Mesoporous Silicon Dioxide 1. Product Overview (Product Overview) 1.1 Basic definitions Zhongqi Mesoporous Silica, umkhiqizo we-pharmaceutical excipient owenziwe nge-sol-gel process, ubonakala njengomphezulu omhlophe ongenamkhawulo. Izici zawo ezichazayo zifaka phakathi isakhiwo se-mesoporous esijwayelekile esinezinhlaka ezivela ku-2 kuya ku-50nm kanye nendawo enkulu ethile yokuphila. Le msebenzi ibonisa amandla aphezulu okulayisha imithi, izinga lokukhululwa elilawulwayo, kanye nokuhambisana okuhle kwe-biocompatibility, ngenkathi ihlala ingekho emthethweni kumakhemikhali asebenzayo. Njengoba kunjalo, isebenza njengemathiriyeli eyinhloko yokwakha izinhlelo zokulethwa kwemithi ezinembile. 1.2 Core values Njengomkhiqizo ophakeme we-pharmaceutical excipient, Zhongqi Mesoporous Silica ixazulula kahle izinselelo zezimboni ezifana nokungafaneleki kahle nokuphila kwemithi okuphansi ezakhiweni ezijwayelekile. Ngokuqondile ukulungiswa kwesakhiwo sezinhlaka kanye nezici zephephandaba, ivumela ukulayisha imithi kahle kanye nokukhululwa okuhlakaniphile, kukhuphula kakhulu ukufinyelela kwe-biological ngenkathi kunciphisa imiphumela emibi. Umkhiqizo uhambisana nezindinganiso eziqinile zezimboni ze-pharmaceutical excipient zomhlaba, uhlinzeka ngensiza eyinhloko yokwakha izakhiwo ezintsha kanye nokuthuthukiswa kwemithi ye-generic 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, ukusabalala kosayizi bezinhlaka kuhlangene (ukuphambuka ≤2nm), indawo ethile ye-BET ingafinyelela ku-300-1000m²/g, kanti ivolumu ye-mesoporous ingafinyelela ku-2.0cm³/g, ihlinzeka ngendawo eyanele yokulayisha imithi. •Ukulawulwa kokukhululwa okuhlakaniphile: Ngokuqondisa ubuso be-pH obuthintekayo, obuthintekayo be-enzyme kanye nezinye "izivalo eziphendulayo", ukhululwa okukhethekile kwemithi ezindaweni ezithile kungafezwa, futhi izinga lokukhululwa lingalawulwa ngokuqondile nge-±5% emithonjeni. •Ukuhambisana okuhle kwe-biocompatibility: I-SiO₂ purity ingaphezu kuka-99.0%, okuqukethwe kwe-heavy metal kungaphansi kuka-10ppm, okuqukethwe kwe-arsenic kungaphansi kuka-3ppm, futhi akukho ukulimala okubonakalayo kwezinhlayiya okuqinisekiswe yizivivinyo ze-cytotoxicity, okuhambisana nezindinganiso zokuphepha kwezinto eziphilayo. •I-highly modifiable: ubuso bungaxhunywa ngokuqondile nezinsiza ezifana ne-folic acid, PEG kanye ne-peptide ukuze kuqinisekiswe ukulethwa okuhlosiwe, futhi ukusebenza kokuhlanganiswa okuhlosiwe kuphakathi kuka-5-8 izikhathi kuphansi kokuhlanganiswa okujwayelekile. 2.2 Process assurance Inqubo yokwakha esekelwe kumasampuli e-cationic surfactant ifinyelela izakhiwo ze-mesoporous ezihambisanayo kakhulu ngokulawula kahle izinga lokushisa, i-pH, kanye nokugxila kwamasampuli. Inqubo yokukhiqiza ihlale ihambisana nezindinganiso ze-GMP ngohlelo lokuhlola usayizi bezinhlaka oluhlanganisiwe, kuqinisekisa ukulawulwa kwekhwalithi okuqinile ngokuhlola ngokuqhubekayo ukuze kugcinwe izinga eliqinile nelilawulwayo phakathi nesikhathi sokukhiqiza. 2.3 Main role 1.Umsizi wokugeleza: thuthukisa ukugeleza kwe-API powder, ukuze umehluko wesisindo sokugcwalisa se-tablets ulawulwe phakathi kuka-±3%, futhi ukusebenza kokucindezela kwe-tablet kukhuphuke ngo-20%; 2.Ukuvimbela: qinisekisa ukuthi impahla ayigxili kwi-punch, yehlise umphumela wokuphuka nokugxila, ikakhulukazi efanele uk preparation ye-Chinese herbal extract enevithikhi ephezulu; 3.Umhlali: thola umswakama omncane kwi-tablet, delay ukwehla kwezingxenye 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 content (ngemuva kokushiswa) ≥99.0% USP-NF <281> I-BET specific surface area (m²/g) 300-1000 I-BET multi-point adsorption method I-Porosity (cm³g) 0.8-2.0 I-BJH law Usayizi wezinhlaka ophakathi (nm) 5-30 I-BJH law Ukulahleka kwesikhumba esomile (105℃,2h) ≤6.0% I-gravimetric analysis Okuqukethwe kwe-heavy metal (ppm) ≤10 I-Atomic absorption spectrophotometry 4. Application fields (Application Fields) 1. Umthwalo wokulethwa kwemithi: Imithi ye-chemotherapy enezinga eliphezulu (njenge-doxorubicin) ingakhululwa kahle nge-pH/ukuphendula kokushisa ukuze kuncishiswe ukulimala kumaseli ajwayelekile; imithi engasolwandle (njenge-paclitaxel) ingagxiliswa ukuze kuthuthukiswe ukuxubana nokufinyelela kwe-biological. 2. I-genetic/vaccine vector: ivikela i-siRNA ne-plasmid DNA ekwehliseni, ithuthukise ukutholwa kwangaphakathi ngokulungiswa ukuze kuqinisekiswe ukulethwa okuhlosiwe; adsorb vaccine antigen futhi wandise isikhathi sokugcina ukuze uqinise impendulo ye-immune. 3. Ukuhlola okuhlanganisiwe nokwelashwa: Layisha ama-fluorescent dyes kanye ne-MRI/CT contrast agents ukuze kwakhiwe ipulatifomu yokuhlola nokwelashwa yokuhlola ngesikhathi sokulethwa kwemithi nezinguquko ze-lesion. 4. Ukuvimbela amagciwane nokulungiswa kwezicubu: layisha ama-silver ions kanye nama-antibiotics ukuze uvimbele amagciwane isikhathi eside (ukulungisa izilonda); isakhiwo se-porous simela i-extracellular matrix, sisekele ukukhula nokuhlukaniswa kwe-stem cells, futhi sithuthukise ukulungiswa kwezinsalela/izikhumba. 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 ubufakazi obufanele bokufaneleka: ukufakwa kwedatha ye-FDA ye-inactive ingredient, i-EU E551 food additive certification. •Uhambisana nezikhombisi-ndlela zokuhambisana zomhlaba: ulandela izincazelo zokukhiqiza ze-GMP kanye nezidingo ze-HACCP food safety system. 6. Key points for handling and storage •Umsebenzi wokulayisha imithi: kunconywa ukuthi kwenziwe ezingeni lokushisa (20-25℃) kanye nomswakama <50%. Indlela yokugxila yokumisa isetshenziswa kumithi esolwandle, futhi indlela yokuphuma kwesixazululo isetshenziswa kumithi esolwandle. Isikhathi sokulayisha kufanele sibe okungenani amahora amabili. •Iphuzu lokulungiswa kobuso: amaqembu asebenzayo afana nama-amino nama-carboxyl kufanele alungiswe ku-pH phakathi kuka-5 no-8 ukuze kugwenywe umonakalo omkhulu we-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 esiyiminyaka emibili, uvule ukuze usebenzise phakathi kwenyanga eyodwa. 7. Product Advantages (PA) •I-high degree of customization: usayizi wezinhlaka kanye nendawo ethile yokuphila kungalawulwa kahle ngokuya ngosayizi we-API molecules, kuhlinzeka ngezixazululo ezikhethekile zokuhlanganiswa. •I-Multidimensional functional integration: inezinhloso eziningi zokulayisha imithi, ukulethwa okuhlosiwe kanye nokukhululwa okuhlakaniphile, okwenza kube lula ukuklama izakhiwo. •I-Global compliance assurance: zonke izinkomba zihlangabezana nezidingo ze-international pharmacopoeia, zisekela izicelo zemithi ezintsha zasekhaya nezangaphandle, zisheshise inqubo yokumaketha umkhiqizo. •I-Technical service improvement: hlinzeka ngentuthuko yephrojekthi yokulayisha imithi, ukuhlolwa kokukhululwa emithonjeni nakwezinye izinsizakalo ezithuthukisayo, ngokwesekwa kweqembu lezakhiwo lezakhiwo. 8. Enterprise system certification and honors •FSSC22000 •ISO22000：2018 •ISO9001：2015 •SHC HALAL •OU KOSHER •FDA attestation •FAMI-QS •SEDEX •I-licence yokukhiqiza yokudla •I-licence yokukhiqiza yokudla •I-National high-tech enterprise •I-Specialized, refined and new enterprises in Guangzhou •I-21 patents from the State Intellectual Property Office