Mesoporous Silicon Dioxide 1. Ukubuka KweMikhiqizo (Product Overview) 1.1 Incazelo eziyisisekelo Zhongqi Mesoporous Silica, umkhiqizo wokwelapha osebenzayo okhiqizwa ngenqubo ye-sol-gel, ubonakala njengothuli oluphaphathekile olumbala omhlophe. Izici zawo ezichazayo zifaka phakathi kwesakhiwo se-mesoporous esijwayelekile esinezakhiwo ezivulekile ezilinganiselwa ku-2 kuya ku-50nm kanye nendawo ethile enkulu yokusebenza. 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 uphumelela ekuxazululeni izinselelo zezimboni ezifana nokungafaneleki kahle nokuphila okuphansi kwemithi ezakhiweni ezijwayelekile. Ngokulawula ngokucophelela isakhiwo sezakhiwo nezici zendawo, ivumela ukulayisha imithi kahle nokukhululwa okuhlakaniphile, kukhuphula kakhulu ukutholakala kwe-biological ngenkathi kunciphisa imiphumela emibi. Umkhiqizo uhambisana nezindinganiso eziqinile zezimboni zokwelapha zomhlaba, unikeza ukwesekwa kwemathiriyeli eyinhloko ekuthuthukiseni izakhiwo 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, ukusatshalaliswa kosayizi bezikhala kuhlangene (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 ezihlosiwe kungafezeka, futhi izinga lokukhululwa lingalawulwa ngokunembile ku-±5% emzimbeni. •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 ukonakaliswa okubonakalayo kwezakhi zofuzo okuqinisekiswe ngovivinyo lwe-cytotoxicity, okuhambisana nezindinganiso zokuphepha kwezinto eziphilayo. •Ukuguqulwa okuphezulu: indawo ingaxhunywa ngokuqinile nezixhumi ezifana ne-folic acid, PEG kanye ne-peptide ukuze kuqinisekiswe ukulethwa okusebenzayo okuhlose, futhi ukusebenza kokuhlanganiswa okuhlose kuphakathi kuka-5-8 izikhathi kuphansi kokuhlanganiswa okujwayelekile. 2.2 Ukuqinisekiswa kwenqubo Inqubo yokwakha esekelwe kumathuluzi e-cationic surfactant ifinyelela izakhiwo ze-mesoporous ezihlangene kakhulu ngokulawula ngokucophelela izinga lokuphendula, i-pH, kanye nokugxila kwethemplethi. Inqubo yokukhiqiza ihlale ihambisana nezindinganiso ze-GMP enezinhlelo zokubheka usayizi bezikhala ezihlanganisiwe, iqinisekisa ukulawulwa kwekhwalithi okuqinile ngokuhlola ngokuqhubekayo ukuze kugcinwe izinga elizinzile nelilawulwayo phakathi nesikhathi sokukhiqiza. 2.3 Indima eyinhloko 1.Umsizi wokugeleza: uthuthukisa ukugeleza kwepowder ye-API, ukuze umehluko wesisindo sokugcwalisa ama-tablet ulawulwe phakathi kuka-±3%, futhi ukusebenza kokucindezela ama-tablet kukhuphuke ngo-20%; 2.Ukuvimbela ukujolisa: ivimbela impahla ukuthi ingabambeki kumphini, yehlisa umphumela wokuphuka nokubambeka, ikakhulukazi efanelekile ekulungiseleleni izithako ze-herbal ezinezinga eliphezulu; 3.Ukuvuselela: ibamba umswakama omncane ku-tablet, ibambezelekile ukwehla kwezakhi zofuzo, futhi ikhulise isikhathi sokuphila kwemithi sibe yizinyanga eziyi-12-24; 4.Umthwali wokukhululwa: Ngokulawula isakhiwo sezakhiwo ukuze kulungiswe izinga lokukhululwa kwemithi, ukufaka u-0.2% ekwakhiweni kwe-tablet yokukhululwa okuqhubekayo kungafinyelela ukukhululwa kwemithi okwesikhathi eside. 3. Ipharamitha ebalulekile yezobuchwepheshe (KTP) Ipharamitha Izinto Uhlaka lwezinkomba Isivivinyo 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 kwe-Atomic absorption spectrophotometry 4. Izigaba zokusebenza (Application Fields) 1. Umthwali wemithi: Imithi ye-chemotherapy enezinga eliphezulu (njenge-doxorubicin) ingakhululwa ngokunembile ngokuphendula kwe-pH/temperature ukuze kuncishiswe ukulimala kumaseli ajwayelekile; imithi engaxhunywanga (njenge-paclitaxel) ingafakwa ukuze kuthuthukiswe ukuxhunywa nokutholakala. 2. I-vector ye-genetic/vaccine: ivikela i-siRNA ne-plasmid DNA ekwehliseni, ithuthukise ukutholwa kwangaphakathi ngokuguqulwa ukuze kuqinisekiswe ukulethwa okuhlose; ibamba i-antigen ye-vaccine futhi ikhulise isikhathi sokugcina ukuze iqinise impendulo ye-immune. 3. Ukuhlola okuhlanganisiwe nokwelashwa: Layisha ama-dyes akhanyayo kanye nezinto zokuhlola ze-MRI/CT ukuze kwakhiwe ipulatifomu yokuhlola nokwelashwa yokubheka ngesikhathi esifanayo ukulethwa kwemithi nezinguquko ezithinta. 4. Ukuvimbela amagciwane nokulungiswa kwezicubu: layisha ama-ion e-silver nezidakamizwa zokuvimbela amagciwane ukuze kuvinjwe amagciwane isikhathi eside (ngokwelashwa kwezilonda); isakhiwo esinezakhiwo simemezela i-extracellular matrix, sisekele ukukhula nokuhlukaniswa kwezicubu ezisemqoka, futhi sithuthukise ukulungiswa kwemathambo/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 kwi-database ye-FDA yezingxenye ezingasebenzi, isitifiketi sokwengeza ukudla se-EU E551. •Ihambisana nezikhombisi-ndlela zokuhambisana zomhlaba: ihambisana nezindinganiso zokukhiqiza ze-GMP nezimfuneko ze-HACCP zokuphepha kokudla. 6. Amathiphu abalulekile okuphatha nokugcina •Umsebenzi wokulayisha 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. •Iphuzu lokuguqulwa kwendawo: amaqembu asebenzayo afana nama-amino nama-carboxyl kufanele aguqulwe ku-pH phakathi kuka-5 no-8 ukuze kugwenywe ukulimala okukhulu kwe-asidi nokuqinisa isakhiwo se-mesoporous. •Izimo zokugcina: Vala ebhodleleni le-reagent elinsundu, ugcine endaweni epholile nepholile (15-25℃, umswakama ophakathi <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 ingalawulwa ngokunembile ngokuya ngosayizi wezicubu ze-API, inikeza izixazululo ezikhethekile zokuthwala. •Ukuhlanganiswa kwemisebenzi eminingi: inezisebenzi eziningi zokulayisha imithi, ukulethwa okuhlose kanye nokukhululwa okuhlakaniphile, okwenza kube lula ukuklama izakhiwo. •Ukuqinisekiswa kokuhambisana komhlaba: zonke izinkomba zihlangabezana nezidingo ze-pharmacopoeia zomhlaba, zisekela ukufakwa kwemithi emisha yasekhaya nakwamanye amazwe, zisheshise inqubo yokumaketha umkhiqizo. •Ukuthuthukiswa kwezinsizakalo zobuchwepheshe: ukuhlinzeka ngentuthuko yenqubo yokulayisha imithi, ukuhlolwa kokukhululwa emzimbeni nezinye izinsizakalo ezingeziwe, ngokwesekwa kweqembu lobuchwepheshe elichwepheshile phakathi kwenqubo yonke. 8. Ukuqinisekiswa kwesistimu yeNkampani kanye nezindondo •FSSC22000 •ISO22000：2018 •ISO9001：2015 •SHC HALAL •OU KOSHER •Ubufakazi be-FDA •FAMI-QS •SEDEX •Ilicence yokukhiqiza yokwengeza ukudla •Ilicence yokukhiqiza yokwengeza ukudla •I-National high-tech enterprise •Izinkampani ezikhethekile, ezithuthukisiwe nezintsha eGuangzhou •Amalungelo angama-30 avela kwi-Office of National Intellectual Property