Cov Kws Tshaj Lij Ua Tom Tsev Thiab Sab Nraud Tham Txog Tus Txheej Txheem Ntawm Cov Tshuaj Kho Mob iav

May 18, 2021

Tso lus

Nrog rau qhov yuav pib siv ntawm kev txheeb xyuas ntsig txog thiab kev pom zoo rau cov ntim ntim tshuaj, kev sim tshuaj thiab cov tshuaj, raws li cov ntaub ntim khoom ntim sib txuas nrog cov tshuaj, kev sib raug zoo ntawm kev lag luam iav kev lag luam yog nce ntxiv, thiab nws cov qauv zoo thiab cov qauv siv tau rov ua rau npaj. Kev saib xyuas ntawm cov chaw lag luam thiab cov chaw lag luam tshuaj iav.


Txij thaum Lub Xya Hli 8 txog 9, thawj lub rooj sib tham ntawm cov rooj sab laj ntawm kev sib tham ntsig txog kev soj ntsuam thiab kev pom zoo - International Symposium ntawm Cov Txheej Txheem ntawm Cov Tshuaj Muaj Cai iav tau muaj nyob hauv Ruicheng, Shanxi.

Lub rooj sib tham tau teeb tsa los ntawm Shanxi Hongguang Medical Glass Co., Ltd nyob rau hauv kev taw qhia ntawm Lub Xeev Pharmacopoeia Committee, txhawb nqa los ntawm Tuam Tshoj Pharmaceutical Ntim Koom Haum thiab cov koom ua ke los ntawm Shanxi Hongguang Medical Glass Co., Ltd. los ntawm CFDA thiab Tuam Tshoj Pharmacopoeia Commission, cov kws tshaj lij los ntawm cov chaw kuaj ntshav, cov kws paub zoo los ntawm cov chaw tsim tshuaj thiab cov iav tshuaj. cov qauv khoom, kev xaiv cov khoom ntim ntawm cov tshuaj lom neeg, kev tshawb fawb kev sib xyaw ntawm cov tshuaj thiab cov ntim ntim tshuaj, kev tswj cov iav zoo, thiab cov kev cai ntawm cov iav suav thiab Asmeskas cov tshuaj noj.

Kev txheeb xyuas tus mob yog qhov muaj txiaj ntsig kom paub meej lub luag haujlwm thiab txo qis kev pom zoo

Lub Tsib Hlis 12, Tsoom Fwv Saib Xyuas Khoom Noj thiab Yeeb Tshuaj tau tshaj tawm Daim Ntawv Tshaj Tawm (tsab ntawv rau Cov Lus Nug) ntawm Cov Lus Sib Txawv ntawm Cov Kev Ntsuam Xyuas thiab Kev Pom Zoo ntawm Cov Khoom Siv Tshuaj rau Cov Khoom Siv Tshuaj Kho Mob Cov Khoom Siv thiab Cov Tshuaj, cim kev hloov zuj zus ntawm kev siv ntawm kev ntsuas kev cuam tshuam.

Kev siv ntawm cov kws tshaj lij kev lag luam, cov tshuaj ntim cov tshuaj ntim khoom thiab kev npaj ntsig txog kev tshuaj xyuas thiab kev pom zoo, kev ntim tshuaj ntim khoom lag luam kev txhim kho kev lag luam tuaj yeem piav qhia raws li qhov tseem ceeb ntawm kev hloov pauv thiab lub sijhawm loj.

Nws tau nkag siab tias kev siv tshuab ntau lawm thiab kev tswj qib ntawm cov ntim cov tshuaj ntim hauv Suav tau txhim kho tsis tu ncua, thiab cov qauv txheej txheem zoo tau maj mam zoo. Tam sim no 130 lub teb chaws tus qauv rau cov ntawv ntim tshuaj tau tawm, thiab 5,166 daim ntawv ntim tshuaj ntim cov ntawv sau npe daim ntawv pov thawj tau muab." Kev pom zoo tam sim no tau ua lub luag haujlwm tseem ceeb hauv kev tswj hwm thiab txhawb nqa kev txhim kho kev lag luam.Yog vim li cas thiaj hloov?" Tus neeg los ntawm Chav Saib Xyuas Tshuaj thiab Tshuaj Sau Npe ntawm CFDA taw qhia tias" nanny zoo li kev saib xyuas" tau ua tiav rau kev npaj tshuaj hauv kev lag luam yav dhau los, thiab lub luag haujlwm rau cov teeb meem zoo feem ntau tsis meej. Qhov kev siv ntawm kev txheeb xyuas ntsig txog yog khaws cia cov kws npaj tshuaj lag luam tau ua lub luag haujlwm tseem ceeb rau qhov zoo, thiab tib lub sijhawm, nws yog qhov muaj txiaj ntsig kom tau qhia txog txoj haujlwm tseem ceeb ntawm kev npaj tshuaj hauv kev ua lag luam thiab ua rau lawv faib cov peev txheej ntawm cov lag luam sab nraud.Second , cais kev tshuaj xyuas thiab kev pom zoo ntawm cov khoom ntim thiab cov khoom siv pov tseg cov khoom siv tsis raug, thiab qhov kev hloov kho no zoo rau txo kev tshuaj ntsuam xyuas thiab kev pom zoo.


& quot; Tom qab ua tiav kev tshuaj xyuas cuam tshuam, cov lag luam cuam tshuam yuav tsum tsom rau peb lub hauv paus ntawm' rov qhia dua tom qab siv',' kev tswj hwm kev pheej hmoo' thiab' hloov kev tswj tuav', thiab pib tshawb fawb cov tshuaj ntim khoom thiab cov kws tshaj lij tshuaj los ntawm kev tshawb fawb thiab kev siv tshuaj yaj yeeb thiab los ntawm qhov pib siab dua kom ua tiav txoj cai hloov." Tus neeg sawv cev CFDA tau hais txog.

Hong Xiaoxu, tus thawj coj ntawm Lub Chaw Haujlwm Tseem Ceeb ntawm Lub Xeev Pharmacopoeia Commission tau hais tias lub tebchaws thiab kev lag luam tau mob siab rau qhov zoo ntawm cov ntawv ntim tshuaj thiab muab tso rau siab dua cov kev cai rau cov ntim ntim tshuaj vim tias muaj peev xwm txaus ntshai kev pheej hmoo ntawm cov khoom ntim tshuaj thiab kev kho mob zam.Ua kev ua ntej ntawm kev soj ntsuam kev sib txawv ntawm cov tshuaj muaj txiaj ntsig zoo thiab kev ua tau zoo, kev tsim kho ntawm cov qauv txheej txheem zoo rau cov ntim khoom ntim tshuaj thiab cov kws kho mob tau ua ntau dua thiab tseem ceeb dua.Pharmaceutical ntim khoom lag luam yuav tsum pib los ntawm kev ua kom zoo, tawg los ntawm kev txwv kev lag luam, ntxiv dag zog rau kev koom tes nrog kev lag luam kws tshuaj, nkag siab txog kev xav tau ntawm kev lag luam kws tshaj lij, koom nrog kev tsim cov qauv tsim nyog, thiab tas li txhim kho qhov zoo thiab theem kev ntawm cov ntim ntim tshuaj.

Cai Hong, Tus Tuav Secretary ntawm Tuam Tshoj Pharmaceutical Packaging Association, tau taw qhia tias cov tuam txhab ua lag luam yog cov thawj coj ua lub luag haujlwm rau kev siv tshuaj, thiab kev siv tshuaj ntim cov khoom, cov kws tshaj lij tshuaj thiab cov tshuaj muaj feem tshuaj xyuas thiab kev pom zoo yog los piv cov txheej txheem kev pom zoo tshuaj thiab kev coj ua kev tshuaj xyuas thiab kev tsim nyog thiab kev pom zoo ntawm cov tshuaj thiab lawv cov khoom ntim raws li lub hauv paus ntsiab lus ntawm kev tswj hwm pheej hmoo. Tom qab kev siv ntawm kev txheeb xyuas ntsig txog, tus neeg thov rau kev npaj tau yog tus thawj tswj hwm tus neeg / tus neeg thov, uas yuav muaj tseeb txhawb kev koom tes ntawm chaw tsim tshuaj thiab ntim cov khoom lag luam ntim khoom lag luam, thiab txhawb kev ciaj sia ntawm fittest ntawm cov ntim tshuaj ntim cov khoom lag luam.Rau cov tuam txhab tshuaj, yuav tsum them nyiaj rau thiab tshwj xeeb rau kev ntim tshuaj, kws tshaj lij kev lag luam tshuaj xyuas, txuas qhov tseem ceeb rau kev hloov lub conte nt thiab cov txheej txheem hloov pauv, nkag siab tob txog cov ntaub ntawv ntim tshuaj thiab cov txheej txheem kws tshaj lij tshuaj, cov khoom lag luam, kev tswj cov txheej txheem cov ntaub ntawv, xws li los ntawm kev ua cov khoom ua lag luam nruj tshawb xyuas kom ntseeg tau tias qhov zoo ntawm cov tshuaj ntim, kws tshaj lij tshuaj, thaum kawg lub luag haujlwm rau tshuaj zoo.


Sun Yi, tus thawj coj ntawm infusion department ntawm Jiangsu Hengrui Pharmaceutical Co., Ltd., tau hais tias kev ntim khoom yog ib qho tseem ceeb ntawm kev npaj, thiab dab tsi muaj feem cuam tshuam rau txoj kev ntsuas tshuaj yog lub ntim khoom. Yog li, kev xaiv cov ntim khoom yuav tsum pib los ntawm kev tshawb fawb txog kev siv tshuaj thiab kev tsim kho.Nws cia siab tias qhov kev siv ntawm kev txheeb xyuas kev txheeb xyuas yuav tsis yog yooj yim tsuas yog cov txheej txheem kev pom zoo thiab txo qhov kev sib txuas ntawm kev tshuaj xyuas, tab sis kuj tseem ua lub luag haujlwm hauv kev txhawb nqa kev tshawb fawb science thiab meej pem. , tiv thaiv cov peev txheej, txuag tau nyiaj thiab txhawb txoj kev tsim kho.


Tsis muaj lub sijhawm los hloov cov qauv kev qhia rau ntim tshuaj ntim

Xyoo tsis ntev los no, cov cawv ntawm cov ntaub ntawv ntim tshuaj ntawm cov khoom lag luam zoo tau dhau los, tshwj xeeb tshaj yog cawv ntawm cov ntaub ntim khoom ntim ntim rau qhov zoo ntawm cov kev txhaj tshuaj tau ua rau muaj kev txaus siab los ntawm kev lag luam.Qhov kev tshawb fawb ntawm cov qauv kev tswj, kev tswj kom zoo thiab sib raug zoo. ntawm ntim cov ntaub ntawv xws li daim iav kws tshuaj tau dhau los ua cov ntsiab lus kub tau sib tham los ntawm ntau lub chaw tsim tshuaj thiab kws ntim tshuaj ntim cov chaw lag luam uas muaj kev lees paub nrog kev pom zoo ntawm kev tshuaj xyuas yav tom ntej.

Nws to taub tias los ntawm sodium bicarbonate txhaj koob ntim iav ntim tawm los ntawm qhov muaj feem ntau tshwm sim ntau zaus, Tebchaws Meskas tsis muaj kev zam.Xu Liangfeng, tus thawj coj zoo ntawm Yabao Pharmaceutical Group Co., Ltd. tau teev" cov teeb meem hauv kev siv cov iav ampoules thiab cov fwj tshuaj xilin" ;, tau hais tias sab hauv lub khob iav xeb; Los yog Si concentration, cov lej feem ntau thiab pH tus nqi hauv cov kua ntsuas tau muaj qhov hloov pauv tseem ceeb, qhia tias tseem muaj peev xwm ntawm lub khob ntim stripping loj dua.

Mr. Zhang Huaimin, tus thawj tswj hwm ntawm Shanxi Hongguang Medical Glass Co., Ltd., tau hais tias" cov khoom yog cov yam ntxwv, qhov zoo yog lub neej", lub tuam txhab tsim cov khoom lag luam hauv tebchaws ampoule ci lo lus. , siab-purity kws tshuaj tsom iav mis thiab hluav taws xob cua sov ua hluav taws xob ntau lawm technology.Hauv xyoo tsis ntev los no, lub tuam txhab tsom rua kev tsim kho tshiab, lub tshuab ua tshuaj kho cov raj iav nplaim hluav taws xob rau lub tshuab hluav taws xob ua kom zoo hluav taws xob, kom qhov hluav taws xob cua kub siv hluav taws xob tau siv ntau dua 80%, kom ua tiav kev tiv thaiv ib puag ncig, kev txuag hluav taws xob thiab kev txo qis kev siv, kev tsim tawm, kev tswj kom zoo thiab lwm yam ntawm cov txiaj ntsig zoo.Yu Jingqiang, tus thawj kws tshaj lij ntawm lub tuam txhab, tau qhia txog nws qhov kev paub ntawm" qhov kev tswj hwm thiab cov txheej txheem tswj ntawm cov tshuaj iav. hlab" nrog rau cov neeg tuaj koom.Nws tau hais tias txhawm rau kom ntseeg tau cov khoom zoo ntawm cov dej muaj tshuaj muaj dej ntau dua ob npaug ntawm lub raj tshuaj, peb yuav tsum pib los ntawm lub hauv paus, thiab ua tiav cov qauv ntsuas tshuaj, ntxuav cov ntaub ntawv nyoos, qhov hnyav tshaj thiab sib xyaw sib xyaw; kev tsim qauv yog tsim nyog, kev xaiv cov khoom tiv taus yog qhov tsim nyog, cov cua sov tswj kev tswj hwm yog ruaj khov, cov khoom kis tau muab kaw, qhov kev tsim qauv tsim kho tau zoo, thiab kev tshawb nrhiav "on-line" tau raws sijhawm.


Tsis muaj lub sijhawm los hloov cov qauv kev qhia rau ntim tshuaj ntim

Xyoo tsis ntev los no, cov cawv ntawm cov ntaub ntim tshuaj ntawm cov khoom lag luam zoo tau dhau los, tshwj xeeb tshaj yog cawv ntawm cov ntawv ntim khoom ntim rau qhov zoo ntawm kev txhaj tshuaj tau ua rau muaj kev txaus siab los ntawm kev lag luam. Cov kev tshawb fawb ntawm cov qauv txheej txheem, kev tswjhwm zoo thiab sib raug zoo ntawm cov khoom ntim xws li cov iav tshuaj tau dhau los ua cov ntsiab lus kub tau tham los ntawm ntau lub chaw lag luam kws tshuaj thiab cov ntaub ntawv ntim tshuaj lag luam uas muaj kev lees paub nrog kev pom zoo txog kev tshuaj xyuas yav tom ntej.

Nws to taub tias los ntawm sodium bicarbonate txhaj koob ntim iav ntim cov ntawv ntim cov khoom tshwm sim los ntawm cov khoom siv ntau dhau uas tau tshwm sim ntau zaus, Tebchaws Asmeskas tsis muaj kev zam. Xu Liangfeng, tus thawj coj zoo ntawm Yabao Pharmaceutical Group Co., Ltd. tau teev" cov teeb meem hauv kev siv iav ampoules thiab cov fwj ntawm xilin" los yog Si concentration, cov zauv ntawm tus naj npawb thiab pH tus nqi hauv cov kua ntsuas tau muaj qhov hloov pauv tseem ceeb, qhia tias qhov tseem ntawm cov thawv ntim khoom ntim tau ntau dua.


Txij li thaum pib ntawm kev hloov pauv ntawm kev ntsuam xyuas tus kheej, Lub Koom Haum Suav Tsuaj Tshuaj Ntim tau ntxiv dag zog nws cov dag zog los txhawb cov tswv cuab cov koom ua lag luam kom ntseeg tau cov khoom zoo thiab koom tes nrog kev txhim kho npaj. Qhia txog kev tswj cov txheej txheem ntau lawm, tsim thiab ua raws cov qauv tswj kev ua haujlwm zoo ntawm cov khoom ntim tshuaj; Txheem ua raws tus neeg muab khoom lag luam tshawb xyuas thiab tsim cov lus qhia tshawb pom cov neeg muab khoom; Consummate koom kev ntsuas qhov system tsim; Los ua cov kev tshawb fawb ntawm cov txheej txheem ntsuas kev ua tau zoo ntawm cov ntim khoom ntim khoom lag luam.


Raws li tus kws tshaj lij uas tau koom nrog kev tsim ntawm" 13th Tsib Xyoos" kev npaj tswv yim ntawm kev lag luam kws kho mob, Cai Hong muaj kev xav txog kev txhawb nqa cov xwm txheej thiab muaj feem cuam tshuam txog kev ntim khoom hauv kev lag luam kws tshuaj. Nws tau hais tias kev ntim khoom thiab kev xa tshuaj yuav yog thaj chaw tseem ceeb hauv kev lag luam kws kho mob thaum lub sijhawm 13-Tsib Lub Phiaj Xwm Tsib-Xyoo. Tshwj xeeb, nws suav nrog kev txhim kho thiab siv cov ntaub ntawv tshiab nrog kev nyab xeeb thiab ua haujlwm tau zoo, thiab cov tawm ntawm ntau yam uas muaj cov qauv zoo thiab tsis zoo. Qhov tseem ceeb ntawm kev nrawm nrawm rau kev txhaj tshuaj ntim los ntawm qis borosilicate iav fwj kom nruab nrab borosilicate iav hloov pauv, kev txhim kho cov koob txhaj tshuaj, infusion hnab, hnab thiab lwm yam khoom siv lub nplhaib ntawm olefin polymer, styrene thermoplastic elastomer thiab lwm yam ntaub ntawv tshiab, yooj yim tom tsim muaj peev xwm oxidized tshuaj nrog cov khoom siv siab, txhim kho kev kho mob theem ntawm polypropylene, polyethylene thiab halogenated butyl roj hmab qib zoo dua. Ib qho ntxiv, koj yuav tsim kho lub ntim tshiab thiab cov xa tshuaj, muab ib qho kev ua haujlwm, ua tau raws li cov txheej txheem kev ua haujlwm, txhim kho cov neeg mob ua kom tiav, kev nyab xeeb rau tshuaj, tshwj xeeb kev tsim cov tshuaj aerosol mist thiab hmoov dosing ntaus ntawv, tus kheej tshuaj txhaj koob tshuaj, koob txhaj tshuaj, tsis siv neeg sib tov tshuaj ntaus, xws li cov koob txhaj tshuaj tshiab, hnab ntau yam thiab tshem tawm cov insoluble hais ua haujlwm ntim infusion ntim, Cov khoom ntim ntse nrog lub cim xeeb muaj nuj nqi thiab cov tswj kev ua haujlwm zoo, ntim zoo rau cov menyuam yaus thiab cov phooj ywg ntim rau cov laus, thiab lwm yam.


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