Iicapsules ezingenanto zisebenza njengezincedisi ezibalulekileyo kumayeza kunye neemveliso zempilo, okuthetha ukuba umgangatho wezinto ezikrwada uchaphazela ngokuthe ngqo ukhuseleko kunye nokusebenza kakuhle kwamayeza okugqibela. Ihlazo lePoison Capsule elaziwayo kwixesha elidlulileyo lalibangelwa ngokuchanekileyo kusetyenziso lwezixhobo ezikumgangatho ophantsi, ngakumbi igelatin yamashishini, ekhokelela kumanqanaba aphezulu echromium kunye nokubangela inkxalabo yoluntu ngokubanzi malunga nomgangatho we-capsule eluhlaza. Ke ngoko, ukwakhiwa kwenkqubo ebanzi yolawulo lomgangatho wemathiriyeli ekrwada likhonkco eliphambili ekuqinisekiseni ukhuseleko lwamachiza.
Ulawulo loMthombo: UKhetho olungqongqo kunye noPhicotho lwababoneleli ngeMathiriyeli ekrwada
Inyathelo eliphambili ekuqinisekiseni umgangatho wezinto ezingenanto ze-capsule eluhlaza kukulawula umthombo. Amashishini okuvelisa kufuneka akhethe ababoneleli abaneziqinisekiso ezithembekileyo kunye nodumo oluhle, ngelixa eseka inkqubo yophicotho-zincwadi engqongqo.
Okokuqala nokuphambili, igelatin{0}yebakala loxubo mayeza kufuneka ibe lukhetho lokuqala. I-Gelatin iyona nto iphambili yee-capsules ezingenanto. Amashishini kufuneka akhethe ngokungqongqo i-gelatin yamachiza ehambelana nemigangatho ye-Chinese Pharmacopoeia, kunye nokusetyenziswa kwe-gelatin ye-industrial processed kwi-scraps yesikhumba inqatshelwe ngokungqongqo. I-gelatin yamachiza ngokuqhelekileyo ivela kumathambo okanye izikhumba zezilwanyana eziphilileyo, kwaye inkqubo yokuvelisa kunye nokulawulwa komgangatho ziphezulu kakhulu kunezo ze-gelatin ye-industrial, ngaloo ndlela inciphisa umngcipheko wokungcoliswa kwesinyithi esinzima kumthombo.
Okwesibini, amashishini kufuneka enze-uphicotho lwarhoqo kwindawo yababoneleli bezinto ezikrwada. Ugxininiso kufuneka lube kukuvavanya imithombo yabo yemathiriyeli ekrwada, iinkqubo zemveliso, iinkqubo zolawulo lomgangatho, kunye nobuchule bokuhlola ukuqinisekisa ukuba umthengisi unokubonelela ngokuzinzileyo ngezinto ezihlangabezana neemfuno. Iziqulatho zophicotho-zincwadi kufuneka zibandakanye inkqubo yokulandelela izinto eziluhlaza, ngokukodwa, ukuba umthombo wezilwanyana, imvelaphi, kunye nenani lebhetshi ye-gelatin inokulandelwa ngokucacileyo; ulawulo lwenkqubo yemveliso ukunqanda{3}}ungcoliseko nokungeniswa kwezinto eziyingozi; kunye nezakhono zokuhlola ukuqinisekisa ukuba umniki-nkonzo unokubonelela ngeZatifikethi ezipheleleyo zokuHlalutya (COA).
Uhlolo olungenayo: Ukuseka iMigangatho yoVavanyo loMgangatho ongqongqo
Emva kokuba imathiriyeli ekrwada ingene kumzi-mveliso, kufuneka ihlolwe ngokungqongqo engenayo kwaye inokufakwa kuphela kwimveliso emva kokudlula. Izinto zokuhlola kufuneka zibe zibanzi kwaye zenziwe ngokungqongqo ngokwemigangatho efanelekileyo efana ne-Chinese Pharmacopoeia.
Umxholo wokuhlola ongundoqo uquka iipropati ze-physicochemical, ukuchonga, iintsalela zetsimbi enzima, imida ye-microbial, kunye nezibonakaliso zokhuseleko. malunga neempawu ze-physicochemical, i-viscosity, amandla okukhenkcela, ukulahleka kokumisa, kunye nomxholo womlotha kufuneka uvavanywe ukuze kuqinisekiswe ukuzinza komzimba we-gelatin, echaphazela ngokuthe ngqo ukusebenza kunye nokuchithwa kwee-capsules. Iimvavanyo zokuchonga ziqinisekisa ukuba izinto eziluhlaza yigelatin ngokusebenzisa iikhemikhali, ukuthintela ukukrexeza.
Owona mba ubalulekileyo luvavanyo lwentsalela yentsimbi enzima, ngakumbi kwichromium (Cr), ilothe (Pb), cadmium (Cd), arsenic (As), kunye nemercury (Hg). Ngokutsho kwe-China Pharmacopoeia, umxholo wechromium kwii-capsules akufuneki udlule i-2 mg / kg, kunye nezinye iintsimbi ezinzima kufuneka zihlangabezane neemfuno ezingqongqo zokugada imingcipheko yetyhefu enzima. Ukongeza, uvavanyo lomda we-microbial luyafuneka ukuze kuqinisekiswe ukuba izinto eziluhlaza azingcoliswanga ziibhaktheriya ze-pathogenic. Kubalulekile ukuqaphela ukuba iinkampani ezininzi ezixuba amayeza azinawo {4}ubuchule bendlu bokubona iintsimbi ezinzima. Ngoko ke, ukugunyazisa ii-arhente zovavanyo zeqela lesithathu eziqinisekisiweyo yinto eqhelekileyo nethembekileyo. Amashishini kufuneka asebenzisane neelebhu zeqela lesithathu{8} elithembekileyo ukuqinisekisa ukuchaneka nokulunga kweziphumo zovavanyo.
Ulawulo lweNkqubo: Ukulawula iMveliso kunye noLawulo loGcino
Nokuba umgangatho wemathiriyeli ekrwada ufanelekile, ulawulo olungafanelekanga ngexesha lenkqubo yemveliso lusenokwazisa ungcoliseko okanye lukhokelele ekuthotyweni komgangatho. Ngoko ke,{1}}ulawulo olupheleleyo lwenkqubo lubalulekile.
Imveliso kufuneka iqhutywe kwiindibano zocweyo ezicocekileyo ezihlangabezana neemfuno ze-Good Manufacturing Practice (GMP). Amashishini kufuneka alawule ngokungqongqo ubushushu, ukufuma, kunye nokucoceka komoya ukunciphisa umngcipheko wongcoliseko lwemicrobial kunye{1}}nongcoliseko. Ngexesha elifanayo, iiNkqubo zokuSebenza eziMgangatho (ii-SOP) kufuneka zenziwe kwaye zenziwe ngokungqongqo, iiparameters zenkqubo yokubeka iliso kwi-gelatin enyibilikayo, ukubumba, ukomisa, ukuhlenga, kunye nokupakisha ukuqinisekisa umgangatho ozinzileyo kunye nohambelanayo kwibhetshi nganye.
Ngaphezu koko, ukuseka inkqubo yokulinganisa izinto kunye nemimiselo engqongqo yokucoca kubalulekile. Oku kuthintela ukubhideka kunye -nongcoliseko ngexesha lemveliso, kwaye ukucocwa ngokucokisekileyo kufuneka kwenziwe emva kokuveliswa kwebhetshi nganye. Iimeko zokugcina izinto eziluhlaza kunye nee-capsules ezigqityiweyo kufuneka zilandele ngokungqongqo iimfuno ze-Chinese Pharmacopoeia. Ngokuqhelekileyo, kufuneka zitywinwe kwaye zigcinwe kwi-10℃ukuya kwi-25℃kunye nomswakama ohambelanayo we-35% ukuya kwi-65% ukuthintela imiba efana nokulibaziseka kokutshatyalaliswa okanye ukukhula kwe-microbial okubangelwa ukufuma okanye ukushisa okuphezulu.
Isiqinisekiso seziko: Ukuphucula uLawulo loMgangatho kunye neeNkqubo zokulandelelwa
Ukuqinisekisa umgangatho wemathiriyeli ekrwada akunakwahlulwa kwiziqinisekiso ezivakalayo zeziko kunye{0}}neendlela zokulawula ixesha elide. Amashishini kufuneka aseke inkqubo epheleleyo yolawulo{2}}yenkqubo yolawulo lomgangatho equka yonke into ukusuka ekuthengeni imathiriyeli ekrwada ukuya ekuthuthweni kwemveliso egqityiweyo, icacisa uxanduva lomgangatho wesebe ngalinye nomntu ngamnye ukuqinisekisa ukuba yonke imisebenzi esemgangathweni iphantsi kolawulo.
Ukuphumeza ukurekhodwa kwebhetshi kunye nolawulo lokulandeleka ngundoqo. Iirekhodi zebhetshi ezineenkcukacha kufuneka zisekwe kwibhetshi nganye yezinto ezikrwada kunye neecapsules ezigqityiweyo, ulwazi lokurekhoda olunjengomthombo wabo, inkqubo yokuvelisa, iziphumo zovavanyo, kunye nesikhokelo sokuhamba. Emva kokuba ingxaki ifunyenwe, kunokwenzeka ukuba ufumane ngokukhawuleza unobangela kunye nobubanzi ngokusebenzisa inkqubo yokulandelela kwaye uthathe amanyathelo okulawula umngcipheko onjengokukhumbula ngexesha elifanelekileyo.
Ekugqibeleni, amashishini kufuneka enze uphononongo oluqhubekayo lomgangatho kunye nophuculo. Rhoqo ushwankathele kwaye uhlalutye idatha efana nomgangatho wempahla ekrwada, idatha yenkqubo yokuvelisa, kunye nezikhalazo zabathengi ukwenza uPhononongo loMgangatho weMveliso (PQR), ngokuqhubekayo uchonga iingxaki ezinokubakho, kwaye uqhube ukuphuculwa okuqhubekayo kwenkqubo yolawulo lomgangatho kunye neenkqubo.
Ukuqukumbela
Ukuqinisekisa umgangatho weizixhobo capsule engenanto ekrwadayiprojekthi ecwangcisiweyo efuna iinzame ezidibeneyo ezivela kwiikhonkco ezininzi, kubandakanywa ukhetho lomthengisi, ukuhlolwa okungenayo, ulawulo lwenkqubo, kunye neziqinisekiso zeziko, ukwenza i-loop yokulawula umgangatho opheleleyo kunye oqinileyo. Ukungakhathali kulo naliphi na ikhonkco kunokungcwaba iingozi zokhuseleko. Amashishini kufuneka asoloko ebeka umthetho-siseko woBulunga kuQala phambili, ngokunyanisekileyo azalisekise uxanduva lwawo oluphambili, kwaye azomeleze-ukuziphatha. Ngeli xesha, iziphathamandla zolawulo kufuneka ziqinise ulongamelo kunye nesikhokelo sokugada ngokudibeneyo umgca osezantsi wokhuseleko lwamachiza, ukuvumela abantu ukuba basebenzise amayeza akhuselekileyo nasebenzayo ngokuzithemba. Ukuba kukho nayiphi na imibuzo malunga nee-capsules ezingenanto, Wamkelekile ukuba uqhagamshelane ne-KornnacCaps.
