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附件 化学药品打针剂与药用玻璃包装容器相容性研讨技术指点准绳(试行)

2021-12-09

一、概述

BENZHIDIANZHUNSHENGSHOUYAOZHENDUIDAZHENJIYUBOLIBAOZHUANGRONGQIDEXIANGRONGXINGYANTAOTINGZHILUNSHU,ZHIZAIZHIDIANYAOPINYANFAJICHUCHANQIYETIXI、GUIFANDITINGZHIYAOPINYUBOLIBAOZHUANGRONGQIDEXIANGRONGXINGYANTAO,ZAIYAOPINYANFASHIDAIDUIYAOYONGBOLI(YIXIAJIANCHENGBOLI)BAOZHUANGRONGQITINGZHITIAOXUAN,BINGZAIQUANBUYANFAJINCHENGZHONGDUIHUAXUEYAOPINDAZHENJIBAOZHUANGTIXIDEHEYONGXINGTINGZHIQUEREN,ZHONGJIUTIAOXUANHELIYONGYUYAOPINJUBEIJIECHUXIANGRONGXINGDEBOLIBAOZHUANGRONGQI,FANGZHIYINYAOYONGBAOZHUANGRONGQINENGGOUZHISHIDENINGJINGXINGWEIXIAN。BENZHIDIANZHUNSHENGSHIZAIXIANXINGLVLIHEGUIFANTIXIHEJINHOURENZHICHENGDUXIANIDINGDE,ZUNSHOULE《JIANJIEDAZHANGYAOPINDEBAOZHUANGZILIAOHERONGQIBANLITILI》(GUODUSHIWUYAOPINJIANSHIBANLIJULINGDI 13 HAO),XIANGYAN/CANKAOLEYUANGUODUSHIWUYAOPINJIANSHIBANLIJUFABUDE《HUAXUEYAOPINDAZHENJIYUSULIAOBAOZHUANGZILIAOXIANGRONGXINGYANTAOJISHUZHIDIANZHUNSHENG(SHIXING)》(GUOSHIYAOJIANZHU〔2012〕267 HAO)DESIXU,JIANJIELEGUOJIWAIXIANGGANDEZHIDIANZHUNSHENGJIYOUGUANZHUANZHU,ZHONGDIANTUQILEDAZHENJIYUBOLIBAOZHUANGRONGQIXIANGGANDEXIANGRONGXINGYANTAONEIRONG。GENZHEXIANGGANLVLIDEBUSHIWANMEIHEYAOWUYANTAOJISHUQINGQIUDEJINBU,BENZHIDIANZHUNSHENGJIANGBUSHIDINGZHENGBINGWANMEI。BENZHIDIANZHUNSHENGSHOUYAOLUNSHULEDAZHENJIYUBOLIBAOZHUANGRONGQIDEXIANGRONGXINGYANTAO,QIYUJIXINGYUBOLIBAOZHUANGRONGQIDEXIANGRONGXINGYANTAOBUZAIBENZHIDIANZHUNSHENGZHONGLUCHEN,BIEDE,BOLIBAOZHUANGRONGQICHANGYUJIAOSAIDENGZUJIANGONGTONGLIYONG,YAOPINYANFAJICHUCHANQIYEKECANPAIZHAOGANZHIDIANZHUNSHENGDEGENJISIXU,ZHANKAIZHIJIYUBOLIBAOZHUANGRONGQIQIYUZUJIANJIZILIAO(RUJIAOSAIDENG)DEXIANGRONGXINGYANTAO。

BENZHIDIANZHUNSHENGSHIJIYUJINCHAORENZHIDEZHENZHUO,QIYUTIBIFANGJINGLIZHENGKEXUEGONGDAOYEKEJIENA。


二、相容性研讨的斟酌要点

2.1 BOLIDEFENLEI

JINCHAO,ZHONGGUOCANKAOISO 12775:1997(E)FENLEITILI,ANZHAOSANYANGHUAERPENG(B2O3)HANLIANGHEJUNYUNXIANRESHOUSUOXISHU(Coefficient of Mean Linear Thermal Expansion,JIANCHENGCOE)DECHABIEJIANGBOLIFENWEILIANGLEI: JIPENGGUIBOLIHENAGAIBOLI,CIZHONGJIANGPENGGUIBOLIYOUFENWEIGAOPENGGUIBOLI、ZHONGPENGGUIBOLI、DIPENGGUIBOLI,RUFUJIAN1SUOSHI。MEIGUO、OUZHOUHERIBENDUIBOLIDEFENLEIYUWOGUOCHABIE,DANQIFENLEISIXUGENJIFENQI,RUFUJIAN2SUOSHI。

2.2 DAZHENJIYUBOLIBAOZHUANGRONGQINENGGOUFASHENGDEBICIGANHUA

2.2.1 BOLIRONGQIDEHUAXUECHENGFENYUCHUCHANGONGYI

PUTONGLAIJIANG,YAOYONGBOLIFANSHIBAOLUOERYANGHUAGUI、SANYANGHUAERPENG、SANYANGHUAERLV、YANGHUANA、YANGHUAJIA、YANGHUAGAI、YANGHUAMEIDENGCHENGFEN。MEIZHONGCHENGFENBILIBINGBUHENGDING,ZAIBIRANGUIMONEIDONGYAO。CHABIEBOLICHUCHANQIYEDEBOLIHUAXUEGOUCHENGHUIYOUSUOCHABIE。

WEILEGAILIANGYAOYONGBOLIDEJINENG,FANSHIHUIZAIBOLIZHONGZENGTIANCHABIEDEYANGHUAWU,RUCHASHOUYANGHUANA、YANGHUAJIA、YANGHUAGAI、YANGHUABEI、YANGHUAXIN、SANYANGHUAERPENGHEFUHUAWUKEXIAJIANGBOLIDERONGHUAWENDUHE/HUOGAILIANGBOLINEIWAIBIAONAISHOUXING;CHASHOUSANYANGHUAERLVNENGGOUGAILIANGBOLIDELIXUEJINENG;CHASHOUTIE、MENG、TAIDENGGUODUJINSHUYANGHUAWUGOUCHENGZHESEBOLIYIFASHENGZHEGUANGCHENGGUO;CHASHOUYANGHUASHEN、YANGHUATIDENGWUZIYICHECHUBOLIZHONGQIPAO,ZENGTIANBOLIDEKUOQINGDU。SHIYI,BOLIZHONGDEJINSHULIZIHUOYANGLIZITUANJUNYOUNENGGOUCONGBOLIZHONGQIANXICHULAI。

BOLIBAOZHUANGRONGQIFANSHIJIENAMOZHIHEGUANSHUGONGYICHUCHAN。CHABIECHUCHANGONGYIDUIBOLICHENGPINPINDEDEYINGXIANGCHABIE,CHUGESHIDUIBOLINEIWAIBIAODENAISHOUXINGYINGXIANGJIAODA。MOZHIBOLIRONGQINEIWAIBIAONAISHOUXINGGENJIBUYI。DUIGUANSHUBOLIZHICHENGDECHABIEFANLIBOLIRONGQI,RUGUANSHUDAZHENJIPING(HUOCHENGXILINPING)、ANBU、BISHIDAZHENQIBOLITAOTONG(HUOCHENGKASHIPING),YUGUANFENGDAZHENQIBOLIZHENGUANDENG,JINGYOUJINCHENGJIARESHIRONGQICHENGXINGDEJINCHENGZHONG,YINWEIBUFENSHOURE(RUDIBUYINGLIHUANBUWEI,JINGBU)JIFADEJIANJINSHUHEPENGSUANYANDEZHENGFAJIFENXIANGCHENGYUANYOU,SHANGSHUBUWEINEIWAIBIAODEHUAXUENAISHOUXINGFANSHIDIYUBOLIRONGQIZHONGWEISHOUREDEBUWEI;BIEDE,CHABIECHANGJIANENGGOUTIAOXUANCHABIEDEGUANSHUCHENGXINGGONGYI,RUDIBUHEJINGBUHUOYANJIAGONGWENDUHEGOUCHENGBOLIRONGQIHOUDETUIHUOWENDU、TUIHUOSHIHOUDENGCHABIE,SHIYIJIBIANJIENABUYICHUCHANSHANGGONGJIDETONGPICIBOLIGUAN,GUANSHUBOLIRONGQIYENENGGOUCUNZAIPINDECHABIE,JISUOBAOZHUANGDEYAOWUDAILAICHABIEDEWEIXIAN。

WEILEJINBUBOLIRONGQINEIWAIBIAONAISHUIXINGDENGJINENG,FANSHIHUIDUIBOLIRONGQIDENEIWAIBIAOTINGZHIHUAXUECHUZHI,RUYONGLIUSUANANCHUZHI。GAICHUZHIGONGYIGURANNENGGOUJINBUBOLIDENAISHUICAINENG,DANNENGGOUHUISHIMOUXIEBOLIDEBUJUNUORUO;BIEDE,YEYOUSHAOXUBOLIRONGQIJIENANEIWAIBIAODUMOCHUZHIDETILI,DANBIXUZHUZHONGDESHI,ZAIYAOPINCHIJIUCHUZANGQIANTIXIA,MOCENGZILIAONENGGOUBEIYAOWUFUSHI,MOCENGZILIAOJIBOLICHENGFENJUNNENGGOUQIANXIJINRUYAOWUZHONG。

2.2.2 DAZHENJIYUBOLIBAOZHUANGRONGQIDEBICIGANHUA

SULVJIAKUAIDENGJINGXIANG;BOLIZHONGDENALIZIQIANXIHOU,ZHISHIYAOYEpHZHIFASHENGBIANGENG,MOUXIEDUXINGJIAODADEJINSHULIZIHUOYANGLIZIJITUANQIANXIJINRUYAOYEYEHUIFASHENGQIANFUDENINGJINGXINGWEIXIAN。

DUIMOUXIEWEILIANG、YIZHICHUANGZHAI、BUJUSHANGCUNZAIYIYUBOLIFASHENGXIFUGUANNENGTUANDEYAOWU,HUOSHICHUFANGZHONGHANYOUWEILIANGGONGXIAOXINGFULIAO(RUKANGYANGJI,LUOHEJI)DEYAOWU,BOLIRONGQIWAIBIAONENGGOUHUIFASHENGXIFUGANHUA,SHIYAOWUJILIANGHUOFULIAOHANLIANGXIAJIANG。

DAZHENJIHUIDUIBOLINEIWAIBIAODENAISHOUXINGFASHENGYINGXIANG,XIAJIANGBOLIRONGQIDEYANHUGANHUAHEGONGXIAOXING,NAIZHIZHISHIBOLIWANGZHUANGBUJUFENSUIZHISHICIZHONGDECHENGFENDAPIRONGCHUBINGFASHENGBOLIXIEHUOTUOPIAN,JIFANINGJINGXINGTIMU。YINGXIANGBOLINEIWAIBIAONAISHOUXINGDESHENFENBAOHANBOLIRONGQIDEHUAXUEGOUCHENG、CHUCHANGONGYI、CHENGXINGHOUDECHUZHITILI,HEYAOWUZHIJIDECHUFANG(GOUCHENGCHENGFEN、LIZIQIANGDU、LUOHEJI、pHZHI)、MIEJUNTILIDENG。MOZHIBOLIRONGQIYIQIEMIANDENEIWAIBIAONAISHOUXINGGENJIBUYI,GUANSHUBOLIRONGQIJIEJINDIBUYINGLIHUANBUWEIHEJINGBUNEIWAIBIAODEHUAXUENAISHOUXINGDIYUQIYUBUWEI,NAIFUSHIXINGSHOUCHABIEYAOWUZHIJIDEYINGXIANGJIAODA。NEIWAIBIAODIANMOCHUZHI(BIFANGYONGLIUSUANANCHUZHI)DEBOLINENGGOUZHISHIWAIBIAOCENGFUGUI,HUIGOUCHENGBOLIBUJUNUORUO。

YINGXIANGBOLINEIWAIBIAONAISHOUXINGDESHENFENKECANJIANFUJIAN3。

2.2.3 WEIDAZHENJITIAOXUANSHIHEDEBOLIBAOZHUANGRONGQI

BENZHIDIANZHUNSHENGSUOZHIDEBOLIBAOZHUANGRONGQIHANGAILEMOZHISHUYEPINGHEDAZHENJIPING,HEGUANSHUDAZHENJIPING、ANBU、BISHIDAZHENQIBOLITAOTONGHEYUGUANFENGDAZHENQIBOLIZHENGUANDENG。FANSHI,YAOYONGBOLIJUBEIJIAOHAODEWULI、HUAXUEBUBIANXING,SHENGWUNINGJINGXINGJUEDUIJIAOGAO。ZAIWEIDAZHENJITIAOXUANBOLIBAOZHUANGRONGQISHI,XUYAOCUNJUANBOLIRONGQIDEYANHUGANHUA、XIANGRONGXING、NINGJINGXING,HEYUGONGYIDEHEYONGXINGDENG。

ZAIXIANGRONGXINGFANGMIAN,XUKAOCHAZHIJIDUIBOLIRONGQIJINENGDEYINGXIANG,HEBOLIRONGQIDUIZHIJIPINDEHENINGJINGXINGDEYINGXIANG,KECUNJUANYIXIAFANGMIANNEIRONG: BOLIDEFANLI、BOLIDEHUAXUEGOUCHENG、BOLIRONGQIDECHUCHANGONGYI、GUIGEJUXI、BOLICHENGXINGHOUDECHUZHITILI;YAOPINHECHUFANGDEXINGZI,RUYAOYEDEpHZHI、LIZIQIANGDUDENG;HEZHIJICHUCHANJINCHENGZHONGDEXIZHUO、MIEJUNDENGGONGYIDUIBOLIRONGQIDEYINGXIANG,RUXIPINGJIEDUANDEGANREMIEJUNGONGYI、ZHIJILENGDONGKUZAOGONGYI、ZHONGDUANMIEJUNGONGYIDENG。

PUTONGHUANJINGXIA,GUANSHUBOLIRONGQIDUOHEYONGYUBAOZHUANGXIAORONGLIANGDAZHENYEHEFENMO,RUANBUPING、BISHIDAZHENQIBOLITAOTONGHEYUGUANFENGDAZHENQIDENG;MOZHIBOLIRONGQIDUOHEYONGYUDARONGLIANGDAZHENJI、XIAORONGLIANGDAZHENYEHEFENMO(MOZHIDAZHENJIPING)DEBAOZHUANG,RUNAGAIBOLISHUYEPING、ZHONGPENGGUIBOLISHUYEPINGDENG。

2.3 XIANGRONGXINGYANTAODEBUZHOU

XIANGRONGXINGYANTAONEIRONGYINGBAOHANBAOZHUANGRONGQIDUIYAOPINDEYINGXIANGHEYAOPINDUIBAOZHUANGRONGQIDEYINGXIANG,SHOUYAOFENWEIYIXIALIUGEBUZHOU: 1)KENDINGJIANJIEDAZHANGYAOPINDEBAOZHUANGZUJIAN;2)LINGHUIHUOCHANFABAOZHUANGZUJIANZILIAODEGOUCHENG、BAOZHUANGZUJIANYUYAOPINDEDAZHANGTILIYUDAZHANGQIANTI、CHUCHANGONGYIJINCHENG,RU: BOLIRONGQIDECHUCHANGONGYI(MOZHIHUOGUANSHU)、BOLIFANLI、BOLICHENGXINGHOUDECHUZHITILIDENG,BINGANZHAODAZHENJIDELIHUAXINGZIDUINITIAOXUANDEBOLIRONGQITINGZHIKAIDUANPINGJIA;3)DUIBOLIBAOZHUANGTINGZHIMONISHIYAN,ZHANWANGBOLIRONGQISHIBUSHIHUIFASHENGTUOPIANHEQIYUTIMU;4)TINGZHIZHIJIYUBAOZHUANGRONGQITIXIDEBICIGANHUAYANTAO,SHOUYAOKAOCHABOLIRONGQIDUIYAOPINDEYINGXIANGHEYAOPINDUIBOLIRONGQIDEYINGXIANG,YINGTINGZHIYAOPINGUANLICHACHAOMINGMUCHACHAO、QIANXISHIYAN、XIFUSHIYAN,TONGSHIDUIBOLINEIWAIBIAODEFUSHIXINGTINGZHIKAOCHA;5)DUISHIYANCHENGGUOTINGZHICHANFA,NINGJINGXINGPINGJIAHE/HUOYANTAO;6)DUIYAOPINYUSUOYONGBAOZHUANGZILIAODEXIANGRONGXINGTINGZHIZONGJIE,DECHUBAOZHUANGTIXISHIBUSHIHEYONGYUYAOPINDELUNDUAN。BOLIRONGQIXIANGRONGXINGYANTAOJUEYIJIHUASHUKECANJIANFUJIAN4。


三、相容性研讨的首要内容与阐发体例

ZAITINGZHIDAZHENJIYUBOLIRONGQIDEXIANGRONGXINGYANTAOQIAN,XUYAOLINGHUIBOLIDEGOUCHENGCHENGFEN、CHUCHANGONGYI,NEIWAIBIAOCHUZHITILIDENGXINXI,ERHOUZAICIGENBENZHISHANGTINGZHIHOUXUDEXIANGRONGXINGYANTAO。ZHEILIDEXIANGRONGXINGYANTAOBAOHANMONISHIYANHEBICIGANHUAYANTAO。

3.1 MONISHIYAN

MONISHIYANDESHOUYAOFANGZHENSHIZHANWANGBOLIRONGQIFASHENGTUOPIANDENENGGOUXING,FANSHIJIENAMONIYAOPINDERONGJI,ZAIJIAOMENGLIEDEQIANTIXIA,DUIBOLIBAOZHUANGTINGZHIDESHIYANYANTAO。

RUOSHIDAZHENJICUNZAIDUOZHONGBAOZHUANGGUIGE,SHIYANYANTAORONGQIYISHOUXUANBIWAIBIAOJIZUIDADEBOLIRONGQI,YINGZHUZHONG,RUOSHISHICHABIEDEGONGJISHANGHE(HUO)CHABIECAIZHIDEBOLIBAOZHUANG,YINGBIELITINGZHISHIYAN。

MONIRONGJI: SHOUXUANHANFANGZHENYAOWUDEDAZHENJI,RUOSHIYAOWUDUICHANFATILIFASHENGJIAORAO,KETIAOXUANYUZHIJIJUBEIBUYIHUOLEISILIHUAXINGZIDEMONIRONGJI,ZHONGDIANZHENZHUORONGYEDEpH、JIXINGJILIZIQIANGDU、LIZIPINZHONGDENG,RUBUHANYAOWUDEKONGQUEZHIJI。MONIQIANTI: MONISHIYANXUZAIJIAOMENGLIEDEQIANTIXIATINGZHI。YINGLIANXIYAOPINZAICHUCHAN、CHUCUN、YUNSHUJILIYONGJINCHENGZHONGDEZUIJIDUQIANTI,BINGTIAOXUANGENGJILIEDESHIYANQIANTI,RUJIARE、HUILIUHUOCHAOSHENG、ZHENDANGDENG。

CHUTIAOXUANYISHANGMONIRONGJIHEMONIQIANTIZHIWAI,YEKECANKAOMEIGUOYAODIAN<1660>BOLINEIWAIBIAONAISHOUXINGPINGJIAZHINANZHONGJIAKUAITUOPIANSHIYANTILI(RUFUJIAN5SUOSHI),BINGLIANXIYAOPINDEpHZHI、LIZIQIANGDUDENGSHENFEN,TIAOXUANMONIRONGJIHEMONIQIANTI。

YINGDABOLIRONGQINEIWAIBIAOTINGZHICHACHAO,BINGDUIFUSHIHOUDEMONIRONGYETINGZHIJIANCECHANFA,YIZHANWANGBOLINEIWAIBIAOFUSHIHEBOLITUOPIANDEPIANXIANG,NENGGOUJINGYOUJINCHENGCHAKANBOLIWAIBIAODEFUSHICHENJITINGZHIKAIDUANPANDING,QIYUCEDINGFANGZHENBAOHANSHIYANYEZHONGSiYUANSUNONGDUZENGTIANLIANG、Si/BHUOSi/AlBIZHIDEZENGTIANLIANG、KEJIANHEBUKEJIANWEILISHUZENGTIANLIANG,pHZHIHUISHENGCHENGDU,HEQIYUDUOZHONGLIZIDEBIANGENGLIANGDENG。

3.2 BICIGANHUAYANTAO

TINGZHIDAZHENJIYUBOLIRONGQIBICIGANHUAYANTAOSHI,YINGJIENANISHANGSHIDECHUFANGGONGYIHEBAOZHUANGRONGQICHUCHANDEZHIJI,BINGJIANGBOLIRONGQIHEDAZHENJIJUNZUOWEISHIYANYANGPIN,YINGJIENAZUISHAO3PIZHIJIYU1PIBAOZHUANGRONGQITINGZHIYANTAO。

KAOCHAQIANTIXUCHONGSHIZHENZHUOYAOPINZAICHUCUN、YUNSHUJILIYONGJINCHENGZHONGNENGGOUMIANDUIDEZUIJIDUQIANTI。KAO

CHASHIHOUDIANDESHEZHIYINGJIYUDUIBOLIBAOZHUANGRONGQIXINGZIDESHUXI、BAOZHUANGRONGQIYUYAOPINBICIYINGXIANGDEQUXIANGERSHEZHI,PUTONGYINGBUSHAOYU(0、3、6GEYUE)SANGESHIYANDIAN。FANSHIYINGTIAOXUANANYIBANQIANTICHUCHAN、BAOZHUANG、ANPAIDEDAZHENJIDEBAOZHUANGRONGQI(ERBUSHIGEBAOZHUANGZUJIAN)TINGZHIBICIGANHUAYANTAO,KECANKAOJIAKUAIBUBIANXINGSHIYANHECHIJIUBUBIANXINGSHIYANDESHIYANQIANTI(WENDUHESHIHOU),ZUISHAOYINGBAOHANCHUFADIANHEQIDIAN,ZHONGXINDIANKEQIADANGDIAOJI,BIFANG,ZAIKAOCHALIZINONGDUDEBIANGENGHUANJINGSHI,WEILESHILIZINONGDU-SHIHOUQUXIANDEXIELVBIANGENGCHENGGUOGENGJUKEPINGJIAXING,KEQIADANGZENGTIANZHONGXINQUYANGDIAN。WEILEJINNENGGOUBAOZHANGRONGYEYUBOLIRONGQIDIBUYINGLIHUANBUWEIHEJIANBUDAZHANG,DUIDAZHENYE,KEJIENARONGQIZHENGLIHEDIANDAODETILITINGZHIBIELISHIYAN。

ZAIDUICHABIENONGDUDEDAZHENJITINGZHIYANTAOSHI,YEKEJIENAICHBUBIANXINGZHIDIANZHUNSHENGZHONGBAOJUDEKUOHAOFAHUOJUZHENFATINGZHISHIYAN。

3.2.1 BOLIRONGQIDUIYAOPINPINDEDEYINGXIANG

3.2.1.1 YAOPINGUANLICHACHAOMINGMU

ZAICHABIEDEKAOCHAQIANTIHESHIHOUDIANDUIYAOPINTINGZHICHACHAOSHI,YINGZHONGDIANCUNJUANBOLIRONGQIJIQIZENGTIANWUZIDUIYAOWUBUBIANXINGDEYINGXIANG,RUDUIYAOPINpHZHI、RONGYEKUOQINGDUYUSECAI、KEJIANYIWU、BURONGXINGWEILI、ZHONGJINSHU、YOUGUANWUZIHEHANLIANGDENGDEYINGXIANG,KECANKAOYAOPINGUIFANTINGZHICHAYAN。DUIpHZHIJIAOMINGANDEYAOPIN,YINGZHONGDIANCUNJUANCONGBOLIZHONGJINCHUDEJIANJINSHULIZIDENGCHENGFENDUIYAOPINBUBIANXINGDEYINGXIANG,RUYAOPINpHZHI、YAOYESECAIDEBIANGENGHUANJING、KEJIANYIWUDECHENGXIANDENG。

3.2.1.2 QIANXISHIYAN

DENGKEYUSHIBOLIBEIFUSHIHUOFASHENGTUOPIANQUXIANGDEYUANSUTINGZHICHACHAO。

DUINEIWAIBIAODUMODEBOLIRONGQI,YINGDAMOCENGZILIAODEZUFENJIQIJIANGJIEWUDEQIANXITONGSHITINGZHIKAOCHA。

3.2.1.3 XIFUSHIYAN

XIFUSHIYANSHOUYAOZHENDUIWEILIANG、YIZHICHUANGZHAI、BUJUSHANGCUNZAIYIYUBOLIFASHENGXIFUDEGUANNENGTUANDEYAOWU,HECHUFANGZHONGHANYOUWEILIANGDEGONGXIAOXINGFULIAOTINGZHI。BAOJUTIAOXUANGAIYAOPINJIAKUAISHIYANHECHIJIULIUYANGSHIYANQIANTI(WENDUHESHIHOU)TINGZHI,FANSHIKETIAOXUANJIAKUAISHIYANHECHIJIULIUYANGSHIYANDEKAOCHASHIHOUDIAN,ANZHAOYAOPINGUIFANTINGZHICHAYAN,BINGANZHAOKAOCHAGONGJU(RUGONGXIAOXINGFULIAO)DENGQIADANGZENGTIANCHAYANMINGMU,SHOUYAODUIYAOPINHENIKAOCHAFULIAODEHANLIANGDENGMINGMUTINGZHICHACHAO。

3.2.2 YAOPINDUIBOLIRONGQINEIWAIBIAODEYINGXIANG

DUIHANWUJISUAN、LUOHEJI、PIANJIAN、GAOLIZIQIANGDUDEDAZHENJI(RUFUJIAN3SUOSHI),YINGZHONGDIANCUNJUANBOLIRONGQIBEIFUSHIHOUCHENGXIANTUOPIAN、WEILI(BOXIE)DENENGGOUXING。KEZAIMONISHIYANHEQIANXISHIYANDETONGSHI,DUIBOLIRONGQINEIWAIBIAOTUOPIANDEQUXIANGHECHENGDUTINGZHIKAOCHA。YINGDANGZHUZHONG,YAOPINDUIBOLIRONGQIJINGBUHEDIBUCHENGXINGJIAGONGCHUDEFUSHICHENGDUYUYAOPINDUIBOLIBIDEFUSHICHENGDUCHABIE,DUIBOLIRONGQIYUYAOPINDAZHANGCHUYUFEIDAZHANGCHUDEFUSHICHENGDUYECHABIE(RUDONGGANZHIJI),ZAIKAOCHAYAOPINDUIBOLIRONGQINEIWAIBIAODEYINGXIANGSHI,XUZHUZHONGDUIBOLIRONGQICHABIEBUWEITINGZHIKAOCHA。

KEJINGYOUJINCHENGDUIBOLIRONGQINEIWAIBIAOJI/HUODAZHENYETINGZHIJIANCECHANFA,PINGJIAYAOPINDUIBOLIRONGQINEIWAIBIAODEYINGXIANG。HANJIANDETILIBAOHANGUANLICHAKANBOLIWAIBIAOFUSHICHENJI(DUIBOLINEIWAIBIAOTINGZHIYAJIALANRANSEDENG),HEDAZHENYEZHONGDEKEJIANYIWU;JIENAWAIBIAOCHANFAJISHUDUIBOLINEIWAIBIAODEHUAXUEFUSHITINGZHIJIANCE;CEDINGDAZHENYEZHONGDEBURONGXINGWEILI、HESHIYANYEZHONGSiYUANSUNONGDUZENGTIANLIANG、Si/BHUOSi/AlBIZHIBIANGENGHEQIYUJINSHULIZIDEBIANGENGQUXIANGDENGTINGZHIKAOCHA,SHANGSHUSHUZHIRUFASHENGJIAOZHEBIANGENG,ZEYUSHIBOLIRONGQINENGGOUSHOUFUSHIFASHENGTUOPIANHEWEILI(BOXIE)HUOWEIXIANZENGTIAN。

ZAITINGZHIBURONGXINGWEILIKAOCHASHI,KECANDENGKEGUOYAODIANFULUIX CTINGZHICHACHAO。YINBOLIWEILIBIRONGJIZHONG,WEILIYICHUXUJILEIZAIRONGQIDIBU,WEILEHUODEJINGQUESHUJU,YINGDARONGYETINGZHICHONGSHIZHENYAOHOUTINGZHICEDING。

YINGDANGZHUZHONG,BOLIRONGQIFASHENGTUOPIANDEPIANXIANGYUYANFUDAZHENYEDESHIHOUSHIFEIJIANJIEXIANGGAN,FANSHIZAIYANFUDAZHENYE3~6GEYUEJINHOUHUOGENGZHANGSHIHOUCAIKECHAKANDAOJIAOZHEDETUOPIANJINGXIANG,WEIMINGBAIYAOPINDUIBOLINEIWAIBIAODEYINGXIANG,KEQIADANGDANWUKAOCHADESHIHOU,RUZAIYAOPINJIAKUAISHIYANXIATINGZHI9~12GEYUESHIYAN,BINGZAICHIJIULIUYANGSHIYANJINCHENGZHONGTINGZHIKAOCHA。

DUIKEJIANJIBUKEJIANWEILICHACHAOJUNHESHIQINGQIU,DANDAZHENYEZHONGLIZINONGDUFASHENGJIAOZHEBIANGENGDEHUANJING,KEJIENASHIHETILI,DUIBURONGXINGWEILICHACHAOTILINANYIJIANCHUDELIJINGGENGXIAODEWEILITINGZHIKAOCHA,DUIBOLIRONGQISHOUFUSHIFASHENGTUOPIANHEWEILI(BOXIE)DEWEIXIANHEQUXIANGTINGZHICHANFAHEPINGJIA。

3.3 KONGQUEJIAORAOSHIYAN

XUYAOSHIKETINGZHIKONGQUEJIAORAOSHIYAN,SHIYANJINCHENGZHONGSUOJIENADESHIYANYONGJU,HETINGZHICANBISHIYANSHI,ZHUNSHENGSHANGYINGJINNENGGOUFANGZHILIYONGBOLIRONGQI。BIEDEBOLIBAOCAIDUOYUJIAOSAIGONGTONGLIYONG,ZAITINGZHIXIANGRONGXINGSHIYANSHI,YINGZHENZHUOFANGZHIJIAOSAIDUISHIYANCHENGGUODEYINGXIANG。

BIFANG: ZAIDUIBOLIBAOZHUANGRONGQITINGZHIXIANGGANSHIYANSHI,KONGQUESHIYANBUYITIAOXUANXIANGJIAOSAIZUOWEIMIFENGJIAN,KETIAOXUANJUSIFUYIXIPING,HEJUSIFUYIXIHUOJUBINGXISAI,HUOQIYUDUOXINGRONGQITINGZHIPINGXINGDUIBI。

3.4 CHANFATILIYUTILIXUEKAOZHENG

MONISHIYANHEQIANXISHIYANYINGJIENAZHUANSHUXINGQIANG、JINGQUE、JINMI、HUOLUODECHANFATILI,YIBAOZHANGSHIYANCHENGGUODEKAODEZHUXING;BINGYINGZHENDUICHABIEDEDAICEMINGMUTIAOXUANSHIHEDECHANFATILI。YINWEIBOLIRONGQIZUIHANJIANDEKETIQUWUWEIJINSHULIZI、BUHUIFAXINGWUZIDENGZUFEN,DUIKETIQUWUHEJINCHUWUDEHANJIANCHANFATILIBAOHAN: DIANGANOUHEDENGLIZITIFASHEGUANGPU(ICP)、YUANZIJIESHOUGUANGPU(AAS)、LIZISEPU(IC)、GAOXIAOYEXIANGSEPU(HPLC),HEYUZHIPUDELIANJIJISHU,ICP-MS、HPLC-MS DENG,TILIXUEYANTAOSHIZHONGDIANCUNJUANHUOLUODU(JIANCEXIAN、JIXIANZHI)、ZHUANSHUXING、JINGQUEXINGDENG。

KAOCHAYAOPINDUIBOLINEIWAIBIAOYINGXIANGDECHANFATILIJIAODUO。KECANZHAOYAODIANTILITINGZHIBURONGXINGWEILI、KEJIANYIWUCHACHAO;KETIAOXUANLIJINGCHANFAYI、SAOMIAODIANZIXIANWEIJING-XSHEXIANNENGLIANGSESANGUANGPUYI(SEM-EDX)DUIWEILITINGZHICHACHAO;YEKETIAOXUANWEIFENGANYUCHAXIANWEIJING(DICXIANWEIJING)、DIANZIXIANWEIJING(EM)HEERCILIZIZHIPUYI(SIMS)HEYUANZILIXIANWEIJING(AFM)、DIANZITANZHEN(EPMA)DENGTILIDUIBOLIWAIBIAODEFUSHICHENGDUHEGONGXIAOCENGDEHUAXUEGOUCHENGTINGZHIKAOCHA。

SHIYANJINCHENGZHONGXUZHUZHONG: TINGZHIMONISHIYANHEQIANXISHIYANSHIBIXUTINGZHITILIXUEKAOZHENG,FANGZHENYUANSUDESHOUSHOUJIEGUANLVYINGHESHIQINGQIU,SHANGSHUSHIYANDETILIHUOLUODUYINGZHIZUAETDECEDINGQINGQIU。YIQIECESHIMINGMUYINGTIJIAOJUBEITONGJIXUEYISIDESHUJU。


四、实验成果阐发与宁静性评价

ANZHAOMONISHIYANCHENGGUODUIBOLIRONGQIZAIYANFUXIANSHIYAOYESHIFASHENGTUOPIANDENENGGOUXINGTINGZHIKAIDUANZHANWANG;JINGYOUJINCHENGDUIYAOPINGUANLIMINGMUCHACHAOSHUJU、QIANXISHIYANZHONGJINCHUWUDEPINZHONGJIHANLIANG、XIFUSHIYANHEYAOPINDUIBOLINEIWAIBIAODEYINGXIANGTINGZHIPINGJIA,CHANFAPANDINGBAOZHUANGTIXISHIBUSHIYUYAOPINJUBEIXIANGRONGXING。

4.1 MONISHIYANCHENGGUOPINGJIA

RUOSHISHIYANJINCHENGZHONG,BOLINEIWAIBIAOCHENGXIANFUSHICHENJI;HUOSHIYANYEZHONG Si YUANSUNONGDU、Si/BHUO Si/Al BIZHI、WEILISHUHE pH ZHIDENGFASHENGJIAOZHEBIANGENG,ZEYUSHIBOLIRONGQIFASHENGTUOPIANDENENGGOUXINGJIAODA。

XUZHUZHONGDESHI,MONISHIYANJINSHIZHANWANGBOLIRONGQIFASHENGTUOPIANDENENGGOUXING,ZAIYANFUXIANSHIYAOWUSHIBINGBUBIRANHUIFASHENGTUOPIAN,SHIYI,KEDUIMONISHIYANCHENGGUOTINGZHIPINGJIA,BINGTIAOXUANYANXUTINGZHIHOUXUXIANGRONGXINGSHIYANRENGSHIGAIHUANBAOZHUANGRONGQIDEGONGJISHANGHE/HUOQIYUPINZHONGDEBAOZHUANGRONGQI。

4.2 YAOPINGUANLIMINGMUCHACHAOCHENGGUOPINGJIA

RUOSHISHIYANFAMINGCHENGXIANRONGYESECAIJIASHEN、FASHENGKEJIANYIWU、pHZHIBIANGENGDENGJINGXIANG,YINGCHANFAYUANYOUBINGDUISHIYANCHENGGUOTINGZHIPINGJIA。RUOSHISHANGSHUBIANGENGYIDAODABUKEJIEGUANDECHENGDU,QIEWEIBOLIRONGQIERZHI,YINGZHENZHUOJIENAQIYUFANLIBOLIBAOZHUANGRONGQIHEQIYUQINGSHIDEBAOZHUANGRONGQI;RUOSHISHIQIYUYUANYOUERZHI,YINGDACHANWUTINGZHIYOUHUA,RUWANMEIZHIJIDECHUFANGGONGYIDENGYISHICHANWUHESHIXIANGGANPINDEJIEZHIQINGQIU。

4.3 QIANXISHIYANCHENGGUOPINGJIA

ANZHAOJINCHUWUDE PDE ZHI、ZHURIZUIDAYONGYAOJILIANGJIJIAOMEIDANGEBAOZHUANGRONGQIZHONGGEJINCHUWUDEZUIDAXUKENONGDU,BINGZAICIGENBENSHANGJINGJIJIAOHUODECHANFAPINGJIAYUZHI(Analytical Evaluation Threshold,AET),CHANFACESHITILIYINGZHIZUGAI AET ZHIDECEDINGQINGQIU。ZAITIJIAOZHUCEZILIAOSHI,YINGGONGJIJINCHUWUDE PDE、AET DENGSHUZHIJIQIJIJIAOJINCHENG。RUOSHIQIANXISHIYANXIANXIANJINCHUWUHANLIANGDIYU PDE SHI,KEYIWEIJINCHUWUDELIANGBUHUIZHUANBIANYAOPINDENINGJINGXING,DUIHUANZHEDENINGJINGXINGWEIXIANXIAO。RUOSHIQIANXISHIYANXIANXIANJINCHUWUDEHANLIANGGAOYUPDE,ZEYIWEIBAOZHUANGRONGQIYUYAOPINBUJUBEIXIANGRONGXING,CHANGYIGAIHUANBAOZHUANGZILIAO。BOLIRONGQIZHONGJINGCHANGSHIYONGJINSHUYUANSU(DAZHENLUZI)DEZHURIXUKESHEQULIANG(PDE)QINGCANJIANFUJIAN6。

4.4 XIFUSHIYANCHENGGUOPINGJIA

RUOSHIXIFUSHIYANCHENGGUOXIANXIANBAOZHUANGRONGQIDUIYAOPINHUOFULIAOCUNZAIJIAOQIANGXIFU,BINGDUIYAOPINPINDEFASHENGLEJIAOZHEYINGXIANG,CHANGYIJIENASHIHEDETILIXIAOMIDUICHANWUZILIANGDEYINGXIANG,BIFANG,GAIHUANBAOZHUANGRONGQI。

4.5 YAOPINDUIBOLINEIWAIBIAODEYINGXIANGCHENGGUOPINGJIA

ZAIMONISHIYANHEQIANXISHIYANJINCHENGZHONG,RUOSHIROUYANCHAKANBOLIWAIBIAOCHENGXIANFUSHICHENJI;HUOCHENGXIANBOXIEHUOTUOPIAN,HUOROUYANKEJIANHEBUKEJIANWEILIDESHUMUCHAOYUEYAODIANJIEZHIQINGQIU,ZETIXINGYAOPINPINDEYIFASHENGLEJIAOZHEYINGXIANG,CHANGYIGAIHUANBAOZHUANGRONGQI。

RUOSHIKEJIANJIBUKEJIANWEILICHACHAOJUNHESHIQINGQIU,DANRONGYEZHONGSiO2NONGDU、Si/BHUOSi/AlBIZHIFASHENGJIAOZHEBIANGENG,TIXINGBOLIRONGQIFASHENGTUOPIANHEWEILI(BOXIE)DEWEIXIANJIQUXIANGZAIZENGDA,XUYANXUZHANKAIXIANGGANYANTAO,BINGYANXUJIANCEBOLIRONGQINEIWAIBIAODEBIANGENG,HUOGAIHUANBAOZHUANGRONGQI。


五、名词诠释

药用玻璃: 具备杰出化学不变性和通明性,且能不变储存医药产物的玻璃资料或成品。

管束玻璃容器、模制玻璃容器: 是按玻璃成型体例对玻璃容器的分类体例,模制瓶是借助各种差别外形的模具成型的产物,管束玻璃容器是用已拉制成型的各种玻璃管二次加工成型的产物。

玻璃内外表耐水性: 是一种外表实验法,是用划定的水注入被测容器到划定的容量,并在划定温度、时候下停止处置后,经由进程滴定浸提液来丈量水对容器内外表的腐蚀程度。

玻璃内外表耐受性: 指玻璃容器在其包装内容物时代,内外表蒙受水、酸、碱等物资的物理、化学腐蚀和温度、压力等环境身分感化的力。

均匀线热收缩系数(Coefficient of Mean Linear Thermal Expansion,简称COE): 均匀线热收缩系数是玻璃主要的热学性子,是指温度降低1℃,单位长度上的伸长量。

外表处置: 为进步玻璃外表的某些机能对玻璃容器外表停止处置的工艺,包含为削减成品碱金属离子的中性化处置、为进步成品外表憎水性的硅化镀膜等。

镀膜玻璃: 为转变玻璃外表的某些机能,经由进程差别的镀膜工艺给容器玻璃内外表覆上特别的化学成份(如化学气相堆积VCD),并颠末必然的工艺使其与玻璃成品烧结一体。按照膜层的成份差别分为无机硅镀膜玻璃和无机硅镀膜玻璃。

脱片: 玻璃内外表的碱金属离子受溶液化学腐蚀,在玻璃外表构成一层高硅氧层。高硅氧层与玻璃外部的未蜕变玻璃收缩系数差别,在温度变更时二者之间会发生应力,致使高硅氧层从主体玻璃上零落到溶液中构成玻璃脱片的景象。除上述缘由之外,也能够存在其余致使玻璃脱片的身分。

人逐日许可裸露量(permitted daily exposure, PDE): 指某一物资被许可摄取而不发生毒性的日均匀最大剂量,某一详细物资的 PDE 值是由不发生反映量、体重调剂系数、种属之间差别的系数、个别差别、短时间打仗急性毒性研讨的可变系数等推算出的。量或宁静性阈值/限制阈值、用药剂量和制剂包装特点等计较每单个包装容器中特定的可提取物和/或浸出物含量,当一个特定的可提取物和/或浸出物程度到达或跨越这个量值时,须要起头对这个可提取物/浸出物停止阐发,并须要报告给相干部分以便起头停止宁静性评价。


六、附件

FUJIAN 1: ZHONGGUOGUODUGUIFANDUIBOLIDEFENLEIHUANJING

1.PNG

FUJIAN 2: MEIGUO、OUZHOUHERIBENDUIBOLIDEFENLEI

2.PNG

FUJIAN3: YINGXIANGBOLINEIWAIBIAONAISHOUXINGDESHENFEN

3.PNG

FUJIAN4: BOLIRONGQIXIANGRONGXINGYANTAOJUEYIJIHUASHU

4.PNG

FUJIAN 5: JIAKUAITUOPIANDEJIEZHIHEQIANTI(MEIGUOYAODIAN<1660>BOLINEIWAIBIAONAISHOUXINGPINGJIAZHINAN)

 5.PNG

FUJIAN6: BOLIRONGQIZHONGJINGCHANGSHIYONGJINSHUYUANSUDEZHURIXUKESHEQULIANG(DAZHENLUZI)

 6.PNG

七、参考文献

1.《ZHONGHUAGUOMINGONGHEGUOYAOPINBANLIFA》(ZHONGHUAGUOMINGONGHEGUOZHUXILINGDI 45 HAO)

2.《YAOPINBANLIFASHIXINGTIAOLI》(ZHONGHUAGUOMINGONGHEGUOGUOWUYUANLINGDI360HAO)

3.《JIANJIEDAZHANGYAOPINDEBAOZHUANGZILIAOHERONGQIBANLITILI》(GUODUSHIWUYAOPINJIANSHIBANLIJULINGDI13HAO)

4.YAOYONGBOLIZILIAOHERONGQIZHIDIANZHUNSHENG(SHOULUODINGJIANGAO)

5.MEIGUOYAODIAN<1660>BOLINEIWAIBIAONAISHOUXINGPINGJIAZHINAN(SHOULUODINGJIANGAO)

6.HUAXUEYAOPINDAZHENJIYUSULIAOBAOZHUANGZILIAOXIANGRONGXINGYANTAOJISHUZHIDIANZHUNSHENG(SHIXING)(GUOSHIYAOJIANZHU〔2012〕267HAO)

7.ICH Q3D Guideline for Elemental Impurities.

8.Identification and Classification of Nonconformities in Molded and Tubular Glass Containers for Pharmaceutical Manufacturing.

http://store.pda.org/ProductCatalog/Product.aspx?ID=2069



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