Mesoporous Silicon Dioxide 1. Ukubuka Kwamkhiqizo (Product Overview) 1.1 Izincazelo eziyisisekelo Zhongqi Mesoporous Silica, umkhiqizo osebenzayo wezokwelapha owenziwe ngenqubo ye-sol-gel, ubonakala njengothuli oluphaphathekile olumbala omhlophe. Izici zawo ezichazayo zifaka phakathi kwesakhiwo esijwayelekile se-mesoporous channel enezinhlaka 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 ungasebenzi ngokwemichilo emisha yezokwelapha. Njengoba kunjalo, usebenza njengemathiriyeli eyinhloko yokwakha izinhlelo zokulethwa kwemithi ezinembile. 1.2 Izinzuzo eziyisisekelo Njengomkhiqizo osezingeni eliphezulu wezokwelapha, Zhongqi Mesoporous Silica uphendula kahle izinselelo zezimboni ezifana nokungafaneleki kokuhlosiwe kanye nesikhathi esifushane sokuphila kwemithi ezakhiweni ezijwayelekile. Ngokulawula kahle isakhiwo sezinhlaka kanye nezici zendawo, ivumela ukulayisha imithi kahle nokukhululwa okuhlakaniphile, kuthuthukisa kakhulu ukutholakala kwe-biological ngenkathi kunciphisa imiphumela emibi ebonakalayo. Umkhiqizo uhambisana nezindinganiso ezinzima zomhlaba wonke zokusebenza kwezokwelapha, uhlinzeka ngensiza eyinhloko yokwakha izinhlelo ezintsha zokwakha nokuthuthukiswa kwemithi ejwayelekile ephezulu. 2. Izici Zomkhiqizo (Product Characteristics) 2.1 Izinzuzo zesakhiwo nezokusebenza •Isakhiwo se-mesoporous esiqondile: usayizi wezikhala ungashintshwa ngokuqhubekayo ukusuka ku-5 kuya ku-30nm, ukusabalala kosayizi bezikhala 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 ama-molecule emithi. •Ukulawulwa kokukhululwa okuhlakaniphile: Ngokusebenzisa ukuguqulwa kwesurface kwezakhiwo ezithintekayo ze-pH, ezithintekayo ze-enzyme nezinye "izivalo eziphendulayo", ukhululwa okukhethekile kwemithi ezindaweni ezihlosiwe kungafezwa, 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 ukuhlolwa kwe-cytotoxicity, okuhambisana nezindinganiso zokuphepha kwezinto eziphilayo. •Ukuguqulwa okuphezulu: ubuso bungaxhunywa ngokuvumelanayo nezinsiza ezihlosiwe ezifana ne-folic acid, PEG kanye ne-peptide ukuze kuqinisekiswe ukulethwa okuhlosekile, futhi ukusebenza kokuhlosiwe kuphakathi kwezikhathi ezi-5-8 eziphezulu kunezithuthi ezijwayelekile. 2.2 Ukuqinisekiswa kwenqubo 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 bezikhala oluhlanganisiwe, kuqinisekisa ukulawulwa kwekhwalithi okuqinile ngokuhlolwa kweqoqo ngalinye ukuze kugcinwe izinga elizinzile nelilawulwayo phakathi nesikhathi sokukhiqiza. 2.3 Indima eyinhloko 1. Ukusiza ukuhamba: kuthuthukisa ukuhamba kwe-API powder, ukuze umehluko wesisindo sokugcwalisa samathayili ulawulwe phakathi kwe-±3%, futhi ukusebenza kokucindezela amathayili kwanda ngama-20%; 2. Ukuvimbela ukuhamba: kuvimba impahla ukuthi ingabambeki kumphini, kunciphisa umphumela wokuphuka nokubambeka, ikakhulukazi efanelekile ekwenzeni izithako zezinhlamvu eziphezulu; 3. Umgibeli: udinga ukuhamba kwamanzi okuncane kumathayili, delay ukwehla kwezinto ezisebenzayo, futhi wandise isikhathi sokuphila kwemithi izinyanga eziyi-12-24; 4. Umthwali wokukhululwa: Ngokulawula isakhiwo sezinhlaka ukuze kulungiswe izinga lokukhululwa kwemithi, ukufaka u-0.2% ekwakhiweni kwamathayili akhululwayo kungafinyelela ukukhululwa kwemithi okwesikhathi eside. 3. Ipharamitha ezisemqoka (KTP) Ipharamitha Izinto Uhlaka lwezinkomba Isivivinyo I-SiO₂ okuqukethwe (ngemuva kokushiswa) ≥99.0% USP-NF <281> I-BET indawo ethile (m²/g) 300-1000 Indlela yokumunca ye-BET I-Porosity (cm³g) 0.8-2.0 Umthetho we-BJH Usayizi wesikhala ophakathi (nm) 5-30 Umthetho we-BJH Ukulahleka kwesisindo esomile (105℃,2h) ≤6.0% ukuhlaziywa kwe-gravimetric Okuqukethwe kwezimbiwa ezinzima (ppm) ≤10 Ukuhlaziywa kwe-atomic absorption spectrophotometry 4. Izinkambu zokusebenza (Application Fields) 1. Umthwali wemithi: Imithi yokwelapha enezikhwama eziphezulu (njenge-doxorubicin) ingakhululwa ngokunembile ngokuphendula kwe-pH/temperature ukuze kuncishiswe ukulimala kumaseli ajwayelekile; imithi engasindi (njenge-paclitaxel) ingafakwa ukuze kuthuthukiswe ukuxubana nokutholakala. 2. I-vector ye-genetic/vaccine: ivikela i-siRNA ne-plasmid DNA ekwehlisweni, ithuthukisa ukutholwa kwamaseli ngokuguqulwa ukuze kuqinisekiswe ukulethwa okuhlosekile; ibamba i-antigen ye-vaccine futhi wandise isikhathi sokugcina ukuze umphenduli we-immunity uqine. 3. Ukuhlola nokwelashwa okuhlanganisiwe: Layisha ama-dyes aphuzi kanye nezithako ze-MRI/CT ukuze kwakhiwe ipulatifomu yokuhlola nokwelapha yokuhlola ngesikhathi sokulethwa kwemithi nezinguquko zezifo. 4. Ukulwa nezifo kanye nokulungiswa kwezicubu: ifakwe ama-ion e-silver kanye nezidakamizwa zokulwa nezifo ukuze ivimbe amagciwane isikhathi eside (ngokwelashwa kwezilonda); isakhiwo se-porous simisela i-extracellular matrix, sisekele ukukhula nokuhlukaniswa kwamangqamuzana, futhi sithuthukisa ukulungiswa kwezitho zomzimba/skin. 5. Izindinganiso nezimfuneko (Standards & Regulations) •Ihambisana nezindinganiso eziningi zepharmacopoeia zomhlaba: USP-NF, European Pharmacopoeia (Ph. Eur.), Japanese Pharmacopoeia (JP), kanye ne-China Pharmacopoeia (ChP 2025). •Thola ubufakazi obuhambisanayo: ukufakwa kwedatha ye-FDA ye-inactive ingredient, isitifiketi sokwengeza ukudla se-EU E551. •Ihambisana nezikhombisi zomhlaba wonke: ihambisana nezincazelo zokukhiqiza ze-GMP nezidingo ze-HACCP zokuphepha kokudla. 6. Iziphakamiso ezisemqoka zokuphatha nokugcina •Umsebenzi wokulayisha imithi: kunconywa ukuthi kwenziwe ekamelweni lokushisa (20-25℃) kanye ne-humidity <50%. Indlela yokufaka yokumunca isetshenziswa kumithi esolubala, futhi indlela yokuphuma kwesixazululo isetshenziswa kumithi esolubala. Isikhathi sokulayisha kufanele sibe okungenani amahora amabili. •Iphuzu lokuguqulwa 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℃, humidity ephansi <50%), gwema ukugcina ukukhanya, kusebenze isikhathi esiyizinyanga ezi-2, uvule ukuze usebenzise phakathi kwezinyanga eziyi-1. 7. Izinzuzo zomkhiqizo (PA) •Izinga eliphezulu lokwenza ngokwezifiso: usayizi wezikhala kanye nendawo ethile kungalawulwa kahle ngokuya ngosayizi wamamolekyuli e-API, kuhlinzeka ngesisombululo esihlukile sokuthwala. •Ukuhlanganiswa kokusebenza okuningi: inezinhloso eziningi zokulayisha imithi, ukulethwa okuhlosekile kanye nokukhululwa okuhlakaniphile, okwenza kube lula ukuklama izakhi. •Ukuqinisekiswa kokuhambisana komhlaba: zonke izinkomba zihlangabezana nezidingo zepharmacopoeia zomhlaba, zisekela ukufaka izicelo zemithi ezintsha ezweni nasemhlabeni jikelele, zisheshisa inqubo yokumaketha umkhiqizo. •Ukuthuthukiswa kwezinsizakalo zobuchwepheshe: hlinzeka ngentuthuko yenqubo yokulayisha imithi, ukuhlolwa kokukhululwa emithonjeni nakwezinye izinsizakalo ezithuthukisayo, ngokwesekwa kweqembu lobuchwepheshe obuchwepheshile phakathi kwenqubo yonke. 8. Ukuqinisekiswa kwesistimu ye-Enterprise kanye nezindondo •FSSC22000 •ISO22000：2018 •ISO9001：2015 •SHC HALAL •OU KOSHER •Ubufakazi be-FDA •FAMI-QS •SEDEX •I-licence yokukhiqiza yokwengeza ukudla •I-licence yokukhiqiza yokwengeza ukudla •I-Enterprise ye-high-tech kazwelonke •Izinkampani ezikhethekile, ezithuthukile nezintsha eGuangzhou •Amalayisense angu-73 avela kwi-Office of State Intellectual Property