Mesoporous Silicon Dioxide 1. Product Overview (Product Overview) 1.1 Basic definitions Zhongqi Mesoporous Silica, umkhiqizo osebenzayo wezokwelapha owenziwe ngenqubo ye-sol-gel, ubonakala njengomphezulu omhlophe ongenamumo. Izici zawo ezichazayo zifaka phakathi isakhiwo esijwayelekile se-mesoporous channel enezinhlaka 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 uqhubeka ungenakuphazamiseka ezakhiweni zokwelapha ezisebenzayo. Njengoba kunjalo, usebenza njengemathiriyeli eyinhloko yokwakha izinhlelo zokulethwa kwemithi ezinembile. 1.2 Core values Njengomkhiqizo wezokwelapha ophakeme, Zhongqi Mesoporous Silica uphumelela ekuxazululeni izinselelo zezimboni ezifana nokungafaneleki kahle nokuphakama okuphansi kwemithi ezakhiweni ezijwayelekile. Ngokulawula kahle isakhiwo sezinhlaka kanye nezici zendawo, ivumela ukulayisha imithi kahle nokukhululwa okuhlakaniphile, kuthuthukisa kakhulu ukutholakala kwe-biological ngenkathi kunciphisa imiphumela emibi emibi. Umkhiqizo uhambisana nezindinganiso eziqinile zomhlaba jikelele zokwelapha, uhlinzeka ngensiza eyinhloko yokwakha izinhlelo ezintsha zokwakha nokuthuthukiswa kwemithi ejwayelekile ephezulu. 2. Product Characteristics (Product Characteristics) 2.1 Structural and performance advantages •Isakhiwo se-mesoporous esiqondile: usayizi wezinhlaka ungashintshwa ngokuqhubekayo ukusuka ku-5 kuya ku-30nm, ukusabalala kosayizi be-pore kuyahambisana (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 wemithi. •Ukulawula ukukhululwa okuhlakaniphile: Ngokusebenzisa ukuguqulwa kwendawo kwe-pH okuthintekayo, okuthintekayo kwe-enzyme nezinye izakhiwo "eziphendulayo", ukukhululwa okukhethekile kwemithi ezindaweni ezihlosiwe kungafezeka, futhi izinga lokukhululwa lingalawulwa ngokuqondile nge-±5% ngaphakathi. •Ukuhambisana okuhle kwe-biocompatibility: 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 zezinto eziphilayo. •Ukuguqulwa okuphezulu: indawo ingaxhunywa 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 Process assurance Inqubo yokwakha esekelwe kumasampula we-cationic surfactant ifinyelela izakhiwo ze-mesoporous ezihambisanayo ngokulawula kahle izinga lokushisa lokuphendula, i-pH, kanye nokugxila kwamasampula. Inqubo yokukhiqiza ihambisana ngokuqinile nezindinganiso ze-GMP enezinhlelo zokubheka usayizi be-pore ezihlanganisiwe, iqinisekisa ukulawulwa kwekhwalithi okuqinile ngokuhlola ngokuqhubekayo ukuze kugcinwe izinga elizinzile nelilawulwayo phakathi nesikhathi sokukhiqiza. 2.3 Main role 1.Umsizi wokugeleza: thuthukisa ukugeleza kwe-powder ye-API, ukuze umehluko wesisindo sokugcwalisa ama-tablets ulawulwe phakathi kuka-±3%, futhi ukusebenza kokucindezela ama-tablet kwandiswe ngo-20%; 2.Ukuvimbela ukuhlanganiswa: vigela impahla ekubambeni, yehlisa umphumela wokuphuka nokubambeka, ikakhulukazi efanelekile ekulungiseleleni izithako ze-herbal ezinamafutha aphezulu; 3.Umsebenzi wokugcina: thola umswakama omncane ku-tablet, delay ukwehla kwezinto ezisebenzayo, futhi wandise isikhathi sokusebenza kwemithi sibe yizinyanga eziyi-12-24; 4.Umthwali wokukhululwa: Ngokulawula isakhiwo sezinhlaka ukuze kulungiswe izinga lokukhululwa kwemithi, ukufaka u-0.2% ekwakhiweni kwe-tablet yokukhululwa okuqhubekayo kungafinyelela ukukhululwa kwemithi isikhathi eside. 3. Key technical parameters (KTP) Parameter items Scope of indicators testing standard SiO₂ content (after burning) ≥99.0% USP-NF <281> BET specific surface area (m²/g) 300-1000 BET multi-point adsorption method Porosity (cm³g) 0.8-2.0 BJH law mean pore size （nm） 5-30 BJH law Dry weight loss (105℃,2h) ≤6.0% gravimetric analysis Heavy metal content (ppm) ≤10 Atomic absorption spectrophotometry 4. Application fields (Application Fields) 1. Umthwali wemithi: Imithi ye-chemotherapy enezinhlaka eziphezulu (njenge-doxorubicin) ingakhululwa ngokunembile ngokuphendula kwe-pH/ukushisa ukuze kuncishiswe ukulimala kumaseli ajwayelekile; imithi engaxhunywanga (njenge-paclitaxel) ingafakwa ukuze kuthuthukiswe ukuxhunywa nokutholakala. 2. I-genetic/vaccine vector: vigela i-siRNA ne-plasmid DNA ekwehliseni, thuthukisa ukutholwa kwamaseli ngokuguqulwa ukuze kuqinisekiswe ukulethwa okuhlosiwe; adsorb vaccine antigen futhi wandise isikhathi sokugcina ukuze uqinise impendulo ye-immune. 3. Ukuhlola nokwelapha okuhlanganisiwe: Layisha ama-dyes akhanyayo kanye nezinsiza zokuhlola i-MRI/CT ukuze kwakhiwe ipulatifomu yokuhlola nokwelapha yokubheka ngesikhathi sokulethwa kwemithi nezinguquko ze-lesion. 4. Ukuvimbela amagciwane nokulungisa izicubu: layisha ama-ion e-silver kanye nezidakamizwa zokuvimbela amagciwane ukuze kuvinjwe amagciwane isikhathi eside (ngokwelashwa kwezilonda); isakhiwo se-porous simisela i-extracellular matrix, sisekele ukukhula nokuhlukaniswa kwamangqamuzana, futhi sithuthukise ukulungiswa kwezicubu/izikhumba. 5. Standards and regulations (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 sokwengeza ukudla. •Uhambisana nezikhombisi-ndlela zokuhambisana zomhlaba: uhambisana nezindinganiso zokukhiqiza ze-GMP nezidingo ze-HACCP zokuphepha kokudla. 6. Key points for handling and storage •Ukulayisha imithi: kunconywa ukuthi kwenziwe ekamelweni lokushisa (20-25℃) kanye nomswakama <50%. Indlela yokufaka yokumunca isetshenziswa kumithi esolwandle, futhi indlela yokuphuma kwe-solvent isetshenziswa kumithi esebenzayo. Isikhathi sokulayisha kufanele sibe okungenani amahora amabili. •Iphuzu lokuguqulwa kwendawo: amaqembu asebenzayo afana nama-amino kanye 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 futhi dry (15-25℃, umswakama ophakathi <50%), gwema ukugcina ukukhanya, kusebenze isikhathi esiyiminyaka emibili, uvule ukuze usebenzise phakathi kwezinyanga eziyi-1. 7. Product Advantages (PA) •Izinga eliphezulu lokwenza ngokwezifiso: usayizi wezinhlaka kanye nendawo ethile ingalawulwa kahle ngokuya ngosayizi wamamolekyuli e-API, ihlinzeka ngezixazululo ezikhethekile zokuthwala. •Ukuhlanganiswa kwemisebenzi eminingi: inezinhlaka eziningi zokulayisha imithi, ukulethwa okuhlosiwe nokukhululwa okuhlakaniphile, okwenza kube lula ukuklama izakhi. •Ukuqinisekiswa kokuhambisana komhlaba: zonke izinkomba zihambisana nezidingo zepharmacopoeia zomhlaba, zisekela ukufaka izicelo zemithi ezintsha ezweni nasemhlabeni, zisheshisa inqubo yokumaketha umkhiqizo. •Ukuthuthukiswa kwesevisi yobuchwepheshe: hlinzeka ngentuthuko yenkqubo yokulayisha imithi, ukuhlolwa kokukhululwa ngaphakathi nezinye izinsizakalo ezithuthukisiwe, ngokwesekwa kweqembu lobuchwepheshe obuchwepheshile kuyo yonke inqubo. 8. Enterprise system certification and honors •FSSC22000 •ISO22000：2018 •ISO9001：2015 •SHC HALAL •OU KOSHER •FDA attestation •FAMI-QS •SEDEX •Imvume yokukhiqiza yokwengeza ukudla •Imvume yokukhiqiza yokwengeza ukudla •I-Enterprise ye-high-tech kazwelonke •Izinkampani ezikhethekile, ezithuthukisiwe nezintsha eGuangzhou •Amalungelo angu-64 avela kwiHhovisi leMali Yezwe