Mesoporous Silicon Dioxide 1. Ukubuka Kwenkampani (Product Overview) 1.1 Incazelo eziyisisekelo Zhongqi Mesoporous Silica, umkhiqizo wokwelapha osebenzayo okwenziwe ngenqubo ye-sol-gel, ubonakala njengomphezulu omhlophe ongenamkhawulo. Izici zawo ezichazayo zifaka phakathi kwesakhiwo esijwayelekile se-mesoporous channel enezikhala ezisukela ku-2 kuya ku-50nm kanye nendawo enkulu ethile yokusebenza. Lo msebenzi 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 Izinzuzo eziyisisekelo Njengomkhiqizo ophakeme wokwelapha, Zhongqi Mesoporous Silica ixazulula kahle izinselelo zezimboni ezifana nokungafinyeleli kahle nokuphila okufushane kwemithi ezakhiweni ezijwayelekile. Ngokulawula kahle isakhiwo se-pore nezici ze-surface, ivumela ukulayisha imithi kahle nokukhululwa okuhlakaniphile, kukhuphula kakhulu ukutholakala kwe-biological ngenkathi kunciphisa imiphumela emibi emibi. Umkhiqizo uhambisana nezindinganiso eziqinile zomhlaba wonke zokwelapha, uhlinzeka ngensiza eyinhloko yokwakha izinhlelo ezintsha zokwakha nokuthuthukiswa kwemithi ye-generic ephezulu. 2. Izici Zomkhiqizo (Product Characteristics) 2.1 Izinzuzo zesakhiwo nezokusebenza •Isakhiwo se-mesoporous esiqondile: usayizi we-pore ungashintshwa ngokuqhubekayo usuka ku-5 kuya ku-30nm, ukusatshalaliswa kosayizi be-pore kuhlangene (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. •Ukulawulwa kokukhululwa okuhlakaniphile: Ngokusebenzisa ukuguqulwa kwesurface kwezakhiwo ezibucayi ze-pH, ezibucayi ze-enzyme nezinye "izivalo eziphendulayo", ukukhululwa okukhethekile kwemithi ezindaweni ezihlosiwe kungafezeka, futhi izinga lokukhululwa lingalawulwa ngokunembile ku-±5% emithonjeni. •Ukuhambisana okuhle kwe-biocompatibility: Ukuhlanzeka kwe-SiO₂ kuphakathi kuka-99.0%, okuqukethwe kwezimbiwa ezinzima kuphansi kuka-10ppm, okuqukethwe kwe-arsenic kuphansi kuka-3ppm, futhi akukho ukulimala okubonakalayo kwamaseli okuqinisekiswa ngovivinyo lwe-cytotoxicity, okuhlangabezana nezindinganiso zokuphepha kwezinto eziphilayo. •Ukuguqulwa okuphezulu: ubuso bungaxhunywa ngokuqinile nezinsiza ezifana ne-folic acid, PEG kanye ne-peptide ukuze kuqinisekiswe ukulethwa okuhlosiwe, futhi ukusebenza kokuhlanganiswa okuhlosiwe kuphakathi kuka-5-8 izikhathi kuphansi kunezithuthi ezijwayelekile. 2.2 Ukuqinisekiswa kwenqubo Inqubo yokwakha esekelwe kumathuluzi e-cationic surfactant ifinyelela izakhiwo ze-mesoporous ezihlangene kakhulu ngokulawula kahle izinga lokushisa lokuphendula, i-pH, kanye nokugxila kwetemplate. Inqubo yokukhiqiza ihlale ilandela izindinganiso ze-GMP ngohlelo lokuhlola usayizi be-pore oluhlanganisiwe, kuqinisekisa ukulawulwa kwekhwalithi okuqinile ngokuhlola ngokuqhubekayo ukuze kugcinwe izinga elizinzile nelilawulwayo phakathi nesikhathi sokukhiqiza. 2.3 Indima eyinhloko 1.Usizo lokugeleza: kuthuthukisa ukugeleza kwe-API powder, ukuze umehluko wesisindo sokugcwalisa ama-tablet ulawulwe phakathi kuka-±3%, futhi ukusebenza kokucindezela ama-tablet kukhuphuke ngo-20%; 2.Ukuvimbela ukujolisa: kuvimba impahla ekubambeni kumphini, kunciphisa ukuvela kokuphuka nokubamba, ikakhulukazi efanelekile ekulungiseleleni izithako ze-chinese herbal ezinamafutha; 3.Ukuzinza: ukuhlinzeka ngamanzi amancane ku-tablet, delay ukwehla kwezithako ezisebenzayo, futhi wandise isikhathi sokuphila kwemithi sibe yizinyanga eziyi-12-24; 4.Umthwali wokukhululwa: Ngokulawula isakhiwo se-pore ukuze kulungiswe izinga lokukhululwa kwemithi, ukufaka u-0.2% ekwakhiweni kwe-tablet yokukhululwa okuqhubekayo kungafezeka ukukhululwa kwemithi isikhathi eside. 3. Ipharamitha ezisemqoka zobuchwepheshe (KTP) Ipharamitha izinto Ububanzi bezinkomba umthetho wokuhlola Okuqukethwe kwe-SiO₂ (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 we-pore ophakathi (nm) 5-30 umthetho we-BJH Ukulahleka kwesisindo esomile (105℃,2h) ≤6.0% ukuhlaziywa kwe-gravimetric Okuqukethwe kwezimbiwa ezinzima (ppm) ≤10 Ukuhlaziywa kokumunca kwe-atomic 4. Izingxenye zokusebenza (Application Fields) 1. Umthwali wemithi: Imithi ye-chemotherapy enezinga eliphezulu (njengokuthi i-doxorubicin) ingakhululwa ngokunembile ngokuphendula kwe-pH/temperature ukuze kuncishiswe ukulimala kumaseli ajwayelekile; imithi engaxhunywanga (njengokuthi i-paclitaxel) ingafakwa ukuze kuthuthukiswe ukuxhunywa nokutholakala. 2. I-genetic/vaccine vector: ivikela i-siRNA ne-plasmid DNA ekwehliseni, ithuthukise ukutholwa kwamaseli ngokuguqulwa ukuze kuqinisekiswe ukulethwa okuhlosiwe; ikhipha i-vaccine antigen futhi wandise isikhathi sokugcina ukuze umphenduli we-immunity uqine. 3. Ukuhlola okuhlanganisiwe nokwelashwa: Layisha ama-dyes akhanyayo kanye ne-MRI/CT contrast agents ukuze kwakhiwe ipulatifomu yokuhlola nokwelashwa yokubheka ngesikhathi esifanayo sokulethwa kwemithi nezinguquko ezibuhlungu. 4. Ukulwa namagciwane nokulungiswa kwezicubu: layisha ama-silver ions kanye nezidakamizwa zokulwa namagciwane ukuze kuvinjwe amagciwane isikhathi eside (ngokwelashwa kwezilonda); isakhiwo se-pore simela i-extracellular matrix, sithuthukisa ukukhula nokuhlukaniswa kwamangqamuzana, futhi siza ekulungiseni amathambo/nokhuni. 5. Izindinganiso nezimfuneko (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 zomhlaba wonke: uhambisana nezindinganiso zokukhiqiza ze-GMP kanye nezimfuneko ze-HACCP food safety system. 6. Iziphakamiso ezibalulekile zokuphatha nokugcina •Ukulayisha imithi: kunconywa ukuthi kwenziwe ezingeni lokushisa (20-25℃) kanye ne-humidity <50%. Indlela yokumunca yokuhlola isetshenziswa kumithi esolubala, futhi indlela yokuphuma kwe-solvent isetshenziswa kumithi esolubala. 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 okuqinile kwe-asidi kanye ne-alkali esakhiweni se-mesoporous. •Izimo zokugcina: Vala ebhodleleni le-reagent elinsundu, ugcine endaweni epholile nepholile (15-25℃, humidity ephansi <50%), gwema ukugcina ukukhanya, kusebenze isikhathi esiyiminyaka emibili, uvule ukuze usebenzise phakathi kwezinyanga eziyi-1. 7. Izinzuzo zomkhiqizo (PA) •I-degree ephezulu yokwenza ngokwezifiso: usayizi we-pore kanye nendawo ethile ingalawulwa ngokunembile ngokuya ngosayizi wemolekyuli ye-API, ihlinzeka ngezixazululo ezikhethekile zokuthwala. •Ukuhlanganiswa kwemisebenzi eminingi: inezisebenzi eziningi zokulayisha imithi, ukulethwa okuhlosiwe nokukhululwa okuhlakaniphile, okwenza kube lula ukuklama izakhiwo. •Ukuqinisekiswa kokuhambisana komhlaba wonke: zonke izinkomba zihlangabezana nezidingo ze-international pharmacopoeia, zisekela izicelo zemithi ezintsha ezweni nasemhlabeni, zisheshisa inqubo yokumaketha umkhiqizo. •Ukuthuthukiswa kwezinsizakalo zobuchwepheshe: ukuhlinzeka ngentuthuko yenqubo yokulayisha imithi, ukuhlolwa kokukhululwa emithonjeni nezinye izinsizakalo ezithuthukisiwe, ngokwesekwa kweqembu lobuchwepheshe elichwepheshile kuyo yonke inqubo. 8. Ukuqinisekiswa kwesistimu yebhizinisi kanye nezindondo •FSSC22000 •ISO22000：2018 •ISO9001：2015 •SHC HALAL •OU KOSHER •Ubufakazi be-FDA •FAMI-QS •SEDEX •I-licence yokukhiqiza izithako zokudla •I-licence yokukhiqiza izithako zokudla •I-National high-tech enterprise •Izinkampani ezikhethekile, ezithuthukisiwe nezintsha eGuangzhou •Amalungelo angu-85 avela kwi-Office of State Intellectual Property