Ikhaya

Kutheni iGelatin ingumxumi osebenzayo weMithi

I-Gelatin ibisetyenziswa kumayeza kangangeminyaka engaphezu kwekhulu, kwaye ngesizathu esihle. Ivela ngokwebhayoloji, ngokubanzi ibonwa njengekhuselekileyo, iguquguquka kwiindlela ezahlukeneyo zomthamo, kwaye iyahambelana nezithako ezahlukeneyo zamayeza ezisebenzayo (ii-API). Njengesixhobo sokongeza amayeza, ibonakala kwiikhaphukhaphu eziqinileyo, ii-softgels, ii-tablet coatings, ii-suppositories, kwaye ikwayi-plasma expander kunye ne-wound-care matrix.

Iindima Ezisebenzayo Ezidlalwa YiGelatin

Isixhobo esinye esincedisayo sinokwenza imisebenzi emininzi kwifomyula enye, yiyo loo nto abathengi beyixabisa:

• Ukwakheka kweqokobhe leekhaphu: I-gelatin's thermoreable gelation kunye neempawu zokwenza ifilimu zixhasa ukwenziwa kweekhaphu zekhaphu eziqinileyo ezineziqwenga ezimbini kunye neekhaphu ze-softgel ezenziwe ngeplastiki.
• Ukubopha kunye nokudibanisa: izisombululo zegelatin zingasetyenziswa njengezinto zokubopha kwiifomyula ezikhethiweyo zeethebhulethi ukuxhasa ukwakheka kwegranule kunye namandla oomatshini.
• Ukufakwa kwefilimu: i-gelatin ingasetyenziswa kwiifomyula ezithile zemveli okanye ezikhethekileyo zokufakwa kwethebhulethi.
• Ukuzinza: kwi-liquids nakwi-semi-solids, i-gelatin iyamisa amasuntswana kwaye iphucula imvakalelo yomlomo okanye i-viscosity.
• Ukuhambelana kwezinto eziphilayo: kwizicelo eziphambili, isebenza njenge-matrix ewohlokayo yokuhanjiswa okulawulwayo.

Oko Kufanele Kuboniswe "kwiBanga leMithi"

Izinto ezicetywayo kufuneka zihlangabezane ne-monograph efanelekileyo ye-pharmacopoeial kunye neenkcukacha ezivunyiweyo ngumthengi, zenziwe phantsi kwenkqubo efanelekileyo yomgangatho, kwaye zixhaswe yiziqinisekiso zomthengisi kunye nedatha yokukhululwa ethile. Ngenxa yokuba iimfuno ziyahluka ngokwemarike, uhlobo lwedosi, kunye nendlela yokusetyenziswa, "udidi lweyeza" kufuneka luqinisekiswe ngokusebenzisa ulawulo olubhaliweyo endaweni yokwamkelwa njengelebheli yokuthengisa.

I-QA kufuneka ikwazi ukuqhagamshela iqashiso ngalinye elifunyenweyo kwinkcazo yezinto ezivunyiweyo, ubuwena bomthengisi, i-COA ethile yeqashiso, imeko yeziqinisekiso, kunye nalo naluphi na uxwebhu olufunekayo lwemvelaphi yesilwanyana okanye i-TSE. Iirekhodi zangaphakathi zebhetshi yomthengisi zihlala zigcinwa ngaphakathi kwenkqubo yakhe yomgangatho kwaye zinokuphononongwa ngeziqinisekiso okanye uphicotho-zincwadi apho kufanelekileyo.

Iprofayili yoKhuseleko Abathengi Abafanele Bayiqonde

Ukufaneleka kwegelatin yamayeza kuxhomekeke ekusetyenzisweni kwayo kunye nolawulo olusetyenziswa kuyo yonke ikhonkco lokubonelela. Abathengi kunye nabavelisi bemveliso yamayeza kufuneka bachonge iimpawu zezinto kunye neengozi zokungcola ezifanelekileyo kwifom yedosi, indlela yokusetyenziswa, ukwenziwa kwayo, kunye nemakethi yendawo ekuyiwa kuyo:

• Umgangatho we-microbiological: misela imida ye-microbial efanelekileyo kwizinto kunye nokusetyenziswa okucetywayo. Uvavanyo lwe-bacterial-endotoxin lunokuba yimfuneko kwizicelo ezithile ze-parenteral okanye ezinye iindlela ezinobungozi obukhulu, kodwa alufuneki ngokuzenzekelayo kuzo zonke iintlobo ze-gelatin yomlomo.
• Ukungcola kwezinto ezisisiseko: vavanya umngcipheko ofanelekileyo wokungcola kwezinto ezisisiseko ngokusebenzisa iimfuno ezifanelekileyo ze-pharmacopoeial, ulwazi lomthengisi, inkqubo yokuvelisa, kunye novavanyo lomngcipheko weziyobisi ezigqityiweyo.
• Imvelaphi yezilwanyana kunye nomngcipheko we-TSE: bhala phantsi uhlobo lwezilwanyana, izicubu, amazwe ezivela kuwo, inkqubo yokwenziwa, ukulandeleka, kunye nolawulo lwe-TSE olufanelekileyo.
• Ukungcola okunxulumene nenkqubo: vavanya izinto ezinokuvela ngokufanelekileyo kwizinto eziluhlaza okanye inkqubo yokuvelisa kwaye usebenzise iinkcukacha ezifanelekileyo kunye neemfuno zovavanyo.
• Iimpawu ezinxulumene nokusebenza: amandla ejeli okulawula, ukuxinana, ukufuma, i-pH, ukucaca, ubungakanani bamasuntswana, okanye ezinye iimpawu ngokwempembelelo yazo kwifomyula kunye nenkqubo ecetywayo.

Amaxwebhu e-BSE/TSE eGelatin ephuma kwiZilwanyana

Kwi-gelatin ethathwe kwi-bovine okanye kwezinye izinto ezinxulumene ne-TSE, uvavanyo kufuneka luqwalasele uhlobo lwesilwanyana, izicubu ezisetyenzisiweyo, amazwe avela kuwo, ukulandeleka kwawo, kunye nenkqubo yokuvelisa. Abathengi kufuneka bacele uxwebhu lwemvelaphi yesilwanyana kunye ne-TSE olufunekayo kwimarike yendawo ekuyiwa kuyo kunye nemveliso yamayeza ekujoliswe kuyo. Kwimeko yaseYurophu, iSatifikethi sokufaneleka se-TSE esisebenzayo sinokuxhasa ukuthotyelwa kweemfuno ze-Ph. Eur. TSE ezifanelekileyo, kodwa asithathi indawo ye-COA okanye sibonise ukuthotyelwa komgangatho othile.

Iindlela Zokulawula kunye Namaxwebhu

Isiqinisekiso se-gelatin yamayeza kufuneka sixhaswe ngamaxwebhu avumela umthengi ukuba ahlole umgangatho wezinto ezisetyenzisiweyo, imvelaphi yesilwanyana, ulawulo lokuvelisa, ukulandeleka, kunye nolawulo lotshintsho. Iphakheji efunekayo ixhomekeke kwimarike yendawo ekuyiwa kuyo, uhlobo lwedosi, indlela yokunikezelwa kwayo, kunye nenkqubo yomthengi yokufaneleka komthengisi. Akukho satifikethi sithile esithatha indawo yovavanyo olupheleleyo, olusekelwe kumngcipheko.

Ukufanisa iBanga neSicelo

I-gelatin yamayeza kufuneka ikhethwe ngokwendlela esebenza ngayo kunye nenkqubo ecwangcisiweyo. Kwiigobolondo ze-capsule eziqinileyo, amandla e-gel, i-viscosity, indlela yokubeka, ukucaca, umbala, umgangatho we-microbiological, kunye nokusebenza kumgca we-capsule konke oku kunokuba yinto efanelekileyo. Ukusebenza kwe-Softgel kukwaxhomekeke kwifomyula epheleleyo ye-shell-kubandakanya i-gelatin, i-plasticizer, kunye namanzi-kunye nokuhambelana nokuzaliswa, ukugqunywa, ukutywinwa, kunye neemeko zokomisa.

Yabelana ngefomu yedosi, umsebenzi ocetywayo, inkqubo yokuvelisa, iimfuno zomthombo wezilwanyana, imakethi yendawo ekuyiwa kuyo, kunye neenkcukacha zezinto ekujoliswe kuzo nomthengisi. Umthengisi angacebisa inqanaba elifunekayo, kodwa umthengi kufuneka alifanelekele kwinkqubo yokwenziwa kunye nemveliso ekucetywayo.

Imibuzo ebuzwa qho

Umbuzo: Ngaba i-gelatin ekumgangatho wokutya ingasetyenziswa kwiimveliso zamayeza?

A: Ayifanele imveliso yamayeza. Ukusetyenziswa kwamayeza kufuna ukwenziwa kwe-GMP kunye novavanyo lokukhululwa kwamayeza olungabonelelwayo kudidi lokutya.

Q: Zeziphi ubungqina be-BSE/TSE endifanele ndibucele?

A: Isibhengezo selizwe elivela kulo, ingxelo yomngcipheko we-TSE/BSE, kunye nobungqina bokuba izilwanyana ezivela kulo zilungele ukutyiwa ngabantu kwiindawo ezinobungozi obuncinci.

Umbuzo: Ngaba i-gelatin iyayichaphazela na isantya sokunyibilika?

A: Ewe. Amandla ejeli kunye nokuqina kwayo kuchaphazela ngokuthe ngqo ukunyibilika kwekhaphu kunye nokukhululwa kwe-API, ngoko ke ukhetho lomgangatho kufuneka lube lolwesicelo esithile.

Q: Ndingaqinisekisa njani ukuba amayeza ayathotyelwa?

A: Kufuneka i-CoA ibhekisele kwi-monograph efanelekileyo (USP/EP/JP/ChP) kwaye, apho kufuneka khona, uvavanyo lomntu wesithathu ngokuchasene nayo.

Izinto ezibalulekileyo ekufuneka ziqwalaselwe

• I-gelatin yamayeza kufuneka yenziwe nge-GMP kwaye ikhutshwe ngokuchasene ne-monograph ye-pharmacopeial — umgangatho wokutya awulingani.
• Amaxwebhu e-BSE/TSE kunye nolawulo lwe-endotoxin/iintsholongwane zezona mfuno ziphambili zokhuseleko, hayi ezongezelelekileyo.
• Ukukhethwa kwamanqaku kufanele kulandele indlela yakho yokulawula kunye nokuchithwa kwempahla, kungekhona uluhlu lwempahla lwababoneleli.
• Umthengisi weyeza lokwenyani ubonelela ngefayile epheleleyo yokulawula kunye nokubonelela ngokuqhubekayo okunciphisa umngcipheko wepayipi yakho.

U-Eric Ma

Umlawuli jikelele

Esebenzisa amava angamashumi amabini eminyaka kwicandelo lokuvelisa i-gelatin kunye ne-collagen, u-Eric uqondise imisebenzi ecwangcisiweyo ehlala inika ukukhula okuqinileyo kweshishini kunye nokwanda kwemarike yehlabathi.