1. Ukubuka Kwenkanyezi (Product Overview) 1.1 Incazelo eziyisisekelo I-colloidal silica dioxide iyisilicon dioxide esinokuphuma okuphezulu okwenziwe ngokuqhubekayo, ibonakala njengepudingi elimhlophe, elikhululekile. Umkhiqizo unama-nano-network structure ayisisekelo, unikeza izinzuzo ezifana nosayizi wezakhi ezihlangene, ukuhamba kahle okuhle, kanye nokuzinza kwemichiza okuqinile. Ayiphenduli nezinto ezisebenzayo zokwelapha. Ngobubanzi bayo obuphezulu besikhala esithile kanye nokuxhumana okuqinile phakathi kwezakhi, i-silica dioxide isebenza njengomkhiqizo obalulekile wokwelapha ukuze kuthuthukiswe ikhwalithi nokuzinza kwezokwelapha. Ithola izicelo emithini, ekudleni, ekudleni kwezilwane, nasemikhakheni ehlobene, ngenkathi ixhasa izixazululo zokusebenza ezenziwe ngokwezifiso. 1.2 Izinzuzo eziyisisekelo Njengomkhiqizo wokwelapha onemisebenzi eminingi, i-Zhongqi Colloidal Silica ixazulula kahle izinselelo zezimboni ezifana nokungahambi kahle kwezakhi ezinzima ezimweni zokwelapha ezinzima kanye nezinkinga zokuhlala emanzini. Ngokusebenzisa ukulawula ikhwalithi okuphelele kulo lonke uchungechunge lokukhiqiza, lo mkhiqizo uqinisekisa ukuhamba kahle nokusebenza okujwayelekile, uvumela abakhiqizi bezokwelapha 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 wezakhi wendawo 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 nokuhamba. •Ukuhamba kahle okuhle: ingakha i-colloid ezinzile ohlelweni lwamanzi, futhi inani le-pH ligcinwa ku-3.5-5.5, elihambisana nezinhlelo eziningi ze-API. Akukho phenomenu yokuhlukana eyenzeka ngemva kwezinsuku eziyi-30 zokuma ku-25℃, ihlangabezana nezidingo zokugcina isikhathi eside zokulungiselela amanzi. •I-impurity residue ephansi kakhulu: I-SiO₂ iqukethe ngaphezu kwe-99.0%, inani le-heavy metal liphansi kune-25ppm, inani le-arsenic liphansi kune-8ppm, umkhawulo wezinto eziphilayo uphansi kune-1000CFU/g, kude kakhulu nezinga lezimboni. 4. Izindawo Zokusetshenziswa 4.1 Izimo zokwelapha eziqinile Amathablethi, ama-capsule, namapudingi: Lezi zingahlukaniswa kahle zisebenzisa imishini yokuhlanganisa ejwayelekile. Uhlelo lusebenza njengovimbelo lokunciphisa ukuxhumana phakathi kwezakhi, kuthuthukisa ukuhamba kahle, futhi kuvimbele ukuhlanganiswa. Iphakamisa ijubane lokucindezela amathablethi ngenkathi ithuthukisa izinqubo zokukhiqiza ukuze kube nokuhamba kahle kwamapudingi. I-adsorbent/umkhiqizo opholile ulawula kahle umswakama nokuqukethwe kwamanzi (ukuguqulwa kuncike kumthamo). Lokhu kunciphisa izinkinga zokuhambisana phakathi kwezingxenye zokwelapha, kukhuthaza ukusabalala okujwayelekile kwezakhi zamapudingi, futhi kuthuthukisa ijubane lokuphuka kwamathablethi. •I-Tablet/capsule: Engeza u-0.1-0.5% njengomsebenzi wokuhamba, onganciphisa i-angle yokuphumula kwepudingi ngo-20-30%, unciphise umehluko wesisindo enqubweni yamathablethi, 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 Ukulungiselela amanzi Amathuluzi okwelapha (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 ngokuqhubekayo ngenkathi ithuthukisa ukujula kwe-gel nokuhambisana kwezinto zokwakha. Ithuthukisa ukuzinza kokuhlala futhi ivimbela ukuhamba kwe-aerosol (idinga imishini yokuhamba ephezulu ukuze kuqinisekiswe ukuhamba kahle ukuze kufezwe ukusebenza okuhle). •I-Oral suspension: Njengomkhiqizo wokuhlala nokujula, ukwengeza u-0.5-2.0% kungakwenza kube nesilinganiso sokuhlala se-API> 95%, kuvimbele ukuhamba kwemithi, futhi kuthuthukise ukunemba kokuthola. •Izithako/izinhlelo zokwelapha zamehlo: kuhambisana nezindinganiso zokukhiqiza ezihlanzekile ze-IPEC-GMP, kungathuthukisa ukuzinza kwesixazululo, kunciphise ingozi yokwakheka kwezakhi, futhi kuhlangabezane nezidingo zokulungiselela amanzi ezithambile. 4.3 Izithako zokudla •Umthwali wezithako ezisebenzayo: umunca ama-vitamins, ama-probiotics nezinye izinto ukuze wandise isikhathi sokuphila kwemikhiqizo futhi wandise isilinganiso sokugcina sokusebenza kwe-biological ngaphezu kwe-30%, efanelekile kumapudingi e-protein, amapudingi okudla nezinye izinto. •Umkhiqizo ophikisana nokuhlanganiswa: emkhathini we-umoya ≤60%, umkhiqizo wepudingi ungagcinwa isikhathi esingaphezu kwezinyanga eziyi-6 ngaphandle kokuhlanganiswa ukuze kuqinisekiswe ukuhamba kahle komkhiqizo. 4.4 Izicelo zokudla: Njengomkhiqizo wokudla oqondile, uthuthukisa ukuhamba kahle kwamapudingi okudla (kuhlanganisa amapudingi e-organic), uvimbela ukuhlanganiswa kokugcina ngenkathi ugcina umswakama; umunca umswakama, efanelekile kumapudingi amanzi/ahamba kahle; isebenza njengomkhiqizo opholile wezokudla ezinjengama-juices wokupheka nezithako zezithelo, futhi isebenza njengomkhiqizo we-thixotropic emikhiqizweni yokupheka ne-baking; ngaphezu kwalokho ithuthukisa ukuhlanzeka kwemishini ngesikhathi sokugaya izinto zokwakha. 4.5 Ukusetshenziswa emkhakheni wezilwane: Thuthukisa ukusebenza kokudla nezobuchwepheshe bokucubungula ukuze kuqinisekiswe ukuhamba kahle nokumelana nokugcina kwepudingi yokwengeza, futhi inikeze izakhiwo ezinhle zokulungisa umswakama kumapudingi; thuthukisa inqubo yokugaya nokugaya ukuze kuvimbele umkhiqizo ukuthi unamathele emshinini. 5. Izindinganiso nezimfuneko (Standards & Regulations) •Uhambisana 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 wonke: uhambisana 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 umkhiqizo wokuhamba 0.1-0.5% Oral suspension Umkhiqizo wokuhlala/Umkhiqizo opholile 0.5-2.0% Nutrient powder umkhiqizo ophikisana nokuhlanganiswa 0.2-1.0% Active ingredient carrier Umunca 5-15% 6.2 Amathiphu abalulekile okusebenza nokugcina •Ukusetshenziswa kokulungiselela okuqinile: kunconywa ukwengeza ngemva kokuhlanganisa i-API kanye ne-diluent, futhi usebenzise ukuhlanganisa okuphezulu okungaphezu kwemizuzu engama-30 ukuze uqinisekise ukusabalala okujwayelekile. •Ukusetshenziswa kokulungiselela amanzi: kufanele kuhlukaniswe ngaphansi kwezimo ze-pH 4-6, futhi kugwenywe ukuxhumana isikhathi eside ne-asidi eqinile kanye ne-alkali ukuze kuvinjwe ukonakaliswa kwesakhiwo se-colloid. •Izimo zokugcina: iphakheji evaliwe, igcinwe endaweni eyomile nepholile (15-25℃, umswakama ophakathi <60%), iyasebenza iminyaka emibili, ivuliwe futhi isetshenziswe ngokushesha. Le mininingwane engenhla iyisikhumbuzo kuphela, futhi ukusetshenziswa kwangempela nokuthola kufanele kulungiswe ngokuya ngempela. 7. Izinzuzo Zomkhiqizo (PA) •Ukufaneleka kwesimo esiphelele: inezici zomkhiqizo wokuhamba kokulungiselela okuqinile kanye nezokulungiselela amanzi, inciphisa uhlobo lwezinto ezisizayo futhi ilungiselela umklamo wefomula. •Ukuqinisekiswa kokuhambisana komhlaba: ukuvuma kwe-multi-pharmaceutical code certification, ukweseka ukubhaliswa kwemithi yasekhaya naphakathi, kunciphisa izingozi zokufinyelela emakethe. •Isevisi eyenziwe ngokwezifiso: ngokuya ngezidingo zamakhasimende, usayizi wezakhi kanye nezici ezithile zesikhala zingalungiswa ukuze kuhanjiswe izixazululo zobuchwepheshe ezikhethekile. •Ukuphakelwa 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, ezihlukile nezintsha eGuangzhou •Amalungelo angama-78 avela kwi-Office of State Intellectual Property