Mesoporous Silicon Dioxide 1. Ukubuka Kwenkambo (Product Overview) 1.1 Incazelo eziyisisekelo Zhongqi Mesoporous Silica, umkhiqizo wezokwelapha owenziwe ngenqubo ye-sol-gel, ubonakala njengothuli oluphaphathekile olumbala omhlophe. Izici zayo ezichazayo zifaka phakathi kwesakhiwo esijwayelekile se-mesoporous channel esinezinhlaka ezivela ku-2 kuya ku-50nm kanye nendawo ethile enkulu kakhulu. 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 njengempahla eyinhloko yokwakha izinhlelo zokulethwa kwemithi ezinembile. 1.2 Izinzuzo eziyisisekelo Njengomkhiqizo wezokwelapha ophakeme, Zhongqi Mesoporous Silica ixazulula kahle izinselelo zemboni ezifana nokungafaneleki kahle nokuphila kwesikhathi esifushane 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. Umkhiqizo uhambisana nezindinganiso eziqinile zomhlaba jikelele zokwelapha, unikeza ukwesekwa kwematerial eyinhloko ekuthuthukisweni kwezakhiwo ezintsha kanye nokuthuthukiswa kwemithi ye-generic ephezulu. 2. Izici Zomkhiqizo (Product Characteristics) 2.1 Izinzuzo zokwakheka nokusebenza •Isakhiwo se-mesoporous esiqondile: usayizi wezikhala ungashintshwa ngokuqhubekayo ukusuka ku-5 kuya ku-30nm, ukusabalala kosayizi 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 emithi. •Ukulawula ukukhululwa okuhlakaniphile: Ngokusebenzisa ukuguqulwa kwendawo kwezakhiwo ezithintekayo ze-pH, ezithintekayo ze-enzyme nezinye "izivalo eziphendulayo", ukukhululwa okukhethekile kwemithi ezindaweni ezithile kungafezeka, futhi izinga lokukhululwa lingalawulwa ngokunembile ku-±5% ngaphakathi. •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 kwamaseli okuqinisekiswa ngovivinyo lwe-cytotoxicity, okuhambisana nezindinganiso zokuphepha kwezinto eziphilayo. •Ukuguqulwa okuphezulu: indawo ingaxhunywa ngokuvumelana nezithako ezifana ne-folic acid, PEG kanye ne-peptide ukuze kuqinisekiswe ukulethwa okuphendulayo, futhi ukusebenza kokuhlanganiswa okuhlosiwe kuphakathi kuka-5-8 izikhathi kuphansi kunezithako ezijwayelekile. 2.2 Ukuqinisekiswa kwezinqubo Inqubo yokwakha esekelwe kumasampula we-cationic surfactant ifinyelela izakhiwo ze-mesoporous ezihambisanayo kakhulu ngokulawula kahle izinga lokushisa kokuphendula, i-pH, kanye nokugxila kwamasampula. Inqubo yokukhiqiza ihambisana ngokuqinile nezindinganiso ze-GMP enezinhlelo zokubheka usayizi wezikhala ezihlanganisiwe, iqinisekisa ukulawulwa kwekhwalithi okuqinile ngokuhlolwa kweqoqo 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 samathayili ulawulwe ngaphakathi ku-±3%, futhi ukusebenza kokucindezela amathayili kukhuphuke ngo-20%; 2.I-Anti-adhesive: ivimbela impahla ekubambeni ku-punch, yehlise umphumela wokuphuka nokubamba, ikakhulukazi ifaneleka kakhulu ekulungiseleleni izithako ze-herbal ezinezinga eliphezulu; 3.I-Stabilizer: ibamba umswakama omncane kumathayili, ibambezelele ukwehla kwezithako ezisebenzayo, futhi ikhulise isikhathi sokuphila kwemithi sibe yizinyanga eziyi-12-24; 4.I-Release carrier: Ngokulawula isakhiwo sezikhala ukuze kulungiswe izinga lokukhululwa kwemithi, ukufaka u-0.2% ekwakhiweni kwamathayili akhululwayo kungafinyelela ukukhululwa kwemithi okwesikhathi eside. 3. Ipharamitha ezisemqoka zobuchwepheshe (KTP) Ipharamitha Izinto Umkhawulo wezinkomba Isilinganiso sokuhlola 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 wesikhala 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. Izinkambu zokusebenza (Application Fields) 1. Umthwalo wemithi: Imithi ye-chemotherapy enezinga eliphezulu (njenge-doxorubicin) ingakhululwa ngokunembile ngokuphendula kwe-pH/temperature ukuze kuncishiswe ukulimala kumaseli ajwayelekile; imithi engaxhunywanga (njenge-paclitaxel) ingagqokiswa ukuze kuthuthukiswe ukuxhunywa nokutholakala. 2. I-genetic/vaccine vector: ivikela i-siRNA ne-plasmid DNA ekuphuleni, ithuthukise ukutholwa kwamaseli ngokuguqulwa ukuze kuqinisekiswe ukulethwa okuhlosiwe; ibamba i-antigen ye-vaccine futhi ikhulise isikhathi sokugcina ukuze iqinise impendulo ye-immune. 3. Ukuhlola okuhlanganisiwe nokwelashwa: Layisha ama-dyes akhanyayo kanye nezithako zokuhlola ze-MRI/CT ukuze kwakhiwe ipulatifomu yokuhlola nokwelapha yokubheka ngesikhathi esifanayo ukulethwa kwemithi nezinguquko ezibuhlungu. 4. I-Antibacterial kanye nokulungiswa kwezicubu: ilayisha ama-ion e-silver kanye nezidakamizwa zokulwa namagciwane ukuze ivimbele amagciwane isikhathi eside (ngokwelashwa kwezilonda); isakhiwo se-porous simela i-extracellular matrix, sisekela ukukhula nokuhlukaniswa kwamangqamuzana, futhi siza ekulungiseni amathambo/nemisipha. 5. Izindinganiso nezimfuneko (Standards & Regulations) •Ihamba 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. •Hamba nezikhombisi-ndlela zokuhambisana zomhlaba: hamba nezincazelo zokukhiqiza ze-GMP kanye nezimfuneko ze-HACCP zokuphepha kokudla. 6. Iziphakamiso ezibalulekile zokuphatha nokugcina •Umsebenzi wokulayisha imithi: kunconywa ukuthi kwenziwe ezingeni lokushisa (20-25℃) kanye nomswakama <50%. Indlela yokumunca yokuhlola isetshenziswa kumithi esolubala, futhi indlela yokuphuma kwesixazululo isetshenziswa kumithi esolubala. Isikhathi sokulayisha kufanele sibe okungenani amahora amabili. •Qaphela ukuguqulwa kwendawo: 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 kwesakhiwo 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 ngaphakathi kwenyanga eyodwa. 7. Izinzuzo zomkhiqizo (PA) •Izinga eliphezulu lokwenza ngokwezifiso: usayizi wezikhala kanye nendawo ethile kungalawulwa kahle ngokuya ngosayizi wama-molecule e-API, kunikeza izixazululo ezikhethekile zokuhambisa. •Ukuhlanganiswa kwemisebenzi eminingi: inezisebenzi eziningi zokulayisha imithi, ukulethwa okuhlosiwe nokukhululwa okuhlakaniphile, okwenza kube lula ukuklama izakhiwo. •Ukuqinisekiswa kokuhambisana komhlaba: zonke izinkomba zihlangabezana nezidingo zepharmacopoeia yomhlaba, zisekela ukufaka izicelo zemithi ezintsha ezweni nasemhlabeni, zisheshise inqubo yokumaketha umkhiqizo. •Ukwenziwa kwezinsizakalo zobuchwepheshe: ukuhlinzeka ngentuthuko yenqubo yokulayisha imithi, ukuhlolwa kokukhululwa kwe-in vitro nezinye izinsizakalo ezithuthukisiwe, ngokwesekwa kweqembu lobuchwepheshe elichwepheshile kuyo yonke inqubo. 8. Ukuqinisekiswa kwesistimu ye-Enterprise kanye neziqinisekiso •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, ezithuthukisiwe nezintsha eGuangzhou •Amalungelo angu-70 avela kwiHhovisi leMali Yezobuchwepheshe.