1. Ukubuka Kwamkhiqizo (Product Overview) 1.1 Izincazelo eziyisisekelo I-Zhongqi Mesoporous Silica, i-excipient yepharmaceutical esebenzayo eyenziwe ngenqubo ye-sol-gel, ibonakala njengomphezulu omhlophe ongenamkhawulo. Izici zayo ezichazayo zifaka phakathi isakhiwo se-mesoporous esijwayelekile esinezakhiwo ezivulekile ezivela ku-2 kuya ku-50nm kanye nendawo ethile enkulu kakhulu. Le msebenzi ibonisa amandla aphezulu okulayisha imithi, izinga lokukhululwa okulawulwayo, kanye nokuhambisana okuhle ne-biocompatibility, ngenkathi ihlala ingekho emthethweni ezithako ezisebenzayo zepharmaceutical. Njengoba kunjalo, isebenza njengemathiriyeli eyinhloko yokwakha izinhlelo zokulethwa kwemithi ezinembile. 1.2 Izinzuzo eziyisisekelo Njengomkhiqizo ophakeme we-excipient yepharmaceutical, i-Zhongqi Mesoporous Silica ixazulula kahle izinselelo zezimboni ezifana nokungafinyeleli kahle nokuphila kwemithi okuphansi ezinhlelweni ezijwayelekile. Ngokulawula kahle isakhiwo sezakhiwo ezivulekile nezici zendawo, ivumela ukulayisha imithi kahle nokukhululwa okuhlakaniphile, okwandisa kakhulu ukutholakala kwe-biological ngenkathi kunciphisa imiphumela emibi emibi. Umkhiqizo uhambisana nezindinganiso eziqinile ze-excipient yepharmaceutical emhlabeni jikelele, unikeza ukwesekwa kwemathiriyeli eyinhloko ekuthuthukiseni izinhlelo ezintsha zokwakha kanye nokuthuthukiswa kwemithi yejenereyikhi ephezulu. 2. Izici Zomkhiqizo (Product Characteristics) 2.1 Izinzuzo zesakhiwo nezokusebenza •Isakhiwo se-mesoporous esiqondile: usayizi wezikhala ungashintshwa ngokuqhubekayo kusuka ku-5 kuya ku-30nm, ukusabalala kosayizi bezikhala kuyi-uniform (ukuphambuka ≤2nm), indawo ethile ye-BET ingafinyelela ku-300-1000m²/g, futhi ivolumu ye-mesoporous ingafinyelela ku-2.0cm³/g, inikeza isikhala esanele sokulayisha imithi. •Ukulawulwa kokukhululwa okuhlakaniphile: Ngokusebenzisa ukuguqulwa kwesurface kwezakhiwo ezithintekayo ze-pH, ezithintekayo ze-enzyme nezinye "izivalo eziphendulayo", ukukhululwa okukhethekile kwemithi ezindaweni ezithile kungafezwa, futhi izinga lokukhululwa lingalawulwa ngokuqondile nge-±5% emzimbeni. •Ukuhambisana okuhle ne-biocompatibility: I-SiO₂ purity ingaphezu kuka-99.0%, okuqukethwe kwezimbiwa ezinzima kungaphansi kuka-10ppm, okuqukethwe kwe-arsenic kungaphansi kuka-3ppm, futhi akukho ukulimala okubonakalayo kwezicubu okuqinisekiswa ukuhlolwa kwe-cytotoxicity, okuhambisana nezindinganiso zokuphepha kwezinto eziphilayo. •Ukuguqulwa okuphezulu: ubuso bungaxhunywa ngokuqinile nezigaba ezinjenge-folic acid, PEG kanye ne-peptide ukuze kuqinisekiswe ukulethwa okuhlosiwe, futhi ukusebenza kokuhlanganiswa okuhlosiwe kuphansi kakhulu kunezithako ezijwayelekile. 2.2 Ukuqinisekiswa kwenqubo Inqubo yokwakha ye-cationic surfactant template-assisted ifinyelela izakhiwo ze-mesoporous ezihambisanayo kakhulu ngokulawula kahle izinga lokushisa lokuphendula, i-pH, kanye nokugxila kwe-template. Inqubo yokukhiqiza ihlale ihambisana nezindinganiso ze-GMP ngokuhlanganiswa kwesistimu yokuhlola usayizi bezikhala, iqinisekisa ukulawulwa kwekhwalithi okuqinile ngokuhlolwa kweqoqo ngokuqoqo ukuze kugcinwe izimo ezinzile nezilawulwayo phakathi nesikhathi sokukhiqiza. 2.3 Indima eyinhloko 1.Ukunceda ukuhamba: kuthuthukisa ukuhamba kwe-API powder, ukuze umehluko wesisindo sokugcwalisa samathablet ulawulwe ngaphakathi kwe-±3%, futhi ukusebenza kokucindezela amathablet kukhuphuke ngo-20%; 2.Ukuvimbela ukuhlanganiswa: ivimbela impahla ekubambeni ku-punch, yehlisa isimo sokuphuka nokubamba, ikakhulukazi ifanele uk preparation ye-Chinese herbal extract eneviscosity ephezulu; 3.Ukuqinisekisa: ibamba umswakama omncane kumathablet, ibambezele ukwehla kwezithako ezisebenzayo, futhi ikhulise isikhathi sokuphila kwemithi sibe yizinyanga eziyi-12-24; 4.Ukuthwala ukukhululwa: Ngokulawula isakhiwo sezikhala ukuze kulungiswe izinga lokukhululwa kwemithi, ukufaka u-0.2% ekwakhiweni kwamathablet akhululwayo kungafinyelela ukukhululwa kwemithi isikhathi eside. 3. Amamojula obuchwepheshe abakhulu (KTP) Izinto zepharamitha Uhlaka lwezinkomba 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 wesikhala esijwayelekile （nm） 5-30 Umthetho we-BJH Ukulahleka kwesikhumba esomile (105℃,2h) ≤6.0% ukuhlaziywa kwe-gravimetric Okuqukethwe kwezimbiwa ezinzima (ppm) ≤10 Ukuhlaziywa kwe-atomic absorption spectrophotometry 4. Izigaba zokusebenza (Application Fields) 1. Umthwali wemithi: Imithi ye-chemotherapy enezikhwama eziphezulu (njenge-doxorubicin) ingakhululwa ngokunembile ngokuphendula kwe-pH/temperature 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; ibamba i-antigen ye-vaccine futhi ikhulise isikhathi sokugcina ukuze iqinise impendulo ye-immune. 3. Ukuhlola nokwelashwa okuhlanganisiwe: Layisha ama-dyes akhanyayo kanye nezinto zokuhlola ze-MRI/CT ukuze kwakhiwe ipulatifomu yokuhlola nokwelapha yokuhlola ngesikhathi sokulethwa kwemithi nezinguquko ze-lesion. 4. Ukuvimbela ubhubhane nokulungiswa kwezicubu: ifakwe ama-ion e-silver kanye nama-antibiotics ukuvimbela amagciwane isikhathi eside (ngokwelashwa kwezilonda); isakhiwo esivulekile simisela i-extracellular matrix, sixhasa ukukhula nokuhlukaniswa kwamangqamuzana, futhi siza ekulungiseni amathambo/nemisipha. 5. Izindinganiso nemithetho (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 kanye nezidingo ze-HACCP zokuphepha kokudla. 6. Iziphakamiso ezibalulekile zokuphatha nokugcina •Ukulayisha imithi: kunconywa ukuthi kwenziwe ekamelweni lokushisa (20-25℃) kanye ne-humidity <50%. Indlela yokumunca yokuhlola isetshenziswa kumithi esolubala, futhi indlela yokuphuma kwe-solvent isetshenziswa kumithi esolubala. Isikhathi sokulayisha kufanele sibe okungenani amahora amabili. •Qaphela ukuguqulwa kwesurface: amaqembu asebenza njenge-amino kanye nama-carboxyl kufanele aguqulwe pH phakathi kuka-5 no-8 ukuze kugwenywe ukulimala okubukhali kwe-asidi kanye 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 kwezinyanga eziyi-1. 7. Izinzuzo zomkhiqizo (PA) •Izinga eliphezulu lokwenza ngokwezifiso: usayizi wezikhala kanye nendawo ethile kungalawulwa kahle ngokuya ngosayizi wezithako ze-API, kunikeza izixazululo ezikhethekile zokuthwala. •Ukuhlanganiswa kokusebenza okuningi: inezisebenzi eziningi zokulayisha imithi, ukulethwa okuhlosiwe kanye nokukhululwa okuhlakaniphile, okwenza kube lula ukwakhiwa kwezinhlelo. •Ukuqinisekiswa kokuhambisana komhlaba: zonke izinkomba zihlangabezana nezidingo ze-pharmacopoeia yomhlaba, zisekela izicelo zemithi ezintsha ezweni nasemhlabeni jikelele, zisheshisa inqubo yokumaketha umkhiqizo. •Ukuthuthukiswa kwesevisi yobuchwepheshe: ukuhlinzeka ngentuthuko yenqubo yokulayisha imithi, ukuhlolwa kokukhululwa emzimbeni nezinye izinsizakalo ezingeziwe, ngokwesekwa kweqembu lobuchwepheshe lochwepheshe kuyo yonke inqubo. 8. Ukuqinisekiswa kwesistimu ye-Enterprise kanye nezindondo •FSSC22000 •ISO22000：2018 •ISO9001：2015 •SHC HALAL •OU KOSHER •Ukuqinisekiswa kwe-FDA •FAMI-QS •SEDEX •I-licence yokukhiqiza izithako zokudla •I-licence yokukhiqiza izithako zokudla •I-Enterprise ye-high-tech kazwelonke •Amabhizinisi akhethekile, ahlanzekile futhi amasha eGuangzhou •Amalungelo angu-17 avela kwi-Office of State Intellectual Property