Mesoporous Silicon Dioxide 1. Ukubuka KweMikhiqizo (Product Overview) 1.1 Incazelo eziyisisekelo Zhongqi Mesoporous Silica, i-excipient yepharmaceutical esebenzayo eyenziwe ngenqubo ye-sol-gel, ibonakala njengomphezulu omhlophe ongenamumo. Izici zayo ezichazayo zifaka phakathi isakhiwo se-mesoporous esijwayelekile esinezakhiwo ezivulekile ezisuka ku-2 kuya ku-50nm kanye nendawo ethile enkulu kakhulu. Le msebenzi ibonisa amandla aphezulu okulayisha imithi, izinga lokukhululwa okulawulwayo, kanye nokuhambisana okuhle kwe-biocompatibility, ngenkathi ihlala ingasebenzi ngokwemikhakha yepharmaceutical esebenzayo. Njengoba kunjalo, isebenza njengemathiriyeli eyinhloko yokwakha izinhlelo zokulethwa kwemithi ezinembile. 1.2 Izinzuzo eziyisisekelo Njengoba i-excipient yepharmaceutical ephezulu, i-Zhongqi Mesoporous Silica ixazulula kahle izinselelo zezimboni ezifana nokungafaneleki kahle nokuphila kwemithi okuphansi ezakhiweni ezijwayelekile. Ngokulawula kahle isakhiwo sezakhiwo ezivulekile kanye nezici zendawo, ivumela ukulayisha imithi kahle nokukhululwa okuhlakaniphile, kukhuphule kakhulu ukutholakala kwe-biological ngenkathi kunciphisa imiphumela emibi. Umkhiqizo uhambisana nezindinganiso eziqinile ze-global pharmaceutical excipient, unikeza ukwesekwa kwemathiriyeli eyinhloko ekuthuthukiseni izakhiwo ezintsha kanye nokuthuthukiswa kwemithi ye-generics ephezulu. 2. Izici Zomkhiqizo (Product Characteristics) 2.1 Izinzuzo zesakhiwo nezokusebenza •Isakhiwo se-mesoporous esiqondile: usayizi wezikhala ungashintshwa ngokunembile ukusuka ku-5 kuya ku-30nm, ukusabalala kosayizi 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 ama-molecule emithi. •Ukulawulwa kokukhululwa okuhlakaniphile: Ngokusebenzisa ukuguqulwa kwendawo kwe-pH, i-enzyme sensitive nezinye "izakhiwo ze-valve eziphendulayo", ukukhululwa okukhethekile kwemithi ezindaweni ezithile kungafezeka, futhi izinga lokukhululwa lingalawulwa ngokuqondile nge-±5% in vitro. •Ukuhambisana okuhle kwe-biocompatibility: i-SiO₂ purity ingaphezu kuka-99.0%, okuqukethwe kwe-heavy metal kuphansi kuka-10ppm, okuqukethwe kwe-arsenic kuphansi kuka-3ppm, futhi akukho ukulimala okubonakalayo kwamaseli okuqinisekiswe ngovivinyo lwe-cytotoxicity, okuhambisana nezindinganiso zokuphepha kwezinto eziphilayo. •I-highly modifiable: indawo ingaxhunywa ngokuvumelanayo nezixhumi ezifana ne-folic acid, i-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 ku-cationic surfactant template ifinyelela izakhiwo ze-mesoporous ezihambisanayo ngokulawula kahle izinga lokushisa kokuphendula, i-pH, kanye nokugxila kwe-template. Inqubo yokukhiqiza ihambisana ngokuqinile nezindinganiso ze-GMP enohlelo lokuhlola usayizi lwezakhiwo oluhlanganisiwe, kuqinisekisa ukulawulwa kwekhwalithi okuqinile ngokuhlola ngemuva kokuhlola ukuze kugcinwe izimo ezizinzile nezilawulwayo phakathi nesikhathi sokukhiqiza. 2.3 Indima eyinhloko 1.Umsizi wokugeleza: uthuthukisa ukugeleza kwe-API powder, ukuze umehluko wesisindo sokugcwalisa samathayili ulawulwe phakathi kuka-±3%, futhi ukusebenza kokucindezela amathayili kukhuphuleka ngo-20%; 2.Ukuvimbela ukuhlanganiswa: ivimbela impahla ukuthi ingabambeki ku-punch, yehlisa umphumela wokuphuka nokubambeka, ikakhulukazi ifaneleka kakhulu ekulungiseleleni izithako ze-herbal ezinezinga eliphezulu; 3.Ukuvuselela: ibamba umswakama omncane kumathayili, ibambezele ukwehla kwezinto ezisebenzayo, 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 kwamathayili akhululwayo kungafinyelela ukukhululwa kwemithi isikhathi eside. 3. Ipharamitha ezisemqoka (KTP) Ipharamitha izinto Ububanzi bezinkomba umthetho wokuhlola 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 esijwayelekile （nm） 5-30 umthetho we-BJH Ukulahleka kwesisindo esomile (105℃,2h) ≤6.0% ukuhlaziywa kwe-gravimetric Okuqukethwe kwe-heavy metal (ppm) ≤10 Ukuhlaziywa kokumunca kwe-atomic absorption 4. Izigaba zokusebenza (Application Fields) 1. Umthwali wemithi: Imithi ye-chemotherapy enezinga eliphezulu (njenge-doxorubicin) ingakhululwa ngokunembile nge-pH/ukuphendula kokushisa ukuze kuncishiswe ukulimala kumaseli ajwayelekile; imithi engasindi (njenge-paclitaxel) ingaboshwa ukuze kuthuthukiswe ukuxubana nokutholakala. 2. I-vector ye-genetic/vaccine: ivikela i-siRNA ne-plasmid DNA ekwehlisweni, ikhulisa ukutholwa kwamaseli ngokuguqulwa ukuze kuqinisekiswe ukulethwa okuhlosiwe; ibamba i-antigen ye-vaccine futhi ikhulise isikhathi sokugcina ukuze kuqinise impendulo ye-immune. 3. Ukuhlola nokwelashwa okuhlanganisiwe: Layisha ama-dyes aphuzi kanye nezithako zokuhlola i-MRI/CT ukuze kwakhiwe ipulatifomu yokuhlola nokwelashwa yokubheka ngesikhathi esifanayo ukulethwa kwemithi nezinguquko ezibangelwa. 4. Ukuvimbela amagciwane nokulungisa izicubu: ibanjwe ngama-silver ions kanye nezidakamizwa zokuvimbela amagciwane ukuze ivimbele amagciwane isikhathi eside (ngokwelashwa kwezilonda); isakhiwo esivulekile simisela i-extracellular matrix, sikhuthaza ukukhula nokuhlukaniswa kwamangqamuzana, futhi siza ekulungiseni amathambo/nemisipha. 5. Izindinganiso nezimfuneko (Standards & Regulations) •Ihambisana nezindinganiso eziningi ze-international pharmacopoeia: 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 zomhlaba wonke: ihambisana nezindinganiso zokukhiqiza ze-GMP nezimfuneko ze-HACCP zokuphepha kokudla. 6. Iziphakamiso ezibalulekile zokuphatha nokugcina •Ukulayisha imithi: kunconywa ukuthi kwenziwe ekamelweni lokushisa (20-25℃) kanye ne-humidity <50%. Indlela yokumunca yokuhlanza isetshenziswa kumithi esolwandle, futhi indlela yokuphuma kwesixazululo isetshenziswa kumithi esebenzayo. Isikhathi sokulayisha kufanele sibe okungenani amahora amabili. •Iphuzu lokuguqulwa kwendawo: amaqembu asebenzayo afana nama-amino nama-carboxyl kufanele aguqulwe 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℃, i-humidity ephakathi <50%), gwema ukugcina ukukhanya, kusebenze isikhathi esiyiminyaka emibili, uvule ukuze usebenzise phakathi kwezinyanga eziyi-1. 7. Izinzuzo zomkhiqizo (PA) •Izinga eliphezulu lokwenziwa: usayizi wezikhala kanye nendawo ethile kungalawulwa ngokunembile ngokuya ngosayizi wamamolekyuli e-API, kunikeza izixazululo ezikhethekile zokuthwala. •Ukuhlanganiswa kwemisebenzi eminingi: inezisebenzi eziningi zokulayisha imithi, ukulethwa okuhlosiwe nokukhululwa okuhlakaniphile, okwenza kube lula ukuklama izakhiwo. •Ukuqinisekiswa kokuhambisana komhlaba: zonke izinkomba zihlangabezana nezidingo ze-international pharmacopoeia, zisekela ukufaka izicelo zemithi ezintsha ezweni nasemhlabeni, zisheshisa inqubo yokumaketha umkhiqizo. •Ukuthuthukiswa kwesevisi yobuchwepheshe: ukuhlinzeka ngentuthuko yephrojekthi yokulayisha imithi, ukuhlola ukukhululwa in vitro nezinye izinsizakalo ezithuthukisiwe, ngokwesekwa kweqembu lobuchwepheshe obuchwepheshile kuyo yonke inqubo. 8. Ukuqinisekiswa kwesistimu ye-Enterprise nezindondo •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 angama-20 avela kwi-Office of State Intellectual Property