1. Ukubuka KweMikhiqizo (Product Overview) 1.1 Incazelo eziyisisekelo I-colloidal silica dioxide iyisilicon dioxide esiphezulu sokuhlanzeka esilungiswe ngezinqubo advanced, ibonakala njengothuli oluphaphathekile, olumhlophe. Umkhiqizo ubonisa isakhiwo se-nano-network esiyinhloko, unikeza izinzuzo ezifana nosayizi wezakhi ezihlangene, ukusabalala okuhle, kanye nokuzinza kwezemikhakha. Ayiphenduli nezithako ezisebenzayo zemithi. Nge-surface area yayo ephezulu ethile kanye nokuxhumana okuqinile phakathi kwezithako, i-silica dioxide isebenza njengomkhiqizo obalulekile wemithi ukuze kuthuthukiswe ikhwalithi nokuzinza kwemikhiqizo yemithi. Ithola izicelo emithini, ekudleni, ekudleni kwezilwane, nasemikhakheni ehlobene, ngenkathi isekela izixazululo zokusebenza ezenziwe ngezifiso. 1.2 Izinzuzo eziyisisekelo Njengomkhiqizo wemithi onemisebenzi eminingi, i-Zhongqi Colloidal Silica ibhekana kahle nezinselelo zezimboni ezifana nokungabi ne-flowability ezimfuthweni ezinzima kanye nezinkinga zokuhlala emikhiqizweni ye-liquid. Ngokusebenzisa ukulawulwa kwekhwalithi okuphelele kuyo yonke i-chain yokukhiqiza, lo mkhiqizo uqinisekisa ukuhlanzeka nokusebenza okuhambisanayo, unika abakhiqizi bemithi amandla okuthuthukisa ukusebenza kahle kokukhiqiza kanye nokuncintisana komkhiqizo. Uhlangabezana nezidingo zokubhaliswa kwemithi zasekhaya nezamazwe omhlaba, ubonisa ukuhamba phambili ekuhlangabezaneni nezidingo ezihlukahlukene zokulawula. 2. Izici Zomkhiqizo (Product Characteristics) •I-Nanostructure: usayizi wezithako uqondiswa ku-12-20nm, udala isakhiwo esihlangene se-three-dimensional, kanti i-BET specific surface area ingafinyelela ku-175-380m²/g, inikeza isisekelo sokumunca kahle nokusabalala. •Ukuzinza okuhle kokusabalala: ingakha i-colloid ezinzile ohlelweni lwe-aqueous, 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 zemikhiqizweni ye-liquid. •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 we-microbial uphansi kuka-1000CFU/g, kude kakhulu nezinga lezimboni. 4. Iziqukathi Zokusebenza 4.1 Izimfuthweni ezinzima Amathablethi, ama-capsule, namathuli: Lezi zingasabalala kahle zisetshenziswa ngezinsiza zokuxuba ezijwayelekile. Uhlelo lusebenza njengovimbela ukuze lunciphise ukuxhumana phakathi kwezithako, kuthuthukise i-flowability, futhi kuvinjeze i-caking. Iphucula isivinini sokucindezela amathablethi ngenkathi ithuthukisa izinqubo zokukhiqiza ukuze kube nokuhamba kahle kwamathuli. I-adsorbent/imathuli emanzini ikwazi kahle ukulawula umswakama nokuhlanganiswa kwe-liquid (ukuguqulwa kuncike kumthamo). Lokhu kunciphisa izinkinga zokuhambisana phakathi kwezithako zemithi, kuthuthukisa ukusabalala okuhle kwezithako zamathuli, futhi kuthuthukisa isivinini sokuphuka kwamathablethi. •I-Tablet/capsule: Engeza u-0.1-0.5% njengomsebenzi wokuphakela, okunganciphisa i-angle yokuphumula kwamathuli ngo-20-30%, kunciphise umehluko wesisindo enqubweni yamathablethi, futhi kuthuthukise ubunzima bamathablethi ngo-15-20% futhi kunciphise ubrittleness. •Inqubo ye-tablet eqondile: thuthukisa ukuhamba kwezinto, kunciphise inani le-lubricant, kunciphise isikhathi sokukhiqiza, kufanelekile ku-acetaminophen, aspirin nezinye izinhlelo ze-API. 4.2 Izimfuthweni ze-liquid Izimfuthweni zemithi (ama-gels, ama-creams, ama-suspensions, njll.): I-viscosity iyahluka ngokuhamba kwesikhala, ivumela ukujula ibe yi-paste noma ibe mncane ukuze kube lula ukuyisebenzisa. Ivimbela ukuhamba okuqinile, ukwehla, nokuhlanza ngenkathi ithuthukisa ukujula kwe-gel nokuhlanganiswa kwezinto zokwakha. Ithuthukisa ukuzinza kokuhlala futhi ivimbela ukuhamba kwe-aerosol (idinga izinsiza eziphakeme zokuhamba ukuze kuqinisekiswe ukusabalala okuhle ukuze kufezwe ukusebenza okuhle). •I-Oral suspension: Njengomsebenzi wokuphakela nokujula, ukwengeza u-0.5-2.0% kungakwenza kube ne-sediment volume ratio ye-API> 95%, ivimbele ukuhamba kwemithi, futhi ithuthukise ukunemba kokuthola. •Izithako/izinhlelo zokubuka: kuhambisana nezindinganiso zokukhiqiza ezihlanzekile ze-IPEC-GMP, kungathuthukisa ukuzinza kwesixazululo, kunciphise ingozi yokwakheka kwezithako, futhi kuhlangabezane nezidingo zemikhiqizweni ye-liquid ezithambile. 4.3 Izithako zokudla •Umthwali wezithako ezisebenzayo: umunca ama-vitamins, ama-probiotics nezinye izithako ukuze wandise isikhathi sokuphila kwemikhiqizo futhi wandise izinga lokugcina le-biological activity ngaphezu kuka-30%, kufanelekile kumathuli e-protein, amathuli okudla nezinye izinto. •Umsebenzi wokuvimbela i-caking: endaweni yokuphuma ≤60%, impahla yothuli ingagcinwa isikhathi eside ngaphezu kwezinyanga eziyi-6 ngaphandle kokuhlanganiswa ukuze kuqinisekiswe ukuhamba komkhiqizo. 4.4 Izicelo zokudla: Njengomkhiqizo wokudla oqondile, uthuthukisa i-flowability yamathuli okudla (kuhlanganise namathuli e-organic apholile), ivimbela i-caking yokugcina ngenkathi igcina umswakama; umunca umswakama, ufanelekile kumathuli anomswakama/ahamba phambili; isebenza njengomsebenzi wokujula wezinto zokudla ezinjengama-pickling juices namafutha emifino, futhi isebenza njengomsebenzi we-thixotropic kumafutha okubilisa nokupheka; ngaphezu kwalokho ithuthukisa ukuhlanzeka kwezinsiza ngesikhathi sokugaya izinto zokwakha. 4.5 Ukusebenza emkhakheni wezokudla: Thuthukisa ukusebenza kokudla kanye nobuchwepheshe bokucubungula ukuze kuqinisekiswe ukuhamba okukhululekile nokumelana nokugcina kwe-powder yokwengeza, futhi inikeze izakhiwo ezinhle zokulungisa umswakama kumathuli; thuthukisa inqubo yokugaya nokugaya ukuze kuvinjwe umkhiqizo ukuthi ungeniswe ezinsizeni. 5. Izindinganiso nezimfuneko (Standards & Regulations) •Ihamba phambili nezindinganiso eziningi ze-international pharmacopoeia: USP-NF, European Pharmacopoeia (Ph. Eur.), Japanese Pharmacopoeia (JP), kanye ne-China Pharmacopoeia (ChP 2025). •Thola isitifiketi esihlobene: i-FDA inactive ingredient database collection, i-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 ohlongozwayo Uhlobo lokulungiselela Umsebenzi ohlongozwayo Umthamo ohlongozwayo Tablet/capsule umphakeli wokuphakela 0.1-0.5% Oral suspension Umsebenzi wokuphakela/Umsebenzi wokujula 0.5-2.0% Nutrient powder umphakeli wokuvimbela i-caking 0.2-1.0% Active ingredient carrier Umunca 5-15% 6.2 Iziqinisekiso ezibalulekile zokusebenza nokugcina •Ukusetshenziswa kwemikhiqizo eqinile: kunconywa ukwengeza ngemuva kokuxuba i-API kanye ne-diluent, futhi usebenzise i-high shear mixing isikhathi esingaphezu kwemizuzu engama-30 ukuze uqinisekise ukusabalala okuhle. •Ukusetshenziswa kwemikhiqizo ye-liquid: kufanele kusabalale ngaphansi kwezimo ze-pH 4-6, futhi kugwenywe ukuxhumana isikhathi eside ne-asidi eqinile kanye ne-alkali ukuze kuvinjwe ukonakala kwesakhiwo se-colloid. •Izimo zokugcina: iphakethe elivaliwe, ligcinwe endaweni eyomile nepholile (15-25℃, umswakama ophakathi <60%), valid for 2 years, vula futhi usebenzise ngokushesha. Le mininingwane engenhla iyisikhumbuzo kuphela, futhi ukusetshenziswa kwangempela kanye nomthamo kufanele kulungiswe ngokuya ngempela yakho. 7. Izinzuzo Zomkhiqizo (PA) •Ukufaneleka kwazo zonke izimo: inezici zokuphakela imikhiqizo eqinile kanye nezokugcina imikhiqizo ye-liquid, kunciphisa uhlobo lwezinto ezisizayo futhi kulungiselela ukuklama kwefomula. •Ukuqinisekiswa kokuhambisana komhlaba: ukuvuma kwe-multi-pharmaceutical code certification, ukweseka ukubhaliswa kwemithi yasekhaya nezamazwe omhlaba, kunciphisa izingozi zokufinyelela emakethe. •Insizakalo ezenziwe ngezifiso: ngokuya ngezidingo zamakhasimende, usayizi wezithako kanye nezici ze-surface area zingalungiswa ukuze kuhanjiswe izixazululo zobuchwepheshe ezikhethekile. •Ukuhlinzekwa okuqhubekayo: inqubo yokukhiqiza isebenzisa ukuvuselelwa kwamandla, futhi ukupakisha kusebenzisa amabhakede ephepha angasetshenziswa kabusha ukuze kuhlangabezane 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, ezithuthukisiwe nezintsha eGuangzhou •Amalungelo angu-93 avela kwi-Office of State Intellectual Property