Mesoporous Silicon Dioxide 1. Product Overview (Product Overview) 1.1 Basic definitions Zhongqi Mesoporous Silica, umkhiqizo ophumelelayo wezokwelapha owenziwe ngenkqubo ye-sol-gel, ubonakala njengothuli oluphaphathekile olumbala omhlophe. 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 okulawulwayo, kanye nokuhambisana okuhle ne-biocompatibility, ngenkathi uhlala ungasebenzi ngokwemichiza ezithako zokwelapha ezisebenzayo. Njengoba kunjalo, usebenza njengemathiriyeli eyinhloko yokwakha izinhlelo zokulethwa kwemithi ezinemininingwane. 1.2 Core values Njengomkhiqizo ophakeme wezokwelapha, Zhongqi Mesoporous Silica uphumelela ekuxazululeni izinselelo zezimboni ezifana nokungafinyeleli kahle nokuphuma kwemithi okuphansi ezakhiweni ezijwayelekile. Ngokulawula kahle isakhiwo se-pore nezici ze-surface, ivumela ukulayisha imithi kahle nokukhululwa okuhlakaniphile, kukhuphula kakhulu ukufinyelela kwe-bio ngenkathi kunciphisa imiphumela emibi emibi. Umkhiqizo uhambisana nezindinganiso eziqinile zomhlaba wonke zokwakhiwa kwezokwelapha, unikeza ukwesekwa kwemathiriyeli 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 we-pore ungashintshwa ngokuqhubekayo ukusuka ku-5 kuya ku-30nm, ukusatshalaliswa kosayizi lwe-pore kuhlangene (ukwephuka ≤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. •Ulawulo lokukhululwa 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% emithini. •Ukuhambisana okuhle ne-biocompatibility: I-SiO₂ ubumsulwa buphakeme kuno-99.0%, okuqukethwe kwezimbiwa ezinzima kuphansi kuka-10ppm, okuqukethwe kwe-arsenic kuphansi kuka-3ppm, futhi akukho ukulimala okubonakalayo kwezicubu okuqinisekiswe ngokuhlolwa kwe-cytotoxicity, okuhambisana nezindinganiso zokuphepha kwezinto eziphilayo. •Ukuguqulwa okuphezulu: i-surface ingaxhunywa ngokuqinile nezixhumi ezinjenge-folic acid, PEG kanye ne-peptide ukuze kufezwe ukulethwa okuhlosiwe, futhi ukusebenza kokuhlanganiswa okuhlosiwe kuphakeme ngama-5-8 izikhathi kunezithuthi ezijwayelekile. 2.2 Process assurance Inqubo yokwakha esekelwe kumathuluzi e-cationic surfactant ifinyelela izakhiwo ze-mesoporous ezihambisanayo kakhulu ngokulawula kahle izinga lokushisa lokuphendula, i-pH, kanye nokugxila kwetemplate. Inqubo yokukhiqiza ihambisana ngokuqinile nezindinganiso ze-GMP enohlelo lokuhlola usayizi lwe-pore oluhlanganisiwe, iqinisekisa ukulawulwa kwekhwalithi okuqinile ngokuhlolwa kweqoqo ngalinye ukuze kugcinwe izimo ezinzile nezilawulwayo phakathi nesikhathi sokukhiqiza. 2.3 Main role 1.Umsizi wokugeleza: uthuthukisa ukugeleza kwe-API powder, ukuze umehluko wesisindo sokugcwalisa ama-tablet ulawulwe ngaphakathi kwe-±3%, futhi ukusebenza kokucindezela ama-tablet kukhuphuke ngama-20%; 2.Ukuvimbela ukujolisa: uvimbela impahla ekubambeni kumphini, unciphise umphumela wokuphuka nokubamba, ikakhulukazi efanelekile ekulungiseleleni izithako ze-herbal ezinezinga eliphezulu; 3.Ukuvuselela: udonsa umswakama omncane kumathebhu, delay ukwehla kwezithako ezisebenzayo, futhi wandise isikhathi sokusebenza kwemithi sibe yizinyanga eziyi-12-24; 4.Umthwali wokukhululwa: Ngokulawula isakhiwo se-pore ukuze kulungiswe izinga lokukhululwa kwemithi, ukufaka u-0.2% ekwakhiweni kwe-tablet yokukhululwa okuqhubekayo kungafeza 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 I-BJH umthetho Usayizi ophakathi we-pore （nm） 5-30 I-BJH umthetho Ukulahleka kwesikhumba esomile (105℃,2h) ≤6.0% ukuhlaziywa kwe-gravimetric Okuqukethwe kwezimbiwa ezinzima (ppm) ≤10 I-Atomic absorption spectrophotometry 4. Application fields (Application Fields) 1. Umthwali wemithi: Imithi yokwelapha enezinga eliphezulu (njenge-doxorubicin) ingakhululwa ngokunembile ngokuphendula kwe-pH/temperature ukuze kuncishiswe ukulimala kumaseli ajwayelekile; imithi engasolwandle (njenge-paclitaxel) ingagqokiswa ukuze kuthuthukiswe ukuxubana nokufinyelela kwe-bio. 2. I-genetic/vaccine vector: ivikela i-siRNA ne-plasmid DNA ekwehlisweni, ithuthukise ukutholwa kwangaphakathi ngokuguqulwa ukuze kufezwe ukulethwa okuhlosiwe; idonsa i-antigen ye-vaccine futhi wandise isikhathi sokugcina ukuze uqinise impendulo ye-immune. 3. Ukuhlola okuhlanganisiwe nokwelashwa: Layisha ama-dyes akhanyayo kanye nezinsiza zokuhlola ze-MRI/CT ukuze kwakhiwe ipulatifomu yokuhlola nokwelashwa yokubheka ngesikhathi sokulethwa kwemithi nezinguquko ze-lesion. 4. Ukuvimbela amagciwane nokulungiswa kwezicubu: layisha ama-ion e-silver nezidakamizwa zokuvimbela amagciwane ukuze kuvinjwe amagciwane isikhathi eside (ngokwelashwa kwezilonda); isakhiwo se-pore simisa i-extracellular matrix, sixhase ukukhula nokuhlukaniswa kwe-stem cells, futhi siza ekulungiseni amathambo/nemisipha. 5. Standards and regulations (Standards & Regulations) •Uhambisana nezindinganiso eziningi ze-international pharmacopoeia: USP-NF, European Pharmacopoeia (Ph. Eur.), Japanese Pharmacopoeia (JP), kanye ne-China Pharmacopoeia (ChP 2025). •Thola isitifiketi esihlobene nezimfuneko: ukufakwa kwedatha ye-FDA ye-inactive ingredient, isitifiketi se-EU E551 sokudla. •Uhambisana nezikhombisi-ndlela zomhlaba wonke: uhambisana 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 yokumunca yokuhlola isetshenziswa kumithi esolwandle, futhi indlela yokuphuma kwesixazululo isetshenziswa kumithi esolwandle. Isikhathi sokulayisha kufanele sibe okungenani amahora amabili. •Iphuzu lokuguqulwa kwesurface: amaqembu asebenzayo afana nama-amino nama-carboxyl kufanele aguqulwe ku-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 esingu-2 iminyaka, uvule ukuze usebenzise phakathi kwezinyanga eziyi-1. 7. Product Advantages (PA) •Izinga eliphezulu lokwenza ngokwezifiso: usayizi we-pore kanye nendawo ethile kungalawulwa kahle ngokuya ngosayizi wamamolekyuli e-API, kunikeza izixazululo ezikhethekile zokuthwala. •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 ukufaka izicelo zemithi ezintsha ezweni nasemhlabeni, zisheshisa inqubo yokumaketha umkhiqizo. •Ukuthuthukiswa kwezinsizakalo zobuchwepheshe: hlinzeka ngentuthuko yephrojekthi yokulayisha imithi, ukuhlolwa kokukhululwa kwe-in vitro nezinye izinsizakalo ezingeziwe, ngokwesekwa kweqembu lobuchwepheshe lochwepheshe kuyo yonke inqubo. 8. Enterprise system certification and honors •FSSC22000 •ISO22000：2018 •ISO9001：2015 •SHC HALAL •OU KOSHER •FDA attestation •FAMI-QS •SEDEX •Imvume yokukhiqiza yokudla •Imvume yokukhiqiza yokudla •I-national high-tech enterprise •Izinkampani ezikhethekile, ezithuthukile nezintsha eGuangzhou •53 patents from the State Intellectual Property Office