Mesoporous Silicon Dioxide 1. Product Overview (Uhlolojikelele Lomkhiqizo) 1.1 Basic definitions Zhongqi Mesoporous Silica, umkhiqizo wokwelapha osebenzayo okwenziwe ngenqubo ye-sol-gel, ubonakala njengomphezulu omhlophe ongenamsebenzi. Izici zawo ezichazayo zifaka phakathi isakhiwo esijwayelekile se-mesoporous channel enezinhlaka 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 ingasebenzi ngokwemikhakha yokwelapha esebenzayo. Njengoba kunjalo, isebenza njengempahla eyinhloko yokwakha izinhlelo zokulethwa kwemithi ezinembile. 1.2 Core values Njengomkhiqizo ophakeme wokwelapha, Zhongqi Mesoporous Silica ixazulula kahle izinselelo zezimboni ezifana nokungafaneleki kahle nokuphila kwemithi okuphansi ezakhiweni ezijwayelekile. Ngokulawula kahle isakhiwo sezinhlaka kanye nezici zendawo, ivumela ukulayisha imithi kahle nokukhululwa okuhlakaniphile, okwandisa kakhulu ukuhlinzeka kwe-biological ngenkathi kunciphisa imiphumela emibi emibi. Umkhiqizo uhambisana nezindinganiso ezinzima zomhlaba wonke zokwelapha, unikeza ukwesekwa kwemali eyinhloko ekuthuthukisweni kokwakhiwa okusha kanye nokuthuthukiswa kwemithi ye-genetic ephezulu. 2. Product Characteristics (Izici Zomkhiqizo) 2.1 Structural and performance advantages •Isakhiwo se-mesoporous esiqondile: usayizi wezinhlaka ungashintshwa ngokuqhubekayo ukusuka ku-5 kuya ku-30nm, ukusabalalisa usayizi wezinhlaka kuhle (ukuphambuka ≤2nm), indawo ethile ye-BET ingafinyelela ku-300-1000m²/g, futhi ivolumu ye-mesoporous ingafinyelela ku-2.0cm³/g, inikeza isikhala esanele sokulayisha izithako zemithi. •Ukulawula ukukhululwa okuhlakaniphile: Ngokusebenzisa ukuguqulwa kwesikhumba se-pH esithintekayo, esithintekayo se-enzyme nezinye "izivalo eziphendulayo", ukukhululwa okukhethekile kwemithi ezindaweni ezihlosiwe kungafezwa, futhi izinga lokukhululwa lingalawulwa ngokunembile ku-±5% emzimbeni. •Ukuhambisana okuhle kwe-biocompatibility: I-SiO₂ ubumsulwa buphakeme kune-99.0%, okuqukethwe kwezimbiwa ezinzima kuphansi kune-10ppm, okuqukethwe kwe-arsenic kuphansi kune-3ppm, futhi akukho ukulimala okubonakalayo kwezinhlayiya okuqinisekisiwe ngokuhlolwa kwe-cytotoxicity, okuhambisana nezindinganiso zokuphepha kwezinto eziphilayo. •Ukuguqulwa okuphezulu: ubuso bungaxhunywa ngokuvumelanayo nezinsiza ezifana ne-folic acid, PEG kanye ne-peptide ukuze kuqinisekiswe ukulethwa okuhlosiwe, futhi ukusebenza kokuhlanganiswa okuhlosiwe kuphakeme ngama-5-8 izikhathi kunezithako ezijwayelekile. 2.2 Process assurance Inqubo yokwakha esekelwe ku-cationic surfactant template ifinyelela izakhiwo ze-mesoporous ezihambisanayo ngokulawula kahle izinga lokushisa, i-pH, kanye nokugxila kwe-template. Inqubo yokukhiqiza ihambisana ngokuqinile nezindinganiso ze-GMP enohlelo lokuhlola usayizi lwezinhlaka oluhlanganisiwe, iqinisekisa ukulawulwa kwekhwalithi okuqinile ngokuhlola ngokuqhubekayo ukuze kugcinwe izinga elizinzile nelilawulwayo phakathi nesikhathi sokukhiqiza. 2.3 Main role 1.Umsizi wokugeleza: uthuthukisa ukugeleza kwe-powder ye-API, ukuze umehluko wesisindo sokugcwalisa se-tablets ulawulwe ngaphakathi ku-±3%, futhi ukusebenza kokucindezela ama-tablet kukhuphuke ngama-20%; 2.Ukuvimbela ukujolisa: ivimbela impahla ekubambeni emgibeni, yehlisa ukuvela kokuphuka nokubamba, ikakhulukazi efanelekile ekulungiseleleni izithako ze-Chinese herbal ezinamafutha; 3.Umsebenzi wokugcina: udonsa umswakama omncane ku-tablet, ubambe ukwehla kwezithako ezisebenzayo, futhi wandise isikhathi sokuphila kwemithi sibe yizinyanga eziyi-12-24; 4.Umthwalo wokukhululwa: Ngokulawula isakhiwo sezinhlaka 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 Umthetho we-BJH Usayizi ophakathi (nm) 5-30 Umthetho we-BJH Ukulahleka kwesisindo esomile (105℃,2h) ≤6.0% ukuhlaziywa kwe-gravimetric Okuqukethwe kwezimbiwa ezinzima (ppm) ≤10 I-Atomic absorption spectrophotometry 4. Application fields (Izindawo Zokusebenza) 1. Umthwalo wokulethwa kwemithi: Imithi ye-chemotherapy enezinga eliphezulu (njenge-doxorubicin) ingakhululwa ngokunembile ngokuphendula kwe-pH/ukushisa ukuze kuncishiswe ukulimala kumaseli ajwayelekile; imithi engaxhumi (njenge-paclitaxel) ingafakwa ukuze kuthuthukiswe ukuxhunywa nokuhlinzeka. 2. I-genetic/vaccine vector: ivikela i-siRNA ne-plasmid DNA ekwehliseni, ithuthukise ukutholwa kwangaphakathi ngokuguqulwa ukuze kuqinisekiswe 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 nezithako ze-MRI/CT ukuze kwakhiwe ipulatifomu yokuhlola nokwelashwa yokuhlola ngesikhathi sokulethwa kwemithi nezinguquko ze-lesion. 4. Ukulwa namagciwane nokulungiswa kwezicubu: ifakwe ama-ion e-silver kanye nezidakamizwa zokulwa namagciwane ukuze ivimbele amagciwane isikhathi eside (ngokwelashwa kwezilonda); isakhiwo se-porous simela i-extracellular matrix, sisekele ukukhula nokuhlukaniswa kwezicubu ezithile, futhi sithuthukise ukulungiswa kwezitho/ezokwakha. 5. Standards and regulations (Izindinganiso & Imigomo) •Ihambisana 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. •Ihambisana nezikhombisi-ndlela zokuhambisana zomhlaba: ihambisana 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 ne-humidity <50%. Indlela yokumunca yokuhlola isetshenziswa kumithi esolubile, futhi indlela yokuphuma kwesixazululo isetshenziswa kumithi esolubile. Isikhathi sokulayisha kufanele sibe okungenani amahora amabili. •Iphuzu lokuguqulwa kwesikhumba: 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 dry (15-25℃, humidity ephansi <50%), gwema ukugcina ukukhanya, kusebenze isikhathi esiyiminyaka emibili, uvule ukuze usebenzise phakathi kwezinyanga eziyi-1. 7. Product Advantages (Izinzuzo Zomkhiqizo) •I-degree ephezulu yokwenza ngezifiso: usayizi wezinhlaka kanye nendawo ethile ingalawulwa ngokunembile ngokuya ngosayizi wezithako ze-API, inikeza izixazululo ezikhethekile zokuthwala. •Ukuhlanganiswa kwemisebenzi eminingi: inezisebenzi eziningi zokulayisha imithi, ukulethwa okuhlosiwe kanye nokukhululwa okuhlakaniphile, okwenza kube lula ukwakhiwa. •Ukuqinisekiswa kokuhambisana komhlaba: zonke izinkomba zihlangabezana nezidingo zepharmacopoeia yomhlaba, zisekela izicelo zemithi ezintsha zasekhaya nezangaphandle, zisheshise inqubo yokumaketha komkhiqizo. •Ukuthuthukiswa kwesevisi yezobuchwepheshe: ukuhlinzeka ngentuthuko yenqubo yokulayisha imithi, ukuhlolwa kokukhululwa emzimbeni kanye nezinye izinsizakalo ezithuthukisiwe, ngokwesekwa kweqembu lezakhiwo zobuchwepheshe ngesikhathi sonke. 8. Enterprise system certification and honors •FSSC22000 •ISO22000：2018 •ISO9001：2015 •SHC HALAL •OU KOSHER •I-FDA attestation •FAMI-QS •SEDEX •Imvume yokukhiqiza yokwengeza ukudla •Imvume yokukhiqiza yokwengeza ukudla •I-High-tech enterprise kazwelonke •Izinkampani ezikhethekile, ezihlukile nezintsha eGuangzhou •Amalungelo angu-69 avela kwi-Office of State Intellectual Property