Mesoporous Silicon Dioxide 1. Product Overview (Product Overview) 1.1 Basic definitions Zhongqi Mesoporous Silica, umkhiqizo wokwelapha osebenza njengomkhiqizo wokwelapha owenziwe ngenqubo ye-sol-gel, ubonakala njengomphezulu omhlophe ongenamumo. Izici zawo ezichazayo zifaka phakathi isakhiwo se-mesoporous esijwayelekile esinezakhiwo ezihlanganisa usayizi wezimbobo 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 engashintshiwe kumakhemikhali asebenzayo. Njengoba kunjalo, usebenza njengomkhiqizo ophakathi kokwakha izinhlelo zokulethwa kwemithi ezinembile. 1.2 Core values Njengomkhiqizo ophakeme wokwelapha, Zhongqi Mesoporous Silica uphumelela ekuxazululeni izinselelo zezimboni ezifana nokungafaneleki kahle nokuphila kwemithi okuphansi ezakhiweni ezijwayelekile. Ngokulawula kahle isakhiwo sezimbobo nezici zendawo, ivumela ukulayisha imithi kahle nokukhululwa okuhlakaniphile, kuthuthukisa kakhulu ukufinyelela kwe-biological ngenkathi kunciphisa imiphumela emibi emibi. Umkhiqizo uhambisana nezindinganiso ezinzima zomhlaba wonke zokwelapha, unikeza ukwesekwa kwemikhiqizo eyinhloko ekuthuthukiseni izakhiwo ezintsha kanye nokuthuthukiswa kwemithi yejenereyikhi ephezulu. 2. Product Characteristics (Product Characteristics) 2.1 Structural and performance advantages •Isakhiwo se-mesoporous esiqondile: usayizi wezimbobo ungashintshwa ngokuqhubekayo ukusuka ku-5 kuya ku-30nm, ukusabalala kosayizi wezimbobo 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 ama-molecule emithi. •Ukulawulwa kokukhululwa okuhlakaniphile: Ngokusebenzisa ukuguqulwa kwesikhumba kwe-pH okuthintekayo, okuthintekayo kwe-enzyme nezinye izakhiwo "eziphendulayo", ukukhululwa okukhethekile kwemithi ezindaweni ezithile kungafezeka, futhi izinga lokukhululwa lingalawulwa ngokuqondile nge-±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 kwezakhi zofuzo okuqinisekiswe ngovivinyo lwe-cytotoxicity, okuhambisana nezindinganiso zokuphepha kwezinto eziphilayo. •Ukuguqulwa okuphezulu: ubuso bungaxhunywa ngokuqinile nezinsiza ezifana ne-folic acid, PEG kanye ne-peptide ukuze kuqinisekiswe ukulethwa okuhlosiwe, futhi ukusebenza kokuhlanganiswa okuhlosiwe kuphakathi kwezikhathi ezi-5-8 eziphezulu 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 ihlale ilandela izindinganiso ze-GMP ngohlelo lokuhlola usayizi wezimbobo oluhlanganisiwe, kuqinisekisa ukulawulwa kwekhwalithi okuqinile ngokuhlola ngokuqhubekayo ukuze kugcinwe izinga elizinzile nelilawulwayo phakathi nesikhathi sokukhiqiza. 2.3 Main role 1.Umsizi wokugeleza: thuthukisa ukugeleza kwe-API powder, ukuze umehluko wesisindo sokugcwalisa samathablet ulawulwe ngaphakathi kwe-±3%, futhi ukusebenza kokucindezela amathablet kwandiswe ngama-20%; 2.Ukuvimbela ukungabikhona: ivimbela impahla ekubambeni emgibeni, yehlisa umphumela wokuphuka nokubamba, ikakhulukazi efanelekile ekulungiseleleni izithako ze-chinese herbal extract ezinamafutha; 3.Umhlali: thola umswakama omncane emathablet, delay ukwehla kwezakhi zofuzo ezisebenzayo, futhi wandise isikhathi sokuphila kwemithi kuze kube yizinyanga eziyi-12-24; 4.Umthwali wokukhululwa: Ngokulawula isakhiwo sezimbobo ukuze kulungiswe izinga lokukhululwa kwemithi, ukufaka u-0.2% ekwakhiweni kwamathablet akhululwayo kungafinyelela ukukhululwa kwemithi isikhathi 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 (njenge-doxorubicin) ingakhululwa ngokunembile ngokuphendula kwe-pH/temperature ukuze kuncishiswe ukulimala kumaseli ajwayelekile; imithi engasindi (njenge-paclitaxel) ingafakwa ukuze kuthuthukiswe ukuxubana nokufinyelela kwe-biological. 2. I-genetic/vaccine vector: ivikela i-siRNA ne-plasmid DNA ekwehliseni, ithuthukise ukutholwa kwangaphakathi ngokuguqulwa ukuze kuqinisekiswe ukulethwa okuhlosiwe; adsorb vaccine antigen futhi wandise isikhathi sokugcina ukuze uqinise impendulo ye-immune. 3. Ukuhlola nokwelapha okuhlanganisiwe: Layisha ama-dyes akhanyayo kanye ne-MRI/CT contrast agents ukuze kwakhiwe ipulatifomu yokuhlola nokwelapha yokuhlola ngesikhathi sokulethwa kwemithi nezinguquko ze-lesion. 4. Ukulwa namagciwane nokulungisa izicubu: layisha ama-ion e-silver kanye nama-antibiotics ukuze uvimbele amagciwane isikhathi eside (ngokwelashwa kwezilonda); isakhiwo se-porous simemela i-extracellular matrix, sixhasa ukukhula nokuhlukaniswa kwe-stem cells, futhi siza ekulungiseni amathambo/nemisipha. 5. Standards and regulations (Standards & Regulations) •Uhambisana 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. •Uhambisana nezikhombisi-ndlela zokuhambisana zomhlaba: ulandela izincazelo zokukhiqiza ze-GMP 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 esolwandle, futhi indlela yokuphuma kwesixazululo isetshenziswa kumithi esolwandle. 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 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 esingu-2 iminyaka, uvule ukuze usebenzise phakathi kwezinyanga eziyi-1. 7. Product Advantages (PA) •Izinga eliphezulu lokwenza ngokwezifiso: usayizi wezimbobo kanye nendawo ethile ingalawulwa kahle ngokuya ngosayizi wama-molecule e-API, inikeza izixazululo ezikhethekile zokuthwala. •Ukuhlanganiswa kwemisebenzi eminingi: inezisebenzi eziningi zokulayisha imithi, ukulethwa okuhlosiwe 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 kwesevisi yobuchwepheshe: hlinzeka ngentuthuko yephrojekthi yokulayisha imithi, ukuhlolwa kokukhululwa emzimbeni nezinye izinsizakalo ezingeziwe, ngokwesekwa kweqembu lobuchwepheshe lochwepheshe phakathi nenqubo yonke. 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 •Izinkampani eziphakeme zobuchwepheshe ezweni •Izinkampani ezikhethekile, ezithuthukile nezintsha eGuangzhou •Amalungelo angu-68 avela kwiHhovisi leMali Yezwe