1. Ukubuka KweMikhiqizo (Product Overview) 1.1 Incazelo eziyisisekelo I-colloidal silica dioxide iyisilicon dioxide esinokuphuma okuphezulu okwenziwe ngokuqhubekayo, ibonakala njengepowder emhlophe, ethambile. 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 kokwakhiwa kwemithi. Itholakala ezindaweni zemithi, ukudla, ukudla kwezilwane, kanye nezinye izinkalo ezihlobene, ngenkathi isekela izixazululo zokusebenza ezikhethekile. 1.2 Izinzuzo eziyisisekelo Njengomkhiqizo wemithi onemisebenzi eminingi, i-Zhongqi Colloidal Silica ibhekana kahle nezinselelo zezimboni ezifana nokungabi namaflow kahle ezakhiweni eziqinile kanye nezinkinga zokuhlala ezilwazini. Ngokusebenzisa ukulawula ikhwalithi okuphelele kulo lonke uchungechunge lokukhiqiza, lo mkhiqizo uqinisekisa ukuhamba okuqhubekayo 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. Izinhloso 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 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. Akuphumi ukuhlela ngemva kwezinsuku eziyi-30 zokuma ku-25℃, kuhambisana nezidingo zokugcina isikhathi eside zokwakhiwa kwezinto ezilwazini. •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. Izindawo Zokusebenza 4.1 Izakhiwo eziqinile Amathablethi, ama-capsule, kanye ne-powder: Lezi zingasabalala kahle zisetshenziswa ngezinsiza zokuxuba ezijwayelekile. Uhlelo lusebenza njengovimbela ukuze lunciphise ukuxhumana phakathi kwezakhi, kuthuthukise ukuhamba okukhululekile, futhi kuvinjeze ukuhlanganiswa. Kwandisa isivinini sokucindezela amathablethi ngenkathi kuthuthukiswa izinqubo zokukhiqiza ukuze kube nokuhamba kwepowder okuphumelelayo. I-adsorbent/umkhiqizo opholile ulawula kahle umswakama kanye nomthamo wamanzi (ukuguqulwa kuncike kumthamo). Lokhu kunciphisa izinkinga zokuhambisana phakathi kwezithako zemithi, kuthuthukisa ukusabalala okufanayo kwezakhi ze-powder, futhi kuthuthukisa isivinini sokuphuka kwamathablethi. •I-Tablet/capsule: Engeza u-0.1-0.5% njengomsebenzi wokuhamba, okunganciphisa i-angle yokuphumula kwepowder ngo-20-30%, kunciphise umehluko wesisindo enqubweni ye-tablet, 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 Ukulungiselela okukhanyayo Izinto ezikhanyayo 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 ukuhlela okhard, ukuhlela, kanye nezimpawu zokuhamba ngenkathi ithuthukisa ukujula kwe-gel kanye nokusabalala kwezinto zokwakha. Ithuthukisa ukuzinza kokuhlanganiswa futhi ivimbela ukuhlela kwe-aerosol (idinga izinsiza ezinamandla zokuhamba ukuze kufezwe ukusebenza okuhle). •I-Oral suspension: Njengomkhiqizo wokuhlanganisa kanye nomthuthukisi, ukwengeza u-0.5-2.0% kungenza umthamo we-sediment ratio ye-API > 95%, ivimbela ukuhlela kwemithi, futhi ithuthukisa ukunemba kokutholwa. •Izithako/izinto zokubhaka: kuhambisana nezindinganiso zokukhiqiza ezihlanzekile ze-IPEC-GMP, kungathuthukisa ukuzinza kwesixazululo, kunciphise ingozi yokwakheka kwezakhi, futhi kuhlangabezane nezidingo zokwakhiwa kwezinto ezithambile. 4.3 Izithako zokudla •Umthwali wezithako ezisebenzayo: umunca ama-vitamins, ama-probiotics nezinye izinto ukuze wandise isikhathi sokugcina kwemikhiqizo futhi wandise umphumela wokugcina we-biological activity ngaphezu kuka-30%, kufanelekile ku-protein powder, nutritional powder nezinye izinto. •Umkhiqizo wokuvimbela ukuhlanganiswa: emkhathini we-humidity ≤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 kwe-powder yokudla (kuhlanganisa ne-powder ye-organic ethambile), ivimbela ukuhlanganiswa ngesikhathi sokugcina ngenkathi igcina umswakama; umunca umswakama, kufanelekile ku-powder ezimanzi/hygroscopic; isebenza njengomthuthukisi wezinto ezikhanyayo ezifana nezikhukhula zokupheka nezinhlanzi, futhi isebenza njengomkhiqizo we-thixotropic ezinsizeni zokubhaka ezisekelwe ku-oyela; 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 izici ezinhle zokulungisa umswakama ezakhiweni; thuthukisa inqubo yokugaya nokugaya ukuze kuvinjeze umkhiqizo ukuthi ungalungiseki ezinsizeni. 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 ubufakazi obufanele bokufaneleka: i-FDA inactive ingredient database collection, i-EU E551 food additive certification. •Landela iziqondiso zokuhambisana zomhlaba: hlangabezana nezindinganiso zokukhiqiza ze-GMP kanye nezidingo ze-HACCP food safety system. 6. Imiyalelo Yokusebenzisa 6.1 Umthamo ohlongozwayo Uhlobo lokulungiselela Inhloso yokusebenza Umthamo ohlongozwayo Tablet/capsule umkhiqizo wokuhamba 0.1-0.5% Oral suspension Umkhiqizo wokuhlanganisa/Umthuthukisi 0.5-2.0% Nutrient powder umkhiqizo wokuvimbela ukuhlanganiswa 0.2-1.0% Active ingredient carrier Umunca 5-15% 6.2 Iziqondiso ezibalulekile zokusebenza nokugcina •Ukusetshenziswa kokulungiselela okuqinile: kunconywa ukwengeza ngemva kokuxuba i-API kanye ne-diluent, futhi usebenzise ukuxuba okuphezulu okungaphezu kwemizuzu engama-30 ukuze kuqinisekiswe ukusabalala okufanayo. •Ukusetshenziswa kokulungiselela okukhanyayo: kufanele kusabalale ngaphansi kwezimo ze-pH 4-6, futhi kugwenywe ukuxhumana isikhathi eside ne-asidi eqinile kanye ne-alkali ukuze kuvinjeze ukonakaliswa kwesakhiwo se-colloid. •Izimo zokugcina: iphakheji evaliwe, igcinwe endaweni eyomile nepholile (15-25℃, umswakama ophakathi <60%), isebenza 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 kwazo zonke izimo: inezici zomkhiqizo wokuhamba kokulungiselela okuqinile kanye nokuzinza kokulungiselela okukhanyayo, kunciphisa uhlobo lwezinto ezisizayo futhi kulungiselela ukwakhiwa kwefomula. •Ukuqinisekiswa kokuhambisana komhlaba: ukuvuma kwe-multi-pharmaceutical code certification, ukweseka ukubhaliswa kwemithi yasekhaya nakwamanye amazwe, kunciphisa izingozi zokufinyelela emakethe. •Isevisi eyenziwe ngokwezifiso: ngokuya ngezidingo zamakhasimende, usayizi wezakhi kanye nezimo ezithile zesikhala 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, ezithuthukile nezintsha eGuangzhou •Amalungelo angu-83 avela kwi-Office of State Intellectual Property