Ikhonkco lemveliso nganye ibalulekile kukhuphiswano olungundoqo lwenkampani ngokuchasene nokhuphiswano olumandla kwishishini lebiopharmaceutical. Thatha imveliso ye-temsirolimus egxininisiweyo yesisombululo senaliti njengomzekelo. Kwanotshintsho oluncinci loxinzelelo luchaphazela imveliso yonke kakhulu.
I-Propylene glycol sisinyibilikisi esibalulekileyo kwi-temsirolimus isisombululo esigxininiswe kwisitofu, kwaye ukugxila kwayo kuchaphazela ngokuthe ngqo ukunyibilika kwechiza kunye nokuzinza. Ugxininiso olufanelekileyo lwepropylene glycol luqinisekisa ukuchithwa okupheleleyo kwe-temsirolimus, ukukhusela i-crystallization yeziyobisi okanye imvula, ukugcina ukuzinza okufanayo ngexesha lokugcinwa kunye nokusetyenziswa, kunye nokuphepha ukunciphisa ukuphumelela okanye ukungaphumeleli ngenxa yokugxininiswa okungafanelekanga.
Umthamo wepropylene glyco uyahluka kwizicelo ezithile. Kwicandelo lamachiza, iimfuno zogxininiso zingqongqo. Ngokutsho kwe-United States Pharmacopeia (USP), ukugxininiswa kwayo kwiisombululo ze-injection akufuneki kudlule i-30% (v / v), kwaye ubuninzi bedosi enye yokuthatha amalungiselelo omlomo kufuneka ibe ngaphantsi kwe-25 mg / kg yesisindo somzimba.
Imicelimngeni emithathu yoLawulo lokuQikelela ngokweMveli
Ixesha kunye noVavanyo lweManuwali olungasebenziyo olunzima
Uvavanyo lwepropylene glycol luxhomekeke kwisampulu yesandla kunye nohlalutyo lwebhubhoratri kwimveliso yemveli. Kaninzi kuthatha iiyure ezininzi ukufumana iziphumo ngelixa kungekho fundo lucacileyo xa ulindile.
Ukutenxa kugxininiso kunokukhokelela ekusileleni kweebhetshi, ukumiswa kwemveliso, kunye nezixhobo ezingasebenziyo, ukwandisa kakhulu imijikelo yemveliso kunye nokunyusa iindleko zexesha. Ubalo lubonisa ukuba ukulibaziseka kuphela kuvavanyo loxinaniso kunokukhokelela ekuphulukaneni okukhulu nexesha lokuvelisa elisebenzayo ngonyaka.
Ukuguquguquka kweengcinga ezingalawulekiyo
Isisombululo esigxininisiweyo se-Temsirolimus kwinaliti ifuna ukugxininiswa okuchanekileyo kwepropylene glycol, njengoko nokuguquguquka okuncinci kunokuchaphazela uzinzo kunye nokhuseleko lwechiza. Ukuphindaphinda okulinganiselweyo kovavanyo lwezandla kwenza kube nzima ukubamba utshintsho lwexesha langempela, luthintele uhlengahlengiso olungexesha.
Ukuphambuka kugxininiso olusemgangathweni kunokubangela imiba yobulunga enje nge-turbidity okanye imvula, enokuthi ikhokelele kwiziphumo ezibi kakhulu zeklinikhi, konakalise isidima seshishini, kwaye kubangele imingcipheko yokukhumbula okanye iingxabano zomthetho.
INkunkuma yeZibonelelo ezifihlakeleyo
Uvavanyo lwezandla rhoqorequires ininzis yeabasebenzi, izixhobo kunye nexesha. Ngaphaya koko, ulawulo loxinaniso olungachanekanga lukhokelela kwinkunkuma yempahla ekrwada, ukusetyenzwa kwakhona kwemveliso, kunye nokunxitywa kwezixhobo, kudala iindleko ezinkulu ezifihlakeleyo. Umzekelo, inkampani exuba amayeza ephakathi ingangenamuyagulaions of lossngenxa yolawulo olungafanelekanga lwepropylene glycol, oluvela kwinkunkuma yezinto ezikrwada kunye nokusebenza kwakhona.
Imfuneko yoLawulo lokuQinisekisa
Asi-excipient ebalulekileyo kwisisombululo esigxininisiweyo se-temsirolimus kwinaliti,i qualiwena ad perforindoda of finel dumbhoxos depend on i concenisithethen of propylene glycol. Ugxininiso olufanelekileyo lwepropylene glycol luqinisekisa ukunyibilika kweziyobisi kunye nokuzinza ngelixa kunciphisa ukucaphuka ukuqinisekisa ukhuseleko lwesigulane.
Isisombululo sokuNcitshiswa kweendleko kunye noPhuculo oluSebenzayo
Ukujongana nemiceli mngeni yolawulo loxinaniso lwesiqhelo, imitha yoxinaniso yeLonnmeter, kunye nokusebenza kwayo okuphezulu, iye yaba “sisixhobo esiyimfihlo” kwiinkampani ezixuba amayeza ukuphumeza imveliso echanekileyo, ukunciphisa iindleko, kunye nokuphucula ukusebenza kakuhle.
Ukubeka iliso ngexesha lokwenyani, ulawulo oluchanekileyo
Imitha yoxinaniso engaphakathi kweLonnmeter isebenzisa iimpawu zokungcangcazela kwefolokhwe ephucukileyo kunye ne-algorithms ekrelekrele yokujonga ugxininiso lwepropylene glycol ngexesha lokwenyani nangokuqhubekayo, ukuhambisa idatha kwinkqubo yolawulo lwemveliso ngaphakathi kwemizuzwana. Abaqhubi banokubona ngokukhawuleza ukuguquguquka koxinzelelo kwaye benze uhlengahlengiso oluchanekileyo ukugcina uzinzo phakathi koluhlu olusemgangathweni. Ukuchaneka kwayo kwe-0.003 g/ml idlula kude kumanqanaba aphakathi kweshishini.
Ulawulo oluSebenzayo, uKusebenza ngokuSebenzisayo
Imitha ibonisa ukuhlanganiswa kwezixhobo ezomeleleyo, ukudibanisa ngokungenamthungo kunye neenkqubo ezahlukeneyo zokuvelisa. Xa ukutenxa kumaxabiso abekiweyo kuchongiwe, ngokuzenzekelayo iqalisa izenzo ezinjengokongezwa kolwelo okanye ukuvuselela ngaphandle kokungenelela okwenziwa ngesandla, okwenza ulawulo lwenkqubo oluzenzekelayo ngokupheleleyo. Oku kunciphisa kakhulu impazamo yomntu kunye neendleko zexesha ngelixa kukhulisa ukusebenza kakuhle kwemveliso. Kuphononongo lwemeko yenkampani eyaziwayo yoxubo-mayeza, ukuqaliswa kwemitha yoxinaniso ye-Lonnmeter engaphakathi kunciphise umjikelo wemveliso ye-temsirolimus egxininisiweyo yesisombululo nge-avareji ye-30%, kunye nokunyuka okuphawulekayo komthamo.
Ukuqinisekiswa koMgangatho, iiNgcipheko eziNcitshisiweyo
Ngolawulo oluchanekileyo loxinaniso, imitha yoxinaniso engaphakathi yeLonnmeter ithintela ngokufanelekileyo imiba yobulunga bamachiza ebangelwa kukuguquguquka koxinaniso, ithoba ngokuphawulekayo izinga lokusilela kweebhetshi kunye nokukhumbula imingcipheko. Inkqubo yayo eyakhelwe-ngaphakathi yokubeka iliso kwimigangatho emininzi ngobulumko ihlalutya kwaye iqikelele iintsingiselo zoxinaniso, ithomalalisa kwangaphambili imingcipheko enokubakho. Ulawulo logxininiso oluzinzileyo lukwaphucula ukuhambelana kwebhetshi ukuya kwibhetshi, ukomeleza ukukhuphisana kwemveliso kwimarike.
IiNzuzo zeXesha elide, ukuPhuculwa kweeNdleko
Ngelixa utyalo-mali lokuqala kwimitha yoxinaniso ye-Lonnmeter iphezulu xa kuthelekiswa, ukuphuculwa kweendleko zexesha elide kukhulu. Ngokunciphisa inkunkuma yezinto ezikrwada, ukuthoba amaxabiso okusebenza kwakhona, kunye nokunciphisa ukunxitywa kwezixhobo, iinkampani zinokulawula ngempumelelo iindleko zemveliso. Idatha yelizwe lokwenyani ibonisa ukuba ukusebenzisa imitha ye-Lonnmeter kunokonga ngaphezulu kwe-20% ngonyaka kwiindleko zemathiriyeli ekrwada nakwiindleko zokuphinda zisebenze. Ukongeza, ukusebenza kakuhle kwemveliso kunye nomgangatho wemveliso uguqulela kwimbuyekezo ephezulu yemarike, ukuzuza ukucutha ixabiso lokwenyani kunye neenzuzo ezisebenzayo.
Kumaza ophuhliso olukumgangatho ophezulu kwishishini le-biopharmaceutical, ulawulo loxinaniso oluchanekileyo lube yinto ephambili ekwandiseni ukhuphiswano. Imitha yoxinaniso engaphakathi yeLonnmeter ayinikeli kuphela itekhnoloji ephezulu kunye nokusebenza okuthembekileyo kodwa ikwabonelela ngezisombululo ezilungiselelweyo kunye nenkxaso ebanzi emva kokuthengisa. Ingaba ukulungelelanisa neenkqubo zokuvelisa eziyinkimbinkimbi okanye ukubonelela ngenkxaso ye-24/7 yobugcisa, sizimisele ukukhusela inkqubo yakho yokuvelisa. Qhagamshelana nathi namhlanje ukuze ufumane isisombululo sakho esilungelelanisiweyo sokubekwa iliso!
Ixesha lokuposa: Jun-03-2025
