Mesoporous Silicon Dioxide 1. Product Overview (Product Overview) 1.1 Basic definitions Zhongqi Mesoporous Silica, umkhiqizo osebenzayo wezokwelapha okwenziwe ngenqubo ye-sol-gel, ubonakala njengothuli oluhlaza okwesibhakabhaka. Izici zawo ezichazayo zifaka phakathi isakhiwo esijwayelekile se-mesoporous channel enezikhala ezivela ku-2 kuya ku-50nm kanye nendawo ethile enkulu kakhulu. Le msebenzi ibonisa amandla aphezulu okulayisha imithi, izinga lokukhululwa okulawulwayo, kanye nokuhambisana okuhle kwe-biocompatibility, ngenkathi ihlala ingaphenduli ezakhiweni zokwelapha ezisebenzayo. Njengoba kunjalo, isebenza njengempahla eyinhloko yokwakha izinhlelo zokulethwa kwemithi ezinembile. 1.2 Core values Njengomkhiqizo osezingeni eliphezulu wezokwelapha, Zhongqi Mesoporous Silica ixazulula kahle izinselelo zezimboni ezifana nokungabi nezinhloso ezinhle nokuphila kwemithi okuphansi ezakhiweni ezijwayelekile. Ngokulawula kahle isakhiwo se-pore nezici ze-surface, ivumela ukulayisha imithi kahle nokukhululwa okuhlakaniphile, kuthuthukisa kakhulu ukutholakala kwe-biological ngenkathi kunciphisa imiphumela emibi. Umkhiqizo uhambisana nezindinganiso eziqinile zomhlaba wonke zokwakhiwa kwezokwelapha, uhlinzeka ngensiza eyinhloko yokuthuthukiswa kwezinhlelo ezintsha zokwakha kanye nokuthuthukiswa kwemithi ye-generic ephezulu. 2. Product Characteristics (Product Characteristics) 2.1 Structural and performance advantages • Isakhiwo se-mesoporous esiqondile: usayizi wepore ungashintshwa ngokuqhubekayo ukusuka ku-5 kuya ku-30nm, ukusabalala kosayizi be-pore kuhlelekile (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 kwe-pH sensitive, enzyme sensitive nezinye "izakhiwo ze-valve eziphendulayo", ukukhululwa okukhethekile kwemithi ezindaweni ezihlosiwe kungafezeka, futhi izinga lokukhululwa lingalawulwa ngokuqondile nge-±5% in vitro. • 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 zezinto eziphilayo. • Ukuguqulwa okuphezulu: ubuso bungaxhunywa ngokuqinile nezinsiza ezinjenge-folic acid, PEG kanye ne-peptide ukuze kuqinisekiswe ukulethwa okuhlosiwe, futhi ukusebenza kokuhlanganiswa okuhlosiwe kuphansi kakhulu kunezithuthi ezijwayelekile. 2.2 Process assurance Inqubo yokwakha esekelwe kumasampuli e-cationic surfactant ifinyelela izakhiwo ze-mesoporous ezihambisanayo kakhulu ngokulawula kahle izinga lokushisa, i-pH, kanye nokugxila kwesampuli. Inqubo yokukhiqiza ihambisana ngokuqinile nezindinganiso ze-GMP enezinhlelo zokubheka usayizi be-pore ezihlanganisiwe, iqinisekisa ukulawulwa kwekhwalithi okuqinile ngokuhlola ngokuqhubekayo ukuze kugcinwe izinga elizinzile nelilawulwayo phakathi nesikhathi sokukhiqiza. 2.3 Main role 1. Ukusiza ukuhamba: kuthuthukisa ukuhamba kwe-API powder, ukuze umehluko wesisindo sokugcwalisa samathayili ulawulwe phakathi kwe-±3%, futhi ukusebenza kokucindezela amathayili kwandiswe ngama-20%; 2. Ukuvimbela ukujolisa: kuvimba impahla ukuthi ingabambeki kumphini, kunciphisa ukuvela kokuphuka nokubambeka, ikakhulukazi efanelekile ekwenzeni izithako ze-herbal ezinezinga eliphezulu; 3. Ukuzinza: ibamba umswakama omncane kumathayili, ibambezele ukwehla kwezinto ezisebenzayo, futhi ikhulise 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 isikhathi 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 wepore ophakathi (nm) 5-30 BJH law Ukulahleka kwesisindo 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 kahle ngokuphendula kwe-pH/temperature ukuze kuncishiswe ukulimala kumaseli ajwayelekile; imithi engasindi (njenge-paclitaxel) ingafakwa ukuze kuthuthukiswe ukuxubana nokutholakala. 2. I-genetic/vaccine vector: ivikela i-siRNA ne-plasmid DNA ekwehlisweni, ithuthukise ukutholwa kwangaphakathi ngokuguqulwa ukuze kuqinisekiswe ukulethwa okuhlosiwe; ibamba i-antigen ye-vaccine futhi ikhulise isikhathi sokugcina ukuze umphenduli we-immunity uqine. 3. Ukuhlola nokwelashwa okuhlanganisiwe: Layisha ama-dyes akhanyayo kanye nezithako ze-MRI/CT ukuze kwakhiwe ipulatifomu yokuhlola nokwelapha yokubheka ngesikhathi sokulethwa kwemithi nezinguquko ze-lesion. 4. Ukuvimbela ubhubhane nokulungiswa kwezicubu: ifakwe ama-ion e-silver kanye nezidakamizwa zokuvimbela ubhubhane ukuze kuvinjelwe amagciwane isikhathi eside (ngokwakhiwa kwezilonda); isakhiwo se-pore simisela i-extracellular matrix, sisekele ukukhula nokuhlukaniswa kwamangqamuzana, futhi siza ekulungiseni amathambo/nokwakhiwa kwesikhumba. 5. Standards and regulations (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 sokwengeza kokudla. • I-hambisana nezikhombisi-ndlela zomhlaba wonke: ihambisana nezindinganiso zokukhiqiza ze-GMP nezidingo ze-HACCP zokuphepha kokudla. 6. Key points for handling and storage • Umsebenzi wokulayisha imithi: kunconywa ukuthi kwenziwe ezingeni lokushisa (20-25℃) kanye nomswakama <50%. Indlela yokufaka ibhande 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 okukhulu kwe-asidi nokwakha isakhiwo se-mesoporous. • Izimo zokugcina: Vala ebhodleleni le-reagent elinsundu, ugcine endaweni epholile nepholile (15-25℃, umswakama ophakathi <50%), gwema ukugcina ukukhanya, kusebenze isikhathi esingama-2, uvule ukuze usebenzise phakathi kwezinyanga eziyi-1. 7. Product Advantages (PA) • Izinga eliphezulu lokwenza ngokwezifiso: usayizi wepore kanye nendawo ethile ingalawulwa kahle ngokuya ngosayizi wama-molecule e-API, 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 ze-international pharmacopoeia, zisekela ukufaka izicelo zemithi ezintsha ezweni nasemhlabeni jikelele, zisheshise inqubo yokumaketha umkhiqizo. • Ukuthuthukiswa kwezinsizakalo zobuchwepheshe: hlinzeka ngentuthuko yenqubo yokulayisha imithi, ukuhlolwa kokukhululwa in vitro nezinye izinsizakalo ezingeziwe, ngokwesekwa kweqembu lobuchwepheshe elichwepheshile phakathi kwenqubo yonke. 8. Enterprise system certification and honors • FSSC22000 • ISO22000：2018 • ISO9001：2015 • SHC HALAL • OU KOSHER • Ukuqinisekiswa kwe-FDA • FAMI-QS • SEDEX • Ilayisensi yokukhiqiza yokwengeza kokudla • Ilayisensi yokukhiqiza yokwengeza kokudla • I-national high-tech enterprise • Izinkampani ezikhethekile, ezithuthukile nezintsha eGuangzhou • Amalayisense angama-24 avela kwi-Office of State Intellectual Property