Mesoporous Silicon Dioxide 1. Ukubuka KweMikhiqizo (Product Overview) 1.1 Incazelo eziyisisekelo Zhongqi Mesoporous Silica, umkhiqizo osebenzayo wezokwelapha owenziwe ngenqubo ye-sol-gel, ubonakala njengomphezulu omhlophe ongenamikhawulo. Izici zawo ezichazayo zifaka phakathi isakhiwo esijwayelekile semikhondo emikhulu enobukhulu bezikhala obuphakathi kuka-2 no-50nm kanye nendawo ethile enkulu kakhulu. Lo mkhiqizo ubonisa amandla aphezulu okulayisha imithi, izinga lokukhululwa okulawulwayo, kanye nokuhambisana okuhle kwezinto eziphilayo, ngenkathi uhlala ungaphenduli ezakhiweni zokwelapha ezisebenzayo. Njengoba kunjalo, usebenza njengomkhiqizo oyinhloko wokwakha izinhlelo zokulethwa kwemithi ezinembile. 1.2 Izinzuzo eziyisisekelo Njengomkhiqizo osezingeni eliphezulu wezokwelapha, Zhongqi Mesoporous Silica uphendula kahle izinselelo zezimboni ezifana nokungafaneleki kahle nokuphila kwesikhathi esifushane kwemithi ezakhiweni ezijwayelekile. Ngokulawula kahle isakhiwo sezakhiwo nezici zendawo, ivumela ukulayisha imithi kahle nokukhululwa okuhlakaniphile, kukhuphule kakhulu ukuhlinzeka kwezinto eziphilayo ngenkathi kunciphisa imiphumela emibi. Umkhiqizo uhambisana nezindinganiso eziqinile zomhlaba wonke zokwakhiwa kwezokwelapha, uhlinzeka ngoxhaso lwezinto eziyisisekelo zokuthuthukiswa kwemikhiqizo emisha kanye nokuthuthukiswa kwemithi ejwayelekile ephezulu. 2. Izici Zomkhiqizo (Product Characteristics) 2.1 Izinzuzo zesakhiwo nezokusebenza •Isakhiwo esiqondile semikhondo emikhulu: ubukhulu bezikhala bungashintshwa ngokuqhubekayo ukusuka ku-5 kuya ku-30nm, ukusabalala kobukhulu bezikhala kuyi-uniform (ukuphambuka ≤2nm), indawo ethile ye-BET ingafinyelela ku-300-1000m²/g, futhi ivolumu yemikhondo emikhulu ingafinyelela ku-2.0cm³/g, ihlinzeka ngendawo eyanele yokulayisha ama-molecule emithi. •Ukulawulwa kokukhululwa okuhlakaniphile: Ngokusebenzisa ukuguqulwa kwesikhumba se-pH esithintekayo, esithintekayo se-enzyme nezinye "izivalo eziphendulayo", ukukhululwa okukhethekile kwemithi ezindaweni ezithile kungafezeka, futhi izinga lokukhululwa lingalawulwa ngokuqondile nge-±5% emithonjeni. •Ukuhambisana okuhle kwezinto eziphilayo: Ukuhlanzeka kwe-SiO₂ kuphakathi kuka-99.0%, okuqukethwe kwezimbiwa ezinzima kuphansi kuka-10ppm, okuqukethwe kwe-arsenic kuphansi kuka-3ppm, futhi akukho ukulimala okubonakalayo kwezicubu okuqinisekiswe 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 kwezinqubo Inqubo yokwakha esekelwe kumasampula we-cationic surfactant ifinyelela izakhiwo ezijwayelekile zemikhondo emikhulu ngokulawula kahle izinga lokushisa, i-pH, kanye nokugxila kwamasampula. Inqubo yokukhiqiza ihambisana nezindinganiso ze-GMP ngohlelo lokubheka ubukhulu bezikhala oluhlanganisiwe, kuqinisekisa ukulawulwa kwekhwalithi okuqinile ngokuhlolwa kweqoqo ngalinye ukuze kugcinwe izinga elizinzile nelilawulwayo phakathi nesikhathi sokukhiqiza. 2.3 Indima eyinhloko 1.Ukunceda ukuhamba: kuthuthukisa ukuhamba 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 kumphongolo, kunciphisa ukuvela kokuphuka nokubambeka, ikakhulukazi efanelekile ekwenzeni izithako ze-herbal ezinezinga eliphezulu; 3.Ukuzinza: ibamba umswakama omncane kumathayili, ibambezele ukwehla kwezinto ezisebenzayo, futhi ikhulise isikhathi sokuphila kwemithi sibe yizinyanga eziyi-12-24; 4.Ukuthutha: Ngokulawula isakhiwo sezakhiwo ukuze kulungiswe izinga lokukhululwa kwemithi, ukufaka u-0.2% ekwakhiweni kwamathayili akhululwayo kungafeza 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 Ubukhulu obuphakathi bezikhala (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. Izingxenye zokusebenza (Application Fields) 1. Umthwali wemithi: Imithi ye-chemotherapy enezinga eliphezulu (njenge-doxorubicin) ingakhululwa kahle ngokuphendula kwe-pH/temperature ukuze kuncishiswe ukulimala kumaseli ajwayelekile; imithi engaxhunywanga (njenge-paclitaxel) ingafakwa ukuze kuthuthukiswe ukuxhunywa nokuhlinzeka. 2. I-vector ye-genetic/vaccine: ivikela i-siRNA ne-plasmid DNA ekwehliseni, ithuthukise ukutholwa kwangaphakathi ngokuguqulwa ukuze kufinyelelwe ekulethweni okuhlosiwe; ibamba i-antigen ye-vaccine futhi ikhulise isikhathi sokugcina ukuze kuqinise impendulo ye-immune. 3. Ukuhlola okuhlanganisiwe nokwelashwa: Layisha ama-dyes akhanyayo kanye nezithako ze-MRI/CT ukuze kwakhiwe ipulatifomu yokuhlola nokwelapha yokubheka ngesikhathi esifanayo sokulethwa kwemithi nezinguquko ezibuhlungu. 4. Ukuvimbela amagciwane nokulungisa izicubu: ifakwe ama-ion e-silver kanye nezidakamizwa zokuvimbela amagciwane isikhathi eside (ngokwelashwa kwezilonda); isakhiwo esinezakhiwo simisela i-extracellular matrix, sisekele ukukhula nokuhlukaniswa kwamangqamuzana, futhi sithuthukise ukulungiswa kwezicubu/izikhumba. 5. Izindinganiso nezimfuneko (Standards & Regulations) •Ihambisana nezindinganiso eziningi zepharmacopoeia zomhlaba: 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, isitifiketi se-EU E551 sokwengeza ukudla. •Ihambisana nezikhombisi-ndlela zokuhambisana zomhlaba: ihambisana nezincazelo zokukhiqiza ze-GMP nezidingo ze-HACCP zokuphepha kokudla. 6. Iziphakamiso ezibalulekile zokuphatha nokugcina •Ukulayisha imithi: kunconywa ukuthi kwenziwe ezingeni lokushisa (20-25℃) kanye nomswakama <50%. Indlela yokumunca yokuhlanza isetshenziswa kumithi esolubala, futhi indlela yokuphuma kwe-solvent isetshenziswa kumithi esolubala. Isikhathi sokulayisha kufanele sibe okungenani amahora amabili. •Ukwaziswa kokuguqulwa kwesikhumba: 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 esakhiweni semikhondo emikhulu. •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 kwezinyanga eziyi-1. 7. Izinzuzo zomkhiqizo (PA) •Izinga eliphezulu lokwenza ngezifiso: ubukhulu bezikhala kanye nendawo ethile ingalawulwa kahle ngokuya ngosayizi wamamolekyuli e-API, ihlinzeka ngoxhaso lwezithuthi ezikhethekile. •Ukuhlanganiswa kwemisebenzi eminingi: inezisebenzi eziningi zokulayisha imithi, ukulethwa okuhlosiwe nokukhululwa okuhlakaniphile, okwenza kube lula ukuklama. •Ukuqinisekiswa kokuhambisana komhlaba: zonke izinkomba zihlangabezana nezidingo zepharmacopoeia zomhlaba, zixhase ukufaka izicelo zemithi emisha yasekhaya nakwamanye amazwe, zisheshise inqubo yokumaketha umkhiqizo. •Ukwenziwa kwezinsizakalo zobuchwepheshe: hlinzeka ngentuthuko yephrojekthi yokulayisha imithi, ukuhlolwa kokukhululwa kwangaphakathi nezinye izinsizakalo ezithuthukisiwe, ngokuxhaswa kweqembu lobuchwepheshe elichwepheshile kuyo yonke inqubo. 8. Ukuqinisekiswa kwesistimu yeNkampani kanye 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-National high-tech enterprise •Izinkampani ezikhethekile, ezihlukile nezintsha eGuangzhou •Amalungelo angu-83 avela kwi-Office of State Intellectual Property