Mesoporous Silicon Dioxide 1. Product Overview (Product Overview) 1.1 Basic definitions Zhongqi Mesoporous Silica, umkhiqizo ophumelelayo wezokwelapha owenziwe ngenqubo ye-sol-gel, ubonakala njengothuli oluphaphathekile oluwhite. Izici zayo ezichazayo zifaka phakathi isakhiwo se-mesoporous esijwayelekile esinezakhiwo ezivulekile ezisuka ku-2 kuya ku-50nm kanye nendawo enkulu ethile yokusebenza. Lo mkhiqizo ubonisa amandla aphezulu okulayisha imithi, izinga lokukhululwa okulawulwayo, kanye nokuhambisana okuhle kwe-biocompatibility, ngenkathi uhlala ungasebenzi ngokwemvelo ezithako zokwelapha ezisebenzayo. Njengoba kunjalo, usebenza njengemathiriyeli eyinhloko yokwakha izinhlelo zokulethwa kwemithi ezinembile. 1.2 Core values Njengomkhiqizo ophakeme wezokwelapha, Zhongqi Mesoporous Silica uphumelela ekuxazululeni izinselelo zezimboni ezifana nokungafaneleki kahle nokuphakama okuphansi kwemithi ezakhiweni ezijwayelekile. Ngokulawula kahle isakhiwo sezakhiwo ezivulekile kanye nezici zendawo, ivumela ukulayisha imithi kahle nokukhululwa okuhlakaniphile, kukhuphula kakhulu ukutholakala kwe-biological ngenkathi kunciphisa imiphumela emibi. Umkhiqizo uhambisana nezindinganiso eziqinile zomhlaba wonke zokwakhiwa kwemithi, uhlinzeka ngensiza eyinhloko yokwakha izinhlelo ezintsha zokwakha imikhiqizo kanye nokuthuthukiswa kwemithi ye-genetic 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, ukusabalala kosayizi bezikhala kuhle (ukuphambuka ≤2nm), indawo ethile ye-BET ingafinyelela ku-300-1000m²/g, futhi ivolumu ye-mesoporous ingafinyelela ku-2.0cm³/g, ihlinzeka ngendawo eyanele yokulayisha imithi. •Ukulawula ukukhululwa okuhlakaniphile: Ngokusebenzisa ukuguqulwa kwesikhumba se-pH esithintekayo, esithintekayo se-enzyme nezinye "izivalo eziphendulayo", ukukhululwa okukhethekile kwemithi ezindaweni ezithile 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 ngokuhlolwa kwe-cytotoxicity, okuhambisana nezindinganiso zokuphepha kwezinto eziphilayo. •Ukuguqulwa okuphezulu: ubuso bungaxhunywa ngokuqinile nezixhumi ezifana ne-folic acid, PEG kanye ne-peptide ukuze kuqinisekiswe ukulethwa okuqondile, futhi ukusebenza kokuhlanganiswa okuqondile kuphakathi kuka-5-8 izikhathi phezulu kunezithuthi ezijwayelekile. 2.2 Process assurance Inqubo yokwakha esekelwe kumasampula we-cationic surfactant ifinyelela izakhiwo ze-mesoporous ezihambisanayo kakhulu ngokulawula kahle izinga lokushisa, i-pH, kanye nokugxila kwamasampula. Inqubo yokukhiqiza ihlale ihambisana nezindinganiso ze-GMP enezinhlelo zokuhlola usayizi bezikhala ezihlanganisiwe, 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-API powder, ukuze umehluko wesisindo sokugcwalisa samathabhu ulawulwe phakathi kuka-±3%, futhi ukusebenza kokucindezela amathabhu kukhuphuke ngo-20%; 2.Ukuvimbela ukujolisa: ivimbela impahla ekubambeni emgibeni, yehlisa umphumela wokuphuka nokubamba, ikakhulukazi ifaneleka kakhulu ekulungiseleleni izithako ze-herbal ezinamafutha aphezulu; 3.Umsebenzi wokugcina: udonsa umswakama omncane emathabhu, delay ukwehla kwezithako ezisebenzayo, futhi wandise isikhathi sokuphila kwemithi sibe yizinyanga eziyi-12-24; 4.Umthwali wokukhululwa: Ngokulawula isakhiwo sezakhiwo ezivulekile ukuze kulungiswe izinga lokukhululwa kwemithi, ukwengeza u-0.2% ekwakhiweni kwamathabhu okukhululwa okuqhubekayo kungafezeka 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. Umthwali wemithi: Imithi ye-chemotherapy enezinga eliphezulu (efana ne-doxorubicin) ingakhululwa ngokunembile ngokuphendula kwe-pH/temperature ukuze kuncishiswe ukulimala kumaseli ajwayelekile; imithi engasongi (efana ne-paclitaxel) ingafakwa ukuze kuthuthukiswe ukuxubana nokutholakala. 2. I-vector ye-genetic/vaccine: ivikela i-siRNA ne-plasmid DNA ekwehlisweni, ithuthukise ukutholwa kwangaphakathi ngokuguqulwa ukuze kuqinisekiswe ukulethwa okuqondile; idonsa i-antigen ye-vaccine futhi wandise isikhathi sokugcina ukuze uqinise impendulo ye-immune. 3. Ukuhlola okuhlanganisiwe nokwelashwa: Layisha ama-dyes akhanyayo kanye nezinsiza zokuhlola ze-MRI/CT ukuze kwakhiwe ipulatifomu yokuhlola nokwelapha yokubheka ngesikhathi esifanayo ukulethwa kwemithi nezinguquko ezibuhlungu. 4. Ukuvimbela amagciwane nokulungisa izicubu: ifakwe ama-ion e-silver nezidakamizwa zokuvimbela amagciwane isikhathi eside (ngokwelashwa kwezilonda); isakhiwo esivulekile simela i-extracellular matrix, sikhuthaza ukukhula nokuhlukaniswa kwezicubu ezisemqoka, futhi siza ekulungiseni amathambo/nemisipha. 5. Standards and regulations (Standards & Regulations) •Ihambisana nezindinganiso eziningi zomhlaba wonke ze-pharmacopoeia: USP-NF, European Pharmacopoeia (Ph. Eur.), Japanese Pharmacopoeia (JP), kanye ne-China Pharmacopoeia (ChP 2025). •Thola isitifiketi esihlobene nesikhwama: ukufakwa kwedatha ye-FDA ye-inactive ingredient, isitifiketi se-EU E551 sokudla. •Ihambisana nezikhombisi-ndlela zokuhambisana zomhlaba wonke: ihambisana nezindinganiso zokukhiqiza ze-GMP kanye nezidingo ze-HACCP zokuphepha kokudla. 6. Key points for handling and storage •Umsebenzi wokulayisha imithi: kunconywa ukuba kwenziwe ekamelweni lokushisa (20-25℃) kanye nokuphakama <50%. Indlela yokufaka yokugxila isetshenziswa kumithi esolwandle, futhi indlela yokuphuma kwesisombululo isetshenziswa kumithi esolwandle. Isikhathi sokulayisha kufanele sibe okungenani amahora amabili. •Iphuzu lokuguqulwa kwesikhumba: amaqembu okusebenza afana nama-amino nama-carboxyl kufanele aguqulwe ku-pH phakathi kuka-5 no-8 ukuze kugwenywe ukulimala okukhulu kwe-asidi nokwakha isakhiwo 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, kuvulelwe ukusetshenziswa phakathi kwezinyanga eziyi-1. 7. Product Advantages (PA) •Izinga eliphezulu lokwenza ngokwezifiso: usayizi wezikhala kanye nendawo ethile ingalawulwa kahle ngokuya ngosayizi wezicubu ze-API, ihlinzeka ngesisombululo esikhethekile sokuthwala. •Ukuhlanganiswa kwemisebenzi eminingi: inezisebenzi eziningi zokulayisha imithi, ukulethwa okuqondile nokukhululwa okuhlakaniphile, okwenza kube lula ukwakhiwa kwezinhlelo. •Ukuqinisekiswa kokuhambisana komhlaba wonke: zonke izinkomba zihlangabezana nezidingo ze-pharmacopoeia yomhlaba, zisekela izicelo zemithi ezintsha zasekhaya nezangaphandle, zisheshisa inqubo yokumaketha umkhiqizo. •Ukuthuthukiswa kwezinsizakalo zobuchwepheshe: hlinzeka ngentuthuko yenqubo yokulayisha imithi, ukuhlolwa kokukhululwa kwe-in vitro nezinye izinsizakalo ezithuthukisiwe, ngokwesekwa kweqembu lobuchwepheshe obuchwepheshile 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, ezihlelekile nezintsha eGuangzhou •Amalayisense angu-39 avela kwiHhovisi yeZimpahla Zobuchwepheshe zeSizwe