Mesoporous Silicon Dioxide 1. Product Overview (Product Overview) 1.1 Basic definitions Zhongqi Mesoporous Silica, umkhiqizo ophumelelayo wezokwelapha owenziwe ngenqubo ye-sol-gel, ubonakala njengomphetho omhlophe ongenamumo. Izici zawo ezichazayo zifaka phakathi isakhiwo esijwayelekile se-mesoporous channel enezikhala ezivela ku-2 kuya ku-50nm kanye nendawo ethile enkulu kakhulu. Lo mkhiqizo ubonisa amandla aphezulu okulayisha imithi, izinga lokukhululwa elilawulwayo, kanye nokuhlangana okuhle kwe-biocompatibility, ngenkathi uhlala engaphenduli ezakhiweni zokwelapha ezisebenzayo. Njengoba kunjalo, usebenza njengempahla eyinhloko yokwakha izinhlelo zokulethwa kwemithi ezinembile. 1.2 Core values Njengomkhiqizo ophakeme wezokwelapha, Zhongqi Mesoporous Silica uphumelela ekuxazululeni izinselelo zezimboni ezifana nokungafaneleki kahle nokuphila kwemithi okuphansi ezakhiweni ezijwayelekile. Ngokulawula kahle isakhiwo se-pore nezici zendawo, ivumela ukulayisha imithi kahle nokukhululwa okuhlakaniphile, kuthuthukisa kakhulu ukutholakala kwe-biological ngenkathi kunciphisa imiphumela emibi. Umkhiqizo uhambisana nezindinganiso eziqinile zomhlaba wonke zokwelapha, uhlinzeka ngensiza eyinhloko yokwakha izinhlelo ezintsha zokwakha nokuthuthukiswa kwemithi ye-generic ephezulu. 2. Product Characteristics (Product Characteristics) 2.1 Structural and performance advantages •Isakhiwo se-mesoporous esiqondile: usayizi we-pore ungashintshwa ngokuqhubekayo usuka ku-5 kuya ku-30nm, ukusabalala kosayizi be-pore 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 ama-molecule emithi. •Ukulawulwa kokukhululwa okuhlakaniphile: Ngokusebenzisa ukuguqulwa kwesurface kwezakhiwo ezithintekayo ze-pH, ezithintekayo ze-enzyme nezinye "izivalo eziphendulayo", ukhululwa okukhethekile kwemithi ezindaweni ezithile kungafezwa, futhi izinga lokukhululwa lingalawulwa ngokuqondile nge-±5% in vitro. •Ukuhlangabezana okuhle kwe-biocompatibility: I-SiO₂ purity ingaphezu kuka-99.0%, okuqukethwe kwe-heavy metal kungaphansi kuka-10ppm, okuqukethwe kwe-arsenic kungaphansi kuka-3ppm, futhi akukho ukulimala okubonakalayo kwamaseli okuqinisekiswa ngovivinyo lwe-cytotoxicity, okuhlangabezana nezindinganiso zokuphepha zezinto eziphilayo. •Ukuguqulwa okuphezulu: ubuso bungaxhunywa ngokuvumelanayo 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 Process assurance Inqubo yokwakha esekelwe kumasampula we-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 be-pore ezihlanganisiwe, iqinisekisa ukulawulwa kwekhwalithi okuqinile ngokuhlolwa kweqoqo ngalinye ukuze kugcinwe izinga elizinzile nelilawulwayo phakathi nesikhathi sokukhiqiza. 2.3 Main role 1.Umsebenzi wokugeleza: thuthukisa ukugeleza kwe-API powder, ukuze umehluko wesisindo sokugcwalisa samathayili ulawulwe ngaphakathi kwe-±3%, futhi ukusebenza kokucindezela amathayili kukhuphuke ngo-20%; 2.Ukuvimbela ukujola: ivimbela impahla ekubambeni ku-punch, yehlise umphumela wokuphuka nokubamba, ikakhulukazi efanelekile ekwenzeni izithako ze-herbal ezinezinga eliphezulu; 3.Umsebenzisi: thola umswakama omncane kumathayili, delay ukwehla kwezinto ezisebenzayo, futhi wandise isikhathi sokuphila kwemithi sibe yizinyanga eziyi-12-24; 4.Umthwali wokukhululwa: Ngokulawula isakhiwo se-pore ukuze kulungiswe izinga lokukhululwa kwemithi, ukufaka u-0.2% ekwakhiweni kwamathayili okukhululwa okuqhubekayo kungafinyelela ukukhululwa kwemithi okwesikhathi eside. 3. Key technical parameters (KTP) Parameter items Scope of indicators testing standard I-SiO₂ content (ngemuva kokushiswa) ≥99.0% USP-NF <281> I-BET specific surface area (m²/g) 300-1000 BET multi-point adsorption method I-Porosity (cm³g) 0.8-2.0 BJH law Usayizi ophakathi (nm) 5-30 BJH law Ukulahleka kwesikhumba esomile (105℃,2h) ≤6.0% gravimetric analysis Okuqukethwe kwe-heavy metal (ppm) ≤10 Atomic absorption spectrophotometry 4. Application fields (Application Fields) 1. Umthwali wemithi: Imithi ye-chemotherapy enezinga eliphezulu (njenge-doxorubicin) ingakhululwa ngokunembile nge-pH/ukuphendula kokushisa ukuze kuncishiswe ukulimala kumaseli ajwayelekile; imithi engasolwandle (njenge-paclitaxel) ingafakwa ukuze kuthuthukiswe ukuxubana nokutholakala. 2. I-genetic/vaccine vector: ivikela i-siRNA ne-plasmid DNA ekwehliseni, ithuthukise ukutholwa kwamaseli ngokuguqulwa ukuze kuqinisekiswe ukulethwa okuhlosiwe; adsorb vaccine antigen futhi wandise isikhathi sokugcina ukuze uqinise impendulo yokuvikela. 3. Ukuhlola nokwelapha okuhlanganisiwe: Layisha ama-dyes akhanyayo kanye nezithako zokuhlola i-MRI/CT ukuze kwakhiwe ipulatifomu yokuhlola nokwelapha yokubheka ngesikhathi esifanayo ukulethwa kwemithi nezinguquko ezibuhlungu. 4. Ukuvimbela amagciwane nokulungisa izicubu: layisha ama-ion e-silver kanye nezidakamizwa zokuvimbela amagciwane isikhathi eside (ngokwelashwa kwezilonda); isakhiwo se-pore simela i-extracellular matrix, sixhasa ukukhula nokuhlukaniswa kwamangqamuzana, futhi siza ekulungiseni amathambo/nemisipha. 5. Standards and regulations (Standards & Regulations) •Uhambisana 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 sokwengeza ukudla. •Uhambisana nezikhombisi-ndlela zokuhambisana zomhlaba: ulandela izindinganiso zokukhiqiza ze-GMP kanye nezidingo ze-HACCP zokuphepha kokudla. 6. Key points for handling and storage •Umsebenzi wokulayisha imithi: kunconywa ukuthi kwenziwe ekamelweni lokushisa (20-25℃) kanye nomswakama <50%. Indlela yokufaka yokugxila isetshenziswa kumithi esolwandle, futhi indlela yokuphuma kwesixazululo isetshenziswa kumithi esolwandle. Isikhathi sokulayisha kufanele sibe okungenani amahora amabili. •I-Note yokuguqulwa kwesurface: amaqembu asebenzayo afana nama-amino nama-carboxyl kufanele aguqulwe pH phakathi kuka-5 no-8 ukuze kugwenywe ukulimala okuqinile 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 esiyiminyaka emibili, uvule ukuze usebenzise phakathi kwezinyanga eziyi-1. 7. Product Advantages (PA) •Izinga eliphezulu lokwenza ngokwezifiso: usayizi we-pore kanye nendawo ethile ingalawulwa kahle ngokuya ngosayizi wamamolekyuli e-API, ihlinzeka ngesisombululo sokuthwala esikhethekile. •Ukuhlanganiswa kwemisebenzi eminingi: inezisebenzi eziningi zokulayisha imithi, ukulethwa okuhlosiwe kanye nokukhululwa okuhlakaniphile, okwenza kube lula ukuklama izakhi. •Ukuqinisekiswa kokuhambisana komhlaba: zonke izinkomba zihlangabezana nezidingo zepharmacopoeia zomhlaba, zisekela ukufakwa kwemithi emisha yasekhaya naphesheya, zisheshisa inqubo yokumaketha umkhiqizo. •Ukuthuthukiswa kwezinsizakalo zobuchwepheshe: hlinzeka ngentuthuko yephrojekthi yokulayisha imithi, ukuhlolwa kokukhululwa in vitro nezinye izinsizakalo ezingeziwe, ngokwesekwa kweqembu lobuchwepheshe elichwepheshile phakathi nenqubo yonke. 8. Enterprise system certification and honors •FSSC22000 •ISO22000：2018 •ISO9001：2015 •SHC HALAL •OU KOSHER •FDA attestation •FAMI-QS •SEDEX •Imvume yokukhiqiza yokwengeza ukudla •Imvume yokukhiqiza yokwengeza ukudla •I-National high-tech enterprise •Izinkampani ezikhethekile, ezithuthukisiwe nezintsha eGuangzhou •Amalungelo angama-35 avela kwi-Office of State Intellectual Property