Mesoporous Silicon Dioxide 1. Ukubuka KweMikhiqizo (Product Overview) 1.1 Incazelo eziyisisekelo Zhongqi Mesoporous Silica, umkhiqizo wokwelapha osebenzayo okwenziwe ngenqubo ye-sol-gel, ubonakala njengothuli oluphaphathekile olumbala omhlophe. Izici zawo ezichazayo zifaka phakathi kwesakhiwo esijwayelekile se-mesoporous channel enezikhala eziphakathi 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 engaphenduli ezakhiweni zokwelapha ezisebenzayo. 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 nokuphakama okuphansi kwemithi emiphumeleni ejwayelekile. Ngokulawula kahle isakhiwo se-pore nezici ze-surface, ivumela ukulayisha imithi kahle nokukhululwa okuhlakaniphile, kukhuphula kakhulu ukutholakala kwe-biological ngenkathi kunciphisa imiphumela emibi. Umkhiqizo uhambisana nezindinganiso ezinzima zomhlaba wonke zokwelapha, uhlinzeka ngensiza eyinhloko yokwakha imikhiqizo emisha kanye nokuthuthukiswa kwemithi ejwayelekile ephezulu. 2. Izici Zomkhiqizo (Product Characteristics) 2.1 Izinzuzo zesakhiwo nezokusebenza • Isakhiwo se-mesoporous esiqondile: usayizi we-pore ungashintshwa ngokuqhubekayo ukusuka ku-5 kuya ku-30nm, ukusatshalaliswa kosayizi be-pore kuhlelekile (ukuphambuka ≤2nm), indawo ethile ye-BET ingafinyelela ku-300-1000m²/g, futhi ivolumu ye-mesoporous ingafinyelela ku-2.0cm³/g, ihlinzeka ngendawo eyanele yokulayisha ama-molecule emithi. • Ukulawula ukukhululwa okuhlakaniphile: Ngokusebenzisa ukuguqulwa kwesurface kwezakhiwo ezithintekayo ze-pH, ezithintekayo ze-enzyme nezinye "izivalo eziphendulayo", ukukhululwa okukhethekile kwemithi ezindaweni ezihlosiwe kungafezeka, futhi izinga lokukhululwa lingalawulwa ngokuqondile nge-±5% emzimbeni. • Ukuhambisana okuhle kwe-biocompatibility: I-SiO₂ ubumsulwa buphezulu 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: 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 phezulu kunezithuthi ezijwayelekile. 2.2 Ukuqinisekiswa kwenqubo Inqubo yokwakha esekelwe kumasampula we-cationic surfactant ifinyelela izakhiwo ze-mesoporous ezihambisanayo kakhulu ngokulawula kahle izinga lokushisa lokuphendula, i-pH, kanye nokugxila kwesampula. Inqubo yokukhiqiza ihlale ihambisana nezindinganiso ze-GMP enezinhlelo zokubheka usayizi be-pore ezihlanganisiwe, iqinisekisa 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 samathayili ulawulwe ngaphakathi kwe-±3%, futhi ukusebenza kokucindezela amathayili kukhuphuke ngo-20%; 2. Ukuvimbela ukujolisa: kuvimba impahla ekubambeni kumphini, kunciphisa umphumela wokuphuka nokubamba, ikakhulukazi efanelekile ekwenzeni izithako ze-chinese herbal extract ezinamafutha; 3. Umgibeli: udinga ukuhamba emanzini amancane atholakala kumathayili, delay ukwehla kwezinto ezisebenzayo, futhi wandise isikhathi sokusebenza kwemithi sibe yizinyanga eziyi-12-24; 4. Umthwali wokukhululwa: Ngokulawula isakhiwo se-pore ukuze kulungiswe izinga lokukhululwa kwemithi, ukufaka u-0.2% kumkhiqizo we-tablet yokukhululwa okuqhubekayo kungafinyelela ukukhululwa kwemithi isikhathi eside. 3. Amamojula obuchwepheshe abakhulu (KTP) Izinto zepharamitha Ububanzi bezinkomba umthetho wokuhlola Okuqukethwe kwe-SiO₂ (ngemva 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 we-pore (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. Umthwali wemithi: Imithi yokwelapha enezinga eliphezulu (njenge-doxorubicin) ingakhululwa ngokunembile ngokuphendula kwe-pH/ukushisa 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 ekuphukeni, ikhulisa ukutholwa kwamaseli ngokuguqulwa ukuze kuqinisekiswe ukulethwa okuhlosiwe; ibamba i-antigen ye-vaccine futhi wandise isikhathi sokugcina ukuze kuqinise impendulo ye-immune. 3. Ukuhlola okuhlanganisiwe nokwelashwa: Layisha ama-dyes akhanyayo kanye nezithako zokuhlola ze-MRI/CT ukuze kwakhiwe ipulatifomu yokuhlola nokwelashwa yokubheka ngesikhathi sokulethwa kwemithi nezinguquko ezibuhlungu. 4. Ukuvimbela amagciwane nokulungiswa kwezicubu: ifakwe ama-ion e-silver kanye nezidakamizwa zokuvimbela amagciwane ukuze kuvinjwe amagciwane isikhathi eside (ngokwelashwa kwezilonda); isakhiwo se-pore simela i-extracellular matrix, sikhuthaza ukukhula nokuhlukaniswa kwamangqamuzana, futhi siza ekulungiseni amathambo/nemisipha. 5. Izindinganiso nemithetho (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 obuhambisanayo: ukufakwa kwedatha ye-FDA ye-inactive ingredient, isitifiketi sokwengeza ukudla se-EU E551. • Uhambisana nezikhombisi-ndlela zomhlaba wonke: uhambisana nezincazelo zokukhiqiza ze-GMP kanye nezidingo ze-HACCP zokuphepha kokudla. 6. Iziphakamiso ezibalulekile zokuphatha nokugcina • Umsebenzi wokulayisha imithi: kunconywa ukuba kwenziwe ekamelweni 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 okukhulu 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) • Izinga eliphezulu lokwenza ngokwezifiso: usayizi we-pore kanye nendawo ethile ingalawulwa kahle ngokuya ngosayizi wamamolekyuli e-API, ihlinzeka ngezixazululo ezikhethekile zokuthwala. • Ukuhlanganiswa kwemisebenzi eminingi: inezisebenzi eziningi zokulayisha imithi, ukulethwa okuhlosiwe nokukhululwa okuhlakaniphile, okwenza kube lula ukuklama imikhiqizo. • Ukuqinisekiswa kokuhambisana komhlaba wonke: zonke izinkomba zihlangabezana nezidingo ze-international pharmacopoeia, zisekela izicelo zemithi emisha yasekhaya nakwamanye amazwe, zisheshisa inqubo yokumaketha umkhiqizo. • Ukuthuthukiswa kwezinsizakalo zobuchwepheshe: hlinzeka ngentuthuko yenqubo yokulayisha imithi, ukuhlolwa kokukhululwa emzimbeni nakwezinye izinsizakalo ezingeziwe, ngokwesekwa kweqembu lobuchwepheshe elinobuchwepheshe kulo lonke uhambo. 8. Ukuqinisekiswa kwesistimu yebhizinisi kanye neziqinisekiso • FSSC22000 • ISO22000：2018 • ISO9001：2015 • SHC HALAL • OU KOSHER • Ukuqinisekiswa kwe-FDA • FAMI-QS • SEDEX • I-licence yokukhiqiza yokwengeza ukudla • I-licence yokukhiqiza yokwengeza ukudla • Ibhizinisi eliphakeme lezobuchwepheshe • Amabhizinisi akhethekile, aphakeme futhi amasha eGuangzhou • Amalayisense angu-26 avela kwiHhovisi Lezimpahla Zobuchwepheshe Zikazwelonke