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化学药品打针剂与塑料包装材料相容性研讨技术指点准绳(试行)

2021-12-09

一、概述

BAOZHUANGTIXISHIZHIBAORONGHEYANHUYAOPINDEYIQIEBAOZHUANGZUJIANDEZONGHE,BAOHANJIANJIEDAZHANGYAOPINDEBAOZHUANGZUJIANHECIJIBAOZHUANGZUJIAN,HOUZHEYONGYUYAOPINDEEDINGYANHU。BENZHIDIANZHUNSHENGSHOUYAOZHENDUIJIANJIEDAZHANGYAOPINDEBAOZHUANGTIXITINGZHILUNSHU。BAOZHUANGTIXIYIFANGMIANWEIYAOPINGONGJIYANHU,YIZHIZUQIYUQIDENINGJINGYOUYONGXINGYONGCHU;BIEDEYIFANGMIANHAIYINGYUYAOPINJUBEIJIECHUDEXIANGRONGXING,JIBUNENGYINRUKEJIFANINGJINGXINGWEIXIANDEJINCHUWU,HUOYINRUJINCHUWUDECHENGDUSHIHENINGJINGXINGQINGQIU。SHIBUSHIXUYAOTINGZHIXIANGRONGXINGYANTAO,HETINGZHIHEZHONGXIANGRONGXINGYANTAO,YINGJIYUDUIZHIJIYUBAOZHUANGCAILIAOCHANSHENGBICIGANHUADENENGGOUXINGHEPINGGUYOUCINENGGOUCHANSHENGNINGJINGXINGWEIXIANDECHENGGUO。YUKOUFUZHIJIBINI,XIRUQIWUJIHUOPENWUJI、DAZHENYEHUODAZHENYONGHUNXUANYE、YANYONGRONGYEHUOHUNXUANYE、BIXIRUQIWUJIHUOPENWUJIDENGZHIJI,YINWEIJIYAOHOUJIANGJIANJIEDAZHANGRENTIGOUZAOHUOJINRUXUEYETIXI,BEIYIWEISHIWEIXIANCHENGDUJIAOGAODEPINZHONG;BIEDE,DADUOYETIXITILIJIZAICHUFANGZHONGCHUHUOXINGCHENGFENWAIHAIHANYOUYIXIEGONGXIAOXINGFULIAO(ZHURONGJI、FANGFUJI、KANGYANGJIDENG),ZHEIXIEGONGXIAOXINGFULIAODECUNZAI,KEZENGJINBAOZHUANGZICAIZHONGCHENGFENDERONGCHU,SHIYIYUBAOZHUANGCAILIAOCHANSHENGBICIGANHUADENENGGOUXINGJIAODA;ANZHAOYAOPINJIYAOLUZIDEWEIXIANCHENGDUJIQIYUBAOZHUANGCAILIAOCHANSHENGBICIGANHUADENENGGOUXINGFENJI,ZHEIXIEZHIJIBEILIEWEIYUBAOZHUANGCAILIAOCHANSHENGBICIGANHUANENGGOUXINGJIAOGAODEGAOWEIXIANZHIJI。DUISHANGSHUZHIJIBIXUTINGZHI

YAOPINYUBAOZHUANGCAILIAODEXIANGRONGXINGYANTAO,YIZHENGSHIBAOZHUANGCAILIAOYUZHIJIJUBEIJIECHUDEXIANGRONGXING。BENZHIDIANZHUNSHENGSHOUYAOZHENDUIDAZHENJIYUSULIAOBAOZHUANGCAILIAODEXIANGRONGXINGYANTAOTINGZHILUNSHU,NEIRONGBAOHANXIANGRONGXINGYANTAODEGENJISIXU、XIANGRONGXINGYANTAODESHOUYAONEIRONG、XIANGRONGXINGSHIYANNEIRONGYUCHANFATILI,HESHIYANCHENGGUOCHANFAYUNINGJINGXINGPINGGUDENG,ZHIZAIZHIDIANYAOPINYANFAJICHUCHANQIYETIXI、GUIFANDITINGZHIYAOPINYUBAOZHUANGCAILIAODEXIANGRONGXINGYANTAO,ZAIYAOPINYANFAZAOQIDUIBAOZHUANGCAILIAOTINGZHITIAOXUAN,BINGZAIQUANBUYANFAJINCHENGZHONGDUIBAOZHUANGTIXIHEYONGXINGTINGZHIQUEREN,YIYOUYONGFANGZHIBAOZHUANGCAILIAONENGGOUYINRUDENINGJINGXINGWEIXIAN,CONGERTIAOXUANLIYONGYUYAOPINJUBEIJIECHUXIANGRONGXINGDEBAOZHUANGCAILIAO。

BENZHIDIANZHUNSHENGSHOUYAOLUNSHUDAZHENJIYUSULIAOBAOZHUANGCAILIAODEXIANGRONGXINGYANTAO,QIYUJIXINGYUBAOZHUANGCAILIAODEXIANGRONGXINGYANTAOBUZAIBENZHIDIANZHUNSHENGZHONGLUCHEN,YAOPINYANFAJICHUCHANQIYEKECANZHAOBENZHIDIANZHUNSHENGDEGENJISIXUJISHOUYAOYANTAONEIRONG,ZHANKAIQIYUJIXINGYUBAOZHUANGCAILIAODEXIANGRONGXINGYANTAO。BENZHIDIANZHUNSHENGSHIJIYU《JIANJIEDAZHANGYAOPINDEBAOZHUANGCAILIAOHERONGQIBANLITILI》(JULINGDI 13HAO),JIANJIEWAIYANGXIANGGANDEZHIDIANZHUNSHENGJIYOUGUANZHUANZHU,TONGSHIANZHAOWOGUOYAOWUYANFADEXIANSHIHUANJINGZHIDINGDE;BINGJIANGGENZHEXIANGGANLVLIDEBUSHIWANMEIHEYAOWUYANTAOJISHUQINGQIUDEJINBUERJINYIBUDINGZHENGWANMEI。


二、相容性研讨的根基思绪

DUIYAOPINLAIJIANG,BAOZHUANGYINGHEYONGYUQIYUQIDELINCHUANGYONGCHU,BINGYINGJUBEIYIXIATEZHENG: YANHUGANHUA、XIANGRONGXING、NINGJINGXINGYUGONGXIAOXING。XIANGRONGXINGSHIYAOPINBAOZHUANGBIXUJUBEIDETEZHENGZHIYI;XIANGRONGXINGYANTAOZESHIZHENGSHIBAOZHUANGCAILIAOYUYAOPINZHIJIANBUCHANSHENGYANJUNDEBICIGANHUA,BINGZHISHIYAOPINYOUYONGXINGHEBUBIANXINGCHANSHENGZHUANBIAN,HUOCHANSHENGNINGJINGXINGWEIXIANDEJINCHENG;YANTAONEIRONGYINGBAOHANBAOZHUANGCAILIAODUIYAOPINDEYINGXIANGHEYAOPINDUIBAOZHUANGCAILIAODEYINGXIANG。YAOPINYUBAOZHUANGCAILIAODEXIANGRONGXINGYANTAO,YINGZAIYAOPINYANFAZAOQIHUOSHIBAOZHUANGCAILIAODETIAOXUANSHIJIUQITOUTINGZHI,BINGGUANCHUANYUYAOPINYANFADEQUANBUJINCHENG。QISHOU,YINGDABAOZHUANGZUJIANSUOYONGCAILIAOHEZENGTIANJIDENGTINGZHICHANFA,ERHOUJINGYOUJINCHENGKAIDUANDEBUBIANXINGSHIYAN、JIAKUAISHIYANHECHIJIUBUBIANXINGSHIYANKAOCHABAOZHUANGCAILIAODUIYAOPINBUBIANXINGDEYINGXIANG,BINGJINGYOUJINCHENGYAOWUYUBAOZHUANGCAILIAODEXIANGRONGXINGYANTAOKAOCHABAOZHUANGZICAIZHONGCHENGFENQIANXIJINRUYAOPINDECHENGDU、BAOZHUANGCAILIAODUIZHIJIZHONGHUOXINGCHENGFENYUGONGXIAOXINGFULIAODEXIFUCHENGDU,QUERENBAOZHUANGCAILIAONENGGOUBAOZHANGYAOPINDELIANGBUBIAN,BINGYUYAOPINXIANGRONGXINGJIECHU。SHANGSHIHOU,RUXUBIANGEBAOZHUANG,ZEYINGPINGGUGAIBIANGEDUIYAOPINDELIANGNENGGOUCHANSHENGDEYINGXIANG,BINGANZHAOYINGXIANGCHENGDUSHEXIANGXIANGGANDESHIYANTINGZHIYANTAO,CHUGESHIYINGTINGZHIBIANGEHOUBAOZHUANGCAILIAOYUYAOPINDEXIANGRONGXINGYANTAO,ZHENGSHIZHEILEIBIANGEQUEFAYIDUIYAOPINDELIANGHEBAOZHUANGCAILIAOGONGXIAOXINGCHANSHENGBUKEJIEGUANDEBIANGE,JIBUHUIZHISHININGJINGXINGWEIXIAN。

CHUYAOPINDUIBAOZHUANGCAILIAOCHANSHENGYINGXIANGBINGZHISHIQIGONGXIAOXINGZHUANBIANXUYAOGAIHUANBAOCAIDEHUANJINGWAI,XIANGRONGXINGYANTAOSHOUYAOSHIZHENDUIBAOZHUANGCAILIAODUIYAOPINDEYINGXIANGTINGZHI。XIANGRONGXINGYANTAOJINCHENGSHOUYAOFENWEIYIXIALIUGEBUZHOU: 1)KENDINGJIANJIEDAZHANGYAOPINDEBAOZHUANGZUJIAN;2)LINGHUIHUOCHANFABAOZHUANGZUJIANCAILIAODEGOUCHENG、BAOZHUANGZUJIANYUYAOPINDEDAZHANGTILIYUDAZHANGQIANTI、CHUCHANGONGYIJINCHENG;3)BIELIDUIBAOZHUANGZUJIANSUOJIENADECHABIEBAOZHUANGCAILIAOTINGZHITIQUSHIYAN,DUIKETIQUWUTINGZHIKAIDUANDEWEIXIANPINGGUBINGZHANWANGQIANFUDEJINCHUWU;4)TINGZHIZHIJIYUBAOZHUANGRONGQITIXIDEBICIGANHUAYANTAO,BAOHANQIANXISHIYANHEXIFUSHIYAN,QUDEBAOZHUANGRONGQITIXIDUIZHUFULIAODEXIFUJIZAIZHIJIZHONGCHENGXIANDEJINCHUWUXINXI;5)DUIZHIJIZHONGDEJINCHUWUCHENGDUTINGZHININGJINGXINGPINGGU;6)DUIYAOPINYUSUOYONGBAOZHUANGCAILIAODEXIANGRONGXINGTINGZHIZONGJIE,DECHUBAOZHUANGTIXISHIBUSHIHEYONGYUYAOPINDELUNDUAN。


三、相容性研讨的首要内容

YAOPINYUBAOZHUANGCAILIAOXIANGRONGXINGYANTAODENEIRONGSHOUYAOBAOHANSANGEFANGMIAN: TIQUSHIYAN、BICIGANHUAYANTAO(BAOHANQIANXISHIYANHEXIFUSHIYAN)HENINGJINGXINGYANTAO。XIANGRONGXINGYANTAODESHIYANCAILIAONENGGOUSHISULIAOCAILIAO,HUOSULIAOZUJIAN,YENENGGOUSHISULIAOBAOZHUANGRONGQI。

1. 提取实验

TIQUSHIYANSHIZHIJIENASHIHEDERONGJI,ZAIJIAOMENGLIEDEQIANTIXIA,DUIBAOZHUANGZUJIANCAILIAOTINGZHIDETIQUSHIYANYANTAO;FANGZHENSHIJINGYOUJINCHENGTIQUSHIYAN,DUIKETIQUWU(BAOZHUANGZICAIZHONGRONGCHUDEZENGTIANWU、DANTIJIQIJIANGJIEWUDENG)TINGZHIKAIDUANDEWEIXIANPINGGUBINGMINGBAIQIANFUDEFANGZHENJINCHUWU,BINGANZHAOTIQUSHIYANYANTAOZHONGQUDEDEKETIQUWUPINZHONGHECHENGDUXINXI,CHENGLIHUOLUODE、ZHUANSHUDECHANFATILI,YIZHIDIANHOUXUDEJINCHUWUYANTAO(QIANXISHIYAN)。

TIQURONGJIFANSHIYINGJUBEIYUZHIJIBUYIHUOJINSIDELIHUAXINGZI,ZHONGDIANZHENZHUO pH、JIXINGJILIZIQIANGDUDENG。TIQUQIANTIPUTONGYINGCANKAOZHIJIDEGONGYIQIANTI,CHUGESHIMIEJUNGONGYIQIANTI,JINGYOUJINCHENGQIADANGJINBUJIAREWENDUHEDANWUJIARESHIHOUDETILIJINNENGGOUDUODITITAOCHUBAOZHUANGZICAIZHONGDEKETIQUWU;DANYINGZHUZHONGTIQUQIANTIBUNENGGUOFENMENGLIE,YIFANGZHIKETIQUWUWANZHENGBUNENGFANYINGJINCHUWUDEHUANJINGDECHANSHENG;TONGSHIHAIYINGZHUZHONGTIQUCAILIAODEZHIBEIJIYUTIQURONGJISHIHEDEJILIANGPEIBI(ANZHAOLINCHUANGYONGFAYONGLIANGSHEXIANG),JICAILIAODEWAIBIAOJI(HUOFENLIANG)YURONGJIDETIJIBI。

CHANFACESHITILIFANSHIJIENAQIXIANGSEPU-ZHIPU(GC-MS)、YEXIANGSEPU-ZHIPU(LC-MS)、LIZISEPU(IC)、DIANGANOUHEDENGLIZITIFASHEGUANGPU(ICP)、YUANZIJIESHOUGUANGPUFA(AAS)DENG。PUTONGANZHAOBAOZHUANGDENINGJINGXINGQINGQIUJIJIAOCHUCHANFAPINGGUYUZHI(Analytical Evaluation Threshold,AET),TIAOXUANKEDAODAQINENGHUOLUOJIANCHUDECHANFATILI;BINGTINGZHITILIHUOLUODU、ZHUANSHUXINGDENGJIANLVEDETILIXUEKAOZHENG。

2. 彼此感化研讨

BICIGANHUAYANTAOBAOHANQIANXISHIYANHEXIFUSHIYAN。QIANXISHIYANYONGYUKAOCHACONGBAOZHUANGZICAIZHONGQIANXIBINGJINRUZHIJIZHONGDEWUZI;XIFUSHIYANZEYONGYUKAOCHAYINWEIBAOCAIXIFUNENGGOUJIFADEHUOXINGCHENGFENHUOGONGXIAOXINGFULIAOHANLIANGDEJIANGLUO。

YOUXIEBICIGANHUAKEZAIBAOZHUANGHEYONGXINGYANTAOJIEDUANFAMING,YOUXIEBICIGANHUAZEZAIBUBIANXINGYANTAOZHONGFANGKESHANXIAN。RUZAIBUBIANXINGYANTAOZHONGFAMINGYAOPINYUBAOZHUANGCAILIAOCHANSHENGBICIGANHUABINGDUIYAOPINDEPINDEHUONINGJINGXINGCHANSHENGYINGXIANGSHI,ZEYINGCHAZHAOYUANYOUBINGJIENAXIANGYINGDEBANFA,RUBIANGEBAOZHUANG,HUOBIANGECHUZANGQIANTIDENG。

JINGYOUJINCHENGJIAKUAIHE/HUOCHIJIUBUBIANXINGSHIYAN(ZHUZHONGYAOPINYINGYUBAOZHUANGCAILIAOCHONGSHIDAZHANG)ZENGTIANXIANGYINGQIANFUFANGZHENJINCHUWUDEJIANCEFANGZHEN,QUDEYAOPINZHONGHANYOUDEJINCHUWUXINXIJIBAOZHUANGCAILIAODUIYAOWUDEXIFUSHUJU。

2.1 QIANXISHIYAN

QIANXISHIYANYOUXUYAOZAIYANFAJIEDUANTINGZHI,BINGZHENGSHISUOYONGBAOZHUANGCAILIAOZAIZHIDINGDEDAZHANGTILIJIDAZHANGQIANTIXIA,JINCHUWU(BAOHANPINZHONGHEHANLIANG)BUHUIZHUANBIANZHIJIDEYOUYONGXINGHEBUBIANXING,QIEBUZHIYUCHANSHENGNINGJINGXINGFANGMIANDEWEIXIAN。

FANSHI,TIQUSHIYANZHONGJIENADETIQURONGJIZHISHIZAIJIXING、pH ZHIJILIZIQIANGDUDENGFANGMIANYUNIBAOZHUANGDEYAOPINFUJIN,BINGBUBIRANSHIZHIJIDEXIANSHICHUFANG,YINWEIZHIJIZHONGDEHUOXINGCHENGFENHUOMOUXIEFULIAODEYINGXIANG,SHIDETIQURONGJI、SHIZAIZHIJIYUBAOZHUANGCAILIAOCHANSHENGDEBICIGANHUANENGGOUCHABIE,JITIQUSHIYANQUDEDEKETIQUWUYUSHIZAIZHIJIQIANXISHIYANQUDEDEJINCHUWUNENGGOUBUFENQI。XIANSHISHANG,TIQUSHIYANDEFANGZHENSHIJINNENGGOUDUODELINGHUIBAOZHUANGZUJIANZICAIZHONGNENGGOUDEZENGTIANWUZI,BINGCONGTIQUSHIYANZHONGQUDEDEKETIQUWUPINZHONGHECHENGDUXINXI,ZHANWANGQIANFUDEJINCHUWU;TONGSHIANZHAOBAOZHUANGDENINGJINGXINGQINGQIUJIJIAOCHUDECHANFAPINGGUYUZHI(AET),TIAOXUANKEDAODAQINENGHUOLUOJIANCHUDECHANFATILI。ERQIANXISHIYANDEFANGZHENSHIJIENACHENGLIDEHUOLUO、ZHUANSHU、KEXINGDETILIJIANCEZHIJIZAIYOUYONGQINEISHIZAIDEJINCHUWUHUANJING,BINGJUCITINGZHININGJINGXINGPINGGU。LINGYINGZHUZHONGDESHI,SULIAOBAOZHUANGZICAIZHONGMOUXIEZUFENGURANKEZAITIQUSHIYANZHONGQUDE,ERZAIQIANXISHIYANZHONGGAIZUFENBINGBUHUIQIANXIZHIZHIJIZHONG(SHIKETIQUWUERBUSHIJINCHUWU);KESHI,GAIWUZIYOUNENGGOUZAIANPAIJINCHENGZHONGCHANSHENGJIANGJIEHUOYUQIYUCHENGFENCHANSHENGFANYING,ERZHEIXIEJIANGJIECHANWUHUOFANYINGCHANWUNENGGOUQIANXIZHIZHIJIZHONG。SHIYI,ZAITINGZHITIQUSHIYANDEGENBENSHANG,RENGYINGJIENASHIZAIZHIJITINGZHIQIANXISHIYAN。

QIANXISHIYANSUOYONGDECHANFATILIFANSHIHUIJIENATIQUSHIYANYANTAOJINCHENGZHONGTIAOXUANKENDINGDECHANFACESHITILI,DANZAITINGZHIJINCHUWUCEANSHI,YINJINCHUWUDENONGDUCHANGCHANGYUANDIYUKETIQUWU,QIEJINCHUWUDECEDINGCHENGGUOSHITINGZHININGJINGXINGPINGGUDESHUJUANZHAO,GUYINGDAJINCHUWUDECEDINGTILITINGZHIZHOUQUANDETILIXUEKAOZHENG,BAOHANJINGQUEDU、JINMIDU(FANFUXING、ZHONGXINJINMIDUHEZHONGXIANXING)、ZHUANSHUXING、JIANCEXIAN、DINGLIANGXIAN,XIANXINGJIGUIMOHENAIYONGXINGDENG;YIZHENGSHIQITILINENGHUOLUO、JINGQUE、BUBIANDIJIANCHUZHIJIZHONGDEJINCHUWU。RUOSHIJINCHUWUYUKETIQUWUDEPINZHONGBUFENQI,JIJINCHUWUCHAOYUELEKETIQUWUDEGUIMO,QIEKETIQUWUDEJIANCETILIBUHEYONGSHI,ZEYINGZHENDUIJINCHUWUDEXIANSHIHUANJINGCHENGLIXINDECHANFACESHITILI,BINGDUIXINJIANTILITINGZHICHONGSHIDETILIXUEKAOZHENG,YIQUEBAOSUOJIANTILIKEHUOLUO、JINGQUE、BUBIANDIJIANCHUZHIJIZHONGXIANGGANDEJINCHUWU。RUOSHIBAOZHUANGCAILIAOYOUCHABIEDECAILIAOFENCENGGOUCHENG,ZEBUZHIXUYAOPINGGUZUINEICENGCHENGFENQIANXIZHIYAOPINZHONGDENENGGOUXING,HAIYINGZHENZHUOZHONGCENG、WAICENGCHENGFENQIANXIZHIYAOPINZHONGDENENGGOUXING;TONGSHIHAIBIXUYAOZHENGSHIZAIWAICENGDEYOUMOHUOZHANHEJIBUHUIQIANXIRUYAOPINZHONG(DUOCENGGONGJIMOWAICENGDEYOUMOHUOZHANHEJIYINJIANJIEFUZHEZAIWAICENGMOSHANG,QIESULIAOMOSHUBANTOUXINGCAILIAO,YOUMOHUOZHANHEJIYOUNENGGOUSHENRUZHIZHIJIZHONG,GUYOUMOHUOZHANHEJISHIBUSHIHUISHENRUZHIZHIJIZHONG,YINGYIBINGZAIQIANXISHIYANZHONGTINGZHIYANTAO)。

2.2 XIFUSHIYAN

XIFUSHIYANSHIDUIHUOXINGCHENGFENHUOFULIAOSHIBUSHIHUIBEIXIFUHUOJINRUBAOZHUANGCAILIAO,JINERZHISHIDEZHIJIPINDEZHUANBIANSUOTINGZHIDEYANTAO。

FANSHI,XIFUSHIYANKEJINGYOUJINCHENGZAIZHIJIDEBUBIANXINGSHIYANZHONGZENGTIANXIANGYINGDEJIANCEFANGZHENTINGZHI。BIFANG,HUOXINGCHENGFEN、FANGFUJI、KANGYANGJIHANLIANGDENG。XIFUSHIYANZHONGYINGZHUZHONGKOUCHUJIANGJIEDEHANLIANGXIAJIANGJUBU,HEKANGYANGJI、FANGFUJIDEGUANLIHAOSUNLIANG。

3. 宁静性研讨

ANZHAOTIQUSHIYANQUDEDEKETIQUWUXINXIJIQIANXISHIYANQUDEDEJINCHUWUXINXI,CHANFAHUIZONGKETIQUWUJIJINCHUWUDEPINZHONGJIHANLIANG,TINGZHIXUYAODEHUAHEWUGUISHUHUOBUJUPANDING,BINGANZHAOBUJUFANLIGUISHUQININGJINGXINGWEIXIANJIBIE。JINGYOUJINCHENGWENXIANJIDUXINGSHUJUKUCHAWENXIANGGANDEDUXINGCAILIAO,HUANSUANCHENGRENZHURIXUKEZUIDALUOLULIANG(Permitted Daily Exposure,PDE);PINGGUJINCHUWUSHIBUSHICUNZAININGJINGXINGWEIXIAN,JIANZHAOCEDINGDEJINCHUWUCHENGDUJIJIAOXIANSHIDEZHURILUOLULIANGYUDULIXUEPINGGUZHONGQUDEDE PDE TINGZHIBINI,ZUOCHUBAOZHUANGTIXISHIBUSHIYUYAOPINJUBEIXIANGRONGXINGDELUNDUAN。

RUOSHIWENXIANJIDUXINGSHUJUKUWUXIANGGANJINCHUWUDEDUXINGCAILIAO,ZEKEDUIXIANGYINGDEJINCHUWUTINGZHININGJINGXINGYANTAO,QUDEXIANGYINGDEDUXINGSHUJU,HUANSUANCHENGRENZHURIXUKEZUIDALUOLULIANG(PDE);PINGGUJINCHUWUSHIBUSHICUNZAININGJINGXINGWEIXIAN,ZUOCHUBAOZHUANGTIXISHIBUSHIYUYAOPINJUBEIXIANGRONGXINGDELUNDUAN。RUOSHIWENXIANJIDUXINGSHUJUKUWUXIANGGANJINCHUWUDEDUXINGCAILIAO,YEWEIJIENAXIANGYINGDEJINCHUWUTINGZHININGJINGXINGYANTAO,ZEKEANZHAONINGJINGXINGYUZHI(Safety Concern Threshold,SCT),PINGGUJINCHUWUSHIBUSHICUNZAININGJINGXINGWEIXIAN,ZUOCHUBAOZHUANGTIXISHIBUSHIYUYAOPINJUBEIXIANGRONGXINGDELUNDUAN。


四、相容性实验内容与阐发体例

XIANGRONGXINGSHIYANBAOHANTIQUSHIYAN、QIANXISHIYANHEXIFUSHIYAN。CHANGYIJIENAXIANGRONGXINGSHIYANJINGCHANGLIYONGDESHIYANTILIHECHANFACESHITILI,RUOYOUQIYUSHIHEDESHIYANTILIHECHANFACESHITILI,JINGKAOZHENGKEXING,YEKELIYONG。

1. 提取实验

TIQUSHIYANSHOUYAOZHENDUIBAOZHUANGCAILIAOTINGZHI,YINGDABAOZHUANGTIXIZHONGDECHABIEBAOZHUANGZUJIANBIELITINGZHITIQUSHIYAN。

ZHIDEZHUZHONGDESHI,ZAIBAOZHUANGCAILIAOZHUCEQIAN,WEILEDUIBAOZHUANGCAILIAODEXINGZITINGZHIZHOUQUANPINGGU,BAOZHUANGCAILIAOCHUCHANQIYEHUIJIENACHABIERONGJITINGZHIBIRANCHENGDUDETIQUSHIYAN,YILINGHUIBAOZHUANGCAILIAOZAICHABIEQIANTIXIANENGGOUCHANSHENGDEKETIQUWU;ZAIDUIYAOWUZHIJITINGZHIYANTAOSHI,YAOPINYANFAJICHUCHANQIYEZESHIZAIBAOZHUANGCAILIAOXINGZIYIZHIDEQIANTIXIA,ZAIBAOZHUANGCAILIAOQIYEGONGJIDEBAOZHUANGCAILIAOCHENGFENXINXIHETIQUSHIYANDEGENBENSHANG,TINGZHIYAOWUZHIJIYUBAOZHUANGCAILIAODETIQUSHIYAN。SHIYI,BENZHIDIANZHUNSHENGKUADADEDAZHENJIYUSULIAOBAOZHUANGCAILIAODETIQUSHIYAN,YUCHENGCHIBAOZHUANGCAILIAOZHUCESUOTINGZHIDEYANTAOFANGZHENCHABIE,SUOTIAOXUANDETIQURONGJIHETIQUQIANTI(JIAN 1.2,1.3)YEYOUSUOPIANZHONG,KESHIBAOZHUANGCAILIAOCHUCHANQIYETINGZHIDETIQUSHIYANKEWEIDAZHENJIYUBAOZHUANGCAILIAODEXIANGRONGXINGSHIYANGONGJIBIRANDECHENGCHIXINGXINXI。

1.1 BAOZHUANGCAILIAOYANGPINDEQIANCHUZHI

JIANGBAOZHUANGCAILIAOXIZHUOQINGJIE,LVZHIXIGANHOUQIECHENG 0.5cm×2cm TIAOZHUANG,ZUOWEIGONGSHIPIN,FANGRUMIBIRONGQINEI,CHASHOUTIQURONGJIYANMEIGONGSHIPINTINGZHIJINTI。KEANXIABIAOSUOSHITIAOXUANGONGSHIPINYUTIQURONGJIDECHASHOULIANG,CHANGYIYOUXIANANGONGSHIPINWAIBIAOJITIAOXUANYUTIQURONGJIDEBILI,DANGYANGPINDEWAIBIAOJIBUNENGKENANSHI,ZEANGONGSHIPINFENLIANGYUTIQURONGJIDEBILITINGZHISHIYAN。

BIAO GONGSHIPINWAIBIAOJIHUOFENLIANGYUTIQURONGJIDEBILI

1.PNG

YEKEJIENADUOGEBAOZHUANGRONGQIZUJIAN(RUDUOGEJIEKOU),YIZENGTIANTIQUWUDENONGDU,HUODUITIQUYANGPINTINGZHIFUJI,SHIZHISHIHECHANFAYIQIDEHUOLUODUQINGQIU。XUYAOCEDINGDESHUJUBAOHAN: BAOZHUANGYANGPINDECHICUN(ZHANG、KUAN、GAO、ZHIJING);PUTONGBAOZHUANGHUANJINGXIAYAOPINYUBAOZHUANGCAILIAOJIANJIEDAZHANGJUBUDEMIANJIHETIQUSHIYANZHONGBAOZHUANGCAILIAOYUTIQURONGJIJIANJIEDAZHANGJUBUDEWAIBIAOJI,RUOSHIBAOZHUANGYANGPINYUTIQURONGJIWEISHUANGMIANDAZHANG,ZEYINGJIJIAOLIANGMIANDEZONGMIANJI;RUOSHIJIENADUOGEBAOZHUANGRONGQIZUJIAN,ZEYINGJIJIAOYANGPINDEZONGMIANJI。BAOZHUANGCAILIAOYUTIQURONGJIDEDAZHANGWAIBIAOJIYINGGAOYUBAOZHUANGCAILIAOYUYAOPINDEXIANSHIDAZHANGMIANJI,YIJINNENGGOUZENGTIANKETIQUWUDEPINZHONGHESHUMU,MONICHUCHAN、YUNSHU、CHUCUNHELIYONGZUICHADEQIANTI。

1.2 TIQURONGJIDETIAOXUAN

ZAIBAOZHUANGCAILIAOZHUCEQIAN,XUDUIBAOZHUANGCAILIAODEXINGZITINGZHIZHOUQUANPINGGU,ZHEISHIHOUDUOJIENAXINGZIGEBIEDETIQURONGJIDUIQITINGZHITIQUSHIYAN,XIANSHISHANG,TIQURONGJIDEXINGZIHEPINZHONGYINGBAOHANXIANSHILIYONGDEYIQIEZHUANGTAI。CHANGKETIAOXUANDETIQURONGJIBAOHANDAZHENYONGSHUI、0.9%LVHUANADAZHENYE、pH 3.5HUANCHONGYE、pH 8.0 HUANCHONGYE、10%HUO 15%YICHUNDENG。WEILINGHUIXIBAOZHUANGCAILIAODEZUFEN,PUTONGTIAOXUANDETIQUQIANTIJUEDUIMENGLIE,OURANHUITIAOXUANNENGJIANGSULIAOBAOZHUANGCAILIAOWANZHENGXIAORONGDETIQURONGJI,KESHIZHEILEISHIYANBINGBUNENGFANYINGZUFENDETIQUHEQIANXIDESHIZAIHUANJING,YEYUANCHAOYUECHUCHAN、YUNSHU、CHUCUNHELIYONGDEXIANSHIZUICHAQIANTI,YUYAOWUZHIJITINGZHIDETIQUSHIYANFANGZHENBINGBUBUYI。

DUIDAZHENJITINGZHITIQUSHIYANYANTAOSHI,YINGJIANGBAOZHUANGCAILIAOZHUCEQIANTINGZHIDEZHOUQUANPINGGUSHUJUZUOWEIGENBEN。ZAICIQIANTIXIA,TIQUSHIYANZHONGSUOYONGDETIQURONGJIXINGZIYINGJINNENGGOUYUXIANSHIBAOZHUANGDEZHIJIBUYIHUOJINSI,ZHONGDIANZHENZHUO pH、JIXINGJILIZIQIANGDUDENGSHENFEN,CHANGYIZAIQIANTIXUKEDEQIANTIXIA,YOUXIANTIAOXUANNIBAOZHUANGDEZHIJIZUOWEITIQURONGJI,YEKEANZHAOZHIJIDETEZHENGTIAOXUANQIYUSHIHEDETIQURONGJI(RUBUHANYAOWUDEKONGQUEZHIJI)。

1.3 TIQUQIANTIDEKENDING

PUTONGHUANJINGXIA,WUZIZAIGAOWENZHUANGTAIXIADEQIANXISULVYAOGAOYUCHANGWENHUOGAOWENZHUANGTAI,SHIYI,TIQUSHIYANXUZAIJIAOMENGLIEDEQIANTIXIATINGZHI。YINGLIANXIYAOPINZAICHUCHAN、CHUCUN、YUNSHUJILIYONGJINCHENGZHONGDEZUICHAQIANTI,KENDINGSHIHEDETIQUTILI,RUJIARE、SUOSHITIQU、HUILIUHUOCHAOSHENGDENG。DUIDAZHENJI,CHANGJIENAJIANGQIANCHUZHIHOUDEBAOZHUANGCAILIAOZHIYUMIFENGRONGQIZHONG,YONGTIQURONGJIJIARETINGZHITIQU。SHIYANSHIXUYAOZHENZHUOCHUCHANGONGYIZHONGNENGGOUDEJIARESHENFEN,RUMIEJUNWENDUHESHIHOU。BIEDE,YEYAOZHUZHONGDAO,ZAIBIMIEJUNWENDUJIABEIMENGLIEDEQIANTIXIA,DUISULIAOCAILIAOHUICHANSHENGZAICHANGWENHUOMIEJUNQIANTIXIABUHUICHANSHENGDEFENSUIGANHUA,SHIYIXUDUITIQUWENDUHESHIHOUTINGZHICHANFAHEKAOCHA,YIBAOZHANGCONGBAOZHUANGZICAIZHONGTITAOCHUJINNENGGOUDUODEKETIQUWU,DANYOUBUZHISHIZENGTIANWUGUOFENJIANGJIENAIZHIJIAORAOSHIYAN。CHANGYIZAITIAOXUANTIQUWENDUSHI,YOUXIANTIAOXUANMIEJUNWENDUHUOZAIQIGENBENSHANGQIADANGZENGTIAN,DANBUYINGSHIBAOZHUANGCAILIAOCHANSHENGBIANXING。

BIFANG: MOUDAZHENJIJIENA 121℃,15 FENZHONGZUOWEIMIEJUNQIANTI,ZAITINGZHITIQUSHIYANSHI,TIQUQIANTIDEQIANGDUYINGGAOYUGAIMIEJUNQIANTI,KETIAOXUAN 121℃,60 FENZHONGHUOQIADANGJINBUWENDU,BINGDANWUTIQUSHIHOU,HUOTIAOXUANQIYUSHIHEQIANTIZUOWEITIQUQIANTI。

1.4 KETIQUWUXINXICHANFA

DUIZAITIQUSHIYANYANTAOZHONGQUDEDEGAOYUCHANFAPINGGUYUZHI(AET)CHENGDUDEKETIQUWUTINGZHIBIANBIE,ZHANWANGQIANFUDEKEJINCHUWU,BAOHANDANTI、ZHAODUANWUZI、CANLIUWU、JIANGJIEWUZI、ZENGTIANJIDENG。

2. 彼此感化研讨

PUTONGYINGTIAOXUANANPUTONGQIANTICHUCHAN、BAOZHUANG、ANPAIDEDAZHENJIDEBAOZHUANGRONGQI,ERBUSHIGEBAOZHUANGZUJIANTINGZHIBICIGANHUAYANTAO,BINGANZHAOZHILIAOYAOHUOFULIAODELIHUAXINGZIHEZHIJIDETEDIANKENDINGBICIGANHUAYANTAODEXIANGXINEIRONGHESHIYANQIANGDU,BICIGANHUAYANTAOKAOCHAMINGMUKEFENWEIWULI、HUAXUE、SHENGWUDENGJIGEFANGMIAN。YINGZUISHAOJIENA 3 PIZHIJIYU 1 PIBAOZHUANGRONGQITINGZHIYANTAO。

2.1 QIANXISHIYAN

2.1.1 KENDINGQIANXISHIYANQIANTI

KENDINGQIANXISHIYANQIANTISHI,YINGCHONGSHIZHENZHUOYAOPINZAICHUCHAN、CHUCUN、YUNSHUJILIYONGJINCHENGZHONGNENGGOUMIANDUIDEZUIJIDUQIANTI。PUTONGCHANGYITIAOXUANGAIYAOPINSHANGSHIBAOZHUANGDEZUIGAONONGDU,ZAIJIAKUAIBUBIANXINGSHIYANHECHIJIUBUBIANXINGSHIYANDEQIANTIXIATINGZHISHIYAN。ZAIDUICHABIENONGDUDECHANWUTINGZHIYANTAOSHI,KEJIENAJUZHENFATINGZHISHIYAN。

2.1.2 KAOCHASHIHOUDIAN

KAOCHASHIHOUDIANDESHEZHIYINGJIYUDUIYAOPINBAOZHUANGCAILIAOXINGZIDESHUXI,BAOZHUANGCAILIAOYUYAOPINBICIYINGXIANGDEQUXIANGERSHEZHI。PUTONGKECANKAOYINGXIANGSHENFENSHIYAN、JIAKUAIBUBIANXINGSHIYANHECHIJIUBUBIANXINGSHIYANDEKAOCHASHIHOUDIANTINGZHISHEZHI,ZUISHAOYINGBAOHANCHUFADIANHEQIDIAN,ZHONGXINDIANKEQIADANGDIAOJI。

2.1.3 KAOCHAMINGMU

PUTONGHUANJINGXIA,YINGANZHAOCAILIAOXINGZI、YAOPINDEPINDEQINGQIUSHEZHIKAOCHAMINGMU。QIANXISHIYANDEKAOCHAMINGMUCHUPINDEGUIFANHUADINGDEMINGMUWAI,HAIYINGANZHAOTIQUSHIYANZHONGQUDEDEKETIQUWUXINXISHEDINGQIANFUDEFANGZHENJINCHUWU,HEZAIANPAIJINCHENGZHONG,BAOZHUANGCAILIAOCHENGFENZHONGDEJIANGJIEWUZIHUOQIYUZHONGSHENGCHENGWUZI。

2.1.4 KAOCHAYANGPINDEANPAI

KAOCHAJINCHENGZHONG,YAOPINYUBAOZHUANGRONGQIYINGCHONGSHIDAZHANG,BINGMONIYAOPINDEXIANSHILIYONGZHUANGTAI,SHEZHIANPAIDIWEISHIXUCHONGSHIZHENZHUOMIFENGJIAN、BIAOQIANHUOYOUMODEDAZHANGHUOYINGXIANG。

2.1.5 ZAIQIANXISHIYANZHONGYINGDAGAOYUCHANFAPINGGUYUZHI(AET)CHENGDUDEXIANGGANJINCHUWUTINGZHIBIANBIE、DINGLIANG,BINGPINGGUJINCHUWUDENINGJINGXING。

2.2 XIFUSHIYAN

BAOJUTIAOXUANGAIYAOPINJIAKUAISHIYANHECHIJIULIUYANGSHIYANQIANTI(WENDUHESHIHOU)TINGZHIXIFUSHIYAN,FANSHIKETIAOXUANJIAKUAISHIYANHECHIJIULIUYANGSHIYANDEKAOCHASHIHOUDIAN,ANZHAOYAOPINGUIFANTINGZHICHAYAN,BINGANZHAOKAOCHAGONGJURUGONGXIAOXINGFULIAODENGQIADANGZENGTIANCHAYANMINGMU,SHOUYAODUIYAOPINHENIKAOCHAFULIAODEHANLIANG、pH DENGMINGMUTINGZHICHACHAO。

KAOCHAYANGPINDEANPAIQINGQIUYUQIANXISHIYANBUYI。

3. 空缺搅扰实验

ZAITINGZHITIQUSHIYAN、QIANXISHIYANHEXIFUSHIYANSHI,MOUXIEHUANJINGXIAXUYAOTINGZHIKONGQUEJIAORAOSHIYAN,YIJIECHUGONGSHIPINBENDIJIAORAO,FANGZHICHENGXIANJIAYANGXINGCHENGGUO。

BIFANG: ZAIDUISULIAOBAOZHUANGRONGQITINGZHITIQUSHIYANSHI,KETIAOXUANPENGGUIBOLIPINGHUOJUSIFUYIXIPING,HEJUSIFUYIXIHUOJUBINGXISAI,HUOQIYUDUOXINGRONGQITINGZHIPINGXINGDUIBISHIYAN,DANBUYITIAOXUANXIANGJIAOSAIZUOWEIMIFENGJIAN。ZAITINGZHIXIFUSHIYANSHI,MOUXIECHENGFEN,RUMOUXIEKANGYANGJIZISHENKEZAIANPAIJINCHENGZHONGCHANSHENGJIANGJIE,WEIFANGZHIJIAORAOSHIYANCHENGGUO,KESHEDUIBIZU,TIAOXUANFANSHIYIWEIBUHUICHANSHENGXIFUDEBAOZHUANGCAILIAO(RUBOLIDENG)ZUODUIBI,TINGZHIPINGXINGSHIYAN。

4. 阐发体例

TINGZHITIQUSHIYANHEQIANXISHIYANYINGJIENAZHUANSHUXINGQIANG、JINGQUE、JINMI、HUOLUODECHANFATILI,YIBAOZHANGSHIYANCHENGGUODEKAODEZHUXING。JINCHAOKEJIENAGELEIGUANGPU、SEPUHELIANYONGTILI,BIELIYONGYUJIANCEYIHUIFAXINGWUZI、BANHUIFAXINGWUZI、BUHUIFAXINGWUZI、JINSHUYUANSU、WUJILIZIDENGZUFEN。YINGZHENDUICHABIEDEDAICEFANGZHENHUAHEWUTIAOXUANSHIHEDECHANFATILI。

ZAITINGZHIDINGXINGYANTAOSHI,PUTONGKETIAOXUANYIXIATILI: YEXIANGSEPU-ZHIPU(LC-MS)、YEXIANGSEPU-HECIGONGZHENBOPU(LC-NMR)、QIXIANGSEPU-ZHIPU(GC-MS)、QIXIANGSEPU-HONGWAIGUANGPU(GC-IR)、LIZISEPU-ZHIPU(IC-MS)DENGLIANYONGJISHU。ZAITINGZHIDINGLIANGYANTAOSHI,PUTONGKETIAOXUANYIXIATILI: ZONGWUJITAN(TOC)、ZONGWUJITAN(TOA)、QIXIANGSEPU-HONGWAIGUANGPU(GC-IR)、YEXIANGSEPU(UV、ELSD、ECD JIANCEQIDENG)、YEXIANGSEPU-ZHIPU(LC-MS)、LIZISEPU(IC)、QIXIANGSEPU(GC)、QIXIANGSEPU-ZHIPU(GC-MS)、GAOXIAOMAOXIGUANDIANYONGFA(HPCE)、YUANZIFENGUANGGUANGDUFA(AAS)DENG。FANSHIHUANJINGXIA,QIXIANGSEPU-ZHIPU(GC-MS)YONGYUKEHUIFAHUOBANHUIFAWUJIWUCHANFA;YEXIANGSEPU-ZHIPU(LC-MS)YONGYUBANHUIFAJIBUHUIFAWUJIWUCHANFA;LIZISEPU(IC)YONGYUWUJIHUOWUJIYANGLIZIHEYINLIZICHANFAHEWUJISUAN、JIANCHANFA;DIANGANOUHEDENGLIZITIYUANZIFASHEGUANGPUFA(ICP-AES)、DIANGANOUHEDENGLIZITIFASHEGUANGPU-ZHIPUFA(ICP-MS)KEYONG

YUCEDINGWUJIYUANSULEITIQUWU(RUWEILIANGYUANSUHEZHONGJINSHUDENG)。BIEDE,ZAISHIHEQIANTIXIABINGJINGKAOZHENGKEXINGSHI,YEKETIAOXUANQIYUCHANFATILI。

ZAIKENDINGCHANFATILIQIAN,NENGGOUANZHAONINGJINGXINGXINXILAIKENDINGKETIQUWUHE/HUOJINCHUWUDEXUKEXIANZHI,BINGJIANGGAIXIANGYINGNONGDUCHENGDUZUOWEICHANFAPINGGUYUZHI(AET),YICILAIKENDINGCHANFATILISHIBUSHIJUBEIJIANCEZHEIXIEWUZIDEHUOLUODU。

WEILEBAOZHANGCHANFATILIDEKAODEZHUXING,XUDUICHANFATILITINGZHIKAOZHENG。TIQUSHIYANSHOUYAOTINGZHITILIZHUANSHUXING、HUOLUODUDENGJIANLVEDETILIXUEKAOZHENG;QIANXISHIYANDETILIXUEKAOZHENGNEIRONGBAOHAN: JINGQUEDU、JINMIDU(FANFUXING、ZHONGXINJINMIDUHEZHONGXIANXING)、ZHUANSHUXING、JIANCEXIAN、DINGLIANGXIAN,XIANXINGJIGUIMOHENAIYONGXINGDENG。YINWEIHENLIANGCHANFADECHUGEXING,YINGCHUGECUNJUANCHANFAYIQI、GEKAOZHENGNEIRONGDEKEJIEGUANXING。


五、实验成果阐发与宁静性评估

ANZHAOTIQUSHIYANJIQIANXISHIYANQUDEDEKETIQUWU、JINCHUWUXINXI,CHANFAHUIZONGJINCHUWUHEKETIQUWUDEPINZHONGJIHANLIANG,TINGZHIBUJUPANDING,JINGYOUJINCHENGNINGJINGXINGYANTAOCHANFAQININGJINGXINGWEIXIANCHENGDU,LIANXIXIFUSHIYANCHENGGUO,CHANFAPANDINGBAOZHUANGTIXISHIBUSHIYUYAOPINJUBEIXIANGRONGXING。

1. 塑料包装材料的宁静性评估

RUOSHIBAOZHUANGRONGQIGEZUJIANSUOYONGSULIAOZICAIZHONGDEZENGTIANJIWEIFUJIAN 4 SUOLIEDEJINGCHANGLIYONGZENGTIANJI,QIEZAIBAOZHUANGZICAIZHONGDEHANLIANGSHIHEFUJIAN 4 DEQINGQIU,NENGGOUYIWEIBAOZHUANGZICAIZHONGSUOHANZENGTIANJIDELIANGSHIHEQINGQIU。RUOSHIJIENADEZENGTIANJIWEICANJIAFUJIAN 4,ZEYINGGONGJIGAIZENGTIANJIZAIBAOZHUANGZICAIZHONGLIYONGHEYONGLIANGDEANZHAO。

2. 肯定阐发评估阈值(AET)

2.1 ANZHAOWENXIANHUOSHIYANQUDEGEJINCHUWUHUOKETIQUWUDERENZHURIXUKEZUIDALUOLULIANG(PDE)。

2.2 RUOSHIBUNENGQUDE PDE SHUJUSHI,YANTAOZHEKECANKAOJINCHAOKEQUDEDEYIZHIHUAHEWUNINGJINGXINGSHUJUKUXIANGGANXINXI,BINGLIANXISUOYANTAOYAOPINDEJIYAOLUZI、YONGYAOZHOUQI、JINCHUWUHUOKETIQUGUITIANXUEBUJUDENGXIANSHIHUANJING,KENDINGSHIHEDENINGJINGXINGYUZHI(SCT)。JINCHAOOUZHOUYAOPINJU(European Medicines Agency,EMA)BAOJUDEYICHUANDUXINGZHIAIWUDENINGJINGXINGYUZHI(SCT) WEI 1.5ug/ RI , GUO JI YAO YONG QI WU JI LIAN MENG ( International Pharmaceutical Aerosol Consortium,IPAC)BAOJUDEXIRUZHIJIDENINGJINGXINGYUZHI(SCT)WEI 0.15ug/RI。ANZHAOJINCHUWUHUOKETIQUWUDE PDE HUO SCT SHUZHI、ZHURIZUIDAYONGYAOJILIANGHEZHIJIBAOZHUANGHUANJING(TIQUSHIYANZHONGLIYONGRONGQIDESHUMU;YUTIQURONGJIJIANJIEDAZHANGDEWAIBIAOJI;ZHIJICHUCHAN、

YUNSHU、CHUZANGHELIYONGJINCHENGZHONGYUYAOYEJIANJIEDAZHANGJUBUDEWAIBIAOJIDENG)JIJIAOMEIDANGEBAOZHUANGRONGQIZHONG,GEJINCHUWUHUOKETIQUWUDEZUIDAXUKEDEXIANSHINONGDU,BINGZAICIGENBENSHANGJINGJIJIAOQUDECHANFAPINGGUXIANZHI(AET),CHANFACESHITILIYINGZHIZUGAI AET ZHIDECEDINGQINGQIU。

ZAITIJIAOZHUCECAILIAOSHI,YINGGONGJIJINCHUWUHUOKETIQUWUDE PDE、SCT、AET DENGSHUZHIJIQIJIJIAOJINCHENG。

3. 可提取物的宁静性评估

RUOSHIBAOZHUANGCAILIAOZHUCEDETIQUSHIYANHEDUIYAOWUZHIJITINGZHIDETIQUSHIYANCHENGGUOJUNXIANXIAN,TIQURONGYEZHONGMOUKETIQUWUDEHANLIANGDIYUQI PDE HUO SCT,ZEPUTONGYIWEIYOUGAIKETIQUWUZHISHIDENINGJINGXINGWEIXIANXIAO,ZAIHOUXUDEQIANXISHIYANKESHENGLVEDUIGAICHENGFENDEYANTAO,DANRENGYINGDANGZAIHOUXUDEQIANXISHIYANZHONGDUIGAICHENGFENNENGGOUCHANSHENGDEJIANGJIECHANWUHUOXIANGGANCHANWUDENGTINGZHIKAOCHA。

RUOSHITIQURONGYEZHONGKETIQUWUDEHANLIANGGAOYU PDE HUO SCT SHI,NENGGOUTIAOXUANTINGZHIHOUXUDEBICIGANHUAYANTAOBINGDUIJINCHUWUTINGZHIXIANGGANDENINGJINGXINGPINGGU,YENENGGOUTIAOXUANGAIHUANBAOZHUANGCAILIAOCONGTOUTINGZHITIQUSHIYAN。

RUOSHIYIWEIWUXUDUIMOUTIQUWUTINGZHIHOUXUDEQIANXISHIYAN,XUGONGJIXIANGYINGDECHENGCHIXINGSHUJUHECHANFABAOGAO。

4. 浸出物的宁静性评估

RUOSHIJINCHUWUHANLIANGDIYU PDE HUO SCT SHI,NENGGOUWEIJINCHUWUDELIANGBUHUIZHUANBIANYAOPINDEYOUYONGXINGJININGJINGXING,DUIHUANZHEDENINGJINGXINGWEIXIANXIAO,BAOZHUANGCAILIAOYUYAOPINJUBEIXIANGRONGXING。

RUOSHIJINCHUWUDEHANLIANGGAOYU SCT,CHANGYITIAOXUANGAIHUANBAOZHUANGCAILIAO。ZAIBUGAIHUANBAOZHUANGCAILIAOSHI,YINGTINGZHIXIANGGANDENINGJINGXINGPINGGU,PINGGUJINCHUWUDENINGJINGXINGWEIXIAN。

RUOSHIJINCHUWUDEHANLIANGGAOYU PDE,ZEYIWEIBAOZHUANGCAILIAOYUYAOPINBUJUBEIXIANGRONGXING,CHANGYIGAIHUANBAOZHUANGCAILIAO。

5. 吸附实验成果阐发:

RUOSHIXIFUSHIYANCHENGGUOXIANXIANBAOZHUANGCAILIAODUIYAOPINHUOFULIAOCUNZAIJIAOQIANGXIFU,BINGDUIYAOPINDELIANGCHANSHENGLEMINGXIANYINGXIANG,CHANGYIGAIHUANBAOZHUANGCAILIAO。


六、名词诠释

相容性研讨: 包装体系与药物相容性研讨是指考查包装体系与药物之间是不是产生迁徙或吸附等, 进而影响药物资量和宁静性而停止的实验进程。

包装体系: 指包容和掩护药品的一切包装组件的总和。包装体系包含间接打仗药品的包装组件和次级包装组件。容器密闭体系同等于包装体系。次级包装组件具备为药品供给额定掩护的功效。

包装组件: 指容器密闭体系中的任何一个构成部件。包装组件分为间接打仗药品的包装组件和次级包装组件,次级包装组件指的是不与药物间接打仗的包装组件。

塑料: 是指以高份子量的分解树脂为首要组分,插手恰当增添剂,如增塑剂、不变剂、阻燃剂、光滑剂、着色剂等,经加工成型的塑性材料,或固化交联构成的刚性材料。

可提取物: 经由进程提取实验取得的从包装资猜中溶出的物资。

浸出物: 经由进程迁徙实验取得的从包装体系中迁徙或是以而产生的并进入至药品中的物资。

人逐日许可最大裸露量(permitted daily exposure, PDE): 指某一物资被许可摄取而不产生毒性的日均匀最大剂量,某一详细物资的 PDE 值是由不产生反映量、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。

宁静性阈值(Safety Concern Threshold,SCT): 当浸出物的程度低于这个值时,其致癌和非致癌的毒性感化及宁静性影响可疏忽不计。

阐发评估阈值(Analytical Evaluation Threshold AET): 按照人逐日许可最大裸露量或宁静性阈值/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估。


七、附件(1-4)

1. CHABIEJIYAOLUZIZHIJIYUBAOZHUANGTIXICHANSHENGBICIGANHUADEWEIXIANFENJIBIAO

 2.PNG

2. HUAXUEYAOPINJIENASULIAOBAOZHUANGCAILIAOXIANGRONGXINGYANTAODEJUEYIJIHUASHU

3.PNG

3.HUAXUEYAOPINDAZHENYEJINGCHANGLIYONGDESULIAOBAOZHUANGCAILIAOJIQINGSHI

SULIAOSHIYOUSHUZHIHEZENGTIANJIGOUCHENG: SHUZHISHISULIAODESHOUYAOCHENGFEN,TAJUEYILESULIAOCHENGPINDEGENJIJINENG。 ZENGTIANJIHUOZHUJIDEGANHUASHIGAILIANGCHENGXINGGONGYIJINENG、GAILIANGCHENGPINDELIYONGJINENGHUOXIAJIANGBENQIAN。

SHUZHIPINZHONG: JUYIXI(PE),JUBINGXI(PP),HUANZHUANGJUXITING(COC)DENG。

DAZHENYEJINGCHANGLIYONGDESULIAOBAOZHUANGQINGSHI

4.PNG

4.SULIAOBAOZHUANGCAILIAOJINGCHANGLIYONGZENGTIANJIJIXIANZHIQINGQIU

5.PNG

6.PNG

7.PNG

8.PNG

ZHU: SULIAOBAOZHUANGCAILIAOJINGCHANGLIYONGZENGTIANJIJIXIANZHIZHIYONGYUDAZHENJIBAOZHUANGDEJUYIXIHEJUBINGXISULIAOJINGCHANGLIYONGZENGTIANJIHEZAISUCAIZHONGDEXIANZHI。XIAMIANSUOLIEZENGTIANJIZHONG,MEIZHONGSHUZHIZHONGZENGTIANKANGYANGJIDEPINZHONGBUNENGKUAYUE 3 ZHONG,ZONGLIANGBUDEKUAYUE 0.3%。SHANGBIAONEIRONGYINZIOUZHOUYAODIAN 7.0 BAN FU LU 3.1 materials used for the manufacture of containers。



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