Mesoporous Silicon Dioxide 1. Product Overview (Product Overview) 1.1 Basic definitions Zhongqi Mesoporous Silica, umkhiqizo osebenzayo wezokwelapha owenziwe ngenqubo ye-sol-gel, ubonakala njengompheki omhlophe ongenamumo. Izici zawo ezichazayo zifaka phakathi kwesakhiwo 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 elilawulwayo, kanye nokuhambisana okuhle kwe-biocompatibility, ngenkathi uhlala engashintshiwe kumakhemikhali asebenzayo wezokwelapha. Njengoba kunjalo, usebenza njengempahla eyinhloko yokwakha izinhlelo zokulethwa kwemithi ezinembile. 1.2 Core values Njengomkhiqizo wezokwelapha ophakeme, Zhongqi Mesoporous Silica uphendula kahle izinselelo zezimboni ezifana nokungabi nezinhloso ezinhle kanye nesikhathi esifushane sokuphila kwemithi ezakhiweni ezijwayelekile. Ngokulawula kahle isakhiwo sezinhlaka kanye nezici zendawo, ivumela ukulayisha imithi kahle nokukhululwa okuhlakaniphile, kuthuthukisa kakhulu ukutholakala kwe-bio ngenkathi kunciphisa imiphumela emibi emibi. Umkhiqizo uhambisana nezindinganiso eziqinile zomhlaba wonke zokwakhiwa kwezokwelapha, uhlinzeka ngensiza eyinhloko yokwakha izinhlelo ezintsha zokwakha kanye nokuthuthukiswa kwemithi yejenereyikhi 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, ukusatshalaliswa kosayizi bezinhlaka kuyi-uniform (ukwephuka ≤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. •Ukwelashwa kokukhululwa okuhlakaniphile: Ngokusebenzisa ukuguqulwa kwendawo kwezakhiwo ezithintekayo ze-pH, ezithintekayo ze-enzyme nezinye "izivalo eziphendulayo", ukukhululwa okuthile kwemithi ezindaweni ezihlosiwe kungafezeka, futhi izinga lokukhululwa lingalawulwa ngokuqondile nge-±5% emithonjeni. •Ukuhambisana okuhle kwe-biocompatibility: ubumsulwa be-SiO₂ bungaphezu kuka-99.0%, okuqukethwe kwezimbiwa ezinzima kungaphansi kuka-10ppm, okuqukethwe kwe-arsenic kungaphansi kuka-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, i-PEG kanye ne-peptide ukuze kuqinisekiswe ukuhanjiswa okuhlosiwe, futhi ukusebenza kokuhlanganiswa okuhlosiwe kuphakathi kuka-5-8 izikhathi phezulu kunezithuthi ezijwayelekile. 2.2 Process assurance Inqubo yokwakha esekelwe kumathuluzi e-cationic surfactant ifinyelela izakhiwo ze-mesoporous ezihambisanayo kakhulu ngokulawula kahle izinga lokushisa kokuphendula, i-pH, kanye nokugxila kwetemplate. Inqubo yokukhiqiza ihambisana ngokuqinile nezindinganiso ze-GMP enohlelo lokuhlola usayizi bezinhlaka oluhlanganisiwe, kuqinisekisa 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 ama-tablets ulawulwe ngaphakathi kwe-±3%, futhi ukusebenza kokucindezela ama-tablet kwandiswe ngo-20%; 2.Ukuvimbela ukuhlanganiswa: uvimbela impahla ekubambeni kumphakeli, unciphisa umphumela wokuphuka nokubamba, ikakhulukazi efanele uk preparation ye-Chinese herbal extract eneviscosity ephezulu; 3.Ukuzinzisa: udonsa umswakama omncane kumathebhu, ubambezele ukwehla kwezinto ezisebenzayo, futhi wandise isikhathi sokuphila kwemithi sibe yizinyanga eziyi-12-24; 4.Umthwali wokukhululwa: Ngokulawula isakhiwo sezinhlaka ukuze kulungiswe izinga lokukhululwa kwemithi, ukufaka u-0.2% ekwakhiweni kwe-tablet yokukhululwa okuqhubekayo kungafinyelela ukukhululwa kwemithi okwesikhathi eside. 3. Key technical parameters (KTP) Parameter items Scope of indicators testing standard SiO₂ content (after burning) ≥99.0% USP-NF <281> BET specific surface area (m²/g) 300-1000 BET multi-point adsorption method Porosity (cm³g) 0.8-2.0 BJH law mean pore size （nm） 5-30 BJH law Dry weight loss (105℃,2h) ≤6.0% gravimetric analysis Heavy metal content (ppm) ≤10 Atomic absorption spectrophotometry 4. Application fields (Application Fields) 1. Umthwali wemithi: Imithi ye-chemotherapy enezinga eliphezulu (efana ne-doxorubicin) ingakhululwa ngokunembile ngokuphendula kwe-pH/temperature ukuze kuncishiswe ukulimala kumaseli ajwayelekile; imithi engaxhunywanga (efana ne-paclitaxel) ingafakwa ukuze kuthuthukiswe ukuxhunywa nokutholakala. 2. I-genetic/vaccine vector: ivikela i-siRNA ne-plasmid DNA ekwehlisweni, ithuthukise ukutholwa kwangaphakathi ngokuguqulwa ukuze kuqinisekiswe ukuhanjiswa okuhlosiwe; idonsa i-antigen ye-vaccine futhi ibambe isikhathi sokugcina ukuze iqinise impendulo ye-immune. 3. Ukuhlola nokwelashwa okuhlanganisiwe: Layisha ama-dyes akhanyayo kanye nezithako ze-MRI/CT ukuze kwakhiwe ipulatifomu yokuhlola nokwelashwa yokubheka ngesikhathi esifanayo ukuhanjiswa kwemithi nezinguquko ze-lesion. 4. Ukuvimbela amagciwane nokulungisa izicubu: ifakwe ama-ion e-silver kanye nezidakamizwa zokuvimbela amagciwane ukuze ivimbele amagciwane isikhathi eside (ngokwe-wound dressing); isakhiwo se-porous simula i-extracellular matrix, sisekele ukukhula nokuhlukaniswa kwamangqamuzana, futhi siza ekulungiseni amathambo/nemisipha. 5. Standards and regulations (Standards & Regulations) •Ihamba nezindinganiso eziningi ze-international pharmacopoeia: USP-NF, European Pharmacopoeia (Ph. Eur.), Japanese Pharmacopoeia (JP), kanye ne-China Pharmacopoeia (ChP 2025). •Thola isitifiketi esihlobene: ukufakwa kwedatabase ye-FDA ye-inactive ingredient, isitifiketi se-EU E551 sokwengeza ukudla. •Hamba nezikhombisi-ndlela zokuhambisana zomhlaba wonke: hamba nezincazelo zokukhiqiza ze-GMP kanye nezidingo ze-HACCP zokuphepha kokudla. 6. Key points for handling and storage •Umsebenzi wokulayisha imithi: kunconywa ukuba kwenziwe ekamelweni lokushisa (20-25℃) kanye nomswakama <50%. Indlela yokudonsa yokuhlola isetshenziselwa imithi esolubala, futhi indlela yokuphuma kwesixazululo isetshenziselwa imithi esolubala. Isikhathi sokulayisha kufanele sibe okungenani amahora amabili. •Qaphela ukuguqulwa 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 kwesakhiwo se-mesoporous. •Izimo zokugcina: Vala ebhodleleni le-reagent elinsundu, ugcine endaweni epholile futhi eyomile (15-25℃, umswakama ophakathi <50%), gwema ukukhanya, kusebenze isikhathi esiyiminyaka emibili, uvule ukuze usebenzise phakathi kwezinyanga eziyi-1. 7. Product Advantages (PA) •Izinga eliphezulu lokwenza ngezifiso: usayizi wezinhlaka kanye nendawo ethile ingalawulwa kahle ngokuya ngosayizi wamamolekyuli e-API, ihlinzeka ngesisombululo esikhethekile sokuthwala. •Ukuhlanganiswa kwemisebenzi eminingi: inezisebenzi eziningi zokulayisha imithi, ukuhanjiswa okuhlosiwe kanye nokukhululwa okuhlakaniphile, okwenza kube lula ukuklama. •Ukuqinisekiswa kokuhambisana komhlaba wonke: zonke izinkomba zihlangabezana nezidingo ze-international pharmacopoeia, zisekela ukufaka izicelo zemithi ezintsha ezweni nasemhlabeni, zisheshise inqubo yokumaketha umkhiqizo. •Ukuthuthukiswa kwezinsizakalo zobuchwepheshe: hlinzeka ngentuthuko yephrojekthi yokulayisha imithi, ukuhlolwa kokukhululwa kwe-in vitro nezinye izinsizakalo ezithuthukisiwe, 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 yokwengeza ukudla •Imvume yokukhiqiza yokwengeza ukudla •I-High-tech enterprise kazwelonke •Izinkampani ezikhethekile, ezithuthukisiwe nezintsha eGuangzhou •Amalungelo angama-34 avela kwi-Office of State Intellectual Property