Mesoporous Silicon Dioxide 1. Product Overview (Product Overview) 1.1 Basic definitions Zhongqi Mesoporous Silica, umkhiqizo osebenzayo wezokwelapha okwenziwe ngenqubo ye-sol-gel, ubonakala njengomphezulu omhlophe ongenamumo. Izici zawo ezichazayo zifaka phakathi isakhiwo se-mesoporous esijwayelekile esinezakhiwo ezivulekile 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 ngokwemvelo ezithako ezisebenzayo zokwelapha. Njengoba kunjalo, usebenza njengemathiriyeli eyinhloko yokwakha izinhlelo zokulethwa kwemithi ezinembile. 1.2 Core values Njengomkhiqizo osezingeni eliphezulu wezokwelapha, i-Zhongqi Mesoporous Silica ikhuluma kahle ngezinkinga zezimboni ezifana nokungafaneleki kahle nokuphila okuphansi kwemithi ezakhiweni ezijwayelekile. Ngokulawula kahle isakhiwo sezakhiwo ezivulekile kanye nezici zendawo, ivumela ukulayisha imithi kahle nokukhululwa okuhlakaniphile, kukhuphula kakhulu ukufinyelela kwe-biological ngenkathi kunciphisa imiphumela emibi. Umkhiqizo uhambisana nezindinganiso eziqinile zomhlaba jikelele zokwelapha, unikeza ukwesekwa kwemathiriyeli eyinhloko ekuthuthukisweni kwemikhiqizo emisha 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, ukusatshalaliswa 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 izakhi zemithi. •Ukulawulwa kokukhululwa okuhlakaniphile: Ngokusebenzisa ukuguqulwa kwesikhumba se-pH esithintekayo, esithintekayo se-enzyme nezinye "izivalo eziphendulayo", ukukhululwa okukhethekile kwemithi ezindaweni ezihlosiwe kungafezeka, futhi izinga lokukhululwa lingalawulwa ngokuqondile nge-±5% emithonjeni. •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 kwezicubu okuqinisekiswe ukuhlolwa kwe-cytotoxicity, okuhambisana nezindinganiso zokuphepha kwezinto eziphilayo. •Ukuguqulwa okuphezulu: ubuso bungaxhunywa ngokuvumelanayo nezinsiza ezifana ne-folic acid, i-PEG kanye ne-peptide ukuze kuqinisekiswe ukulethwa okuhlosiwe, futhi ukusebenza kokuhlanganiswa okuhlosiwe kuphakathi kwe-5-8 izikhathi phezulu kunezithuthi ezijwayelekile. 2.2 Process assurance Inqubo yokwakha esekelwe kumasampuli we-cationic surfactant ifinyelela izakhiwo ze-mesoporous ezihambisanayo ngokulawula kahle izinga lokushisa lokuphendula, i-pH, kanye nokugxila kwesampuli. Inqubo yokukhiqiza ihlale ilandela izindinganiso ze-GMP ngohlelo lokuhlola usayizi lwezikhala oluhlanganisiwe, iqinisekisa ukulawulwa kwekhwalithi okuqinile ngokuhlolwa kweqoqo ngalinye 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 samathabhu ulawulwe ngaphakathi kwe-±3%, futhi ukusebenza kokucindezela amathabhu kukhuphuke ngama-20%; 2.Ukuvimbela: ivimbela impahla ekubambeni kumphini, yehlisa umphumela wokuphuka nokubamba, ikakhulukazi ifanele uk preparation ye-Chinese herbal extract enevithikhi ephezulu; 3.Ukuzinzisa: ibamba umswakama omncane kumathabhu, ibambezelekile ukwehla kwezithako ezisebenzayo, futhi ikhulise isikhathi sokuphila kwemithi sibe yizinyanga eziyi-12-24; 4.Ukuthwala ukukhululwa: Ngokulawula isakhiwo sezikhala ukuze kulungiswe izinga lokukhululwa kwemithi, ukufaka u-0.2% kumkhiqizo we-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. Drug delivery carrier: Imithi ye-chemotherapy enezinga eliphezulu (njenge-doxorubicin) ingakhululwa ngokunembile nge-pH/ukushisa ukuphendula ukuze kuncishiswe ukulimala kumaseli ajwayelekile; imithi engasondleki (njenge-paclitaxel) ingafakwa ukuze kuthuthukiswe ukuxubana nokufinyelela kwe-biological. 2. Genetic/vaccine vector: ivikela i-siRNA ne-plasmid DNA ekwehlisweni, ithuthukisa ukutholwa kwangaphakathi ngokuguqulwa ukuze kuqinisekiswe ukulethwa okuhlosiwe; ibamba i-antigen ye-vaccine futhi ikhulise isikhathi sokugcina ukuze iqinise impendulo yokuvikela. 3. Integrated diagnosis and treatment: Layisha ama-dyes akhanyayo kanye nezinsiza zokuhlola ze-MRI/CT ukuze kwakhiwe ipulatifomu yokuhlola nokwelashwa yokuhlola ngesikhathi sokulethwa kwemithi nezinguquko ezithinta. 4. Antibacterial and tissue repair: ifakwe ama-ion e-silver kanye nezidakamizwa zokubulala amagciwane ukuze ivimbele amagciwane isikhathi eside (ngokwelashwa kwezilonda); isakhiwo esivulekile simisela i-extracellular matrix, sikhuthaza ukukhula nokuhlukaniswa kwezicubu ezisemqoka, futhi siza ekululameni kwemathambo/nemisipha. 5. Standards and regulations (Standards & Regulations) •Ihambisana nezindinganiso eziningi zepharmacopoeia zomhlaba: USP-NF, European Pharmacopoeia (Ph. Eur.), Japanese Pharmacopoeia (JP), kanye ne-China Pharmacopoeia (ChP 2025). •Thola ubufakazi obuhambisanayo: ukufakwa kwedatha ye-FDA ye-inactive ingredient, i-EU E551 yokwengeza 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 nomswakama <50%. Indlela yokufaka ibhande isetshenziswa kumithi esolubala, futhi indlela yokupholisa isetshenziswa kumithi esolubala. Isikhathi sokulayisha kufanele sibe okungenani amahora amabili. •Iziqondiso zokuguqulwa kwesikhumba: 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 ukugcina ukukhanya, kusebenze isikhathi esiyiminyaka emibili, kuvuleka ukuze kusebenze ngaphakathi kwenyanga eyodwa. 7. Product Advantages (PA) •Izinga eliphezulu lokwenza ngokwezifiso: usayizi wezikhala kanye nendawo ethile ingalawulwa kahle ngokuya ngosayizi wezinto ze-API, inikeza izixazululo ezikhethekile zokuthwala. •Ukuhlanganiswa kwemisebenzi eminingi: inezinhloso eziningi zokulayisha imithi, ukulethwa okuhlosiwe kanye nokukhululwa okuhlakaniphile, okwenza kube lula ukwakhiwa kwemikhiqizo. •Ukuqinisekiswa kokuhambisana komhlaba: zonke izinkomba zihlangabezana nezidingo zepharmacopoeia zomhlaba, zisekela ukufakwa kwemithi emisha yasekhaya nakwamanye amazwe, zisheshisa inqubo yokumaketha komkhiqizo. •Ukuthuthukiswa kwezinsizakalo zobuchwepheshe: ukuhlinzeka ngentuthuko yenqubo yokulayisha imithi, ukuhlolwa kokukhululwa kwe-in vitro nezinye izinsizakalo ezithuthukisiwe, ngokwesekwa kweqembu lobuchwepheshe obuchwepheshile kuyo yonke inqubo. 8. Enterprise system certification and honors •FSSC22000 •ISO22000：2018 •ISO9001：2015 •SHC HALAL •OU KOSHER •FDA attestation •FAMI-QS •SEDEX •I-licence yokukhiqiza yokwengeza ukudla •I-licence yokukhiqiza yokwengeza ukudla •I-Enterprise ye-high-tech kazwelonke •Izinkampani ezikhethekile, ezithuthukisiwe nezintsha eGuangzhou •Amalungelo angu-41 avela kwi-Office of State Intellectual Property