1. Isifinyezo somkhiqizo (Isifinyezo somkhiqizo) 1.1 Izincazelo eziyisisekelo I-Colloidal silica dioxide iyisikhombisa esihlanzekile kakhulu esilungiswa ngezindlela ezithuthukisiwe, esibukeka njengempuphu emhlophe, evulekile. Umkhiqizo unezici zesakhiwo senanobhodi esiyisisekelo, okunikeza izinzuzo ezifana nosayizi wezinhlayiya olinganayo, ukuhlakazeka okuhle kakhulu, kanye nokuzinza okunamandla kwamakhemikhali. Ayihlangani nezithako ezisebenzayo zemithi. Ngendawo yayo enkulu yokuphikisana nokuxhumana okunamandla phakathi kwezinhlayiya, i-silica dioxide isebenza njengesithako esibalulekile semithi ukuze kuthuthukiswe ikhwalithi nokuzinza kwezinhlanganisela zemithi. Ithola izicelo emithini, ekudleni, emifundweni, nasezindaweni ezihlobene, ngenkathi isekela izixazululo zokusebenza ezenziwe ngokwezifiso. 1.2 Izindinganiso eziyisisekelo Njengesithako semithi esisebenza ngezindlela eziningi, i-Zhongqi Colloidal Silica ixazulula ngempumelelo izinselele zemboni ezifana nokugeleza okungalungile ezindaweni ezomile kanye nezinkinga zokuhlala ezinhlanganisweni ezingamanzi. Ngokulawula ikhwalithi okuphelele kuyo yonke indawo yokukhiqiza, lo mkhiqizo uqinisekisa ukuhlanzeka nokusebenza okungaguquki, unika amandla abakhiqizi bemithi ukuthi bathuthukise ukusebenza kokukhiqiza nokuncintisana komkhiqizo. Ihambisana kakhulu nezimfuneko zokubhaliswa kwemithi yasekhaya neyamazwe omhlaba, ibonisa ukuguquguquka kwayo ekuhlangabezaneni nezidingo ezahlukahlukene zokulawula. 2. Izici zomkhiqizo (Izici zomkhiqizo) • Nanostructure: usayizi wezinhlayiya zemvelo ulawulwa ku-12-20nm, wakha isakhiwo senanobhodi esilinganayo, futhi indawo yokuphikisana ye-BET ingafinyelela ku-175-380m²/g, inikeza isisekelo sokumunca nokuhlakazeka okusebenzayo. • Ukuzinza okuhle kakhulu kokuhlakazeka: ingakha i-colloid ezinzile ohlelweni lwamanzi, futhi inani le-pH ligcinwa ku-3.5-5.5, elilungele izinhlelo eziningi ze-API. Akukho ukuhlukana okwenzeka ngemuva kwezinsuku ezingama-30 zokuma ku-25℃, kuhlangabezana nezidingo zesitoreji eside sezinhlanganisela ezingamanzi. • Ukuhlanzeka okuphansi kakhulu: okuqukethwe yi-SiO₂ kungaphezu kuka-99.0%, okuqukethwe kwezinsimbi ezisindayo kungaphansi kuka-25ppm, okuqukethwe kwe-arsenic kungaphansi kuka-8ppm, umkhawulo we-microbial ungaphansi kuka-1000CFU/g, kude kakhulu ngaphansi kwesilinganiso semboni. 4. Izindawo zokusebenza 4.1 Izinhlanganisela eziqinile Amatafulethi, amakhepsuli, nezimpuphu: Lezi zingahlakazeka ngokulinganayo kusetshenziswa imishini yokuxuba ejwayelekile. Uhlelo lusebenza njengomgoqo wokunciphisa ukuxhumana phakathi kwezinhlayiya, kuthuthukisa ukugeleza kwamahhala, futhi kuvimbela ukubambana. Kukhawulezisa isivinini sokucindezela amatafulethi ngenkathi kuthuthukiswa izinqubo zokukhiqiza ukuze kube nokuhamba okubushelela kwezimpupu. Isithako esincelisayo/esimunca amanzi siphatha kahle umswakama nokuqukethwe koketshezi (izinga lokuguquguquka lincike kumthamo). Lokhu kunciphisa izinkinga zokuhambisana phakathi kwezithako zemithi, kukhuthaza ukuhlakazeka okulinganayo kwezithako zezimpuphu, futhi kuthuthukisa isivinini sokuhlakazeka kwamatafulethi. • Itafulethi/ikhepsuli: Engeza u-0.1-0.5% njengosizo lokugeleza, olunganciphisa i-engeli yokuphumula yempuphu ngo-20-30%, kunciphise umehluko wesisindo engozini yetafulethi, futhi kuthuthukise ubulukhuni bamatafulethi ngo-15-20% futhi kunciphise ukwaphuka. • Ingozi yokuqondisa itafulethi: thuthukisa ukuhamba kwezinto, unciphise inani lokugcoba, unciphise umjikelezo wokukhiqiza, ilungele i-acetaminophen, i-aspirin nezinye izinhlelo ze-API. 4.2 Izinhlanganisela ezingamanzi Imikhiqizo yemithi engamanzi (ama-gel, ama-cream, izinhlanganisela, njll.): Ukuqina kuyahlukahluka ngokwezinga lokushesha, kuvumela ukujiya kube i-paste noma ukuncipha ukuze kube lula ukusebenza. Kuvimbela ukuhlala kanzima, ukuhlala, nokudweba ngenkathi kuthuthukiswa ukucaca kwe-gel nokuhlakazeka okulinganayo kwezithako. Kuthuthukisa ukuzinza kwezinhlanganisela futhi kuvimbela ukuhlala kwe-aerosol (kudinga imishini ephezulu yokushesha ukuze kube nokuhlakazeka okuphelele ukuze kutholwe ukusebenza okuhle kakhulu). • Inhlanganisela yomlomo: Njengesithako sokumisa nokujiya, ukwengezwa kuka-0.5-2.0% kungenza isilinganiso sezindawo ezihlala kuso ze-API> 95%, kuvimbela ukuhlukana kwemithi, futhi kuthuthukise ukunemba komthamo. • Imizila/izilungiselelo zamehlo: ngokuhambisana nezindinganiso zokukhiqiza ezihlanzekile ze-IPEC-GMP, zingathuthukisa ukuzinza kwesixazululo, kunciphise ingozi yokwakheka kwezinhlayiya, futhi zivumelane nezidingo zezinhlanganisela ezingamanzi ezibucayi. 4.3 Izithako zokudla okunomsoco • Isithwali sezithako ezisebenzayo: imunca amavithamini, ama-probiotics nezinye izithako ukuze kunwetshwe impilo yeshalofu yemikhiqizo futhi kwandiswe izinga lokugcinwa komsebenzi webhayoloji ngaphezu kuka-30%, ilungele impuphu yamaprotheni, impuphu yokudla okunomsoco neminye imikhiqizo. • Isithako esivimbela ukubambana: endaweni enomswakama ongaphansi kuka-60%, impuphu ingagcinwa isikhathi esingaphezu kwezinyanga ezi-6 ngaphandle kokubambana ukuze kuqinisekiswe ukuhamba komkhiqizo. 4.4 Izicelo zokudla: Njengesithako sokudla esiqondile, sithuthukisa ukuhamba kwezimpuphu zokudla (kuhlanganise nezimpuphu ezithambile zemvelo), sivimbela ukubambana kwesitoreji ngenkathi sigcina ukoma; imunca umswakama, ilungele izimpuphu ezimanzi/ezimunca umswakama; isebenza njengesijiya sokudla okungamanzi njengamanzi okunosawoti namafutha emifino, futhi isebenza njengesithako se-thixotropic emafutheni okubhaka nokupheka; ngaphezu kwalokho kuthuthukisa ukuhlanzeka kwemishini phakathi nezinqubo zokugaya izithako. 4.5 Isicelo endaweni yokuphakelayo: Thuthukisa ukusebenza kokuphakelayo kanye nobuchwepheshe bokucubungula ukuze kuqinisekiswe ukuhamba kwamahhala nokumelana nesitoreji kwempuphu yesithako, futhi unikeze izakhiwo ezinhle zokulungisa umswakama kumakhethini; thuthukisa inqubo yokugaya nokugaya ukuze uvimbele umkhiqizo ukuthi ungabambeleli emishini. 5. Izindinganiso nemithetho (Izindinganiso Nemithetho) • Kuhambisana nezindinganiso eziningi zamacembu emithi omhlaba: USP-NF, European Pharmacopoeia (Ph. Eur.), Japanese Pharmacopoeia (JP), kanye ne-China Pharmacopoeia (ChP 2025). • Thola isitifiketi esifanele: iqoqo le-FDA inactive ingredient database, isitifiketi sesithako sokudla se-EU E551. • Landela imihlahlandlela yokuhambisana yomhlaba: hlangabezana nezindinganiso zokukhiqiza ze-GMP nezidingo zesistimu yokuphepha kokudla ze-HACCP. 6. Imiyalo yokusetshenziswa 6.1 Umthamo onconyiwe Uhlobo lwenhlangano Inhloso yokusebenza Isilinganiso sokwengeza esinconyiwe Itafulethi/ikhepsuli Usizo lokugeleza 0.1-0.5% Inhlanganisela yomlomo Ukumisa/Isijiya 0.5-2.0% Impuphu yokudla okunomsoco Isithako esivimbela ukubambana 0.2-1.0% Isithwali sezithako ezisebenzayo Isithako esincelisayo 5-15% 6.2 Amaphuzu abalulekile okusebenza nokugcina • Isicelo senhlangano eqinile: kunconywa ukuthi kwengezwe ngemuva kokuxuba i-API kanye ne-diluent, futhi kusetshenziswe ukuxuba okuphezulu isikhathi esingaphezu kwemizuzu engama-30 ukuze kuqinisekiswe ukuhlakazeka okulinganayo. • Isicelo senhlangano engamanzi: kufanele ihlakazwe ngaphansi kwesimo se-pH 4-6, futhi kugwenywe ukuxhumana isikhathi eside ne-acid ne-alkali enamandla ukuze kuvinjwe ukubhujiswa kwesakhiwo se-colloid. • Izimo zokugcina: ukupakishwa okuvaliwe, kugcinwe endaweni eyomile futhi epholile (15-25℃, umswakama ohlobene <60%), kuvumelekile iminyaka emi-2, kuvulwe futhi kusetshenziswe ngokushesha okukhulu. Ulwazi olungenhla luyisetshenziswa kuphela, futhi ukusetshenziswa kwangempela kanye nomthamo kufanele kulungiswe ngokuya ngefomula yakho. 7. Izinzuzo zomkhiqizo (PA) • Ukulungiswa kwesimo esigcwele: kunesici sosizo lokugeleza lwenhlangano eqinile nokuzinza kwenhlangano engamanzi, kunciphisa uhlobo lwezinto ezisizayo futhi kwenza kube lula ukuklama ifomula. • Isiqinisekiso sokuhambisana komhlaba: ukumbozwa okuningi kwekhodi yemithi, ukwesekwa kokubhaliswa nokumenyezelwa kwemithi yasekhaya neyamazwe omhlaba, kunciphisa izingozi zokufinyelela emakethe. • Inkonzo eyenziwe ngokwezifiso: ngokuya ngezidingo zamakhasimende, usayizi wezinhlayiya kanye nezinga lendawo yokuphikisana kungalungiswa ukuze kunikezwe izixazululo zobuchwepheshe ezingekho emthethweni. • Isipho esisimeme: inqubo yokukhiqiza isebenzisa ukubuyiswa kwamandla, futhi ukupakisha kusetshenziswa izikhwama zamaphepha eziningi ezingasetshenziswa kabusha ukuze kulinganiswe ukusebenza nezidingo zokuvikela imvelo. 8. Isitifiketi sesistimu yebhizinisi nezindondo • FSSC22000 • ISO22000:2018 • ISO9001:2015 • SHC HALAL • OU KOSHER • FDA attestation • FAMI-QS • SEDEX • Ilayisensi yokukhiqiza izithako zokudla • Ilayisensi yokukhiqiza izithako zokuphakelayo • Ibhizinisi lobuchwepheshe obuphezulu likazwelonke • Izinkampani ezikhethekile, ezicwengekile nezintsha e-Guangzhou • Izimvume ezingama-17 ezivela kuHhovisi le-Intellectual Property State