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 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 ungasebenzi ngokwemvelo ezithako zokwelapha ezisebenzayo. Njengoba kunjalo, usebenza njengemathiriyeli eyinhloko yokwakha izinhlelo zokulethwa kwemithi ezinembile. 1.2 Izinzuzo eziyisisekelo Njengomkhiqizo wezokwelapha ophakeme, Zhongqi Mesoporous Silica ixazulula kahle izinselelo zezimboni ezifana nokungafinyeleli kahle nokuphila kwemithi okuphansi ezinhlelweni ezijwayelekile. Ngokulawula kahle isakhiwo sezinhlaka kanye nezici zendawo, ivumela ukulayisha imithi kahle kanye nokukhululwa okuhlakaniphile, kukhuphula kakhulu ukutholakala kwe-biological ngenkathi kunciphisa imiphumela emibi. Umkhiqizo uhambisana nezindinganiso eziqinile zomhlaba jikelele zokwelapha, uhlinzeka ngensiza eyinhloko yokwakha izinhlelo ezintsha zokwakha imikhiqizo yokwelapha. 2. Izici Zomkhiqizo (Product Characteristics) 2.1 Izinzuzo zesakhiwo nokusebenza •Isakhiwo se-mesoporous esiqondile: usayizi wezinhlaka ungashintshwa ngokuqhubekayo ukusuka ku-5 kuya ku-30nm, ukusabalala kosayizi bephoreku kuyi-uniform (ukuphambuka ≤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 ezithile kungafezwa, 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 okuqinisekiswa ngovivinyo lwe-cytotoxicity, okuhambisana nezindinganiso zokuphepha zezinto eziphilayo. •Ukuguqulwa okuphezulu: indawo ingaxhunywa ngokuqinile nezixhumi 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 ku-cationic surfactant template ifinyelela izakhiwo ze-mesoporous ezihambisanayo kakhulu ngokulawula kahle izinga lokushisa, i-pH, kanye nokugxila kwe-template. Inqubo yokukhiqiza ihlale ihambisana nezindinganiso ze-GMP enezinhlelo zokubheka usayizi bephoreku 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 ngaphakathi kwe-±3%, futhi ukusebenza kokucindezela amathayili kukhuphuke ngo-20%; 2.Ukuvimbela ukujolisa: kuvimba impahla ukuthi ingabambeki ku-punch, kunciphisa ukuvela kokuphuka nokubambeka, ikakhulukazi efanelekile ekulungiseleleni izithako ze-Chinese herbal extract ezinamafutha; 3.Ukuvuselela: i-adsorb moisture encane kumathayili, ibambezele ukwehla kwezithako ezisebenzayo, futhi ikhulise 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 kungafinyelela ukukhululwa kwemithi okwesikhathi eside. 3. Ipharamitha ezibalulekile zobuchwepheshe (KTP) Ipharamitha Izinto Izingxenye zophawu Izinga lokuhlola Okuqukethwe kwe-SiO₂ (ngemva 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 kwephoreku (nm) 5-30 Umthetho we-BJH Ukulahleka kwesisindo esomile (105℃,2h) ≤6.0% Ukuhlaziywa kwe-gravimetric Okuqukethwe kwe-heavy metal (ppm) ≤10 I-Atomic absorption spectrophotometry 4. Izinkambu zokusebenza (Application Fields) 1. Umthwali wemithi: Imithi yokwelapha enezinga eliphezulu (njenge-doxorubicin) ingakhululwa ngokunembile nge-pH/ukushisa ukuphendula ukuze kuncishiswe ukulimala kumaseli ajwayelekile; imithi engasolwandle (njenge-paclitaxel) ingafakwa ukuze kuthuthukiswe ukuxubana nokutholakala. 2. I-vector ye-genetic/vaccine: ivikela i-siRNA ne-plasmid DNA ekwehliseni, ikhulise ukutholwa kwamaseli ngokuguqulwa ukuze kuqinisekiswe ukulethwa okuhlosiwe; i-adsorb vaccine antigen futhi ikhulise isikhathi sokugcina ukuze umphenduli we-immunity uqine. 3. Ukuhlola nokwelashwa okuhlanganisiwe: Layisha ama-dyes akhanyayo kanye ne-MRI/CT contrast agents ukuze kwakhiwe ipulatifomu yokuhlola nokwelapha yokubheka ngesikhathi esifanayo sokulethwa kwemithi nezinguquko ze-lesion. 4. Ukuvimbela amagciwane nokulungiswa kwezicubu: ifakwe ama-silver ions nezidakamizwa zokuvimbela amagciwane isikhathi eside (ngokwelashwa kwezilonda); isakhiwo se-porous simisela i-extracellular matrix, sikhuthaza ukukhula nokuhlukaniswa kwamangqamuzana, futhi siza ekulungiseni amathambo/nemisipha. 5. Izindinganiso nemithetho (Standards & Regulations) •Ihambisana nezindinganiso eziningi ze-international pharmacopoeia: 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, i-EU E551 food additive certification. •Ihambisana nezikhombisi-ndlela zokuhambisana zomhlaba: ihambisana nezindinganiso zokukhiqiza ze-GMP kanye nezidingo ze-HACCP zokuphepha kokudla. 6. Iziphakamiso ezibalulekile zokuphatha nokugcina •Umsebenzi wokulayisha imithi: kunconywa ukuthi kwenziwe ekamelweni lokushisa (20-25℃) kanye ne-humidity <50%. Indlela yokumunca yokuhlanza isetshenziswa kumithi esolwandle, futhi indlela yokuphuma kwe-solvent isetshenziswa kumithi enezinhlaka zamafutha. 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 okuqinile kwe-asidi kanye ne-alkali isakhiwo se-mesoporous. •Izimo zokugcina: Vala ebhodleleni le-reagent elinsundu, ugcine endaweni epholile nephephile (15-25℃, humidity ephansi <50%), gwema ukugcina ukukhanya, kusebenze isikhathi esiyiminyaka emibili, uvule ukuze usebenzise ngaphakathi kwenyanga eyodwa. 7. Izinzuzo zomkhiqizo (PA) •Izinga eliphezulu lokwenza ngokwezifiso: usayizi wezinhlaka kanye nendawo ethile ingalawulwa kahle ngokuya ngosayizi wamamolekyuli e-API, ihlinzeka ngesisombululo sokuthwala esikhethekile. •Ukuhlanganiswa kwemisebenzi eminingi: inezisebenzi eziningi zokulayisha imithi, ukulethwa okuhlosiwe kanye nokukhululwa okuhlakaniphile, okwenza kube lula ukuklama. •Ukuqinisekiswa kokuhambisana komhlaba: zonke izinkomba zihlangabezana nezidingo ze-international pharmacopoeia, 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 nenqubo 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 izithako zokudla •I-licence yokukhiqiza izithako zokudla •Ibhizinisi eliphakeme le-high-tech •Ibhizinisi elikhethekile, elihlelekile nelisha eGuangzhou •Amalungelo angu-38 avela kwi-Office of State Intellectual Property