Mesoporous Silicon Dioxide 1. Ukubuka Kwenkanyezi (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 enezinhlaka ezivela ku-2 kuya ku-50nm kanye nendawo ethile enkulu kakhulu. Lo mkhiqizo ubonisa amandla aphezulu okulayisha imithi, izinga lokukhulula elilawulwayo, kanye nokuhambisana okuhle ne-biocompatibility, ngenkathi uhlala ungasebenzi ngokwemvelo ezithako zokwelapha ezisebenzayo. Njengoba kunjalo, usebenza njengomkhiqizo oyinhloko wokwakha izinhlelo zokulethwa kwemithi ezinembile. 1.2 Izinzuzo eziyisisekelo Njengomkhiqizo wezokwelapha ophakeme, Zhongqi Mesoporous Silica uphumelela ekuxazululeni izinselelo zezimboni ezifana nokungafinyeleli kahle nokuphila kwesikhathi esifushane kwemithi ezinhlelweni ezijwayelekile. Ngokulawula kahle isakhiwo sezinhlaka kanye nezici zendawo, ivumela ukulayisha imithi kahle nokukhulula okuhlakaniphile, kuthuthukisa kakhulu ukutholakala kwe-biological ngenkathi kunciphisa imiphumela emibi. Umkhiqizo uhambisana nezindinganiso eziqinile zomhlaba jikelele zokwelapha, unikeza ukwesekwa kwemikhiqizo eyinhloko ekuthuthukisweni kwezinhlelo ezintsha zokwakha kanye nokuthuthukiswa kwemithi ye-generic ephezulu. 2. Izici Zomkhiqizo (Product Characteristics) 2.1 Izinzuzo zesakhiwo nezokusebenza •Isakhiwo se-mesoporous esiqondile: usayizi wezinhlaka ungashintshwa ngokunembile kusuka ku-5 kuya ku-30nm, ukusabalala kosayizi bezinhlaka 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 imithi. •Ukulawula ukukhulula okuhlakaniphile: Ngokusebenzisa ukuguqulwa kwesurface kwe-pH sensitive, enzyme sensitive nezinye "izakhiwo ze-valve eziphendulayo", ukukhulula okukhethekile kwemithi ezindaweni ezihlosiwe kungafezeka, futhi izinga lokukhulula lingalawulwa ngokunembile ku-±5% in vitro. •Ukuhambisana okuhle ne-biocompatibility: I-SiO₂ purity ingaphezu kuka-99.0%, okuqukethwe kwe-heavy metal kungaphansi kuka-10ppm, okuqukethwe kwe-arsenic kungaphansi kuka-3ppm, futhi akukho ukulimala okubonakalayo kwezinhlayiya okuqinisekiswe ngovivinyo lwe-cytotoxicity, okuhambisana nezindinganiso zokuphepha zezinto eziphilayo. •I-modifiable kakhulu: ubuso bungaxhunywa ngokuqinile nezinsiza ezihlosiwe ezifana ne-folic acid, PEG kanye ne-peptide ukuze kufezwe ukulethwa okuhlosiwe, futhi ukusebenza kokuhlanganiswa okuhlosiwe kuphakathi kuka-5-8 izikhathi kuphansi kunezithuthi ezijwayelekile. 2.2 Ukuqinisekiswa kwezinqubo Inqubo yokwakha esekelwe ku-cationic surfactant template ithola izakhiwo ze-mesoporous ezihambisanayo kakhulu ngokulawula kahle izinga lokushisa kokuphendula, i-pH, kanye nokugxila kwe-template. Inqubo yokukhiqiza ihlale ihambisana nezindinganiso ze-GMP enohlelo lokubheka usayizi lwezinhlaka ku-inthanethi, iqinisekisa ukulawulwa kwekhwalithi okuqinile ngokuhlolwa kwe-batch-by-batch ukuze kugcinwe izinga elizinzile nelilawulwayo phakathi nesikhathi sokukhiqiza. 2.3 Indima enkulu 1.Usizo lokugeleza: kuthuthukisa ukugeleza kwe-API powder, ukuze umehluko wesisindo sokugcwalisa samathablet ulawulwe ngaphakathi ku-±3%, futhi ukusebenza kokucindezela amathablet kukhuphuke ngo-20%; 2.Ukuvimbela ukuhlanganiswa: kuvimba impahla ukuthi ingabambeki ku-punch, kunciphisa ukuvela kokuphuka nokubambeka, ikakhulukazi efanelekile ekulungiseleleni izithako ze-chinese herbal ezinamafutha; 3.Ukuzinza: ibamba umswakama omncane kumathablet, ibambezele ukwehla kwezithako ezisebenzayo, futhi ikhulise isikhathi sokuphila kwemithi sibe yizinyanga eziyi-12-24; 4.Ukukhulula umthwali: Ngokulawula isakhiwo sezinhlaka ukuze kulungiswe izinga lokukhulula imithi, ukufaka u-0.2% ekwakhiweni kwamathablet akhululwayo kungafeza ukukhulula kwemithi okwesikhathi eside. 3. Ipharamitha ezisemqoka zobuchwepheshe (KTP) Ipharamitha Izinto Umkhawulo wezinkomba Isilinganiso sokuhlola I-SiO₂ okuqukethwe (ngemuva kokushiswa) ≥99.0% USP-NF <281> I-BET indawo ethile (m²/g) 300-1000 I-BET multi-point adsorption method I-Porosity (cm³g) 0.8-2.0 I-BJH law Usayizi ophakathi kwezinhlaka （nm） 5-30 I-BJH law 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 ye-chemotherapy enezinga eliphezulu (njenge-doxorubicin) ingakhululwa ngokunembile nge-pH/ukushisa ukuphendula ukuze kuncishiswe ukulimala kumaseli ajwayelekile; imithi engasakazeki (njenge-paclitaxel) ingafakwa ukuze kuthuthukiswe ukwakheka nokutholakala. 2. I-vector ye-genetic/vaccine: ivikela i-siRNA ne-plasmid DNA ekwehliseni, ithuthukisa ukutholwa kwangaphakathi ngokuguqulwa ukuze kufezwe ukulethwa okuhlosiwe; ibamba i-antigen ye-vaccine futhi ikhulise isikhathi sokugcina ukuze iqinise impendulo ye-immune. 3. Ukuhlola nokwelashwa okuhlanganisiwe: Layisha ama-dyes akhanyayo kanye ne-MRI/CT contrast agents ukuze kwakhiwe ipulatifomu yokuhlola nokwelashwa yokubheka ngesikhathi esifanayo ukulethwa kwemithi nezinguquko ze-lesion. 4. Ukulwa namagciwane nokulungisa izicubu: ilayisha ama-silver ions kanye nama-antibiotics ukuvimbela amagciwane isikhathi eside (ngokwelashwa kwezilonda); isakhiwo se-porous simela i-extracellular matrix, sisekele ukukhula nokuhlukaniswa kwe-stem cells, futhi sithuthukise ukulungiswa kwezitho/skin. 5. Izindinganiso nemithetho (Standards & Regulations) •Ihamba nezindinganiso eziningi ze-international pharmacopoeia: USP-NF, European Pharmacopoeia (Ph. Eur.), Japanese Pharmacopoeia (JP), kanye ne-China Pharmacopoeia (ChP 2025). •Thola isitifiketi esihlobene: ukufakwa kwi-FDA inactive ingredient database, i-EU E551 food additive certification. •Hamba nezikhombisi-ndlela zokuhambisana zomhlaba: hamba nezincazelo zokukhiqiza ze-GMP kanye nezidingo ze-HACCP food safety system. 6. Iziphakamiso ezibalulekile zokuphatha nokugcina •Umsebenzi wokulayisha imithi: kunconywa ukuthi kwenziwe ekamelweni lokushisa (20-25℃) kanye nomswakama <50%. Indlela yokumunca yokumunca isetshenziswa kumithi esolubala, futhi indlela yokuphuma kwe-solvent isetshenziswa kumithi esolubala. Isikhathi sokulayisha kufanele sibe okungenani amahora amabili. •Qaphela ukuguqulwa kwesurface: 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 elinsomi, ugcine endaweni epholile nepholile (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 ngokwezifiso: usayizi wezinhlaka kanye nendawo ethile kungalawulwa ngokunembile ngokuya ngosayizi we-API molecules, kuhlinzeka ngezixazululo ezikhethekile zokuthwala. •Ukuhlanganiswa kwemisebenzi eminingi: inezisebenzi eziningi zokulayisha imithi, ukulethwa okuhlosiwe nokukhulula okuhlakaniphile, okwenza kube lula ukuklama izinhlelo. •Ukuqinisekiswa kokuhambisana komhlaba: zonke izinkomba zihambisana nezidingo ze-international pharmacopoeia, zisekela izicelo zemithi ezintsha zasekhaya nezangaphandle, zisheshisa inqubo yokumaketha umkhiqizo. •Ukwenziwa kwezinsizakalo zobuchwepheshe: hlinzeka ngentuthuko yephrojekthi yokulayisha imithi, ukuhlolwa kokukhulula in vitro nezinye izinsizakalo ezingeziwe, ngokwesekwa kweqembu lobuchwepheshe lochwepheshe phakathi kwenqubo yonke. 8. Ukuqinisekiswa kwesistimu ye-Enterprise kanye neziqinisekiso •FSSC22000 •ISO22000：2018 •ISO9001：2015 •SHC HALAL •OU KOSHER •I-FDA attestation •FAMI-QS •SEDEX •I-licence yokukhiqiza izithako zokudla •I-licence yokukhiqiza izithako zokudla •I-National high-tech enterprise •Izinkampani ezikhethekile, ezithuthukisiwe nezintsha eGuangzhou •Amalungelo angu-76 avela kwi-Office of State Intellectual Property