Mesoporous Silicon Dioxide 1. Ukubuka Kwenkambo (Product Overview) 1.1 Incazelo eziyisisekelo Zhongqi Mesoporous Silica, umkhiqizo wokwelapha osebenzayo owenziwe ngenqubo ye-sol-gel, ubonakala njengothuli oluphaphathekile olumbala omhlophe. Izici zawo ezichazayo zifaka phakathi kwesakhiwo esijwayelekile se-mesoporous channel enobukhulu bezikhala obuphakathi kuka-2 no-50nm kanye nendawo ethile enkulu kakhulu. Lo mkhiqizo ubonisa amandla aphezulu okulayisha imithi, izinga lokukhululwa okulawulwayo, kanye nokuhambisana okuhle kwe-biocompatibility, ngenkathi uhlala ungasebenzi ngokwemikhakha ye-pharmaceutical active. Njengoba kunjalo, usebenza njengemathiriyeli eyinhloko yokwakha izinhlelo zokulethwa kwemithi ezinembile. 1.2 Izinzuzo eziyisisekelo Njengomkhiqizo ophakeme wokwelapha, Zhongqi Mesoporous Silica uphendula kahle izinselelo zezimboni ezifana nokungafinyeleli kahle nokuphila kwemithi okuphansi ezinhlelweni ezijwayelekile. Ngokulawula kahle isakhiwo sezikhala nezici zendawo, ivumela ukulayisha imithi kahle nokukhululwa okuhlakaniphile, okwandisa kakhulu ukufinyeleleka kwe-biological ngenkathi kunciphisa imiphumela emibi emibi. Umkhiqizo uhambisana nezindinganiso eziqinile zomhlaba wonke zokwelapha, unikeza ukwesekwa kwemathiriyeli eyinhloko ekuthuthukisweni kwezinhlelo ezintsha zokwakha kanye nokuthuthukiswa kwemithi ye-genetic ephezulu. 2. Izici Zomkhiqizo (Product Characteristics) 2.1 Izinzuzo zokwakhiwa nokusebenza •Isakhiwo se-mesoporous esiqondile: ubukhulu bezikhala bungashintshwa ngokuqhubekayo ukusuka ku-5 kuya ku-30nm, ukusabalala kobukhulu bezikhala 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 imithi. •Ukulawulwa kokukhululwa okuhlakaniphile: Ngokusebenzisa ukuguqulwa kwendawo kwezakhiwo ezibucayi ze-pH, ezibucayi ze-enzyme nezinye "izivalo eziphendulayo", ukukhululwa okukhethekile kwemithi ezindaweni ezithile 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. •Ukuguqulwa okuphezulu: indawo ingaxhunywa ngokuvumelanayo nezinsiza ezifana ne-folic acid, PEG kanye ne-peptide ukuze kuqinisekiswe ukulethwa okuhlosiwe, futhi ukusebenza kokuhlanganiswa okuhlosiwe kuphakathi kuka-5-8 izikhathi phezulu kunezithuthi ezijwayelekile. 2.2 Ukuqinisekiswa kwezinqubo Inqubo yokwakha esekelwe kumathuluzi e-cationic surfactant ifinyelela izakhiwo ze-mesoporous ezihambisanayo ngokulawula kahle izinga lokushisa lokuphendula, i-pH, kanye nokugxila kwetemplate. Inqubo yokukhiqiza ihambisana ngokuqinile nezindinganiso ze-GMP enezinhlelo zokubheka ubukhulu bezikhala 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 ama-tablet ulawulwe ngaphakathi kuka-±3%, futhi ukusebenza kokucindezela ama-tablet kwandiswe ngo-20%; 2.I-Anti-adhesive: ivimbela impahla ekubambeni kumphunga, yehlisa umphumela wokuphuka nokubamba, ikakhulukazi efanelekile ekulungiseleleni izithako ze-herbal ezinezinga eliphezulu; 3.I-Stabilizer: ibamba umswakama omncane ku-tablet, ibambezelekile ukwehla kwezinto 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 kwe-tablet yokukhululwa okuqhubekayo kungafinyelela ukukhululwa kwemithi okwesikhathi eside. 3. Ipharamitha ezisemqoka (KTP) Ipharamitha Izinto Uhlaka lwezinkomba Isilinganiso sokuhlola 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 Ubukhulu bezikhala (nm) 5-30 Umthetho we-BJH Ukulahleka kwesisindo esomile (105℃,2h) ≤6.0% Ukuhlaziywa kwe-gravimetric Okuqukethwe kwezimbiwa ezinzima (ppm) ≤10 I-Atomic absorption spectrophotometry 4. Izigaba zokusebenza (Application Fields) 1. Umthwali wemithi: Imithi ye-chemotherapy enezinga eliphezulu (njenge-doxorubicin) ingakhululwa kahle ngokuphendula kwe-pH/temperature ukuze kuncishiswe ukulimala kumaseli ajwayelekile; imithi engaxhunywanga (njenge-paclitaxel) ingafakwa ukuze kuthuthukiswe ukuxhunywa nokufinyeleleka. 2. I-vector ye-genetic/vaccine: ivikela i-siRNA ne-plasmid DNA ekwehliseni, ithuthukise ukutholwa kwamaseli ngokuguqulwa ukuze kuqinisekiswe ukulethwa okuhlosiwe; ibamba i-antigen ye-vaccine futhi ikhulise isikhathi sokugcina ukuze umphendulo we-immunity uqine. 3. Ukuhlola nokwelashwa okuhlanganisiwe: Layisha ama-dyes apholile kanye nezithako ze-MRI/CT ukuze kwakhiwe ipulatifomu yokuhlola nokwelapha yokubheka ngesikhathi esifanayo ukulethwa kwemithi nezinguquko ezithinta. 4. I-Antibacterial kanye nokulungiswa kwezicubu: ifakwe ama-ion e-silver kanye nemithi yokulwa namagciwane ukuze ivimbele amagciwane isikhathi eside (ukulungisa izilonda); isakhiwo se-porous simisela i-extracellular matrix, sisekele ukukhula nokuhlukaniswa kwamangqamuzana, futhi sibe nomthelela ekulungiseni amathambo/nemisipha. 5. Izindinganiso nezimfuneko (Standards & Regulations) •Ihambisana nezindinganiso eziningi ze-pharmacopoeia 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. •Ihambisana nezikhombisi-ndlela zokuhambisana zomhlaba: ihambisana nezincazelo zokukhiqiza ze-GMP nezimfuneko ze-HACCP zokuphepha kokudla. 6. Iziphakamiso ezibalulekile zokuphatha nokugcina •Ukulayisha imithi: kunconywa ukuthi kwenziwe ezingeni lokushisa (20-25℃) kanye nomswakama <50%. Indlela yokumunca yokuhlola isetshenziswa kumithi esolubala, futhi indlela yokuphuma kwe-solvent isetshenziswa kumithi esolubala. Isikhathi sokulayisha kufanele sibe okungenani amahora amabili. •Qaphela ukuguqulwa kwendawo: amaqembu asebenzayo afana nama-amino nama-carboxyl kufanele aguqulwe ezingeni le-pH phakathi kuka-5 no-8 ukuze kugwenywe ukulimala okuqinile kwe-asidi nokwakha isakhiwo se-mesoporous. •Izimo zokugcina: Vala ebhodleleni le-reagent elinsundu, ugcine endaweni epholile nepholile (15-25℃, umswakama ophakathi <50%), gwema ukugcina ukukhanya, kusebenze isikhathi esiyiminyaka emibili, uvule ukuze usebenzise phakathi kwenyanga eyodwa. 7. Izinzuzo zomkhiqizo (PA) •Izinga eliphezulu lokwenza ngokwezifiso: ubukhulu bezikhala kanye nendawo ethile ingalawulwa kahle ngokwezinga le-API molecules, inikeza izixazululo ezikhethekile zokuthwala. •Ukuhlanganiswa kwemisebenzi eminingi: inezisebenzi eziningi zokulayisha imithi, ukulethwa okuhlosiwe nokukhululwa okuhlakaniphile, okwenza kube lula ukuklama izinhlelo. •Ukuqinisekiswa kokuhambisana komhlaba: zonke izinkomba zihlangabezana nezidingo ze-pharmacopoeia zomhlaba, zisekela ukufaka izicelo zemithi ezintsha ezweni nasemhlabeni, zisheshise inqubo yokumaketha umkhiqizo. •Ukuthuthukiswa kwezinsizakalo zobuchwepheshe: ukuhlinzeka ngentuthuko yenqubo yokulayisha imithi, ukuhlolwa kokukhululwa emzimbeni nezinye izinsizakalo ezingeziwe, ngokwesekwa kweqembu lobuchwepheshe obuchwepheshile kuyo yonke inqubo. 8. Ukuqinisekiswa kwesistimu ye-Enterprise kanye neziqinisekiso •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-Enterprise ye-high-tech kazwelonke •Izinkampani ezikhethekile, ezithuthukisiwe nezintsha eGuangzhou •Amalungelo angu-61 avela kwi-Office of State Intellectual Property