1. Ukubuka KweMikhiqizo (Product Overview) 1.1 Incazelo eziyisisekelo I-colloidal silica dioxide iyisilicon dioxide esiphezulu esilungiswe ngokuqhubekayo, ibonakala njengepudingi elimhlophe, elikhululekile. Umkhiqizo unama-nano-network structure ayisisekelo, unikeza izinzuzo ezifana nosayizi wezakhi ezifanayo, ukusabalala okuhle, kanye nokuzinza kwemichiza okuqinile. Ayiphenduli nezithako ezisebenzayo zemithi. Ngobubanzi bayo obuphezulu besikhala esithile kanye nokuxhumana okuqinile phakathi kwezakhi, i-silica dioxide isebenza njengomkhiqizo obalulekile wemithi ukuze kuthuthukiswe ikhwalithi nokuzinza kwemikhiqizo yemithi. Itholakala ezindaweni zemithi, ukudla, ukudla kwezilwane, kanye nezinye izindawo ezihlobene, ngenkathi isekela izixazululo zokusebenza ezenziwe ngezifiso. 1.2 Izinzuzo eziyisisekelo Njengomkhiqizo wemithi onemisebenzi eminingi, i-Zhongqi Colloidal Silica ixazulula kahle izinselelo zezimboni ezifana nokungabi namandla okuhamba kahle ezimfuthweni ezinzima kanye nezinkinga zokuhlala ezilungisweni ze-liquid. Ngokusebenzisa ukulawula ikhwalithi okuphelele kuzo zonke izigaba zokukhiqiza, lo mkhiqizo uqinisekisa ukuhlala kwe-purity nokusebenza, uvumela abakhiqizi bemithi ukuba bathuthukise ukusebenza kahle kokukhiqiza kanye nokuncintisana komkhiqizo. Uhlangabezana nezidingo zokubhaliswa kwemithi ezweni nasemhlabeni jikelele, ubonisa ukuhamba kahle ekuhlangabezaneni nezidingo ezihlukahlukene zokulawula. 2. Izici Zomkhiqizo (Product Characteristics) • I-Nanostructure: usayizi wezinto ezisemqoka ulawulwa 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. • Ukuhlala okuhle kokusabalala: ingakha i-colloid ezinzile ohlelweni lwamanzi, futhi inani le-pH ligcinwa ku-3.5-5.5, elihambisana nezinhlelo eziningi ze-API. Akukho phenomenu yokuhlukaniswa eyenzeka ngemuva kwezinsuku eziyi-30 zokuma ku-25℃, ihlangabezana nezidingo zokugcina isikhathi eside zokulungiselela iziphuzo. • I-impurity residue ephansi kakhulu: I-SiO₂ content ingaphezu 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. Izindawo Zokusebenza 4.1 Izimo zokuphakelwa ezinzima Amathablethi, ama-capsules, kanye nepudingi: Lezi zingasabalala kahle zisetshenziswa ngezinsiza zokuxuba ezijwayelekile. Uhlelo lusebenza njengovimbelo ukuze lunciphise ukuxhumana phakathi kwezakhi, kuthuthukise ukuhamba kahle, futhi kuvinjeze ukuhlanganiswa. Iphakamisa isivinini sokucindezela amathablethi ngenkathi ithuthukisa izinqubo zokukhiqiza ukuze kube nokuhamba kahle kwepudingi. I-adsorbent/umkhiqizo omunca amanzi ulawula kahle umswakama kanye nomthamo we-liquid (ukuguqulwa kuncike kumthamo). Lokhu kunciphisa izinkinga zokuhambisana phakathi kwezingxenye zemithi, kuthuthukisa ukusabalala okufanayo kwezinto ze-powder, futhi kuthuthukisa isivinini sokuphuka kwamathablethi. • Ithablethi/ama-capsule: Engeza u-0.1-0.5% njengomsebenzi wokuhamba, onganciphisa i-angle yokuphumula kwepudingi ngo-20-30%, unciphise umehluko wesisindo enqubweni ye-tablet, futhi uthuthukise ubunzima bamathablethi ngo-15-20% futhi unciphise ubrittleness. • Inqubo ye-tablet eqondile: thuthukisa ukuhamba kwemikhiqizo, unciphise inani le-lubricant, yehlisa isikhathi sokukhiqiza, efanelekile ku-acetaminophen, aspirin nezinye izinhlelo ze-API. 4.2 Izilungiselelo ze-liquid Izilungiselelo zemithi (ama-gels, ama-creams, ama-suspensions, njll.): I-viscosity iyahluka ngokuhamba, ivumela ukujula ibe yi-paste noma ibe mncane ukuze kube lula ukuyisebenzisa. Ivimbela ukuhamba okuqinile, ukuhlangana, nokuhamba okuphakeme ngenkathi ithuthukisa ukujula kwe-gel nokuhambisana kwezinto zokwakha. Ithuthukisa ukuzinza kokuhlala futhi ivimbela ukuhamba kwe-aerosol (idinga imishini ephezulu yokuhamba ukuze kufezwe ukusebenza okuhle). • Ukuhlangana kokuphuza: Njengomkhiqizo ophakamisayo kanye nomkhiqizo ohlanganisayo, ukwengeza u-0.5-2.0% kungenza umthamo we-sediment ratio ye-API> 95%, ivimbela ukuhlukaniswa kwemithi, futhi ithuthukisa ukunemba kokuphakelwa. • Izithako/izilungiselelo zamehlo: kuhambisana nezindinganiso zokukhiqiza ezihlanzekile ze-IPEC-GMP, kungathuthukisa ukuzinza kwesixazululo, kunciphise ingozi yokwakheka kwezinto, futhi kulungele izidingo zezilungiselelo ze-liquid ezibucayi. 4.3 Izithako zokudla • Umthwali wezithako ezisebenzayo: umunca ama-vitamins, ama-probiotics nezinye izithako ukuze wandise isikhathi sokuphila kwemikhiqizo futhi wandise isilinganiso sokugcina sokusebenza kwemvelo ngaphezu kuka-30%, efanelekile ku-protein powder, nutritional powder nezinye izinto. • Umkhiqizo ophikisana nokuhlanganiswa: emkhathini wezinga lokushisa ≤60%, impahla ye-powder ingagcinwa isikhathi esingaphezu kwezinyanga eziyi-6 ngaphandle kokuhlanganiswa ukuze kuqinisekiswe ukuhamba komkhiqizo. 4.4 Izicelo zokudla: Njengomkhiqizo wokudla oqondile, uthuthukisa ukuhamba kwepudingi yokudla (kuhlanganisa ama-powder anokwakheka okuthambile), ivimbela ukuhlanganiswa kokugcina ngenkathi igcina umswakama; umunca umswakama, efanelekile kuma-powder anokwakheka okuthambile/okumuncu; isebenza njengomkhiqizo ohlanganisayo wezidlo ezinjengama-pickling juices kanye nama-oyili ezitshalo, futhi isebenza njengomkhiqizo we-thixotropic ezinsizeni zokubhaka ezisekelwe ku-oyili; ngaphezu kwalokho ithuthukisa ukuhlanzeka kwemishini ngesikhathi sokugaya izinto zokwakha. 4.5 Ukusebenza emkhakheni wokudla: Thuthukisa ukusebenza kokudla kanye nobuchwepheshe bokucubungula ukuze kuqinisekiswe ukuhamba okukhululekile nokumelana nokugcina kwepudingi yokwengeza, futhi unikeze izakhiwo ezinhle zokulungisa umswakama kumaparticles; thuthukisa inqubo yokugaya nokugaya ukuze uvimbele umkhiqizo ukuthi ungabambeki emshinini. 5. Izindinganiso nezimfuneko (Standards & Regulations) • Uhlangabezana nezindinganiso eziningi ze-international pharmacopoeia: USP-NF, European Pharmacopoeia (Ph. Eur.), Japanese Pharmacopoeia (JP), kanye ne-China Pharmacopoeia (ChP 2025). • Thola izitifiketi ezihlobene nezifundo: i-FDA inactive ingredient database collection, EU E551 food additive certification. • Landela iziqondiso zokuhambisana zomhlaba wonke: uhambisana nezindinganiso zokukhiqiza ze-GMP kanye nezidingo ze-HACCP food safety system. 6. Imiyalelo Yokusebenzisa 6.1 Umthamo ohlongozwayo Uhlobo lokulungiselela Inhloso yokusebenza Umthamo ohlongozwayo Ithablethi/ama-capsule umkhiqizo wokuhamba 0.1-0.5% Ukuhlangana kokuphuza Umkhiqizo ophakamisayo/Umkhiqizo ohlanganisayo 0.5-2.0% I-powder yokudla umkhiqizo ophikisana nokuhlanganiswa 0.2-1.0% Umthwali wezithako ezisebenzayo Umunca 5-15% 6.2 Iziphakamiso ezibalulekile zokusebenza nokugcina • Ukusebenza kokulungiselela okwenziwe ngokuqinile: kunconywa ukwengeza ngemuva kokuxuba i-API kanye ne-diluent, futhi usebenzise ukuxuba okuphezulu okungaphezu kwemizuzu engama-30 ukuze uqinisekise ukusabalala okufanayo. • Ukusebenza kokulungiselela kwe-liquid: kufanele kusabalalise ngaphansi kwezimo ze-pH 4-6, futhi ugweme ukuxhumana isikhathi eside ne-asidi eqinile kanye ne-alkali ukuze uvimbele ukonakala kwesakhiwo se-colloid. • Izimo zokugcina: iphakheji evaliwe, igcinwe endaweni eyomile nepholile (15-25℃, umswakama ophakathi <60%), iphelele iminyaka emibili, ivule futhi usebenzise ngokushesha. Le mininingwane engenhla iyisikhumbuzo kuphela, futhi ukusetshenziswa kwangempela kanye nomthamo kufanele kulungiswe ngokuya ngempela yakho. 7. Izinzuzo Zomkhiqizo (PA) • Ukuhambisana kwesimo esiphelele: inezici zomkhiqizo wokuhamba kokulungiselela okwenziwe ngokuqinile kanye nokuzinza kokulungiselela kwe-liquid, kunciphisa uhlobo lwezinto ezisizayo futhi kulula ukuklama ifomula. • Ukuqinisekiswa kokuhambisana komhlaba: ukuvuma izitifiketi eziningi ze-pharmaceutical code, ukweseka ukubhaliswa kwemithi yasekhaya naphakathi, kunciphisa izingozi zokufinyelela emakethe. • Isevisi eyenziwe ngezifiso: ngokuya ngezidingo zamakhasimende, usayizi wezinto kanye nezimo ezithile zesikhala zingalungiswa ukuze kuhanjiswe izixazululo zobuchwepheshe ezikhethekile. • Ukuhlinzekwa okuqhubekayo: inqubo yokukhiqiza isebenzisa ukuvuselelwa kwamandla, futhi iphakheji isebenzisa amabhakede ephepha angasetshenziswa kabusha ukuze kuhlangatshezwane nezidingo zokusebenza kanye nezokuvikelwa kwemvelo. 8. Ukuqinisekiswa kwesistimu yeNkampani kanye nezihlonipho • FSSC22000 • ISO22000:2018 • ISO9001:2015 • SHC HALAL • OU KOSHER • I-FDA attestation • FAMI-QS • SEDEX • Ilayisensi yokukhiqiza yokwengeza ukudla • Ilayisensi yokukhiqiza yokwengeza ukudla kwezilwane • I-National high-tech enterprise • Izinkampani ezikhethekile, ezithuthukisiwe nezintsha eGuangzhou • Amapatent angu-79 avela kwi-Office of State Intellectual Property