Mesoporous Silicon Dioxide 1. Ukubuka KweMikhiqizo (Product Overview) 1.1 Incazelo eziyisisekelo Zhongqi Mesoporous Silica, umkhiqizo wezokwelapha owenziwe ngenqubo ye-sol-gel, ubonakala njengomphezulu omhlophe ongenamumo. Izici zawo ezichazayo zifaka phakathi kwesakhiwo esijwayelekile se-mesoporous channel esinezinhlaka ezivela ku-2 kuya ku-50nm kanye nendawo ethile enkulu kakhulu. Lo msebenzi ubonisa amandla aphezulu okulayisha imithi, izinga lokukhululwa okulawulwayo, kanye nokuhambisana okuhle kwe-biocompatibility, ngenkathi uhlala ungasebenzi ngokwemikhakha yokwelapha. Njengoba kunjalo, usebenza njengemathiriyeli eyinhloko yokwakha izinhlelo zokulethwa kwemithi ezinembile. 1.2 Izinzuzo eziyisisekelo Njengomkhiqizo wezokwelapha ophakeme, Zhongqi Mesoporous Silica ixazulula kahle izinselelo zezimboni ezifana nokungafaneleki kahle nokuphila kwemithi okuphansi ezinhlelweni ezijwayelekile. Ngokulawula kahle isakhiwo sezinhlaka kanye nezici zendawo, ivumela ukulayisha imithi kahle nokukhululwa okuhlakaniphile, kukhuphula kakhulu ukufinyelela kwe-biological ngenkathi kunciphisa imiphumela emibi. Umkhiqizo uhambisana nezindinganiso eziqinile zomhlaba wonke zokwelapha, unikeza ukwesekwa kwemathiriyeli eyinhloko ekuthuthukiseni izinhlelo ezintsha zokwakha nokuthuthukiswa kwemithi yejenereyiki ephezulu. 2. Izici Zomkhiqizo (Product Characteristics) 2.1 Izinzuzo zokwakheka nokusebenza •Isakhiwo se-mesoporous esiqondile: usayizi wezinhlaka ungashintshwa ngokuqhubekayo ukusuka ku-5 kuya ku-30nm, ukusatshalaliswa kosayizi be-pore kuhlangene (ukuphambuka ≤2nm), indawo ethile ye-BET ingafinyelela ku-300-1000m²/g, kanti ivolumu ye-mesoporous ingafinyelela ku-2.0cm³/g, inikeza isikhala esanele sokulayisha izithako zemithi. •Ulawulo lokukhululwa okuhlakaniphile: Ngokusebenzisa ukuguqulwa kwendawo kwe-pH sensitive, enzyme sensitive nezinye "izakhiwo ze-valve eziphendulayo", ukukhululwa okukhethekile kwemithi ezindaweni ezihlosiwe kungafezwa, futhi izinga lokukhululwa lingalawulwa ngokuqondile nge-±5% in vitro. •Ukuhambisana okuhle kwe-biocompatibility: I-SiO₂ purity ingaphezu kuka-99.0%, okuqukethwe kwezimbiwa ezinzima kungaphansi kuka-10ppm, okuqukethwe kwe-arsenic kungaphansi kuka-3ppm, futhi akukho ukulimala okubonakalayo kwamaseli okuqinisekiswa ngovivinyo lwe-cytotoxicity, okuhambisana nezindinganiso zokuphepha kwezinto eziphilayo. •Ukuguqulwa okuphezulu: indawo ingaxhunywa ngokuvumelanayo nezinsiza ezifana ne-folic acid, PEG kanye ne-peptide ukuze kufezwe ukulethwa okuhlosiwe, futhi ukusebenza kokuhlanganiswa okuhlosiwe kuphakathi kuka-5-8 izikhathi phezulu kunezithako ezijwayelekile. 2.2 Ukuqinisekiswa kwezinqubo Inqubo yokwakha esekelwe kumathuluzi e-cationic surfactant ifinyelela izakhiwo ze-mesoporous ezihambisanayo kakhulu ngokulawula kahle izinga lokushisa kokuphendula, i-pH, kanye nokugxila kwetemplate. Inqubo yokukhiqiza ihlale ihambisana nezindinganiso ze-GMP enohlelo lokubheka usayizi lwezinhlaka oluhlanganisiwe, iqinisekisa ukulawulwa kwekhwalithi okuqinile ngokuhlolwa kweqoqo ngalinye ukuze kugcinwe izinga eliqinile nelilawulwayo phakathi nesikhathi sokukhiqiza. 2.3 Indima enkulu 1.Umsizi wokugeleza: uthuthukisa ukugeleza kwe-API powder, ukuze umehluko wesisindo sokugcwalisa samathayili ulawulwe ngaphakathi kwe-±3%, futhi ukusebenza kokucindezela amathayili kukhuphuke ngo-20%; 2.Ukuvimbela ukuhlanganiswa: ivimbela impahla ekubambeni kumphini, yehlisa umphumela wokuphuka nokubamba, ikakhulukazi ifaneleka kakhulu ekulungiseleleni izithako ze-herbal ezinezinga eliphezulu; 3.Umsebenzi wokugcina: udonsa umswakama omncane kumathayili, delay ukwehla kwezithako ezisebenzayo, futhi wandise isikhathi sokuphila kwemithi sibe yizinyanga eziyi-12-24; 4.Umthwali wokukhululwa: Ngokulawula isakhiwo sezinhlaka ukuze kulungiswe izinga lokukhululwa kwemithi, ukufaka u-0.2% ekwakhiweni kwamathayili okukhululwa okuqhubekayo kungafinyelela ukukhululwa kwemithi okwesikhathi eside. 3. Ipharamitha ezisemqoka zobuchwepheshe (KTP) Iziphakamiso zepharamitha Ububanzi bezinkomba umthetho wokuhlola Okuqukethwe kwe-SiO₂ (ngemuva kokushiswa) ≥99.0% USP-NF <281> I-BET indawo ethile (m²/g) 300-1000 Indlela yokumunca ye-BET I-Porosity (cm³g) 0.8-2.0 Umthetho we-BJH usayizi ophakathi (nm) 5-30 Umthetho we-BJH Ukulahleka kwesisindo esomile (105℃,2h) ≤6.0% ukuhlaziywa kwe-gravimetric Okuqukethwe kwezimbiwa ezinzima (ppm) ≤10 Ukuhlaziywa kokumunca kwe-atomic 4. Izigaba zokusebenza (Application Fields) 1. Umthwali wemithi: Imithi ye-chemotherapy enezinga eliphezulu (njenge-doxorubicin) ingakhululwa ngokunembile nge-pH/ukuphendula kokushisa ukuze kuncishiswe ukulimala kumaseli ajwayelekile; imithi engaxhunywanga (njenge-paclitaxel) ingafakwa ukuze kuthuthukiswe ukuxhunywa nokufinyelela kwe-biological. 2. I-vector ye-genetic/vaccine: ivikela i-siRNA ne-plasmid DNA ekwehlisweni, ikhulisa ukutholwa kwamaseli ngokuguqulwa ukuze kufezwe ukulethwa okuhlosiwe; idonsa i-antigen ye-vaccine futhi wandise isikhathi sokugcina ukuze umphendulo we-immunity uqine. 3. Ukuhlola nokwelashwa okuhlanganisiwe: Layisha ama-dyes akhanyayo kanye nezinsiza zokuhlola ze-MRI/CT ukuze kwakhiwe ipulatifomu yokuhlola nokwelashwa yokubheka ngesikhathi esifanayo ukulethwa kwemithi nezinguquko ezibuhlungu. 4. Ukuvimbela amagciwane nokulungisa izicubu: ifakwe ama-ion e-silver nezidakamizwa zokuvimbela amagciwane isikhathi eside (ngokwelashwa kwezilonda); isakhiwo se-porous simisa i-extracellular matrix, sisekele ukukhula nokuhlukaniswa kwamangqamuzana, futhi sithuthukise ukulungiswa kwezinsimbi/ezokhuni. 5. Izindinganiso nemithetho (Standards & Regulations) •Ihambisana nezindinganiso eziningi zepharmacopoeia zomhlaba: USP-NF, European Pharmacopoeia (Ph. Eur.), Japanese Pharmacopoeia (JP), kanye neChina Pharmacopoeia (ChP 2025). •Thola isitifiketi esihlobene: ukufakwa kwedatha ye-FDA ye-inactive ingredient, isitifiketi se-EU E551 sokudla. •Ihambisana nezikhombisi-ndlela zokuhambisana zomhlaba: ihambisana nezindinganiso zokukhiqiza ze-GMP kanye nezidingo ze-HACCP zokuphepha kokudla. 6. Iziphakamiso ezisemqoka zokuphatha nokugcina •Umsebenzi wokulayisha imithi: kunconywa ukuthi kwenziwe ekamelweni lokushisa (20-25℃) kanye nomswakama <50%. Indlela yokumunca yokuhlola isetshenziswa kumithi esolubala, futhi indlela yokuphuma kwesisombululo isetshenziswa kumithi esolubala. Isikhathi sokulayisha kufanele sibe okungenani amahora amabili. •Qaphela ukuguqulwa kwendawo: amaqembu asebenzayo afana nama-amino nama-carboxyl kufanele aguqulwe ku-pH phakathi kuka-5 no-8 ukuze kugwenywe ukulimala okukhulu kwe-asidi kanye ne-alkali kwesakhiwo se-mesoporous. •Izimo zokugcina: Vala ebhodleleni le-reagent elinsundu, ugcine endaweni epholile futhi eyomile (15-25℃, umswakama ophakathi <50%), gwema ukugcina ukukhanya, kusebenze isikhathi esiyizinyanga ezi-2, uvule ukuze usebenze phakathi nezinyanga eziyi-1. 7. Izinzuzo zomkhiqizo (PA) •Izinga eliphezulu lokwenza ngokwezifiso: usayizi wezinhlaka kanye nendawo ethile kungalawulwa kahle ngokuya ngosayizi wezithako ze-API, kunikeza izixazululo ezikhethekile zokuthwala. •Ukuhlanganiswa kwemisebenzi eminingi: inezisebenzi eziningi zokulayisha imithi, ukulethwa okuhlosiwe nokukhululwa okuhlakaniphile, okwenza kube lula ukuklama izinhlelo. •Ukuqinisekiswa kokuhambisana komhlaba: zonke izinkomba zihlangabezana nezidingo zepharmacopoeia zomhlaba, kusekela ukufaka izicelo zemithi ezintsha ezweni nasemhlabeni, kusheshisa inqubo yokumaketha umkhiqizo. •Ukuthuthukiswa kwesevisi yobuchwepheshe: ukuhlinzeka ngentuthuko yenqubo yokulayisha imithi, ukuhlolwa kokukhululwa kwe-in vitro nezinye izinsizakalo ezingeziwe, ngokwesekwa kweqembu lobuchwepheshe lochwepheshe kuyo yonke inqubo. 8. Ukuqinisekiswa kwesistimu ye-Enterprise kanye nezindondo •FSSC22000 •ISO22000:2018 •ISO9001:2015 •SHC HALAL •OU KOSHER •Ubufakazi be-FDA •FAMI-QS •SEDEX •I-licence yokukhiqiza izithako zokudla •I-licence yokukhiqiza izithako zokudla •I-Enterprise ye-high-tech kazwelonke •Izinkampani ezikhethekile, ezithuthukile nezintsha eGuangzhou •Amalungelo angama-27 avela kwiHhovisi leMali yeZwe