1. Ukubuka KweMikhiqizo (Product Overview) 1.1 Incazelo eziyisisekelo I-colloidal silica dioxide iyisilicon dioxide esiphezulu esenziwe ngamasu athuthukile, ibonakala njengepudingi eliphuzi, elikhululekile. Umkhiqizo unama-nano-network structure ayisisekelo, unikeza izinzuzo ezifana nosayizi wezakhi ezifanayo, ukuhamba kahle okuhle, kanye nokuzinza kwezemikhakha. Ayiphenduli nezithako ezisebenzayo zemithi. Ngenxa yesikhala esikhulu esithile sokuphila kanye nokuxhumana okuqinile phakathi kwezakhi, i-silica dioxide isebenza njengomkhiqizo obalulekile wezokwelapha ukuze kuthuthukiswe ikhwalithi nokuzinza kwezinhlelo zokwelapha. Isebenza emithini, ukudla, ukudla kwezilwane, nasemikhakheni ehlobene, ngenkathi isekela izixazululo zokusebenza ezikhethekile. 1.2 Izinzuzo eziyisisekelo Njengomkhiqizo wezokwelapha onemisebenzi eminingi, i-Zhongqi Colloidal Silica ixazulula kahle izinselelo zemboni ezifana nokungahambi kahle kwezinto ezithile ezibhalwe ngokuqinile kanye nezinkinga zokuhlala ezinhlelweni ze-liquid. Ngokulawula ikhwalithi okuphelele kulo lonke uhlelo lokukhiqiza, lo mkhiqizo uqinisekisa ukuhlala kwekhwalithi nokusebenza, 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 uyalawulwa ku-12-20nm, udala isakhiwo esihlangene se-three-dimensional, kanti isikhala esithile se-BET singafinyelela ku-175-380m²/g, sinikeza 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 yokuhlukaniswa eyenzeka ngemuva kwezinsuku eziyi-30 zokuma ku-25℃, ihlangabezana nezidingo zokugcina isikhathi eside kwezinhlelo ze-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 wezinto eziphilayo uphansi kuka-1000CFU/g, kude kakhulu nezinga le-emboni. 4. Iziqu Zokusebenza 4.1 Izinto ezibhalwe ngokuqinile Amathablethi, ama-capsules, namapudingi: Lezi zingahlukaniswa kahle zisebenzisa imishini yokuxuba ejwayelekile. 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 okuphelele kwepudingi. I-adsorbent/umkhiqizo opholile ulawula kahle umswakama nokuhamba kwamanzi (ukuguqulwa kuncike kumthamo). Lokhu kunciphisa izinkinga zokuhambisana phakathi kwezithako zemithi, kukhuthaza ukusabalala okufanayo kwezinto eziphathelene nepudingi, futhi kuthuthukisa isivinini sokuphuka kwamathablethi. •I-Tablet/capsule: Engeza u-0.1-0.5% njengomsebenzi wokuhamba, okunganciphisa i-angle yokuphumula kwepudingi ngo-20-30%, kunciphise umehluko wesisindo ohlelweni lwamathablethi, futhi kuthuthukise ubunzima bamathablethi ngo-15-20% 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 Izinhlelo ze-liquid Izinto zokwelapha (ama-gels, ama-creams, ama-suspensions, njll.): I-viscosity iyahluka ngokuhamba, ivumela ukujula kube yi-paste noma kube lula ukuze kusebenze. Ivimbela ukuhamba okuqinile, ukuhamba, nokuhamba ngenkathi ithuthukisa ukujula kwe-gel nokuhambisana kwezinto zokwakha. Ithuthukisa ukuzinza kokuhamba futhi ivimbela ukuhamba kwe-aerosol (idinga imishini ephezulu yokuhamba ukuze kufinyelelwe ukusebenza okuhle). •I-Oral suspension: Njengomkhiqizo wokuphakamisa nokujula, ukwengeza u-0.5-2.0% kungakwenza kube ne-sediment volume ratio ye-API> 95%, ivimbela ukuhamba kwemithi, futhi ithuthukisa ukunemba kokuthola. •Izithako/izinhlelo zokwelapha: kuhambisana nezindinganiso zokukhiqiza ezihlanzekile ze-IPEC-GMP, kungathuthukisa ukuzinza kwesixazululo, kunciphise ingozi yokwakheka kwezakhi, futhi kuhlangabezane nezidingo zezinhlelo ze-liquid ezibucayi. 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 kumapudingi e-protein, amapudingi okudla nezinye izinto. •Umkhiqizo ophikisana nokuhlanganiswa: emkhathini wokungcola ≤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 (kuhlanganise namapudingi e-organic apholile), ivimbela ukuhlanganiswa kokugcina ngenkathi igcina umswakama; umunca umswakama, ufanelekile kumapudingi amanzi/ahamba; isebenza njengomkhiqizo opholile wezokudla ezinjengama-pickling juices kanye nama-oyili emifino, futhi isebenza njengomkhiqizo we-thixotropic ezinsizeni zokubhaka nezokupheka 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 inikeze izakhiwo ezinhle zokulungisa umswakama kumapudingi; thuthukisa inqubo yokugaya nokugaya ukuze kuvinjezelwe umkhiqizo ekwenzeni imishini. 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 ubufakazi obufanele: i-FDA inactive ingredient database collection, i-EU E551 food additive certification. •Landela iziqondiso zokuhambisana zomhlaba: hamba nezindinganiso zokukhiqiza ze-GMP kanye nezidingo ze-HACCP food safety system. 6. Imiyalelo Yokusebenzisa 6.1 Umthamo ohlongozwayo Uhlobo lokulungiselela Inhloso yokusebenza Umthamo ohlongozwayo I-Tablet/capsule umkhiqizo wokuhamba 0.1-0.5% I-Oral suspension Umkhiqizo wokuphakamisa/ukujula 0.5-2.0% I-Nutrient powder umkhiqizo ophikisana nokuhlanganiswa 0.2-1.0% Umthwali wezithako ezisebenzayo Umunca 5-15% 6.2 Amathiphu abalulekile okusebenza nokugcina •Ukusebenza kokulungiselela okuqinile: kunconywa ukwengeza ngemuva kokuxuba i-API kanye ne-diluent, futhi usebenzise ukuxuba okuphezulu okungaphezu kwemizuzu engama-30 ukuze uqinisekise ukusabalala okufanayo. •Ukusebenza kokulungiselela i-liquid: kufanele kuhlukaniswe 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: iphakheji evaliwe, igcinwe endaweni eyomile nepholile (15-25℃, umswakama ophakathi <60%), iyasebenza iminyaka emibili, ivule futhi usebenzise ngokushesha. Le mininingwane engenhla iyisikhumbuzo kuphela, futhi ukusetshenziswa kwangempela nokuthamo kufanele kulungiswe ngokuya ngombhalo wakho. 7. Izinzuzo Zomkhiqizo (PA) •Ukufaneleka kwesimo esiphelele: inezici zomkhiqizo wokuhamba wezinto ezibhalwe ngokuqinile kanye nokuzinza kokulungiselela i-liquid, kunciphisa uhlobo lwezinto ezisizayo futhi kulula ukwakha umkhiqizo. •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 wezinto nezici ezithile zingalungiswa ukuze kuhanjiswe izixazululo zobuchwepheshe ezikhethekile. •Ukuphakelwa okuqhubekayo: inqubo yokukhiqiza isebenzisa ukuvuselelwa kwamandla, futhi iphakheji isebenzisa amabhakede ephepha angasetshenziswa kabusha ukuze kuhlangabezane nezidingo zokusebenza kanye nezokuvikela imvelo. 8. Ukuqinisekiswa kwesistimu yeNkampani kanye nezindondo •FSSC22000 •ISO22000：2018 •ISO9001：2015 •SHC HALAL •OU KOSHER •I-FDA attestation •FAMI-QS •SEDEX •I-licence yokukhiqiza yokudla •I-licence yokukhiqiza yokudla kwezilwane •I-National high-tech enterprise •Izinkampani ezikhethekile, ezithuthukile nezintsha eGuangzhou •Amalungelo angu-82 avela kwi-Office of State Intellectual Property