Mesoporous Silicon Dioxide 1. Isithombe Somkhiqizo (Product Overview) 1.1 Incazelo eziyisisekelo Zhongqi Mesoporous Silica, umkhiqizo wezokwelapha owenziwe ngenkqubo ye-sol-gel, ubonakala njengomphezulu omhlophe ongenamkhawulo. Izici zawo ezichazayo zifaka phakathi isakhiwo se-mesoporous esijwayelekile esinezinhlaka ezivela ku-2 kuya ku-50nm kanye nendawo ethile enkulu kakhulu. Le msebenzi ibonisa amandla aphezulu okulayisha imithi, izinga lokukhulula elilawulwayo, kanye nokuhambisana okuhle ne-biocompatibility, ngenkathi ihlala ingekho emthethweni ezithako zokwelapha ezisebenzayo. Njengoba kunjalo, iyinsiza eyinhloko yokwakha izinhlelo zokulethwa kwemithi ezinembile. 1.2 Izinzuzo eziyisisekelo Njengomkhiqizo wezokwelapha ophakeme, Zhongqi Mesoporous Silica ixazulula kahle izinselelo zezimboni ezifana nokungafaneleki kahle nokuphila kwesikhathi esifushane kwemithi ezakhiweni ezijwayelekile. Ngokulawula kahle isakhiwo sezinhlaka kanye nezici zendawo, ivumela ukulayisha imithi kahle nokukhulula okuhlakaniphile, okwandisa kakhulu ukufinyelela kwe-biological ngenkathi kunciphisa imiphumela emibi. Umkhiqizo uhambisana nezindinganiso eziqinile zomhlaba wonke zokwelapha, unikeza ukwesekwa kwezinto eziyisisekelo ekuthuthukiseni izakhiwo ezintsha kanye nokuthuthukiswa kwemithi ye-generic ephezulu. 2. Izici zomkhiqizo (Product Characteristics) 2.1 Izinzuzo zesakhiwo nezokusebenza •Isakhiwo se-mesoporous esiqondile: usayizi wezinhlaka ungashintshwa ngokuqhubekayo ukusuka ku-5 kuya ku-30nm, ukusabalala kosayizi bephoreku 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 izithako zemithi. •Ukulawula ukukhulula okuhlakaniphile: Ngokusebenzisa ukuguqulwa kwendawo kwe-pH okuthintekayo, okuthintekayo kwe-enzyme nezinye "izivalo eziphendulayo", ukukhulula okukhethekile kwemithi ezindaweni ezithile kungafezwa, futhi izinga lokukhulula lingalawulwa ngokuqondile nge-±5% emzimbeni. •Ukuhambisana okuhle ne-biocompatibility: I-SiO₂ ubumsulwa bukhulu kuno-99.0%, okuqukethwe kwezimbiwa ezinzima kungaphansi kuka-10ppm, okuqukethwe kwe-arsenic kungaphansi kuka-3ppm, futhi akukho ukulimala okubonakalayo kwezinhlayiya okuqinisekiswe ngovivinyo lwe-cytotoxicity, okuhlangabezana nezindinganiso zokuphepha zezinto eziphilayo. •Ukuguqulwa okuphezulu: indawo ingaxhunywa ngokuvumelanayo nezinsiza ezifana ne-folic acid, PEG kanye ne-peptide ukuze kuqinisekiswe ukulethwa okuqondile, futhi ukusebenza kokuhlanganiswa okuqondile kuphakathi kuka-5-8 izikhathi phezulu kunezithako ezijwayelekile. 2.2 Ukuqinisekiswa kwenqubo Inqubo yokwakha esekelwe kumasampuli e-cationic surfactant ifinyelela izakhiwo ze-mesoporous ezihambisanayo kakhulu ngokulawula kahle izinga lokushisa, i-pH, kanye nokugxila kumasampuli. Inqubo yokukhiqiza ihlale ihambisana nezindinganiso ze-GMP enohlelo lokubheka usayizi bephoreku oluhlanganisiwe, iqinisekisa ukulawula kwekhwalithi okuqinile ngokuhlola ngokuqhubekayo ukuze kugcinwe izinga elizinzile nelilawulwayo phakathi nesikhathi sokukhiqiza. 2.3 Indima enkulu 1.Umsizi wokugeleza: thuthukisa ukugeleza kwe-API powder, ukuze umehluko wesisindo sokugcwalisa samathayili ulawulwe ngaphakathi kuka-±3%, futhi ukusebenza kokucindezela amathayili kwandiswe ngo-20%; 2.Ukuvimbela ukujolisa: ivimbela impahla ekubambeni kumphakeli, yehlisa umphumela wokuphuka nokubambeka, ikakhulukazi ifaneleka kakhulu ekulungiseleleni izithako ze-chinese herbal ezinamafutha; 3.Umsizi: thola umswakama omncane kumathayili, delay ukwehla kwezithako ezisebenzayo, futhi wandise isikhathi sokuphila kwemithi sibe yizinyanga eziyi-12-24; 4.Umsizi wokukhulula: Ngokulawula isakhiwo sezinhlaka ukuze kulungiswe izinga lokukhulula imithi, ukufaka u-0.2% ekwakhiweni kwamathayili akhululekile kungafinyelela ukukhulula kwemithi isikhathi eside. 3. Ipharamitha ezisemqoka (KTP) Ipharamitha Izinto Iziqondiso zokuhlola 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 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. Umsizi wokulethwa kwemithi: Imithi ye-chemotherapy enezinga eliphezulu (njenge-doxorubicin) ingakhululwa ngokunembile nge-pH/ukushisa ukuphendula ukuze kuncishiswe ukulimala kumaseli ajwayelekile; imithi engasolwandle (njenge-paclitaxel) ingafakwa ukuze kuthuthukiswe ukuxubana nokufinyelela kwe-biological. 2. I-vector ye-genetic/vaccine: ivikela i-siRNA ne-plasmid DNA ekwehliseni, ithuthukise ukwamukelwa kwangaphakathi ngokuguqulwa ukuze kuqinisekiswe ukulethwa okuqondile; adsorb vaccine antigen futhi wandise isikhathi sokugcina ukuze uqinise impendulo ye-immune. 3. Ukuhlola nokwelashwa okuhlanganisiwe: Layisha ama-dyes akhanyayo kanye nezithako zokuhlola ze-MRI/CT ukuze kwakhiwe ipulatifomu yokuhlola nokwelashwa yokubheka ngesikhathi esifanayo sokulethwa kwemithi nezinguquko ezibuhlungu. 4. Ukuvimbela amagciwane nokulungisa izicubu: layisha ama-ion e-silver nezidakamizwa zokuvimbela amagciwane isikhathi eside (ngokwelashwa kwezilonda); isakhiwo se-porous simela i-extracellular matrix, sikhuthaza ukukhula nokuhlukaniswa kwezinhlayiya, futhi siza ekulungiseni amathambo/nemisipha. 5. Izindinganiso nemithetho (Standards & Regulations) •Ihamba 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, ukuqinisekiswa kwe-EU E551 yokudla. •Hamba nezikhombisi-ndlela zokuhambisana zomhlaba wonke: hamba nezincazelo zokukhiqiza ze-GMP kanye nezidingo ze-HACCP zokuphepha kokudla. 6. Iziphakamiso ezibalulekile zokuphatha nokugcina •Umsebenzi wokulayisha imithi: kunconywa ukuthi kwenziwe ezingeni lokushisa (20-25℃) kanye nomswakama <50%. Indlela yokumunca yokufaka imithi esolwandle, futhi indlela yokuphuma kwesixazululo isetshenziselwa imithi engasolwandle. 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 umonakalo omkhulu we-asidi kanye ne-alkali esakhiweni 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 kwezinyanga eziyi-1. 7. Izinzuzo zomkhiqizo (PA) •Izinga eliphezulu lokwenza ngokwezifiso: usayizi wezinhlaka kanye nendawo ethile ingalawulwa kahle ngokuya ngosayizi wezithako ze-API, inikeza izixazululo ezikhethekile zokuhambisa. •Ukuhlanganiswa kwemisebenzi eminingi: inezinhloso eziningi zokulayisha imithi, ukulethwa okuqondile kanye nokukhulula okuhlakaniphile, okwenza kube lula ukuklama izakhiwo. •Ukuqinisekiswa kokuhambisana komhlaba wonke: zonke izinkomba zihlangabezana nezidingo ze-international pharmacopoeia, zisekela ukufaka izicelo zemithi ezintsha ezweni nasemhlabeni, zisheshisa inqubo yokumaketha umkhiqizo. •Ukuthuthukiswa kwezinsizakalo zobuchwepheshe: hlinzeka ngentuthuko yephrojekthi yokulayisha imithi, ukuhlolwa kokukhulula emzimbeni nezinye izinsizakalo ezingeziwe, ngokwesekwa kweqembu lobuchwepheshe lochwepheshe 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 •Ilicence yokukhiqiza izithako zokudla •Ilicence yokukhiqiza izithako zokudla •I-Enterprise ye-high-tech kazwelonke •Izinkampani ezikhethekile, ezithuthukile nezintsha eGuangzhou •Amalungelo angu-50 avela kwi-Office of National Intellectual Property