Mesoporous Silicon Dioxide 1. Ukubuka Kwenkambo (Product Overview) 1.1 Incazelo eziyisisekelo Zhongqi Mesoporous Silica, umkhiqizo wokwelapha osebenzayo okhiqizwa ngenqubo ye-sol-gel, ubonakala njengothuli oluphaphathekile olumpunga. Izici zawo ezichazayo zifaka phakathi kwesakhiwo esijwayelekile se-mesoporous channel esinezinhlaka ezivela ku-2 kuya ku-50nm kanye nendawo enkulu ethile yokuphila. Lo msebenzi ubonisa amandla aphezulu okulayisha imithi, izinga lokukhululwa okulawulwayo, kanye nokuhambisana okuhle kwe-biocompatibility, ngenkathi uqhubeka ungenakuphazamiseka ezakhiweni zokwelapha ezisebenzayo. Njengoba kunjalo, usebenza njengemathiriyeli eyinhloko yokwakha izinhlelo zokulethwa kwemithi ezinembile. 1.2 Izinzuzo eziyisisekelo Njengomkhiqizo ophakeme wokwelapha, Zhongqi Mesoporous Silica ixazulula kahle izinselelo zezimboni ezifana nokungafaneleki kahle nokuphila kwemithi okuphansi ezakhiweni ezijwayelekile. Ngokulawula kahle isakhiwo sezinhlaka kanye nezici ze-surface, ivumela ukulayisha imithi kahle kanye nokukhululwa okuhlakaniphile, kuthuthukisa kakhulu ukufinyelela kwe-bio ngenkathi kunciphisa imiphumela emibi. Umkhiqizo uhambisana nezindinganiso ezinzima zomhlaba wonke zokwelapha, uhlinzeka ngesisekelo semathiriyeli eyinhloko sokuthuthukiswa kwezinhlelo ezintsha zokwakha kanye nokuthuthukiswa kwemithi ye-generic ephezulu. 2. Izici Zomkhiqizo (Product Characteristics) 2.1 Izinzuzo zesakhiwo nezokusebenza •Isakhiwo se-mesoporous esiqondile: usayizi wezinhlaka ungashintshwa ngokuqhubekayo ukusuka ku-5 kuya ku-30nm, ukusabalala kosayizi bezinhlaka kuyi-uniform (ukuphambuka ≤2nm), indawo ethile ye-BET ingafinyelela ku-300-1000m²/g, futhi ivolumu ye-mesoporous ingafinyelela ku-2.0cm³/g, ihlinzeka ngendawo eyanele yokulayisha imithi. •Ukulawula ukukhululwa okuhlakaniphile: Ngokusebenzisa ukuguqulwa kwesurface kwe-pH sensitive, enzyme sensitive nezinye "izakhiwo ze-valve eziphendulayo", ukukhululwa okukhethekile kwemithi ezindaweni ezihlosiwe kungafezwa, futhi izinga lokukhululwa lingalawulwa ngokunembile ku-±5% ngaphakathi. •Ukuhambisana okuhle kwe-biocompatibility: I-SiO₂ purity ingaphezu kuka-99.0%, okuqukethwe kwe-heavy metal kuphansi kuka-10ppm, okuqukethwe kwe-arsenic kuphansi kuka-3ppm, futhi akukho ukulimala okubonakalayo kwamaseli okuqinisekiswa ngovivinyo lwe-cytotoxicity, okuhambisana nezindinganiso zokuphepha kwezinto eziphilayo. •Ukuguqulwa okuphezulu: i-surface ingaxhunywa ngokuvumelanayo nezinsiza ezifana ne-folic acid, PEG kanye ne-peptide ukuze kuqinisekiswe ukulethwa okuhlosiwe, futhi ukusebenza kokuhlanganiswa okuhlosiwe kuphakathi kuka-5-8 izikhathi kuphansi kunokwakhiwa okujwayelekile. 2.2 Ukuqinisekiswa kwenqubo Inqubo yokwakha esekelwe kumathuluzi e-cationic surfactant ifinyelela izakhiwo ze-mesoporous ezihambisanayo kakhulu ngokulawula kahle izinga lokushisa lokuphendula, i-pH, kanye nokugxila kwetemplate. Inqubo yokukhiqiza ihambisana ngokuqinile nezindinganiso ze-GMP enohlelo lokubheka usayizi bezinhlaka oluhlanganisiwe, iqinisekisa ukulawulwa kwekhwalithi okuqinile ngokuhlola ngokuqhubekayo ukuze kugcinwe izinga elizinzile nelilawulwayo phakathi kokuqedwa kokukhiqiza. 2.3 Indima eyinhloko 1.Usizo lokugeleza: kuthuthukisa ukugeleza kwe-API powder, ukuze umehluko wesisindo sokugcwalisa samathayili ulawulwe phakathi kuka-±3%, futhi ukusebenza kokucindezela amathayili kwandiswe ngo-20%; 2.I-Anti-adhesive: ivimbela impahla ekubambeni kumphini, yehlisa ukuvela kokuphuka nokubamba, ikakhulukazi efanelekile ekulungiseleleni izithako ze-chinese herbal ezinamafutha; 3.I-Stabilizer: ibamba umswakama omncane kumathayili, ibambezelela ukwehla kwezinto ezisebenzayo, futhi ikhulise isikhathi sokuphila kwemithi sibe yizinyanga eziyi-12-24; 4.I-Release carrier: Ngokulawula isakhiwo sezinhlaka ukuze kulungiswe izinga lokukhululwa kwemithi, ukufaka u-0.2% ekwakhiweni kwamathayili akhululwayo kungafinyelela ukukhululwa kwemithi okwesikhathi eside. 3. Ipharamitha ebalulekile yezobuchwepheshe (KTP) Ipharamitha izinto Uhlaka lwezinkomba 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 kwe-heavy metal (ppm) ≤10 Ukuhlaziywa kokumunca kwe-atomic 4. Izinkambu zokusebenza (Application Fields) 1. Umthwali wemithi: Imithi ye-chemotherapy enezinga eliphezulu (njenge-doxorubicin) ingakhululwa ngokunembile ngokuphendula kwe-pH/temperature ukuze kuncishiswe ukulimala kumaseli ajwayelekile; imithi engasakazeki (njenge-paclitaxel) ingafakwa ukuze kuthuthukiswe ukusakazeka nokufinyelela kwe-bio. 2. I-genetic/vaccine vector: ivikela i-siRNA ne-plasmid DNA ekwehliseni, ithuthukise ukutholwa kwamaseli ngokuguqulwa ukuze kuqinisekiswe ukulethwa okuhlosiwe; ibamba i-antigen ye-vaccine futhi ikhulise isikhathi sokugcina ukuze iqinise impendulo ye-immune. 3. Ukuhlola okuhlanganisiwe nokwelashwa: Layisha ama-dyes akhanyayo kanye nezinsiza zokuhlola i-MRI/CT ukuze kwakhiwe ipulatifomu yokuhlola nokwelapha yokubheka ngesikhathi esifanayo ukulethwa kwemithi nezinguquko ezindaweni ezithintekayo. 4. I-Antibacterial kanye nokulungiswa kwezicubu: ifakwe ama-ion e-silver kanye nezidakamizwa zokubulala amagciwane ukuze ivimbele amagciwane isikhathi eside (ngokwelashwa kwezilonda); isakhiwo se-porous simemezela i-extracellular matrix, sisekele ukukhula nokuhlukaniswa kwamangqamuzana, futhi sithuthukise ukulungiswa kwezinsalela/ezokwakha. 5. Izindinganiso nezimfuneko (Standards & Regulations) •Ihambisana nezindinganiso eziningi zepharmacopoeia zomhlaba: USP-NF, European Pharmacopoeia (Ph. Eur.), Japanese Pharmacopoeia (JP), kanye ne-China Pharmacopoeia (ChP 2025). •Thola isitifiketi esihlobene: ukufakwa kwedatha ye-FDA ye-inactive ingredient, isitifiketi se-EU E551 sokudla. •Ihambisana nezikhombisi-ndlela zokuhambisana zomhlaba: ihambisana nezincazelo zokukhiqiza ze-GMP kanye nezimfuneko ze-HACCP zokuphepha kokudla. 6. Iziphakamiso ezibalulekile zokuphatha nokugcina •Umsebenzi wokulayisha imithi: kunconywa ukuthi kwenziwe ezingeni lokushisa lendawo (20-25℃) kanye nomswakama <50%. Indlela yokumunca yokuhlola isetshenziswa kumithi esolubala, futhi indlela yokuphuma kwe-solvent isetshenziswa kumithi esolubala. Isikhathi sokulayisha kufanele sibe okungenani amahora amabili. •Qaphela ukuguqulwa kwesurface: amaqembu asebenzayo afana nama-amino nama-carboxyl kufanele aguqulwe ku-pH phakathi kuka-5 no-8 ukuze kugwenywe ukulimala okuqinile kwe-asidi kanye ne-alkali esakhiweni se-mesoporous. •Izimo zokugcina: Vala ebhodleleni le-reagent elinsundu, ugcine endaweni epholile nepholile (15-25℃, umswakama ophakathi <50%), gwema ukugcina ukukhanya, kusebenze okwesikhathi eside izinyanga eziyi-2, uvule ukuze usebenzise ngaphakathi kwezinyanga eziyi-1. 7. Izinzuzo zomkhiqizo (PA) •Izinga eliphezulu lokwenza ngokwezifiso: usayizi wezinhlaka kanye nendawo ethile ingalawulwa kahle ngokwezinga le-API molecules, ihlinzeka ngesisombululo esikhethekile sokuthwala. •Ukuhlanganiswa kwemisebenzi eminingi: inezisebenzi eziningi zokulayisha imithi, ukulethwa okuhlosiwe nokukhululwa okuhlakaniphile, okwenza kube lula ukuklama izakhi. •Ukuqinisekiswa kokuhambisana komhlaba: zonke izinkomba zihlangabezana nezidingo zepharmacopoeia zomhlaba, zisekela ukufakwa kwemithi emisha yasekhaya nasezizweni, zisheshise inqubo yokumaketha umkhiqizo. •Ukuthuthukiswa kwesevisi yobuchwepheshe: ukuhlinzeka ngentuthuko yephrojekthi yokulayisha imithi, ukuhlolwa kokukhululwa kwe-in vitro nezinye izinsizakalo ezithuthukisiwe, ngokwesekwa kweqembu lobuchwepheshe lochwepheshe kuyo yonke inqubo. 8. Ukuqinisekiswa kwesistimu ye-Enterprise kanye neziqinisekiso •FSSC22000 •ISO22000：2018 •ISO9001：2015 •SHC HALAL •OU KOSHER •I-FDA attestation •FAMI-QS •SEDEX •I-licence yokukhiqiza izithako zokudla •I-licence yokukhiqiza izithako zokudla •I-Enterprise ephezulu ye-tech kazwelonke •Izinkampani ezikhethekile, ezithuthukile nezintsha eGuangzhou •Amalungelo angama-23 avela kwiHhovisi Lezimpahla Zobuchwepheshe Zikazwelonke