Mesoporous Silicon Dioxide 1. Product Overview (Product Overview) 1.1 Basic definitions Zhongqi Mesoporous Silica, umkhiqizo osebenzayo wezokwelapha owenziwe ngenqubo ye-sol-gel, ubonakala njengothuli oluphaphathekile olumbala omhlophe. Izici zawo ezichazayo zifaka phakathi isakhiwo esijwayelekile se-mesoporous channel enobukhulu bezikhala obuphakathi kuka-2 no-50nm kanye nendawo ethile enkulu kakhulu. Lo msebenzi ubonisa amandla aphezulu okulayisha imithi, izinga lokukhululwa okulawulwayo, kanye nokuhambisana okuhle kwe-biocompatibility, ngenkathi uhlala ungasebenzi ngokwemikhakha ye-pharmaceutical. Njengoba kunjalo, usebenza njengemathiriyeli eyinhloko yokwakha izinhlelo zokulethwa kwemithi ezinembile. 1.2 Core values Njengomkhiqizo osezingeni eliphezulu wezokwelapha, Zhongqi Mesoporous Silica ixazulula kahle izinselelo zemboni ezifana nokungafaneleki kahle nokuphila okuncane kwemithi ezakhiweni ezijwayelekile. Ngokulawula kahle isakhiwo sezikhala nezici zendawo, ivumela ukulayisha imithi kahle nokukhululwa okuhlakaniphile, kuthuthukisa kakhulu ukutholakala kwe-biological ngenkathi kunciphisa imiphumela emibi emibi. Umkhiqizo uhambisana nezindinganiso eziqinile zomhlaba jikelele zokwakhiwa kwezokwelapha, unikeza ukwesekwa kwemathiriyeli eyinhloko ekuthuthukiseni izakhiwo ezintsha kanye nokuthuthukiswa kwemithi ye-generics ephezulu. 2. Product Characteristics (Product Characteristics) 2.1 Structural and performance advantages •Isakhiwo se-mesoporous esiqondile: ubukhulu bezikhala bungashintshwa njalo ukusuka ku-5 kuya ku-30nm, ukusabalala kobukhulu 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 ama-molecule wemithi. •Ulawulo lokukhululwa okuhlakaniphile: Ngokusebenzisa ukuguqulwa kwesurface kwezakhiwo ezithintekayo ze-pH, ezithintekayo ze-enzyme nezinye "izivalo eziphendulayo", ukukhululwa okukhethekile kwemithi ezindaweni ezithile kungafezwa, futhi izinga lokukhululwa lingalawulwa ngokunembile ku-±5% emithonjeni. •Ukuhambisana okuhle kwe-biocompatibility: I-SiO₂ purity ingaphezu kuka-99.0%, okuqukethwe kwe-heavy metal kuphansi kuka-10ppm, okuqukethwe kwe-arsenic kuphansi kuka-3ppm, futhi akukho ukulimala okubonakalayo kwezinhlayiya okuqinisekiswe ngovivinyo lwe-cytotoxicity, okuhambisana nezindinganiso zokuphepha kwezinto eziphilayo. •Ukuguqulwa okuphezulu: ubuso bungaxhunywa ngokuvumelanayo nezixhumi ezinjenge-folic acid, PEG kanye ne-peptide ukuze kuqinisekiswe ukuhanjiswa okuhlosiwe, futhi ukusebenza kokuhlanganiswa okuhlosiwe kuphezulu ngama-5-8 izikhathi kunezithuthi ezijwayelekile. 2.2 Process assurance Inqubo yokwakha esekelwe kumasampula e-cationic surfactant ifinyelela izakhiwo ze-mesoporous ezihambisanayo ngokulawula kahle izinga lokushisa, i-pH, kanye nokugxila kwamasampula. Inqubo yokukhiqiza ihlale ilandela izindinganiso ze-GMP ngohlelo lokubheka ubukhulu bezikhala oluhlanganisiwe, kuqinisekisa ukulawulwa kwekhwalithi okuqinile ngokuhlola okuhlelekile ukuze kugcinwe izimo ezinzile nezilawulwayo phakathi nesikhathi sokukhiqiza. 2.3 Main role 1.Umsizi wokugeleza: thuthukisa ukugeleza kwe-API powder, ukuze umehluko wesisindo sokugcwalisa samathayili ulawulwe ngaphakathi ku-±3%, futhi ukusebenza kokucindezela amathayili kwandiswe ngama-20%; 2.Ukuvimbela ukuhlanganiswa: vimbela impahla ekubambeni, yehlise umphumela wokuphuka nokubamba, ikakhulukazi efanelekile ekulungiseleleni izithako ze-herbal ezinezinga eliphezulu; 3.Ukuvuselela: thola umswakama omncane emathayili, delay ukwehla kwezithako ezisebenzayo, futhi wandise isikhathi sokuphila kwemithi sibe yizinyanga eziyi-12-24; 4.Umthwali wokukhululwa: Ngokulawula isakhiwo sezikhala ukuze kulungiswe izinga lokukhululwa kwemithi, ukufaka u-0.2% ekwakhiweni kwamathayili 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 yokwelapha enezinga eliphezulu (njenge-doxorubicin) ingakhululwa ngokunembile ngokuphendula kwe-pH/temperature ukuze kuncishiswe ukulimala kwezinhlayiya ezijwayelekile; imithi engaxhumi (njenge-paclitaxel) ingafakwa ukuze kuthuthukiswe ukuxhunywa nokutholakala. 2. I-vector ye-genetic/vaccine: ivikela i-siRNA ne-plasmid DNA ekwehliseni, ithuthukise ukutholwa kwangaphakathi ngokuguqulwa ukuze kuqinisekiswe ukuhanjiswa okuhlosiwe; thola i-antigen ye-vaccine futhi wandise isikhathi sokugcina ukuze uqinise impendulo ye-immune. 3. Ukuhlola nokwelashwa okuhlanganisiwe: Layisha ama-dyes akhanyayo kanye nezinsiza zokuhlola ze-MRI/CT ukuze kwakhiwe ipulatifomu yokuhlola nokwelashwa yokubheka ngesikhathi esifanayo ukuhanjiswa kwemithi nezinguquko ze-lesion. 4. Ukuvimbela amagciwane nokulungiswa kwezicubu: layisha ama-ion e-silver kanye nezidakamizwa zokuvimbela amagciwane ukuze kuvinjelwe amagciwane isikhathi eside (ngokwelashwa kwezinhlayiya); isakhiwo esinezakhi simemezela i-extracellular matrix, sixhasa ukukhula nokuhlukaniswa kwezinhlayiya ze-stem, 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 sokudla. •Uhambisana nezikhombisi-ndlela zokuhambisana zomhlaba: ulandela izindinganiso zokukhiqiza ze-GMP kanye nezidingo ze-HACCP zokuphepha kokudla. 6. Key points for handling and storage •Umsebenzi wokulayisha imithi: kunconywa ukuthi kwenziwe ezingeni lokushisa lendawo (20-25℃) kanye nomswakama <50%. Indlela yokumunca yokumunca isetshenziselwa imithi esolwandle, futhi indlela yokuphuma kwesixazululo isetshenziselwa imithi esolwandle. Isikhathi sokulayisha kufanele sibe okungenani amahora amabili. •Qaphela ukuguqulwa kwesurface: 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 esakhiweni se-mesoporous. •Izimo zokugcina: Vala ebhodleleni le-reagent elinsundu, ugcine endaweni epholile futhi eyomile (15-25℃, umswakama ophakathi <50%), gwema ukugcina ukukhanya, kusebenze iminyaka emibili, uvule ukuze usebenzise phakathi kwezinyanga eziyi-1. 7. Product Advantages (PA) •Izinga eliphezulu lokwenza ngezifiso: ubukhulu bezikhala kanye nendawo ethile ingalawulwa kahle ngokuya ngosayizi wama-molecule we-API, inikeza izixazululo ezikhethekile zokuthwala. •Ukuhlanganiswa kwemisebenzi eminingi: inezinhloso eziningi zokulayisha imithi, ukuhanjiswa okuhlosiwe nokukhululwa okuhlakaniphile, okwenza kube lula ukuklama izakhiwo. •Ukuqinisekiswa kokuhambisana komhlaba: zonke izinkomba zihlangabezana nezidingo zepharmacopoeia zomhlaba, 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 ezingeziwe, ngokwesekwa kweqembu lobuchwepheshe elichwepheshile 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 yokudla •Imvume yokukhiqiza yokudla •I-Enterprise ye-high-tech kazwelonke •Izinkampani ezikhethekile, ezicacile nezintsha eGuangzhou •Amalungelo angama-43 avela kwiHhovisi leMali Yezwe