Mesoporous Silicon Dioxide 1. Ukubuka KweMikhiqizo (Product Overview) 1.1 Izincazelo eziyisisekelo Zhongqi Mesoporous Silica, umkhiqizo wezokwelapha owenziwe ngenqubo ye-sol-gel, ubonakala njengothuli oluphaphathekile olumbala omhlophe. Izici zayo ezichazayo zifaka phakathi kwesakhiwo esijwayelekile se-mesoporous channel esinezinhlaka ezivela ku-2 kuya ku-50nm kanye nendawo ethile enkulu kakhulu. Lo msebenzi ubonisa amandla aphezulu okulayisha imithi, izinga lokukhululwa okulawulwayo, kanye nokuhambisana okuhle kwe-biocompatibility, ngenkathi uhlala ungashintshiwe kumakhemikhali asebenzayo. Njengoba kunjalo, usebenza njengomkhiqizo oyinhloko wokwakha izinhlelo zokulethwa kwemithi ezinemininingwane. 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 nokukhululwa okuhlakaniphile, kuthuthukisa kakhulu ukuhlinzeka nge-bioavailability ngenkathi kunciphisa imiphumela emibi emibi. Umkhiqizo uhambisana nezindinganiso eziqinile zomhlaba wonke zokwakhiwa kwemithi, uhlinzeka ngesisekelo esiyinhloko sokuthuthukiswa kwezakhiwo ezintsha kanye nokuthuthukiswa kwemithi yejenerikhi ephezulu. 2. Izici Zomkhiqizo (Product Characteristics) 2.1 Izinzuzo zokwakheka nokusebenza •Isakhiwo se-mesoporous esiqondile: usayizi wezinhlaka ungashintshwa njalo ukusuka ku-5 kuya ku-30nm, ukusabalala kosayizi bezinhlaka kuyi-uniform (ukwephuka ≤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 kwendawo kwe-pH sensitive, enzyme sensitive nezinye "izivalo eziphendulayo", ukukhululwa okukhethekile kwemithi ezindaweni ezihlosiwe 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 kwezinhlayiya okuqinisekiswe ngovivinyo lwe-cytotoxicity, okuhambisana nezindinganiso zokuphepha kwezinto eziphilayo. •Ukuguqulwa okuphezulu: indawo ingaxhunywa ngokuqinile nezinsiza ezifana ne-folic acid, PEG kanye ne-peptide ukuze kuqinisekiswe ukulethwa okuhlosiwe, futhi ukusebenza kokuhlanganiswa okuhlosiwe kuphumelela izikhathi ezi-5-8 ngaphezulu kwezithuthi ezijwayelekile. 2.2 Ukuqinisekiswa kwezinqubo Inqubo yokwakha esekelwe kumasampula we-cationic surfactant ifinyelela izakhiwo ze-mesoporous ezihambisanayo kakhulu ngokulawula kahle izinga lokushisa, i-pH, kanye nokugxila kwamasampula. Inqubo yokukhiqiza ihlale ilandela izindinganiso ze-GMP ngohlelo lokuhlola usayizi bezinhlaka oluhlanganisiwe, iqinisekisa ukulawulwa kwekhwalithi okuqinile ngokuhlola ngokuqhubekayo ukuze kugcinwe izimo ezizinzile nezilawulwayo phakathi nesikhathi sokukhiqiza. 2.3 Indima eyinhloko 1.Umsizi wokugeleza: thuthukisa ukugeleza kwe-API powder, ukuze umehluko wesisindo sokugcwalisa samathayili ulawulwe ngaphakathi kwe-±3%, futhi ukusebenza kokucindezela amathayili kwandiswe ngama-20%; 2.Ukuvimbela ukujolisa: vimbela impahla ekubambeni kumphongolo, yehlise isimo sokuphuka nokubamba, ikakhulukazi efanelekile ekwenzeni izithako ze-chinese herbal extract ezinamafutha; 3.Umhlali: thola umswakama omncane kumathayili, delay ukwehla kwezinto ezisebenzayo, futhi wandise isikhathi sokuphila kwemithi sibe yizinyanga eziyi-12-24; 4.Umthwali wokukhululwa: Ngokulawula isakhiwo sezinhlaka ukuze kulungiswe izinga lokukhululwa kwemithi, ukufaka u-0.2% ekwakhiweni kwamathayili okukhululwa okuqhubekayo kungafeza ukukhululwa kwemithi isikhathi eside. 3. Ipharamitha ebalulekile yezobuchwepheshe (KTP) Izinhlobo zepharamitha Uhlaka lwezinkomba Isivivinyo esijwayelekile Okuqukethwe kwe-SiO₂ (ngemuva kokushiswa) ≥99.0% USP-NF <281> I-BET ethile ye-surface area (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 kokumunca kwe-atomic 4. Izinkambu zokusebenza (Application Fields) 1. Umthwali wemithi: Imithi yokwelapha enezinsiza eziphezulu (njenge-doxorubicin) ingakhululwa kahle ngokuphendula kwe-pH/ukushisa ukuze kuncishiswe ukulimala kumaseli ajwayelekile; imithi engasakazeki (njenge-paclitaxel) ingafakwa ukuze kuthuthukiswe ukwakheka nokuhlinzeka. 2. I-vector ye-genetic/vaccine: ivikela i-siRNA ne-plasmid DNA ekwehliseni, ithuthukise ukutholwa kwangaphakathi ngokuguqulwa ukuze kuqinisekiswe ukulethwa okuhlosiwe; thola i-antigen ye-vaccine futhi wandise isikhathi sokugcina ukuze uqinise impendulo ye-immune. 3. Ukuhlola okuhlanganisiwe nokwelashwa: Layisha ama-dyes akhanyayo kanye nezinsiza zokuphikisa ze-MRI/CT ukuze kwakhiwe ipulatifomu yokuhlola nokwelapha yokuhlola ngokuhlanganyela kokulethwa kwemithi nezinguquko ze-lesion. 4. Ukulwa namagciwane nokulungisa izicubu: layisha ama-ion e-silver kanye nezidakamizwa zokulwa namagciwane ukuze uvimbele amagciwane isikhathi eside (ngokwelashwa kwezilonda); isakhiwo se-porous simisela i-extracellular matrix, sithuthukisa ukukhula nokuhlukaniswa kwamangqamuzana, futhi siza ekulungiseni amathambo/nemisipha. 5. Izindinganiso nezimfuneko (Standards & Regulations) •Uhambisana nezindinganiso eziningi zepharmacopoeia 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 sokudla. •Uhambisana nezikhombisi-ndlela zokuhambisana zomhlaba: ulandela izincazelo 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 yokuhlola isetshenziswa kumithi esolubala, futhi indlela yokuphuma kwesixazululo 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 okukhulu kwe-asidi kanye ne-alkali kwesakhiwo se-mesoporous. •Izimo zokugcina: Vala ebhodleleni le-reagent elinsundu, ugcine endaweni epholile futhi eyomile (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: usayizi wezinhlaka kanye nendawo ethile ingalawulwa kahle ngokuya ngosayizi wamamolekyuli e-API, ihlinzeka ngesisombululo esikhethekile sokuthwala. •Ukuhlanganiswa kwemisebenzi eminingi: inezisebenzi eziningi zokulayisha imithi, ukulethwa okuhlosiwe nokukhululwa okuhlakaniphile, okwenza kube lula ukuklama izakhiwo. •Ukuqinisekiswa kokuhambisana komhlaba: zonke izinkomba zihlangabezana nezidingo zepharmacopoeia zomhlaba, zisekela izicelo zemithi ezintsha zasekhaya nezangaphandle, zisheshisa inqubo yokumaketha umkhiqizo. •Ukuthuthukiswa kwezinsizakalo zobuchwepheshe: hlinzeka ngentuthuko yenqubo yokulayisha imithi, ukuhlolwa kokukhululwa emzimbeni nezinye izinsizakalo ezingeziwe, ngokwesekwa kweqembu lezeMisebenzi lobuchwepheshe ngesikhathi sonke. 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, ezihloniphekile nezintsha eGuangzhou •Amalungelo angu-81 avela kwiHhovisi leMali Yezwe.