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
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. HUAXUEYAOPINJIENASULIAOBAOZHUANGCAILIAOXIANGRONGXINGYANTAODEJUEYIJIHUASHU
3．HUAXUEYAOPINDAZHENYEJINGCHANGLIYONGDESULIAOBAOZHUANGCAILIAOJIQINGSHI
SULIAOSHIYOUSHUZHIHEZENGTIANJIGOUCHENG: SHUZHISHISULIAODESHOUYAOCHENGFEN，TAJUEYILESULIAOCHENGPINDEGENJIJINENG。 ZENGTIANJIHUOZHUJIDEGANHUASHIGAILIANGCHENGXINGGONGYIJINENG、GAILIANGCHENGPINDELIYONGJINENGHUOXIAJIANGBENQIAN。
SHUZHIPINZHONG: JUYIXI（PE），JUBINGXI（PP），HUANZHUANGJUXITING（COC）DENG。
DAZHENYEJINGCHANGLIYONGDESULIAOBAOZHUANGQINGSHI
4．SULIAOBAOZHUANGCAILIAOJINGCHANGLIYONGZENGTIANJIJIXIANZHIQINGQIU
ZHU: SULIAOBAOZHUANGCAILIAOJINGCHANGLIYONGZENGTIANJIJIXIANZHIZHIYONGYUDAZHENJIBAOZHUANGDEJUYIXIHEJUBINGXISULIAOJINGCHANGLIYONGZENGTIANJIHEZAISUCAIZHONGDEXIANZHI。XIAMIANSUOLIEZENGTIANJIZHONG，MEIZHONGSHUZHIZHONGZENGTIANKANGYANGJIDEPINZHONGBUNENGKUAYUE 3 ZHONG，ZONGLIANGBUDEKUAYUE 0.3%。SHANGBIAONEIRONGYINZIOUZHOUYAODIAN 7.0 BAN FU LU 3.1 materials used for the manufacture of containers。
