Mesoporous Silicon Dioxide 1. Ukubuka Kwamkhiqizo (Product Overview) 1.1 Incazelo eziyisisekelo Zhongqi Mesoporous Silica, umkhiqizo wezokwelapha owenziwe ngenqubo ye-sol-gel, ubonakala njengothuli oluphaphathekile olumbala omhlophe. Izici zayo ezichazayo zifaka phakathi kwesakhiwo esijwayelekile se-mesoporous channel esinezinhlaka ezivela ku-2 kuya ku-50nm kanye nendawo ethile enkulu kakhulu. Lo mkhiqizo ubonisa amandla aphezulu okulayisha imithi, izinga lokukhululwa okulawulwayo, kanye nokuhambisana okuhle ne-biocompatibility, ngenkathi uhlala ungasebenzi ngokwemikhakha ye-pharmaceutical active. Njengoba kunjalo, usebenza njengemathiriyeli eyinhloko yokwakha izinhlelo zokulethwa kwemithi ezinembile. 1.2 Izinzuzo eziyisisekelo Njengomkhiqizo wezokwelapha ophakeme, Zhongqi Mesoporous Silica uphumelela ekuxazululeni izinselelo zezimboni ezifana nokungafaneleki kahle nokuphila okufushane kwemithi ezakhiweni ezijwayelekile. Ngokulawula kahle isakhiwo sezinhlaka kanye nezici zendawo, ivumela ukulayisha imithi kahle nokukhululwa okuhlakaniphile, okwandisa kakhulu ukutholakala kwe-bio ngenkathi kunciphisa imiphumela emibi. Umkhiqizo uhambisana nezindinganiso eziqinile zomhlaba jikelele zokwelapha, unikeza ukwesekwa kwemathiriyeli eyinhloko ekuthuthukisweni kwezakhiwo ezintsha kanye 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, ukusabalala kosayizi wezinhlaka kuhlangene (ukuphambuka ≤2nm), indawo ethile ye-BET ingafinyelela ku-300-1000m²/g, futhi ivolumu ye-mesoporous ingafinyelela ku-2.0cm³/g, inikeza indawo eyanele yokulayisha imithi. •Ukulawulwa kokukhululwa okuhlakaniphile: Ngokusebenzisa ukuguqulwa kwendawo kwezakhiwo ezibucayi ze-pH, ezibucayi ze-enzyme nezinye "izivalo eziphendulayo", ukukhululwa okukhethekile kwemithi ezindaweni ezithile kungafezeka, futhi izinga lokukhululwa lingalawulwa ngokuqondile nge-±5% emzimbeni. •Ukuhambisana okuhle ne-biocompatibility: I-SiO₂ ubumsulwa buphakeme kune-99.0%, okuqukethwe kwezimbiwa ezinzima kuphansi kune-10ppm, okuqukethwe kwe-arsenic kuphansi kune-3ppm, futhi akukho ukulimala okubonakalayo kwamaseli okuqinisekiswa ngovivinyo lwe-cytotoxicity, okuhlangabezana nezindinganiso zokuphepha kwezinto eziphilayo. •Ukuguqulwa okuphezulu: indawo ingaxhunywa ngokuqinile nezixhumi ezifana ne-folic acid, PEG kanye ne-peptide ukuze kuqinisekiswe ukulethwa okuphendulayo, futhi ukusebenza kokuhlanganiswa okuhlosiwe kuphakathi kuka-5-8 izikhathi kuphansi kunezithuthi ezijwayelekile. 2.2 Ukuqinisekiswa kwenqubo Inqubo yokwakha esekelwe kumasampula e-cationic surfactant ifinyelela izakhiwo ze-mesoporous ezihambisanayo kakhulu ngokulawula kahle izinga lokushisa lokuphendula, i-pH, kanye nokugxila kwesampula. Inqubo yokukhiqiza ihlale ihambisana nezindinganiso ze-GMP ngohlelo lokuhlola usayizi lwezinhlaka oluhlanganisiwe, kuqinisekisa ukulawulwa kwekhwalithi okuqinile ngokuhlolwa kweqoqo ngokuqoqo ukuze kugcinwe izinga elizinzile nelilawulwayo phakathi nesikhathi sokukhiqiza. 2.3 Indima eyinhloko 1.Umsizi wokugeleza: uthuthukisa ukugeleza kwe-powder ye-API, ukuze umehluko wesisindo sokugcwalisa ama-tablet ulawulwe ngaphakathi kwe-±3%, futhi ukusebenza kokucindezela ama-tablet kukhuphuke ngo-20%; 2.Ukuvimbela ukujolisa: uvimbela impahla ekubambeni kumphakeli, unciphisa isimo sokuphuka nokubamba, ikakhulukazi efanelekile ekulungiseleleni izithako ze-herbal ezinamafutha aphezulu; 3.Ukuvikelwa: udonsa umswakama omncane ku-tablet, delay ukwehla kwezithako ezisebenzayo, futhi wandise isikhathi sokuphila kwemithi ku-12-24 izinyanga; 4.Umthwali wokukhululwa: Ngokulawula isakhiwo sezinhlaka ukuze kulungiswe izinga lokukhululwa kwemithi, ukufaka u-0.2% ekwakhiweni kwe-tablet yokukhululwa okuqhubekayo kungafinyelela ukukhululwa kwemithi okwesikhathi eside. 3. Ipharamitha ebalulekile yezobuchwepheshe (KTP) Ipharamitha Izinto Umkhawulo wezinkomba Isilinganiso sokuhlola 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 Usayizi ophakathi (nm) 5-30 Umthetho we-BJH Ukulahleka kwesisindo esomile (105℃,2h) ≤6.0% ukuhlaziywa kwe-gravimetric Okuqukethwe kwezimbiwa ezinzima (ppm) ≤10 Ukuhlaziywa kokumunca kwe-atomic 4. Izigaba zokusebenza (Application Fields) 1. Umthwali wemithi: Imithi ye-chemotherapy enezinga eliphezulu (njenge-doxorubicin) ingakhululwa ngok准确 pH/ukuphendula kwezinga lokushisa ukuze kuncishiswe ukulimala kumaseli ajwayelekile; imithi engaxhunywanga (njenge-paclitaxel) ingafakwa ukuze kuthuthukiswe ukuxhunywa nokutholakala. 2. I-vector ye-genetic/vaccine: ivikela i-siRNA ne-plasmid DNA ekwehliseni, ithuthukise ukutholwa kwamaseli ngokuguqulwa ukuze kuqinisekiswe ukulethwa okuhlosiwe; idonsa i-antigen ye-vaccine futhi wandise isikhathi sokugcina ukuze uqinise impendulo ye-immune. 3. Ukuhlola nokwelashwa okuhlanganisiwe: Layisha ama-dyes akhanyayo kanye nezinsiza zokuhlola ze-MRI/CT ukuze kwakhiwe ipulatifomu yokuhlola nokwelashwa yokuhlola ngesikhathi sokulethwa kwemithi nezinguquko ezithinta. 4. Ukuvimbela amagciwane nokulungiswa kwezicubu: ifakwe ama-ion e-silver nezidakamizwa zokuvimbela amagciwane isikhathi eside (ngokwelashwa kwezilonda); isakhiwo se-porous simela i-extracellular matrix, sisekela ukukhula nokuhlukaniswa kwamangqamuzana, futhi siza ekulungiseni amathambo/nemisipha. 5. Izindinganiso nezimfuneko (Standards & Regulations) •Ihambisana nezindinganiso eziningi ze-pharmacopoeia 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 sokudla. •Ihambisana nezikhombisi-ndlela zokuhambisana zomhlaba: ihambisana nezindinganiso zokukhiqiza ze-GMP nezimfuneko ze-HACCP zokuphepha kokudla. 6. Amaphuzu abalulekile okuphatha nokugcina •Ukulayisha imithi: kunconywa ukuthi 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. •Ukwenziwa kwendawo: amaqembu asebenzayo afana nama-amino nama-carboxyl kufanele aguqulwe ku-pH phakathi kuka-5 no-8 ukuze kugwenywe umonakalo omkhulu we-asidi ne-alkali esakhiweni se-mesoporous. •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 kwenyanga eyodwa. 7. Izinzuzo zomkhiqizo (PA) •Izinga eliphezulu lokwenza ngokwezifiso: usayizi wezinhlaka kanye nendawo ethile kungalawulwa kahle ngokuya ngosayizi we-molecule ye-API, kunikeza izixazululo ezikhethekile zokuthwala. •Ukuhlanganiswa kwemisebenzi eminingi: inezisebenzi eziningi zokulayisha imithi, ukulethwa okuhlosiwe kanye nokukhululwa okuhlakaniphile, okwenza kube lula ukwakhiwa kwezakhiwo. •Ukuqinisekiswa kokuhambisana komhlaba: zonke izinkomba zihlangabezana nezidingo ze-pharmacopoeia zomhlaba, zisekela ukufaka izicelo zemithi ezintsha ezweni nasemhlabeni, zisheshise inqubo yokumaketha umkhiqizo. •Ukuthuthukiswa kwesevisi yobuchwepheshe: ukuhlinzeka ngentuthuko yenqubo yokulayisha imithi, ukuhlolwa kokukhululwa emzimbeni nezinye izinsizakalo ezithuthukisiwe, ngokwesekwa kweqembu lobuchwepheshe elichwepheshile kuyo yonke inqubo. 8. Ukuqinisekiswa kwesistimu yebhizinisi nezihlonipho •FSSC22000 •ISO22000：2018 •ISO9001：2015 •SHC HALAL •OU KOSHER •Ubufakazi be-FDA •FAMI-QS •SEDEX •Ilicence yokukhiqiza izithako zokudla •Ilicence yokukhiqiza izithako zokudla •Ibhizinisi eliphakeme lezobuchwepheshe •Izinhlangano ezikhethekile, ezithuthukisiwe nezintsha eGuangzhou •Amalungelo angu-58 avela kwiHhovisi leZimpahla Zobuhlakani Zomhlaba