1. Ukubuka KweMikhiqizo (Product Overview) 1.1 Incazelo eziyisisekelo I-colloidal silica dioxide iyisilicon dioxide esiphezulu sokuhlanzeka esilungiswe ngezinqubo advanced, ibonakala njengephowder eluhlaza, elula. Umkhiqizo unama-nano-network structure ayisisekelo, unikeza izinzuzo ezifana nosayizi wezakhi ezihambisanayo, ukusabalala okuhle, kanye nokuzinza okuqinile kwezemithi. Ayiphenduli nezithako ezisebenzayo zemithi. Ngobubanzi bayo obuphezulu besikhala esithile kanye nokuxhumana okuqinile phakathi kwezithako, i-silica dioxide isebenza njengomkhiqizo obalulekile wezokwelapha ukuze kuthuthukiswe ikhwalithi nokuzinza kwezithako zemithi. Ithola izicelo emithini, ekudleni, ekudleni kwezilwane, nasemikhakheni ehambisanayo, ngenkathi isekela izixazululo zokusebenza ezikhethekile. 1.2 Izinzuzo eziyisisekelo Njengomkhiqizo wezokwelapha onemisebenzi eminingi, i-Zhongqi Colloidal Silica ixazulula kahle izinselelo zezimboni ezifana nokungahambi kahle kwezithako ezithile ezimweni zokwelapha ezinzima kanye nezinkinga zokuhlala emanzini. Ngokusebenzisa ukulawula ikhwalithi okuphelele kuyo yonke imikhakha yokukhiqiza, lo mkhiqizo uqinisekisa ukuhlanzeka nokusebenza okuhambisanayo, uvumela abakhiqizi bezokwelapha ukuba bathuthukise ukusebenza kahle kokukhiqiza kanye nokuncintisana komkhiqizo. Uhlangabezana nezidingo zokubhaliswa kwemithi ezweni nasemhlabeni jikelele, ubonisa ubuchwepheshe bayo bokuhlangabezana nezidingo ezahlukahlukene zokulawula. 2. Izici Zomkhiqizo (Product Characteristics) •I-Nanostructure: usayizi wezithako uqondiswa ku-12-20nm, udala isakhiwo esihambisanayo se-three-dimensional network, futhi indawo ethile ye-BET ingafinyelela ku-175-380m²/g, inikeza isisekelo sokumunca kahle nokusabalala. •Ukuzinza kokusabalala okuhle: ingakha i-colloid ezinzile ohlelweni lwamanzi, futhi inani le-pH ligcinwa ku-3.5-5.5, elihambisana nezinhlelo eziningi ze-API. Akukho phenomene yokuhlukaniswa eyenzeka ngemuva kwezinsuku eziyi-30 zokuma ku-25℃, ihlangabezana nezidingo zokugcina isikhathi eside kwezithako ezimanzini. •I-impurity residue ephansi kakhulu: I-SiO₂ iqukethe ngaphezu kuka-99.0%, inani le-heavy metal liphansi kuka-25ppm, inani le-arsenic liphansi kuka-8ppm, umkhawulo wezinto eziphilayo uphansi kuka-1000CFU/g, kude kakhulu nezinga lezimboni. 4. Izigaba Zokusetshenziswa 4.1 Izinhlobo zokwelapha eziqinile Amathablethi, ama-capsule, namaphowder: Lezi zingasabalala kahle zisetshenziswa ngezinsiza zokuxuba ezijwayelekile. Uhlelo lusebenza njengovimbelo ukuze lunciphise ukuxhumana phakathi kwezithako, kuthuthukise ukuhamba okukhululekile, futhi kuvinjeze ukuhlanganiswa. Iphakamisa isivinini sokucindezela amathablethi ngenkathi ithuthukisa izinqubo zokukhiqiza ukuze kube nokuhamba okuphelele kwamaphowder. I-adsorbent/umkhiqizo opholile ulawula kahle umswakama nokuqukethwe kwamanzi (ukuguqulwa kuncike kumthamo). Lokhu kunciphisa izinkinga zokuhambisana phakathi kwezithako zemithi, kuthuthukisa ukusabalala okuhambisanayo kwezithako zamaphowder, futhi kuthuthukisa isivinini sokuphuka kwamathablethi. •I-Tablet/capsule: Engeza u-0.1-0.5% njengomsizi wokuhamba, onganciphisa i-angle yokuphumula kwamaphowder ngo-20-30%, unciphise umehluko wesisindo enqubweni yamathablethi, futhi uthuthukise ubunzima bamathablethi ngo-15-20% futhi unciphise ukujula. •Inqubo ye-tablet eqondile: thuthukisa ukuhamba kwezinto, unciphise inani le-lubricant, yehlisa isikhathi sokukhiqiza, efanelekile ku-acetaminophen, aspirin nezinye izinhlelo ze-API. 4.2 Izithako ezimanzini Izithako zemithi (ama-gels, ama-creams, ama-suspensions, njll.): I-viscosity iyahluka ngokushaywa, ivumela ukujula kube yi-paste noma kube lula ukuze kusebenze. Ivimbela ukuhamba okhard, ukuhlangana, nokuhamba okuphakeme ngenkathi ithuthukisa ukujula kwe-gel nokuhambisana kwezinto ezisemqoka. Ithuthukisa ukuzinza kokuhlala futhi ivimbela ukuhamba kwe-aerosol (idinga imishini ephezulu yokushaywa ukuze kufezwe ukusabalala okuhle). •I-Oral suspension: Njengomkhiqizo wokuhlala nokujula, ukwengeza u-0.5-2.0% kungakwenza kube ne-sediment volume ratio ye-API> 95%, ivimbele ukuhamba kwemithi, futhi ithuthukise ukunemba kokuthamo. •Izithako/izithako zamehlo: kuhambisana nezindinganiso zokukhiqiza ezihlanzekile ze-IPEC-GMP, kungathuthukisa ukuzinza kwesixazululo, kunciphise ingozi yokwakheka kwezithako, futhi kuhlangabezane nezidingo zezithako ezithambile. 4.3 Izithako zokudla •Umthwali wezithako ezisebenzayo: umunca ama-vitamins, ama-probiotics nezinye izithako ukuze wandise isikhathi sokugcina kwemikhiqizo futhi wandise umphumela wokuphila ngaphezu kuka-30%, efanelekile kumaphowder e-protein, amaphowder okudla nezinye izinto. •Umkhiqizo ophikisana nokuhlanganiswa: emkhathini we-umswakama ≤60%, umkhiqizo opholile ungagcinwa isikhathi eside ngaphezu kwezinyanga eziyi-6 ngaphandle kokuhlanganiswa ukuze kuqinisekiswe ukuhamba komkhiqizo. 4.4 Izicelo zokudla: Njengomkhiqizo wokudla oqondile, uthuthukisa ukuhamba kwamaphowder okudla (kuhlanganise namaphowder e-organic alula), ivimbela ukuhamba kokugcina ngenkathi igcina umswakama; umunca umswakama, efanelekile kumaphowder anomswakama/okuhlanza; isebenza njengomkhiqizo ojulile wezithako ezimanzini ezifana nezinsipho zokupheka nezamafutha ezitshalo, futhi isebenza njengomkhiqizo we-thixotropic kumafutha okupheka nokupheka; futhi ithuthukisa ukuhlanzeka kwemishini ngesikhathi sokugaya izinto ezisemqoka. 4.5 Ukusetshenziswa emkhakheni wezilwane: Thuthukisa ukusebenza kokudla nezobuchwepheshe bokucubungula ukuze kuqinisekiswe ukuhamba okukhululekile nokumelana nokugcina kwephowder yokwengeza, futhi inikeze izakhiwo ezinhle zokulungisa umswakama ezithakeni; thuthukisa inqubo yokugaya nokugaya ukuze kuvinjezelwe umkhiqizo ekubambeni kwemishini. 5. Izindinganiso nezimfuneko (Standards & Regulations) •Ihamba phambili nezindinganiso eziningi zepharmacopoeia zomhlaba: USP-NF, European Pharmacopoeia (Ph. Eur.), Japanese Pharmacopoeia (JP), kanye ne-China Pharmacopoeia (ChP 2025). •Thola isitifiketi esihambisanayo: i-FDA inactive ingredient database collection, EU E551 food additive certification. •Landela iziqondiso zokuhambisana zomhlaba: hamba phambili nezindinganiso zokukhiqiza ze-GMP nezidingo ze-HACCP food safety system. 6. Imiyalelo Yokusebenzisa 6.1 Umthamo ophakanyisiwe Uhlobo lokulungiselela Inhloso yokusebenza Umthamo ophakanyisiwe Tablet/capsule umsizi wokuhamba 0.1-0.5% Oral suspension Umkhiqizo wokuhlala/ujule 0.5-2.0% Nutrient powder umkhiqizo ophikisana nokuhlanganiswa 0.2-1.0% Active ingredient carrier Umunca 5-15% 6.2 Iziqondiso ezibalulekile zokusebenza nokugcina •Ukusetshenziswa kwezithako eziqinile: kunconywa ukwengeza ngemuva kokuxuba i-API kanye ne-diluent, futhi usebenzise ukuxuba okuphezulu okungaphezu kwemizuzu engama-30 ukuze uqinisekise ukusabalala okuhambisanayo. •Ukusetshenziswa kwezithako ezimanzini: kufanele kusabalalise ngaphansi kwezimo ze-pH 4-6, futhi kugwenywe ukuxhumana isikhathi eside ne-asidi eqinile kanye ne-alkali ukuze kuvinjezelwe ukonakaliswa kwesakhiwo se-colloid. •Izimo zokugcina: iphakethe elivaliwe, ligcinwe endaweni eyomile nepholile (15-25℃, umswakama ophakathi <60%), kusebenze isikhathi esingu-2 iminyaka, uvule futhi usebenzise ngokushesha. Le mininingwane engenhla iyisikhumbuzo kuphela, futhi ukusetshenziswa kwangempela nokuthamo kufanele kulungiswe ngokuya ngefomula yakho. 7. Izinzuzo Zomkhiqizo (PA) •Ukuzivumelanisa kwesimo sonke: inezici zokuhamba kwezithako eziqinile kanye nokuzinza kwezithako ezimanzini, inciphisa uhlobo lwezinto ezisizayo futhi ilungiselela umklamo wefomula. •Ukuqinisekiswa kokuhambisana komhlaba: ukuhlinzeka nge-multi-pharmaceutical code certification coverage, ukweseka ukubhaliswa kwemithi yasekhaya naphesheya, kunciphisa izingozi zokufinyelela emakethe. •Isevisi eyenziwe ngokwezifiso: ngokuya ngezidingo zamakhasimende, usayizi wezithako nezici ezithile zingalungiswa ukuze kuhanjiswe izixazululo zobuchwepheshe ezikhethekile. •Ukuphakelwa okuqhubekayo: inqubo yokukhiqiza isebenzisa ukuvuselelwa kwamandla, futhi iphakethe lisebenzisa amabhakede ephepha angasetshenziswa kabusha ukuze kuhlangatshezwane nezidingo zokusebenza kanye nezokuvikelwa kwemvelo. 8. Ukuqinisekiswa kwesistimu yeNkampani kanye nezindondo •FSSC22000 •ISO22000：2018 •ISO9001：2015 •SHC HALAL •OU KOSHER •I-FDA attestation •FAMI-QS •SEDEX •Ilayisensi yokukhiqiza yokudla •Ilayisensi yokukhiqiza yokudla kwezilwane •I-National high-tech enterprise •Izinkampani ezikhethekile, ezihlelekile nezintsha eGuangzhou •Amalungelo angu-86 avela kwi-Office of State Intellectual Property