amakuru

Kumenyekanisha Oxidizing ishobora kuva muri Clinical Syringe Rubber Stopper

Gukoresha inshuro imwe ibikoresho bya polymeriki bigenda bikoreshwa muburyo butandukanye bwo gutunganya ibinyabuzima.Ibi birashobora guterwa ahanini nuburyo butandukanye bwibisabwa hamwe no guhuza no guhuza n'imikorere, ndetse no ku giciro gito ugereranije kandi kubera ko isuku idasabwa. [1] [2]

Mubisanzwe, mugihe gikoreshwa muburyo busanzwe bwimuka yimiti yimiti yitwa "leachables", mugihe com-pound yimuka mugihe cya laboratoire ikabije bakunze kwitwa "gukuramo."Kuba haribishobora kubaho bishobora guhangayikishwa cyane n’inganda z’ubuvuzi ， kubera ko poroteyine zo kuvura zikunze guhinduka mu buryo bw’imiterere zishobora guterwa no kuba hari umwanda, niba izo zifite amatsinda akora. [3] [4]Kuvana mubikoresho byubuyobozi birashobora gufatwa nkimpanuka nyinshi, nubwo igihe cyo guhura gishobora kutaba kirekire ugereranije nububiko bwigihe kirekire.
Ku bijyanye n’ibisabwa n’amabwiriza, Amategeko y’Amerika yo muri Leta zunze ubumwe za Amerika Umutwe wa 21 avuga ko ibikoresho byo gukora [6] kimwe no gufunga kontineri [7] bidashobora guhindura umutekano, ubwiza cyangwa ubuziranenge bw’ibiyobyabwenge.Kubera iyo mpamvu, kugira ngo ibicuruzwa byifashe neza n’umutekano w’abarwayi, kuba ibyo byanduye bishobora guturuka ku mubare munini w’ibikoresho byandikirwa DP, bigomba gukurikiranwa no kugenzurwa mu ntambwe zose zitunganywa, mu gihe cyo gukora, kubika no kuyobora bwa nyuma.
Kubera ko muri rusange ibikoresho byubuyobozi bishyirwa mubikorwa byubuvuzi, abatanga ibicuruzwa nababikora akenshi bagena kandi bagasuzuma ibibaho byimuka yimiti ukurikije ikoreshwa ryibicuruzwa runaka, urugero, kumifuka yo gushiramo, gusa igisubizo cyamazi kirimo, urugero, 0.9% (w / v) NaCl, irasuzumwa.Icyakora, mbere byerekanwe ko kuba hari ibintu bigize formulaire hamwe na solubilizasique, nka proteine ​​ivura ubwayo cyangwa surfactants zitari ionic bishobora guhinduka kandi bikongerera imbaraga kwimuka ryimvange zidafite inkingi ugereranije nibisubizo byoroshye byamazi. [7] ]
Byari intego rero yumushinga wubu kugirango tumenye ibishobora guterwa biva muri siringi isanzwe ikoreshwa.Kubwibyo, twakoze kwigana-gukoresha ubushakashatsi bworoshye dukoresheje amazi 0.1% (w / v) PS20 nkigisubizo cya DP surrogate.Ibisubizo byabonetse byakemuwe byasesenguwe nibisanzwe bivanwa hamwe nuburyo bwo gusesengura.Ibice bya syringe byarasenyutse kugirango hamenyekane isoko yambere yo kurekura.
Mu bushakashatsi bwakoreshejwe mu bushakashatsi bwakoreshejwe ku buvuzi bwakoreshejwe mu buvuzi kandi bwemejwe na CE bwifashishwa mu gukoresha imiti ishobora gutera kanseri ishobora gutera kanseri, ari yo 1,1, 2,2-tetrachloroethane yavumbuwe mu bitekerezo biri hejuru ya ICH M7 ikomoka ku isesengura ry’isesengura (AET) ).Iperereza ryimbitse ryatangiye kugira ngo hamenyekane icyuma gikubiyemo reberi nkisoko yambere ya TCE.
Mubyukuri, dushobora kwerekana tudashidikanya ko TCE itari igerwaho na reberi ihagarara.Byongeye kandi, ubushakashatsi bwerekanye ko kugeza ubu uruganda rutazwi rufite imiterere ya okiside rwarimo ruva mu cyuma cya reberi, rwashoboraga guhagarika DCM kugeza TCE.
Kugirango hamenyekane ibimera biva mu mazi, icyuma cya reberi hamwe n’ibiyikuramo byaranzwe n’uburyo butandukanye bwo gusesengura.Peroxide itandukanye kama, ishobora gukoreshwa nkabashinzwe gutangiza polymerisation mugihe cyo gukora ibikoresho bya pulasitiki ， hakozwe iperereza kubushobozi bwabo bwo guhumeka DCM kuri TCE. Kugirango hemezwe bidashidikanywaho imiterere Luperox⑧ 101 idahwitse nka okiside igereranywa, isesengura rya NMR ryakozwe.Ibikoresho bya reberi ya methanolike hamwe na Luperox 101 ya methanolike byerekanwe hamwe byumye.Ibisigisigi byongeye gushyirwaho muri methanol-d4 kandi bisesengurwa na NMR.Uwatangije polymerisation Luperox⑧101 yemejwe rero ko ari okiside ishobora gukoreshwa na siringi ya rubber ihagarikwa.
Hamwe n’ubushakashatsi bwerekanwe hano, abanditsi bafite intego yo gukangurira abantu kumenya imiti ikomoka ku miti ikoreshwa mu buvuzi, cyane cyane ku bijyanye n’imiti “itagaragara” ariko yangiza cyane.Gukurikirana TCE birashobora rero kuba uburyo butandukanye kandi bworoshye bwo kugenzura ubuziranenge bwa DP mu ntambwe zose zitunganijwe bityo bikagira uruhare mu mutekano w’abarwayi.[13]

Reba

[1] Shukla AA, Gottschalk U. Gukoresha inshuro imwe tekinoroji ikoreshwa mu gukora ibinyabuzima.Inzira ya Biotechnol.2013; 31 (3): 147-154.

Lopes AG.Gukoresha inshuro imwe mu nganda zikomoka ku binyabuzima: gusubiramo ingaruka za tekinoloji-nologiya igezweho, imbogamizi n'imbogamizi.Ibiribwa Bioprod.2015; 93: 98-114.

[3] Paskiet D, Jenke D, Umupira D, Houston C, Norwood DL, Markovic I. Ibicuruzwa byujuje ubuziranenge Ikigo cy’ubushakashatsi (PQRI) gishobora gukururwa hamwe n’ibishobora gukururwa mu matsinda akorera ibikorwa by’ibiyobyabwenge n’ibicuruzwa by’amaso (PODP).PDA] Pharm Sci Technol.2013; 67 (5): 430- 447.

[4] Wang W, Ignatius AA, Thakkar SV.Ingaruka zumwanda usigaye hamwe nuwanduye kuri proteine ​​itajegajega.J Pharmaceut Sci 2014; 103 (5): 1315-1330.

[5] Paudel K, Hauk A, TV ya Maier, Menzel R. Ibiranga ubwinshi bwimiterere yimyunyu ngugu muri biofarmaceutical downstream gutunganya.Eur J Pharmaceut Sci.2020; 143: 1 05069.

[6] Amerika ishinzwe ibiryo n'ibiyobyabwenge FDA.21 CFR Sec.211.65, Kubaka ibikoresho.Yasubiwemo guhera ku ya 1 Mata 2019.

[7] Reta zunzubumwe zamerika Ubuyobozi bushinzwe ibiribwa nibiyobyabwenge FDA.21 CFR Sec.211.94, Ibikoresho byibiyobyabwenge nibifunga.Yasubiwemo guhera ku ya 1 Mata 2020.

8[Koresha Polvmer Sci.2003: 89 (4): 1049- 1057.

[9] Itsinda ryibikorwa bya BioPhorum BPOG.Imyitozo ngororangingo nziza yo gukuramo ibizamini bya polymeric imwe-imwe ikoreshwa mu gukora biofarmaceutical.BioPhorum Operations Group Ltd (gutangaza kumurongo);2020.

[10] Khan TA, Mahler HC, Kishore RS.Imikoranire yingenzi ya surfactants muburyo bwo kuvura poroteyine: gusubiramo.FurJ Pharm Riopharm.2015; 97 (Pt A): 60- -67.

Ishami ry’ubuzima muri Leta zunze ubumwe z’Amerika rishinzwe serivisi z’abantu, Ubuyobozi bw’ibiribwa n’ibiyobyabwenge FDA, Ikigo gishinzwe gusuzuma ibiyobyabwenge n’ubushakashatsi CDER, Ikigo gishinzwe gusuzuma ibinyabuzima no gusuzuma CBER.Ubuyobozi bwinganda - gusuzuma ubudahangarwa bw'umubiri

[12] Bee JS, Randolph TW, Umubaji JF, Musenyeri SM, Dimitrova MN.Ingaruka zubuso nibishobora kugaragara kumiterere ya biofarmaceuticals.J Pharmaceut Sci.2011; 100 (10): 4158- -4170.

[13] Kishore RS, Kiese S, Fischer S, Pappenberger A, Grauschopf U, Mahler HC.Kwangirika kwa polysorbates 20 na 80 n'ingaruka zishobora kugira ku ituze rya biotherapeutics.Pharm Res.2011; 28 (5): 1194-1210.