Mesoporous Silicon Dioxide 1. Product Overview (Product Overview) 1.1 Basic definitions Zhongqi Mesoporous Silica, umkhiqizo wokwelapha osebenzayo owenziwe ngenqubo ye-sol-gel, ubonakala njengothuli oluphaphathekile olumbala omhlophe. Izici zawo ezichazayo zifaka phakathi isakhiwo esijwayelekile se-mesoporous channel enezikhala eziphakathi kuka-2 no-50nm kanye nendawo ethile enkulu kakhulu. Lo msebenzi ubonisa amandla aphezulu okulayisha imithi, izinga lokukhululwa okulawulwayo, kanye nokuhambisana okuhle kwe-biocompatibility, ngenkathi uhlala ungashintshiwe kumakhemikhali asebenzayo. Njengoba kunjalo, usebenza njengempahla eyinhloko yokwakha izinhlelo zokulethwa kwemithi ezinembile. 1.2 Core values Njengomkhiqizo ophakeme wokwelapha, Zhongqi Mesoporous Silica uphumelela ekuxazululeni izinselelo zezimboni ezifana nokungafaneleki kahle nokuphila kwemithi okuphansi ezakhiweni ezijwayelekile. Ngokulawula kahle isakhiwo sezikhala nezici zendawo, ivumela ukulayisha imithi kahle nokukhululwa okuhlakaniphile, okwandisa kakhulu ukutholakala kwe-bio ngenkathi kunciphisa imiphumela emibi emibi. Umkhiqizo uhambisana nezindinganiso eziqinile zomhlaba wonke zokwelapha, unikeza ukwesekwa kwematerial eyinhloko ekuthuthukisweni kwezakhiwo ezintsha kanye nokuthuthukiswa kwemithi ye-generic ephezulu. 2. Product Characteristics (Product Characteristics) 2.1 Structural and performance advantages •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, futhi ivolumu ye-mesoporous ingafinyelela ku-2.0cm³/g, inikeza isikhala esanele sokulayisha ama-molecule emithi. •Ukulawulwa kokukhululwa okuhlakaniphile: Ngokusebenzisa ukuguqulwa kwesurface kwezakhiwo ezithintekayo ze-pH, ezithintekayo ze-enzyme nezinye "izivalo eziphendulayo", ukukhululwa okukhethekile kwemithi ezindaweni ezihlosiwe kungafezeka, futhi izinga lokukhululwa lingalawulwa ngokuqondile nge-±5% emzimbeni. •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 kwezinto eziphilayo. •Ukuguqulwa okuphezulu: ubuso bungaxhunywa ngokuqinile nezinsiza ezinjenge-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 kokuphendula, i-pH, kanye nokugxila kwamasampula. Inqubo yokukhiqiza ihlale ihambisana nezindinganiso ze-GMP enezinhlelo zokubheka usayizi wezikhala ezihlanganisiwe, iqinisekisa ukulawulwa kwekhwalithi okuqinile ngokuhlola ngokuqhubekayo ukuze kugcinwe izinga elizinzile nelilawulwayo phakathi nesikhathi sokukhiqiza. 2.3 Main role 1.Umsizi wokugeleza: thuthukisa ukugeleza kwe-API powder, ukuze umehluko wesisindo sokugcwalisa samathayili ulawulwe phakathi kuka-±3%, futhi ukusebenza kokucindezela amathayili kwandiswe ngo-20%; 2.Ukuvimbela: qinisekisa ukuthi impahla ayigxili kwi-punch, yehlise ukuvela kokuphuka nokugxila, ikakhulukazi efanelekile ekulungiseleleni izithako ze-chinese herbal extract ezinamafutha; 3.Umsebenzi wokugcinwa: thola umswakama omncane emathayili, delay ukwehla kwezinto ezisebenzayo, futhi wandise isikhathi sokuphila kwemithi sibe yizinyanga eziyi-12-24; 4.Umthwali wokukhululwa: Ngokulawula isakhiwo sezikhala ukuze kulungiswe izinga lokukhululwa kwemithi, ukufaka u-0.2% ekwakhiweni kwamathayili okukhululwa okuqhubekayo kungafezeka ukukhululwa kwemithi okwesikhathi eside. 3. Key technical parameters (KTP) Parameter items Scope of indicators testing standard I-SiO₂ okuqukethwe (ngemuva kokushiswa) ≥99.0% USP-NF <281> I-BET indawo ethile (m²/g) 300-1000 I-BET indlela yokumunca eminingi I-Porosity (cm³g) 0.8-2.0 Umthetho we-BJH Usayizi wesikhala ophakathi (nm) 5-30 Umthetho we-BJH Umswakama owomile (105℃,2h) ≤6.0% ukuhlaziywa kwe-gravimetric Okuqukethwe kwezimbiwa ezinzima (ppm) ≤10 Ukuhlaziywa kokumunca kwe-atomic 4. Application fields (Application Fields) 1. Umthwali wemithi: Imithi ye-chemotherapy enezithako eziphezulu (njenge-doxorubicin) ingakhululwa kahle ngokuphendula kwe-pH/temperature ukuze kuncishiswe ukulimala kumaseli ajwayelekile; imithi engasakazeki (njenge-paclitaxel) ingafakwa ukuze kuthuthukiswe ukusakazeka nokutholakala. 2. I-vector ye-genetic/vaccine: ivikela i-siRNA ne-plasmid DNA ekwehlisweni, ikhulise ukutholwa kwe-cellular ngokuguqulwa ukuze kuqinisekiswe ukulethwa okuhlosiwe; thola i-antigen ye-vaccine futhi wandise isikhathi sokugcina ukuze uqinise impendulo ye-immune. 3. Ukuhlola nokwelashwa okuhlanganisiwe: Layisha ama-dyes akhanyayo kanye ne-MRI/CT contrast agents ukuze kwakhiwe ipulatifomu yokuhlola nokwelapha yokubheka ngesikhathi esifanayo sokulethwa kwemithi nezinguquko ezithinta. 4. Ukuvimbela amagciwane nokulungiswa kwezicubu: layisha ama-ion e-silver kanye nezidakamizwa zokuvimbela amagciwane ukuze kuvinjwe amagciwane isikhathi eside (ngokwelashwa kwezilonda); isakhiwo esinezakhi simelana ne-extracellular matrix, sixhasa ukukhula nokuhlukaniswa kwe-stem cells, futhi siza ekulungiseni amathambo/ezinhliziyweni. 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 esihambisanayo: ukufakwa kwedatha ye-FDA ye-inactive ingredient, isitifiketi se-EU E551 sokudla. •Uhambisana nezikhombandlela zokuhambisana zomhlaba: uhambisana nezindinganiso 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 yokumunca yokumunca isetshenziswa kumithi esolubala, futhi indlela yokuphuma kwe-solvent isetshenziswa kumithi esolubala. Isikhathi sokulayisha kufanele sibe okungenani amahora amabili. •Iphuzu lokuguqulwa 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 esakhiweni 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 wezikhala kanye nendawo ethile ingalawulwa kahle ngokuya ngosayizi wamamolekyuli e-API, inikeza izixazululo ezikhethekile zokuthwala. •Ukuhlanganiswa kwemisebenzi eminingi: inezisebenzi eziningi zokulayisha imithi, ukulethwa okuhlosiwe nokukhululwa okuhlakaniphile, okwenza kube lula ukuklama izakhiwo. •Ukuqinisekiswa kokuhambisana komhlaba: zonke izinkomba zihlangabezana nezidingo zepharmacopoeia zomhlaba, zisekela ukufaka izicelo zemithi ezintsha ezweni nasemhlabeni, zisheshise inqubo yokumaketha umkhiqizo. •Ukuthuthukiswa kwesevisi yobuchwepheshe: hlinzeka ngentuthuko yenqubo yokulayisha imithi, ukuhlolwa kokukhululwa emzimbeni nezinye izinsizakalo ezithuthukisiwe, ngokwesekwa kweqembu lobuchwepheshe elichwepheshile kuyo yonke inqubo. 8. Enterprise system certification and honors •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 ye-high-tech kazwelonke •Izinkampani ezikhethekile, ezithuthukisiwe nezintsha eGuangzhou •Amalungelo angu-84 avela kwi-Office of State Intellectual Property