Mesoporous Silicon Dioxide 1. Ukubuka Kwenkanyezi (Product Overview) 1.1 Incazelo eziyisisekelo Zhongqi Mesoporous Silica, umkhiqizo wokwelapha osebenzayo okhiqizwa ngenqubo ye-sol-gel, ubonakala njengothuli oluphaphathekile olumbala omhlophe. Izici zayo ezichazayo zifaka phakathi isakhiwo esijwayelekile se-mesoporous esinezakhiwo ezivulekile ezilinganiselwa ku-2 kuya ku-50nm kanye nendawo ethile enkulu kakhulu. Lo mkhiqizo ubonisa amandla aphezulu okulayisha imithi, izinga lokukhululwa okulawulwayo, kanye nokuhambisana okuhle kwe-biocompatibility, ngenkathi uhlala engashintshiwe kumakhemikhali asebenzayo. Njengoba kunjalo, usebenza njengemathiriyeli eyinhloko yokwakha izinhlelo zokulethwa kwemithi ezinembile. 1.2 Izinzuzo eziyisisekelo Njengomkhiqizo ophakeme wokwelapha, Zhongqi Mesoporous Silica uphumelela ekuxazululeni izinselelo zezimboni ezifana nokungafinyeleli kahle nokuphila kwemithi okuphansi ezakhiweni ezijwayelekile. Ngokulawula kahle isakhiwo sezakhiwo ezivulekile kanye nezici zendawo, ivumela ukulayisha imithi kahle nokukhululwa okuhlakaniphile, okwandisa kakhulu ukutholakala kwe-biological ngenkathi kwehlisa imiphumela emibi emibi. Umkhiqizo uhambisana nezindinganiso eziqinile zomhlaba wonke zokwelapha, uhlinzeka ngensiza eyinhloko yokwakha izakhiwo ezintsha kanye nokuthuthukiswa kwemithi ye-genetic ephezulu. 2. Izici Zomkhiqizo (Product Characteristics) 2.1 Izinzuzo zesakhiwo nezokusebenza • Isakhiwo se-mesoporous esiqondile: usayizi wezikhala ungashintshwa ngokuqhubekayo ukusuka ku-5 kuya ku-30nm, ukusabalala kosayizi bezikhala kuhlelekile (ukuphambuka ≤2nm), indawo ethile ye-BET ingafinyelela ku-300-1000m²/g, kanti ivolumu ye-mesoporous ingafinyelela ku-2.0cm³/g, ihlinzeka ngendawo eyanele yokulayisha ama-molecule emithi. • Ukulawulwa kokukhululwa okuhlakaniphile: Ngokusebenzisa ukuguqulwa kwesurface kwe-pH sensitive, enzyme sensitive nezinye izakhiwo "eziphendulayo", ukukhululwa okukhethekile kwemithi ezindaweni ezihlosiwe kungafezeka, futhi izinga lokukhululwa lingalawulwa ngokuqondile nge-±5% emithonjeni. • 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 kwezicubu okuqinisekiswe ngovivinyo lwe-cytotoxicity, okuhambisana nezindinganiso zokuphepha zezinto eziphilayo. • Ukuguqulwa okuphezulu: ubuso bungaxhunywa ngokuqondile nezinsiza ezifana ne-folic acid, PEG kanye ne-peptide ukuze kuqinisekiswe ukulethwa okuhlosiwe, futhi ukusebenza kokuhlanganiswa okuhlosiwe kuphakathi kuka-5-8 izikhathi phezulu kunezithuthi ezijwayelekile. 2.2 Ukuqinisekiswa kwezinqubo Inqubo yokwakha esekelwe kumasampula e-cationic surfactant ifinyelela izakhiwo ze-mesoporous ezihambisanayo kakhulu ngokulawula kahle izinga lokushisa lokuphendula, i-pH, kanye nokugxila kwesampula. Inqubo yokukhiqiza ihambisana ngokuqinile nezindinganiso ze-GMP enezinhlelo zokubheka usayizi bezikhala ezihlanganisiwe, iqinisekisa ukulawulwa kwekhwalithi okuqinile ngokuhlola ngokuqhubekayo ukuze kugcinwe izinga elizinzile nelilawulwayo phakathi nesikhathi sokukhiqiza. 2.3 Indima eyinhloko 1. Usizo lokugeleza: kuthuthukisa ukugeleza kwe-API powder, ukuze umehluko wesisindo sokugcwalisa samathayili ulawulwe ngaphakathi kwe-±3%, futhi ukusebenza kokucindezela amathayili kukhuphuke ngo-20%; 2. Ukuvimbela ukujolisa: kuvinjezelwe izinto ezincikayo ekuphakamiseni, kwehlisa umphumela wokuphuka nokujolisa, ikakhulukazi efanelekile ekulungiseleleni izithako ze-herbal ezinamafutha aphezulu; 3. Umgibeli: udinga ukuhlinzeka ngamanzi amancane atholakala kumathayili, delay ukwehla kwezinto ezisebenzayo, futhi wandise isikhathi sokuphila kwemithi ku-12-24 izinyanga; 4. Umthwali wokukhululwa: Ngokulawula isakhiwo sezakhiwo ukuze kulungiswe izinga lokukhululwa kwemithi, ukufaka u-0.2% ekwakhiweni kwamathayili okukhululwa okuqhubekayo kungafinyelela ukukhululwa kwemithi isikhathi eside. 3. Ipharamitha ebalulekile yezobuchwepheshe (KTP) Ipharamitha Izinto Umkhawulo wezinkomba Isivivinyo 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 wesikhala 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. Izinkambu zokusebenza (Application Fields) 1. Umthwali wemithi: Imithi yokwelapha enezinga eliphezulu (njenge-doxorubicin) ingakhululwa ngokunembile nge-pH/ukushisa ukuphendula ukuze kwehliswe ukulimala kumaseli ajwayelekile; imithi engasongi (njenge-paclitaxel) ingafakwa ukuze kuthuthukiswe ukuxubana nokutholakala. 2. I-vector ye-genetic/vaccine: ivikela i-siRNA ne-plasmid DNA ekuphuleni, ithuthukisa ukutholwa kwangaphakathi ngokuguqulwa ukuze kuqinisekiswe ukulethwa okuhlosiwe; ibamba i-antigen ye-vaccine futhi wandise isikhathi sokugcina ukuze umphenduli we-immunity uqine. 3. Ukuhlola nokwelashwa okuhlanganisiwe: Layisha ama-dyes akhanyayo kanye ne-MRI/CT contrast agents ukuze kwakhiwe ipulatifomu yokuhlola nokwelapha yokubheka ngesikhathi sokulethwa kwemithi nezinguquko ezibangelwa. 4. Ukuvimbela amagciwane nokulungiswa kwezicubu: layisha ama-ion e-silver kanye nezidakamizwa zokuvimbela amagciwane ukuze kuvinjezelwe amagciwane isikhathi eside (ngokwelashwa kwezilonda); isakhiwo esivulekile simela i-extracellular matrix, sisekele ukukhula nokuhlukaniswa kwezicubu eziphilayo, futhi siza ekulungiseni amathambo/nemisipha. 5. Izindinganiso nezimfuneko (Standards & Regulations) • I-hambisana nezindinganiso eziningi ze-international pharmacopoeia: 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. • I-hambisana nezikhombisi zomhlaba wonke: ihambisana nezindinganiso zokukhiqiza ze-GMP nezimfuneko ze-HACCP zokuphepha kokudla. 6. Amathiphu abalulekile okuphatha nokugcina • Ukulayisha imithi: kunconywa ukuthi kwenziwe ezingeni lokushisa (20-25℃) kanye ne-humidity <50%. Indlela yokumunca yokuhlola isetshenziswa kumithi esolubile, futhi indlela yokuphuma kwe-solvent isetshenziswa kumithi esolubile. 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 okukhulu 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 isikhathi esiyiminyaka emibili, uvule ukuze usebenzise phakathi kwezinyanga eziyi-1. 7. Izinzuzo zomkhiqizo (PA) • Izinga eliphezulu lokwenza ngokwezifiso: usayizi wezikhala kanye nendawo ethile kungalawulwa kahle ngokuya ngosayizi wama-molecule e-API, kuhlinzeka ngesisombululo esikhethekile sokuthwala. • Ukuhlanganiswa kwemisebenzi eminingi: inezisebenzi eziningi zokulayisha imithi, ukulethwa okuhlosiwe nokukhululwa okuhlakaniphile, okwenza kube lula ukuklama izakhiwo. • Ukuqinisekiswa kokuhambisana komhlaba wonke: zonke izinkomba zihlangabezana nezidingo ze-international pharmacopoeia, zisekela ukusungulwa kwemithi emisha yasekhaya nasezindaweni zangaphandle, zisheshisa inqubo yokumaketha umkhiqizo. • Ukuthuthukiswa kwezinsizakalo zobuchwepheshe: ukuhlinzeka ngentuthuko yenqubo yokulayisha imithi, ukuhlolwa kokukhululwa kwe-in vitro nezinye izinsizakalo ezingeziwe, ngokusekelwa kweqembu lobuchwepheshe elichwepheshile kuyo yonke inqubo. 8. Ukuqinisekiswa kwesistimu yebhizinisi kanye nezindondo • FSSC22000 • ISO22000：2018 • ISO9001：2015 • SHC HALAL • OU KOSHER • Ukuqinisekiswa kwe-FDA • FAMI-QS • SEDEX • Ilayisensi yokukhiqiza izithako zokudla • Ilayisensi yokukhiqiza izithako zokudla • Ibhizinisi eliphakeme lezobuchwepheshe • Izinhlangano ezikhethekile, ezithuthukisiwe nezintsha eGuangzhou • Amalayisense angu-36 avela kwiHhovisi lezeMali laseShayina