Mesoporous Silicon Dioxide 1. Ukubuka Kwenkampani (Product Overview) 1.1 Incazelo eziyisisekelo Zhongqi Mesoporous Silica, umkhiqizo wezokwelapha owenziwe nge-sol-gel process, ubonakala njengothuli oluphaphathekile olumbala omhlophe. Izici zawo ezichazayo zifaka phakathi isakhiwo esijwayelekile se-mesoporous channel esinezinhlaka ezivela ku-2 kuya ku-50nm kanye nendawo enkulu ethile yokuphila. Le msebenzi ibonisa amandla aphezulu okulayisha imithi, izinga lokukhululwa okulawulwayo, kanye nokuhambisana okuhle kwe-biocompatibility, ngenkathi ihlala ingaphenduli kumakhemikhali asebenzayo. Njengoba kunjalo, isebenza njengemathiriyeli eyinhloko yokwakha izinhlelo zokulethwa kwemithi ezinembile. 1.2 Izinzuzo eziyisisekelo Njengomkhiqizo wezokwelapha ophakeme, Zhongqi Mesoporous Silica ixazulula kahle izinselelo zezimboni ezifana nokungafaneleki kahle nokuphila kwemithi okuphansi ezinhlelweni ezijwayelekile. Ngokulawula kahle isakhiwo sezinhlaka kanye nezici zendawo, ivumela ukulayisha imithi kahle nokukhululwa okuhlakaniphile, kuthuthukisa kakhulu ukufinyelela kwe-biological ngenkathi kunciphisa imiphumela emibi. Umkhiqizo uhambisana nezindinganiso ezinzima zomhlaba wonke zokwelapha, uhlinzeka ngesisekelo semathiriyeli esiyinhloko sokuthuthukiswa kwezinhlelo ezintsha zokwakha nokuthuthukiswa kwemithi ye-generic ephezulu. 2. Izici Zomkhiqizo (Product Characteristics) 2.1 Izinzuzo zesakhiwo nezokusebenza •Isakhiwo se-mesoporous esiqondile: usayizi wezinhlaka ungashintshwa ngokuqhubekayo ukusuka ku-5 kuya ku-30nm, ukusatshalaliswa kosayizi be-pore kuhlangene (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. •Ukulawula ukukhululwa okuhlakaniphile: Ngokusebenzisa ukuguqulwa kwendawo kwezakhiwo ezithintekayo ze-pH, ezithintekayo ze-enzyme nezinye "izivalo eziphendulayo", ukukhululwa okukhethekile kwemithi ezindaweni ezihlosiwe kungafezeka, futhi izinga lokukhululwa lingalawulwa ngokuqondile nge-±5% in vitro. •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 kwamaseli okuqinisekiswa ngovivinyo lwe-cytotoxicity, okuhambisana nezindinganiso zokuphepha kwezinto eziphilayo. •Kulungiseka kakhulu: indawo ingaxhunywa ngokuqinile nezixhumi ezinjenge-folic acid, PEG kanye ne-peptide ukuze kuqinisekiswe ukulethwa okuhlosiwe, futhi ukusebenza kokuhlanganiswa okuhlosiwe kuphansi kakhulu kunezithuthi 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 kwesampula. Inqubo yokukhiqiza ihlale ilandela izindinganiso ze-GMP ngohlelo lokuhlola usayizi lwezinhlaka oluhlanganisiwe, kuqinisekiswa ukulawulwa kwekhwalithi okuqinile ngokuhlolwa kweqoqo ngalinye ukuze kugcinwe izimo ezinzima nezilawulwayo phakathi nesikhathi sokukhiqiza. 2.3 Indima enkulu 1.Umsizi wokugeleza: thuthukisa ukugeleza kwe-API powder, ukuze umehluko wesisindo sokugcwalisa samathablet ulawulwe ngaphakathi kwe-±3%, futhi ukusebenza kokucindezela amathablet kukhuphuke ngo-20%; 2.Ukuvimbela ukujola: vimbela impahla ekubambeni emgibeni, yehlise umphumela wokuphuka nokubamba, ikakhulukazi efanelekile ekwenzeni izithako ze-herbal ezinezinga eliphezulu; 3.Ukuvikelwa: thola umswakama omncane kumathablet, delay ukwehla kwezinto ezisebenzayo, futhi wandise isikhathi sokuphila kwemithi ku-12-24 izinyanga; 4.Umthwali wokukhululwa: Ngokulawula isakhiwo sezinhlaka ukuze kulungiswe izinga lokukhululwa kwemithi, ukwengeza u-0.2% ekwakhiweni kwamathablet akhululwayo kungafinyelela ukukhululwa kwemithi kwesikhathi eside. 3. Ipharamitha ezisemqoka zobuchwepheshe (KTP) Ipharamitha Izinto Umkhawulo wezinkomba Isivivinyo I-SiO₂ okuqukethwe (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 kwesikhumba (105℃,2h) ≤6.0% Ukuhlaziywa kwe-gravimetric Okuqukethwe kwezimbiwa ezinzima (ppm) ≤10 I-Atomic absorption spectrophotometry 4. Izigaba zokusebenza (Application Fields) 1. Umthwali wemithi: Imithi yokwelapha enezinga eliphezulu (njenge-doxorubicin) ingakhululwa ngokunembile ngokuphendula kwe-pH/ukushisa ukuze kuncishiswe ukulimala kumaseli ajwayelekile; imithi engasakazeki (njenge-paclitaxel) ingafakwa ukuze kuthuthukiswe ukwakheka nokufinyelela. 2. I-vector ye-genetic/vaccine: ivikela i-siRNA ne-plasmid DNA ekwehliseni, ithuthukise ukutholwa kwamaseli ngokuguqulwa ukuze kufinyelelwe ukulethwa okuhlosiwe; thola i-antigen ye-vaccine futhi wandise isikhathi sokugcina ukuze uqinise impendulo ye-immune. 3. Ukuhlola nokwelapha okuhlanganisiwe: Layisha ama-dyes akhanyayo kanye nezithako ze-MRI/CT ukuze kwakhiwe ipulatifomu yokuhlola nokwelapha yokubheka ngesikhathi esifanayo sokulethwa kwemithi nezinguquko ezibuhlungu. 4. Ukuvimbela amagciwane nokulungiswa kwezicubu: layisha ama-ion e-silver nezidakamizwa zokuvimbela amagciwane ukuze kuvinjelwe amagciwane isikhathi eside (ngokwelashwa kwezilonda); isakhiwo se-porous simisela i-extracellular matrix, sixhase ukukhula nokuhlukaniswa kwamangqamuzana, futhi siza ekulungiseni amathambo/izikhumba. 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 ubufakazi obufanele bokufaneleka: ukufakwa kwedatha ye-FDA ye-inactive ingredient, isitifiketi se-EU E551 sokwengeza ukudla. •Uhambisana nezikhombisi-ndlela zokuhambisana zomhlaba: ulandela izindinganiso zokukhiqiza ze-GMP nezimfuneko ze-HACCP zokuphepha kokudla. 6. Iziphakamiso ezibalulekile zokuphatha nokugcina •Umsebenzi wokulayisha imithi: kunconywa ukuba 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. •Iphuzu lokuguqulwa kwendawo: 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 kwesakhiwo se-mesoporous. •Izimo zokugcina: Vala ebhodleleni le-reagent elinsundu, ugcine endaweni epholile nepholile (15-25℃, umswakama ophakathi <50%), gwema ukukhanya, kusebenze isikhathi esiyiminyaka emibili, uvule ukuze usebenzise phakathi kwezinyanga eziyi-1. 7. Izinzuzo Zomkhiqizo (PA) •Izinga eliphezulu lokwenziwa: usayizi wezinhlaka kanye nendawo ethile ingalawulwa kahle ngokuya ngosayizi we-molecule ye-API, ihlinzeka ngesisombululo esikhethekile sokuthwala. •Ukuhlanganiswa kokusebenza okuningi: inezisebenzi eziningi zokulayisha imithi, ukulethwa okuhlosiwe nokukhululwa okuhlakaniphile, okwenza kube lula ukuklama izinhlelo. •Ukuqinisekiswa kokuhambisana komhlaba: zonke izinkomba zihlangabezana nezidingo zepharmacopoeia zomhlaba, zisekela ukufaka izicelo zemithi ezintsha ezweni nasemhlabeni, zisheshise inqubo yokumaketha umkhiqizo. •Ukuthuthukiswa kwezinsizakalo zobuchwepheshe: hlinzeka ngentuthuko yephrojekthi yokulayisha imithi, ukuhlolwa kokukhululwa in vitro nezinye izinsizakalo ezithuthukisiwe, ngokwesekwa kweqembu lobuchwepheshe elichwepheshile phakathi kwenqubo yonke. 8. Ukuqinisekiswa kwesistimu yebhizinisi 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 •Ibhizinisi eliphakeme lezobuchwepheshe •Izinhlangano ezikhethekile, ezithuthukisiwe nezintsha eGuangzhou •Amalungelo angama-40 avela kwi-Office of State Intellectual Property