Ulawulo lomgangatho kunye nemigangatho ye-paclitaxel

I-Paclitaxel yimveliso yendalo eyinkimbinkimbi kunye nomsebenzi onamandla we-antitumor.Ngenxa yobuninzi kunye nobunzima besakhiwo sayo.kuyimfuneko ukulawula ngokungqongqo ukulawulwa komgangatho kunye nemigangathopaclitaxel.Ulawulo lomgangatho kunye nemigangatho ye-paclitaxel ichazwe ngokweenkcukacha ngezantsi.

Ukulawulwa komgangatho we-paclitaxel

I-1.ulawulo lwezinto ezibonakalayo: izinto eziluhlaza ze-paclitaxel kufuneka zithengwe kubathengisi abaqeqeshiweyo.kwaye uqinisekise ukucoceka kunye nomgangatho wezinto eziphathekayo.Izinto ezibonakalayo kufuneka zibe phantsi kokuhlolwa okungqongqo okusemgangathweni.kuquka uhlalutyo lweekhemikhali.ukubonwa kwe-microbial.ukufumanisa ukungcola.etc. .ukuqinisekisa ukuba ziyahlangabezana neemfuno zemveliso.

I-2.inkqubo yokulawula inkqubo yokuvelisa: Kwinkqubo yokuvelisa i-paclitaxel.imilinganiselo yokulawula umgangatho ongqongqo kufuneka ithathwe.kubandakanya ukuqinisekiswa kwenkqubo.indawo yokulawula i-critical control point monitoring.intermediate testing.etc..ukuqinisekisa ukuzinza kwenkqubo yokuvelisa kunye nokuhambelana kwemveliso.

3.ukuhlolwa kwemveliso egqityiweyo:paclitaxelIimveliso kufuneka zibe ngumgangatho obanzi wokuhlola.kuquka iimpawu.purity.content.related substances.intsalela zesolvent kunye nezinye izinto ukuqinisekisa ukhuseleko lwemveliso kunye nokusebenza.

Ukuhlolwa kokuzinza kwe-4.imveliso ye-paclitaxel kufuneka ibe nokuhlolwa kokuzinza kwexesha elide ukuvavanya utshintsho lwazo lomgangatho phantsi kweemeko ezahlukeneyo zokugcina.ukubonelela ngesiseko sokuqinisekiswa kwemveliso.

Umgangatho we-paclitaxel

1.Ukumiselwa komxholo:indlela zokumisela umxholo we-paclitaxel ikakhulu zibandakanya ukusebenza okuphezulu kwechromatography yolwelo.i-ultraviolet ebonakalayo i-spectrophotometry njalo njalo.Imigangatho engqongqo yolawulo lwangaphakathi kufuneka isekwe ukuqinisekisa ukuba umxholo webhetshi nganye yeemveliso uyahlangabezana nemimiselo.

2.Ukuhlolwa kwezinto ezinxulumeneyo:izinto ezinxulumene ne-paclitaxel ziquka i-metabolites yayo kunye neemveliso zokubola.Iindlela kunye nemigangatho yokuhlola izinto ezifanelekileyo kufuneka zisekwe ukuqinisekisa ukuba umxholo wezinto ezifanelekileyo kwimveliso egqityiweyo ungaphakathi koluhlu oluchaziweyo.

I-3.i-solvent residue check: I-solvents ye-Organic ingasetyenziselwa inkqubo yokuvelisa i-paclitaxel.so imveliso egqityiweyo kufuneka ihlolwe i-residu ye-solvent ukuqinisekisa ukuthotyelwa kwemimiselo.

4.ezinye izinto zokuhlola:Ngaphezu kwezi zinto zokuhlola zingentla.ezinye izinto kufuneka kwakhona zitshekishwe ngokweemfuno zomgangatho wemveliso.njengokuhanjiswa kobungakanani besuntswana.pH value.moisture.etc.

Isishwankathelo

Njengechiza elibalulekileyo lokulwa nethumba.ulawulo lomgangatho kunye nomgangatho wepaclitaxelzibaluleke kakhulu ukhuseleko kunye nokusebenza kakuhle kwemveliso.Amanyathelo okulawula umgangatho angqongqo kufuneka athathwe kwinkqubo yokuvelisa ukuseka imigangatho yemigangatho yenzululwazi kunye nengqiqo ukuqinisekisa ukuba umgangatho webhetshi nganye yeemveliso uzinzile kwaye uthembekile.Ngexesha elifanayo. .ukulawula kufuneka kuqiniswe ukuqinisekisa ukhuseleko kunye nokuthotyelwa ngexesha lokuvelisa kunye nokusetyenziswa.Ngokuphucula okuqhubekayo kunye nokuphuculwa kwemigangatho yokulawula umgangatho.umgangatho wokuvelisa kunye nomphumo wokusetyenziswa kwesigulane we-paclitaxel unokuphuculwa ngakumbi.

Qaphela:Iinzuzo ezinokubakho kunye nezicelo ezichazwe kweli nqaku zithathwe kuncwadi olupapashiweyo.