Mesoporous Silicon Dioxide 1. Product Overview (Product Overview) 1.1 Basic definitions Zhongqi Mesoporous Silica, umkhiqizo wokwelapha osebenzayo owenziwe ngenqubo ye-sol-gel, ubonakala njengothuli oluphaphathekile olumhlophe. Izici zayo ezichazayo zifaka phakathi isakhiwo esijwayelekile se-mesoporous channel esinezinhlaka ezivela ku-2 kuya ku-50nm kanye nendawo ethile enkulu kakhulu. Le msebenzi ibonisa amandla aphezulu okulayisha imithi, izinga lokukhululwa okulawulwayo, kanye nokuhambisana okuhle kwe-biocompatibility, ngenkathi ihlala ingashintshiwe kumakhemikhali asebenzayo. Njengoba kunjalo, isebenza njengemathiriyali eyinhloko yokwakha izinhlelo zokulethwa kwemithi ezinembile. 1.2 Core values Njengomkhiqizo ophakeme wokwelapha, Zhongqi Mesoporous Silica ixazulula kahle izinselelo zemboni ezifana nokungafinyeleli kahle nokuphila kwemithi okuphansi ezakhiweni ezijwayelekile. Ngokulawula kahle isakhiwo sezinhlaka kanye nezici zendawo, ivumela ukulayisha imithi kahle nokukhululwa okuhlakaniphile, kukhuphula kakhulu ukufinyelela kwe-biological ngenkathi kunciphisa imiphumela emibi. Umkhiqizo uhambisana nezindinganiso eziqinile zomhlaba wonke zokwelapha, unikeza ukwesekwa kwemathiriyali eyinhloko ekuthuthukiseni 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 kusuka ku-5 kuya ku-30nm, ukusabalalisa usayizi wezinhlaka kuyi-uniform (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: Ngokwenza izinguquko ebusweni bezakhiwo ezithintekayo ze-pH, ezithintekayo ze-enzyme nezinye "izivalo eziphendulayo", ukhululwa okukhethekile kwemithi ezindaweni ezihlosiwe kungafezwa, futhi izinga lokukhululwa lingalawulwa ngokuqondile nge-±5% emzimbeni. •Ukuhambisana okuhle kwe-biocompatibility: I-SiO₂ purity ingaphezu 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. •Ukushintshwa okuphezulu: ubuso bungaxhunywa ngokuqinile nezinsiza ezifana ne-folic acid, PEG kanye ne-peptide ukuze kufezwe ukulethwa okuhlosiwe, futhi ukusebenza kokuhlanganiswa okuhlosiwe kuphakathi kuka-5-8 izikhathi kuphansi kunezithuthi ezijwayelekile. 2.2 Process assurance Inqubo yokwakha esekelwe kumasampula we-cationic surfactant ifinyelela izakhiwo ze-mesoporous ezihambisanayo kakhulu ngokulawula kahle izinga lokushisa lokuphendula, i-pH, kanye nokugxila kwesampula. Inqubo yokukhiqiza ihlale ihambisana nezindinganiso ze-GMP ngohlelo lokubheka usayizi lwezinhlaka oluhlanganisiwe, kuqinisekisa ukulawulwa kwekhwalithi okuqinile ngokuhlolwa kweqoqo ngalinye ukuze kugcinwe izinga eliqinile nelilawulwayo phakathi nesikhathi sokukhiqiza. 2.3 Main role 1.Ukwelula ukuhamba: kuthuthukisa ukuhamba kwe-API powder, ukuze umehluko wesisindo sokugcwalisa samathayili ulawulwe phakathi kuka-±3%, futhi ukusebenza kokucindezela amathayili kukhuphuke ngo-20%; 2.Ukuvimbela ukujolisa: ivimbela impahla ukuthi ingabambeki kumphongolo, yehlise umphumela wokuphuka nokubambeka, ikakhulukazi efanelekile ekulungiseleleni izithako ze-herbal ezinezinga eliphezulu; 3.Ukuzinza: ibamba umswakama omncane kumathayili, ibambezele ukwehla kwezithako ezisebenzayo, futhi ikhulise isikhathi sokuphila kwemithi sibe yizinyanga eziyi-12-24; 4.Umthwali wokukhululwa: Ngokulawula isakhiwo sezinhlaka ukuze kulungiswe izinga lokukhululwa kwemithi, ukufaka u-0.2% ekwakhiweni kwamathayili okukhululwa okuqhubekayo kungafinyelela 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 usuku oluphakathi (nm) 5-30 I-BJH law Ukulahleka kwesisindo esomile (105℃,2h) ≤6.0% ukuhlaziywa kwe-gravimetric Okuqukethwe kwezimbiwa ezinzima (ppm) ≤10 I-Atomic absorption spectrophotometry 4. Application fields (Application Fields) 1. Umthwali wemithi: Imithi yokwelapha enezinga eliphezulu (efana ne-doxorubicin) ingakhululwa ngokunembile nge-pH/ukuphendula kokushisa ukuze kuncishiswe ukulimala kumaseli ajwayelekile; imithi engaxhunywanga (efana ne-paclitaxel) ingafakwa ukuze kuthuthukiswe ukuxhunywa nokufinyelela kwe-biological. 2. I-genetic/vaccine vector: ivikela i-siRNA ne-plasmid DNA ekwehliseni, ikhulise ukutholwa kwamaseli ngokwenza izinguquko ukuze kufezwe ukulethwa okuhlosiwe; ibamba i-antigen ye-vaccine futhi ikhulise isikhathi sokugcina ukuze iqinise impendulo ye-immunity. 3. Ukuhlola nokwelapha okuhlanganisiwe: Layisha ama-dyes akhanyayo kanye nezinto zokuhlola ze-MRI/CT ukuze kwakhiwe ipulatifomu yokuhlola nokwelapha yokubheka ngesikhathi esifanayo ukulethwa kwemithi nezinguquko ezibuhlungu. 4. Ukuvimbela amagciwane nokulungiswa kwezicubu: ifakwe ama-ion e-silver nezidakamizwa zokuvimbela amagciwane isikhathi eside (ngokwelashwa kwezilonda); isakhiwo se-porous simisela i-extracellular matrix, sixhasa ukukhula nokuhlukaniswa kwamangqamuzana, futhi siza ekulungiseni amathambo/nokuhlanzeka. 5. Standards and regulations (Standards & Regulations) •Ihamba phambili 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. •Hamba phambili nezikhombisi-ndlela zokuhambisana zomhlaba: hamba phambili nezindinganiso 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 yokumisa yokumisa isetshenziswa kumithi esolubala, futhi indlela yokuphuma kwe-solvent isetshenziswa kumithi esolubala. Isikhathi sokulayisha kufanele sibe okungenani amahora amabili. •Iphuzu lokwenza izinguquko ebusweni: amaqembu asebenzayo afana nama-amino nama-carboxyl kufanele aguqulwe ku-pH phakathi kuka-5 no-8 ukuze kugwenywe ukulimala okuqinile 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 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, inikeza izixazululo ezikhethekile zokuthwala. •Ukuhlanganiswa kwezici eziningi: inezici eziningi zokulayisha imithi, ukulethwa okuhlosiwe nokukhululwa okuhlakaniphile, okwenza kube lula ukuklama izakhiwo. •Ukuqinisekiswa kokuhambisana komhlaba: zonke izinkomba zihambisana nezidingo zepharmacopoeia zomhlaba, zisekela ukufaka izicelo zemithi ezintsha ezweni nasemhlabeni, zisheshise inqubo yokumaketha umkhiqizo. •Ukuthuthukiswa kwesevisi yobuchwepheshe: hlinzeka ngentuthuko yephrojekthi yokulayisha imithi, ukuhlolwa kokukhululwa emzimbeni nezinye izinsizakalo ezingeziwe, ngokwesekwa kweqembu lobuchwepheshe obuchwepheshile kuyo yonke inqubo. 8. Enterprise system certification and honors •FSSC22000 •ISO22000：2018 •ISO9001：2015 •SHC HALAL •OU KOSHER •I-FDA attestation •FAMI-QS •SEDEX •I-licence yokukhiqiza yokwengeza ukudla •I-licence yokukhiqiza yokwengeza ukudla •I-National high-tech enterprise •Izinkampani ezikhethekile, ezithuthukile nezintsha eGuangzhou •Amalungelo angu-59 avela kwi-Office of State Intellectual Property