Mesoporous Silicon Dioxide 1. Ukubuka Kwenkanyezi (Product Overview) 1.1 Incazelo eziyisisekelo Zhongqi Mesoporous Silica, umkhiqizo ophumelelayo wezokwelapha owenziwe ngenqubo ye-sol-gel, ubonakala njengothuli oluphaphathekile olumbala omhlophe. Izici zawo ezichazayo zifaka phakathi kwesakhiwo esijwayelekile se-mesoporous channel enezikhala ezilinganayo ezivela ku-2 kuya ku-50nm kanye nendawo ethile enkulu kakhulu. Lo mkhiqizo ubonisa amandla aphezulu okulayisha imithi, izinga lokukhululwa okulawulwayo, kanye nokuhambisana okuhle kwe-biocompatibility, ngenkathi uhlala engashintshiwe kumakhemikhali asebenzayo. Njengoba kunjalo, usebenza njengemathiriyeli eyinhloko yokwakha izinhlelo zokulethwa kwemithi ezinembile. 1.2 Izinzuzo eziyisisekelo Njengomkhiqizo ophakeme wezokwelapha, Zhongqi Mesoporous Silica uphendula kahle izinselelo zemboni ezifana nokungafinyeleli kahle nokuphakama okuphansi kwemithi ezinhlelweni ezijwayelekile. Ngokulawula kahle isakhiwo se-pore nezici ze-surface, ivumela ukulayisha imithi kahle nokukhululwa okuhlakaniphile, kukhuphula kakhulu ukuhlinzeka kwe-biological ngenkathi kunciphisa imiphumela emibi emibi. Umkhiqizo uhambisana nezindinganiso eziqinile zomhlaba jikelele zokwelapha, uhlinzeka ngensiza eyinhloko yokwakha izinhlelo ezintsha zokwakha nokuthuthukisa imithi ejwayelekile ephezulu. 2. Izici Zomkhiqizo (Product Characteristics) 2.1 Izinzuzo zesakhiwo nokusebenza •Isakhiwo se-mesoporous esiqondile: usayizi we-pore ungashintshwa ngokuqhubekayo ukusuka ku-5 kuya ku-30nm, ukusatshalaliswa kosayizi be-pore kuhlelekile (ukwephuka ≤2nm), indawo ethile ye-BET ingafinyelela ku-300-1000m²/g, futhi ivolumu ye-mesoporous ingafinyelela ku-2.0cm³/g, ihlinzeka ngendawo eyanele yokulayisha imithi. •Ukulawulwa kokukhululwa okuhlakaniphile: Ngokwenza izinguquko ebusweni bezakhiwo ezibucayi, ezithintekayo ze-pH, ezithintekayo ze-enzyme nezinye "izivalo eziphendulayo", ukukhululwa okukhethekile kwemithi ezindaweni ezithile kungafezeka, futhi izinga lokukhululwa lingalawulwa ngokuqondile nge-±5% emzimbeni. •Ukuhambisana okuhle kwe-biocompatibility: I-SiO₂ ubumsulwa bungezansi 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 zezinto eziphilayo. •Ukushintshwa 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 kwezinqubo Inqubo yokwakha esekelwe kumathuluzi e-cationic surfactant ifinyelela izakhiwo ze-mesoporous ezihambisanayo kakhulu ngokulawula kahle izinga lokushisa, i-pH, kanye nokugxila kwe-template. Inqubo yokukhiqiza ihambisana ngokuqinile nezindinganiso ze-GMP enezinhlelo zokuhlola usayizi be-pore ezihlanganisiwe, iqinisekisa ukulawulwa kwekhwalithi okuqinile ngokuhlolwa kweqoqo ngalinye 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 phakathi kuka-±3%, futhi ukusebenza kokucindezela amathayili kukhuphuke ngo-20%; 2.Ukuvimbela ukuhlanganiswa: kuvimba impahla ukuthi ingabambeki ku-punch, kunciphisa ukuvela kokuphuka nokubambeka, ikakhulukazi efanelekile ekwenzeni izithako zezinhlamvu eziphezulu; 3.Ukuqinisekisa: ukugxila emanzini amancane atholakala kumathayili, delay ukwehla kwezinto ezisebenzayo, futhi wandise isikhathi sokuphila kwemithi sibe yizinyanga eziyi-12-24; 4.Umthwali wokukhululwa: Ngokulawula isakhiwo se-pore ukuze kulungiswe izinga lokukhululwa kwemithi, ukufaka u-0.2% ekwakhiweni kwamathayili akhululwayo kungafinyelela ukukhululwa kwemithi isikhathi eside. 3. Ipharamitha ebalulekile yezobuchwepheshe (KTP) Ipharamitha Izinto Ipharamitha yokuhlola 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 kokumunca kwe-atomic 4. Izinkambu zokusebenza (Application Fields) 1. Umthwali wemithi: Imithi ye-chemotherapy enezinga eliphezulu (njenge-doxorubicin) ingakhululwa ngokunembile ngokuphendula kwe-pH/ukushisa ukuze kuncishiswe ukulimala kumaseli ajwayelekile; imithi engaxhunywanga (njenge-paclitaxel) ingafakwa ukuze kuthuthukiswe ukuxhumana nokuhlinzeka. 2. I-vector ye-Genetic/vaccine: ivikela i-siRNA ne-plasmid DNA ekuphukeni, ithuthukisa ukutholwa kwangaphakathi ngokwenza izinguquko ukuze kufinyelelwe ukulethwa okuhlosiwe; ibamba i-antigen ye-vaccine futhi wandise isikhathi sokugcina ukuze umphenduli we-immunity uqine. 3. Ukuhlola okuhlanganisiwe nokwelashwa: Layisha ama-dyes akhanyayo kanye ne-MRI/CT contrast agents ukuze kwakhiwe ipulatifomu yokuhlola nokwelashwa yokuhlola ngesikhathi sokulethwa kwemithi nezinguquko ze-lesion. 4. Ukuvimbela amagciwane nokulungisa izicubu: ifakwe ama-ion e-silver kanye nemithi yokuvimbela amagciwane ukuze ivimbe amagciwane isikhathi eside (ngokwelashwa kwezilonda); isakhiwo se-pore simela i-extracellular matrix, sisekele ukukhula nokuhlukaniswa kwezinhlayiya, futhi siza ekulungiseni amathambo/nemisipha. 5. Izindinganiso nezimfuneko (Standards & Regulations) •Ihambisana nezindinganiso eziningi zephakheji zomhlaba: 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 se-EU E551 sokudla. •Ihambisana nezikhombisi-ndlela zokuhambisana zomhlaba: ihambisana nezindinganiso zokukhiqiza ze-GMP nezidingo ze-HACCP zokuphepha kokudla. 6. Iziphakamiso ezibalulekile zokuphatha nokugcina •Umsebenzi wokulayisha imithi: kunconywa ukuthi kwenziwe ezingeni lokushisa elijwayelekile (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 lokwenza izinguquko ebusweni: 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℃, umswakama ophakathi <50%), gwema ukugcina ukukhanya, kusebenze isikhathi esiyiminyaka emibili, uvule ukuze usebenzise ngaphakathi kwenyanga eyodwa. 7. Izinzuzo zomkhiqizo (PA) •Izinga eliphezulu lokwenza ngokwezifiso: usayizi we-pore kanye nendawo ethile ingalawulwa kahle ngokuya ngosayizi we-API molecules, ihlinzeka ngezixazululo ezikhethekile zokuthwala. •Ukuhlanganiswa kwemisebenzi eminingi: inezisebenzi eziningi zokulayisha imithi, ukulethwa okuhlosiwe nokukhululwa okuhlakaniphile, okwenza kube lula ukuklama izinhlelo. •Ukuqinisekiswa kokuhambisana komhlaba: zonke izinkomba zihlangabezana nezidingo zephakheji zomhlaba, zisekela izicelo zemithi ezintsha zasekhaya nezangaphandle, zisheshise inqubo yokumaketha umkhiqizo. •Ukwenziwa kwezinsizakalo zobuchwepheshe: hlinzeka ngentuthuko yephrojekthi yokulayisha imithi, ukuhlolwa kokukhululwa emzimbeni nezinye izinsizakalo ezithuthukisiwe, ngokwesekwa kweqembu lobuchwepheshe elichwepheshile phakathi kwenqubo yonke. 8. Ukuqinisekiswa kwesistimu yeNkampani nezihlonipho •FSSC22000 •ISO22000：2018 •ISO9001：2015 •SHC HALAL •OU KOSHER •Ubufakazi be-FDA •FAMI-QS •SEDEX •Ilicence yokukhiqiza izithako zokudla •Ilicence yokukhiqiza izithako zokudla •I-National high-tech enterprise •Izinkampani ezikhethekile, ezithuthukisiwe nezintsha eGuangzhou •Amalungelo angu-71 avela kwiHhovisi leMali yeSizwe