<br /><br />　　那么，究竟多少的辐照量是安全的?我国卫生部于1997年出台的《C o60辐照中药灭菌剂量标准〔卫药发1997第38号〕》(下称《标准》)规定的中药辐照大吸收剂量标准是，散剂3kG y，片剂3kG y，丸剂5kG y，中药原料粉6kG y.不过，对照美国药典(U SP25)，上述标准显得相对宽松，美国规定的标准是2.5kG y为有效灭菌剂量。<br /><br />　　我国由于缺乏对辐照药品专用的检测仪器，对此类产品的监管一直没有展开。依照相关规定，进行辐照的产品必须加贴辐照标识。<br /></div> <div class="newsPage"></div> <div class="clear"></div> <div class="adv-more"> <a href="https://www.zyzhan.com/" target="_blank"><img src="https://www.zyzhan.com/images/news/adv-more.jpg" alt=""></a> </div> <div class="turnPage"> <p>上一篇：<a href="https://www.zyzhan.com/news/detail/60477.html" target="_blank">助推工业简单便捷生产不干胶贴标机赢得用户青睐</a></p> <p>下一篇：<a 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break; case "供应": searchUrl = "https://supply.zyzhan.com/sale/t0_p0/"; break; case "求购": searchUrl = "https://www.zyzhan.com/purchase-buy/t0/list_p0.html"; break; case "招标": searchUrl = "https://www.zyzhan.com/offer_tender/t0/list_p0.html "; break; case "资讯": searchUrl = "https://www.zyzhan.com/news/t0/list_p0.html"; break; //case "应用": //searchUrl = "https://application.zyzhan.com/list-0_p0.html"; //break; case "企讯": searchUrl = "https://www.zyzhan.com/company_news/t0/list_p0.html"; break; case "企业": searchUrl = "https://www.zyzhan.com/company/a_t0/list_p0.html"; break; case "展会": searchUrl = "https://www.zyzhan.com/exhinew/t0/list_p0.html"; break; case "专题": searchUrl = "https://www.zyzhan.com/topics/t0/list.html"; break; case "技术": searchUrl = "https://www.zyzhan.com/tech_news/t0/list_p0.html"; break; case "资料": searchUrl = "https://www.zyzhan.com/technology/t0/list_p0.html"; break; case "样本": searchUrl = "https://www.zyzhan.com/sample/t0/list_p0.html"; break; case "品牌": searchUrl = "https://www.zyzhan.com/brands/t0/list_p0.html"; break; case "视频": searchUrl = "https://www.zyzhan.com/video/ht0_p0/"; break; case "直播": searchUrl = "https://www.zyzhan.com/video/ct0_p0/"; break; case "人才": searchUrl = "https://www.zyzhan.com/job/recruitment/t0/list_p0.html"; break; default: searchUrl = "https://www.zyzhan.com/chanpin-0_p0.html"; break; } }); utils.focusBlur($("input[name='K']")); $("#searchFormtwo").submit(function () { var searchStr = $(this).find("input").val(); searchStr = searchStr.replace("多个关键词间加空格，如：", ""); if (searchStr == "请输入关键字") { searchStr = ""; } else { var patrn = /chanpin/ig; if (patrn.exec(searchUrl)) { var classidBykey = Vivian.GetClassIDByKey(searchStr).value; //"0"; searchUrl = "https://www.zyzhan.com/chanpin-" + classidBykey + "_p0.html"; } } $(this).find("input").val(searchStr); $(this).attr("method", "post"); $(this).attr("action", searchUrl); }); $(window).scroll(function(event) { var navTop = $('.top').offset().top; var sct = 50; if ((document.documentElement.scrollTop || document.body.scrollTop) > navTop) { $('.fix-navigation').fadeIn(); } else { $('.fix-navigation').fadeOut(); } }); </script> <script src="https://www.zyzhan.com/js/jquery.js?v=20160323220201"></script> <script src="https://public.mtnets.com/Js/common.js" charset="utf-8"></script> <script src="https://public.mtnets.com/Plugins/holder/holder.js" type="text/javascript" charset="utf-8"></script> <script src="https://www.zyzhan.com/JavaScript/single.carousel.min.js" type="text/javascript" charset="utf-8"></script> <script src="https://www.zyzhan.com/JavaScript/news_show.js" type="text/javascript" charset="utf-8"></script> <script src="https://www.zyzhan.com/javascript/rightBar.js" type="text/javascript" charset="utf-8"></script> <script type="text/javascript" src="https://www.zyzhan.com/js/comment1.js"></script> <input id="hid_NewsID" value="60476" type="hidden" /> <input id="hid_UserID" value="0" type="hidden" /> <input id="hid_NewsClassID" value="10" type="hidden" /> <input id="hid_ObjectTitle" value="提高制药品质辐射灭菌技术优势突出" type="hidden" /> <input id="hid_TableName" value="MT_News_Industry" type="hidden" /> <script> function getHost() { var url=window.location.href; var host = "null"; if(typeof url == "undefined" || null == url) { url = window.location.href; } var regex = /(.*\:\/\/[^\/]*).*/; var match = url.match(regex); if(typeof match != "undefined" && null != match) { host = match[1]; } return "<a href=\"" + host + "\">" + host + "</a>"; } function UpdateVoteDetailNum(voteID) { var CheckType="$VoteCheckType"; var ids=""; var voteNum=$VoteNum; if (CheckType=="0") { if(jQuery("input:radio[name=votelist][checked]").length==0) { alert("请选择投票！"); return false; } ids=jQuery("input:radio[name=votelist][checked]").val(); addNum=1; } else { jQuery("input:checkbox[name=votelist]").each(function(){ if(jQuery(this).attr('checked')==true) ids+=jQuery(this).val() + ","; }); if(ids!="") ids= ids.substring(0, ids.length - 1); else { alert("请选择投票！"); return false; } } var obj2=Vivian.UpdateVoteDetailNum(voteID,ids).value; var obj=Vivian.ReListVote($ObjectID).value; var jsonobj = eval("data=" + obj); for(var i=0;i<jsonobj.Detail.length;i++) { jQuery("#voteItemA" + jsonobj.Detail[i].ID).html("<div class=\"progress\"><b class=\"bg" +(i+1) +"\" style=\"width:" + jsonobj.Detail[i].Percentage + ";\"></b></div>"); jQuery("#voteItemB" + jsonobj.Detail[i].ID).html(jsonobj.Detail[i].Percentage); jQuery("#voteItemC" + jsonobj.Detail[i].ID).html("<p>" + jsonobj.Detail[i].Num + "</p>"); } if(obj2=="1") { jQuery("#showInfo").show(); voteNum=voteNum+ids.split(',').length; jQuery("#voteNum").html(voteNum); } jQuery("#buttonVote").html("您已投票"); jQuery("#buttonVote").attr("className","allvote"); } </script> <script> $(function() { var fix = $('.contentLeft'); //滚动悬浮块 var end = $('.zyPicture'); //滚动到这个元素后结束固定 var fixTop = fix.offset().top, //滚动悬浮块与顶部的距离 fixHeight = fix.height(); //滚动悬浮块高度 var endTop, miss; //结束元素与顶部的距离 var 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提高制药品质 辐射灭菌技术优势突出_制药工业,制药设备,灭菌器-制药网

提高制药品质辐射灭菌技术优势突出_制药工业,制药设备,灭菌器-制药网