Mesoporous Silicon Dioxide 1. Product Overview (Product Overview) 1.1 Basic definitions Zhongqi Mesoporous Silica, umkhiqizo osebenzayo wezokwelapha okwenziwe ngenqubo ye-sol-gel, ubonakala njengomphefumulo omhlophe. Izici zawo ezichazayo zifaka phakathi isakhiwo esijwayelekile se-mesoporous channel enezinhlaka ezivela 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 ungasebenzi ngokwemikhakha ye-pharmaceutical active. Njengoba kunjalo, usebenza njengempahla eyinhloko yokwakha izinhlelo zokulethwa kwemithi ezinembile. 1.2 Core values Njengomkhiqizo ophakeme wezokwelapha, Zhongqi Mesoporous Silica ixazulula kahle izinselelo zezimboni ezifana nokungahambisani kahle nokuphila okuphansi kwemithi ezakhiweni ezijwayelekile. Ngokulawula kahle isakhiwo sezinhlaka kanye nezici zendawo, ivumela ukulayisha imithi kahle nokukhululwa okuhlakaniphile, kuthuthukisa kakhulu ukufinyelela kwe-bio ngenkathi kunciphisa imiphumela emibi emibi. Umkhiqizo uhambisana nezindinganiso ezinzima zomhlaba jikelele zokwelapha, unikeza ukwesekwa kwemikhiqizo eyinhloko ekuthuthukiseni izakhiwo ezintsha kanye nokuthuthukiswa kwemithi ye-generic ephezulu. 2. Product Characteristics (Product Characteristics) 2.1 Structural and performance advantages •Isakhiwo se-mesoporous esiqondile: usayizi wezinhlaka ungashintshwa ngokuqhubekayo ukusuka ku-5 kuya ku-30nm, ukusabalalisa usayizi wezinhlaka kuhlangene (ukuphambuka ≤2nm), indawo ethile ye-BET ingafinyelela ku-300-1000m²/g, futhi ivolumu ye-mesoporous ingafinyelela ku-2.0cm³/g, inikeza isikhala esanele sokulayisha imithi. •Ulawulo lokukhululwa okuhlakaniphile: Ngokusebenzisa ukuguqulwa kwendawo kwezakhiwo ezithintekayo ze-pH, ezithintekayo ze-enzyme nezinye "izivalo eziphendulayo", ukukhululwa okukhethekile kwemithi ezindaweni ezithile kungafezwa, futhi izinga lokukhululwa lingalawulwa ngokuqondile nge-±5% ngaphakathi. •Ukuhambisana okuhle kwe-biocompatibility: I-SiO₂ ubumsulwa bayo buphakeme kakhulu ku-99.0%, okuqukethwe kwemitha emikhulu kuphansi ku-10ppm, okuqukethwe kwe-arsenic kuphansi ku-3ppm, futhi akukho ukulimala okubonakalayo kwamaseli okuqinisekiswa ngovivinyo lwe-cytotoxicity, okuhambisana nezindinganiso zokuphepha kwezinto eziphilayo. •Ukuguqulwa okuphezulu: indawo ingaxhunywa ngokuqinile nezinsiza ezifana ne-folic acid, PEG kanye ne-peptide ukuze kufezwe ukulethwa okuhlosiwe, futhi ukusebenza kokuhlanganiswa okuhlosiwe kuphakathi kuka-5-8 izikhathi phezulu kunezithuthi ezijwayelekile. 2.2 Process assurance Inqubo yokwakha esekelwe kumasampula e-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 zokuhlola usayizi zezinhlaka ezihlanganisiwe, iqinisekisa ukulawula kwekhwalithi okuqinile ngokuhlola ngokuqhubekayo ukuze kugcinwe izinga elizinzile nelilawulwayo phakathi nesikhathi sokukhiqiza. 2.3 Main role 1.Umsizi wokugeleza: uthuthukisa ukugeleza kwe-API powder, ukuze umehluko wesisindo sokugcwalisa samathayili ulawulwe phakathi kuka-±3%, futhi ukusebenza kokucindezela amathayili kukhuphuke ngo-20%; 2.Ukuvimbela ukuhlanganiswa: ivimbela impahla ukuthi ingabambeki kumphakeli, yehlisa umphumela wokuphuka nokubambeka, ikakhulukazi efanelekile ekulungiseleleni izithako ze-chinese herbal ezinamafutha; 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 sezinhlaka ukuze kulungiswe izinga lokukhululwa kwemithi, ukufaka u-0.2% ekwakhiweni kwamathayili akhululwayo kungafinyelela ukukhululwa kwemithi isikhathi 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 ophakathi (nm) 5-30 Umthetho we-BJH Ukulahleka kwesisindo esomile (105℃,2h) ≤6.0% ukuhlaziywa kwe-gravimetric Okuqukethwe kwemitha emikhulu (ppm) ≤10 I-Atomic absorption spectrophotometry 4. Application fields (Application Fields) 1. Umthwali wemithi: Imithi ye-chemotherapy enezikhwama eziphezulu (njenge-doxorubicin) ingakhululwa ngokunembile ngokuphendula kwe-pH/temperature ukuze kuncishiswe ukulimala kumaseli ajwayelekile; imithi engaxhunywanga (njenge-paclitaxel) ingafakwa ukuze kuthuthukiswe ukuxhunywa nokufinyelela kwe-bio. 2. I-vector ye-genetic/vaccine: ivikela i-siRNA ne-plasmid DNA ekwehliseni, ithuthukise ukutholwa kwamaseli ngokuguqulwa ukuze kufezwe ukulethwa okuhlosiwe; ibamba i-antigen ye-vaccine futhi ikhulise isikhathi sokugcina ukuze iqinise impendulo ye-immune. 3. Ukuhlola nokwelapha okuhlanganisiwe: Layisha ama-dyes akhanyayo kanye nezithako ze-MRI/CT ukuze kwakhiwe ipulatifomu yokuhlola nokwelapha yokubheka ngesikhathi sokulethwa kwemithi nezinguquko ezithinta. 4. Ukuvimbela amagciwane nokulungisa izicubu: ifakwe ama-ion e-silver kanye nezidakamizwa zokuvimbela amagciwane isikhathi eside (ngokwelashwa kwezilonda); isakhiwo se-porous simela i-extracellular matrix, sixhasa ukukhula nokuhlukaniswa kwamangqamuzana, futhi siza ekulungiseni amathambo/izikhumba. 5. Standards and regulations (Standards & Regulations) •Ihamba 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. •Hamba nezikhombisi-ndlela zokuhambisana zomhlaba: hamba nezincazelo 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 yokumunca isetshenziswa kumithi esolayo, futhi indlela yokuphuma kwesixazululo isetshenziswa kumithi esolayo. Isikhathi sokulayisha kufanele sibe okungenani amahora amabili. •Iphuzu lokuguqulwa kwendawo: 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 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 wezinhlaka kanye nendawo ethile kungalawulwa kahle ngokuya ngosayizi wemolekyuli ye-API, kunikeza izixazululo ezikhethekile zokuthwala. •Ukuhlanganiswa kwemisebenzi eminingi: inezisebenzi eziningi zokulayisha imithi, ukulethwa okuhlosiwe kanye nokukhululwa okuhlakaniphile, okwenza kube lula ukuklama izakhiwo. •Ukuqinisekiswa kokuhambisana komhlaba: zonke izinkomba zihlangabezana nezidingo zepharmacopoeia zomhlaba, kusekela ukufaka izicelo zemithi ezintsha ezweni nasemhlabeni, kusheshise inqubo yokumaketha umkhiqizo. •Ukuthuthukiswa kwezinsizakalo zobuchwepheshe: hlinzeka ngentuthuko yokulayisha imithi, ukuhlolwa kokukhululwa kwe-in vitro nezinye izinsizakalo ezingeziwe, ngokwesekwa kweqembu lobuchwepheshe obuchwepheshile kuyo yonke inqubo. 8. Enterprise system certification and honors •FSSC22000 •ISO22000：2018 •ISO9001：2015 •SHC HALAL •OU KOSHER •I-FDA attestation •FAMI-QS •SEDEX •Imvume yokukhiqiza izithako zokudla •Imvume yokukhiqiza izithako zokudla •I-National high-tech enterprise •Izinkampani ezikhethekile, ezihlelekile nezintsha eGuangzhou •Amalungelo angama-72 avela kwi-Office of State Intellectual Property