1. Ukubuka KweMikhiqizo (Product Overview) 1.1 Incazelo eziyisisekelo I-colloidal silica dioxide iyisilicon dioxide esiphezulu sokuhlanzeka esilungiswe ngezinqubo ezithuthukile, ibonakala njengothuli oluphaphathekile, oluwhite. Umkhiqizo unama-nano-network structure ayinhloko, unikeza izinzuzo ezifana nosayizi wezakhi ezihlangene, ukuhamba kahle okuhle, kanye nokuzinza kwezemikhiqizo. Ayiphenduli nezithako ezisebenzayo zemithi. Ngobubanzi bayo obuphezulu besikhala esithile kanye nokuxhumana okuqinile phakathi kwezithako, i-silica dioxide iyinsiza ebalulekile yemithi yokwandisa ikhwalithi nokuzinza kwemikhiqizo yemithi. Itholakala ezindaweni zemithi, ukudla, ukudla kwezilwane, kanye nezinye izindawo ezihlobene, ngenkathi isekela izixazululo zokusebenza ezenziwe ngezifiso. 1.2 Izinzuzo eziyisisekelo Njengensiza yemithi enezinhloso eziningi, i-Zhongqi Colloidal Silica ixazulula kahle izinselelo zezimboni ezifana nokungahambi kahle kwezinto ezinzima ezibhalwe phansi kanye nezinkinga zokuhlala emanzini. Ngokulawula ikhwalithi ngokuphelele kuyo yonke imikhakha yokukhiqiza, lo mkhiqizo uqinisekisa ukuhamba kahle nokusebenza okujwayelekile, 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 sezinhlaka ezintathu, futhi indawo ethile ye-BET 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 phenomene yokuhlukaniswa eyenzeka ngemuva kwezinsuku eziyi-30 zokuma ku-25℃, ihlangabezana nezidingo zokugcina isikhathi eside zemikhiqizo emanzini. •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. Iziqukathi Zokusebenza 4.1 Izinhlobo zokupakisha ezinzima Amathablethi, ama-capsule, kanye nothuli: Lezi zingahlukaniswa kahle zisebenzisa imishini yokuxuba ejwayelekile. Uhlelo lusebenza njengovimbela ukunciphisa ukuxhumana phakathi kwezithako, kuthuthukisa ukuhamba kahle, futhi kuvimbele ukuhlanganiswa. Iphakamisa isivinini sokucindezela amathablethi ngenkathi ithuthukisa izinqubo zokukhiqiza zokuhamba kahle kothuli. I-adsorbent/okumunca amanzi ikwazi kahle ukulawula umswakama nokuhamba kwamanzi (ukuguqulwa kuncike kumthamo). Lokhu kunciphisa izinkinga zokuhambisana phakathi kwezithako zemithi, kuthuthukisa ukusabalala okujwayelekile kwezithako zothuli, futhi kuthuthukisa isivinini sokuphuka kwamathablethi. •I-Tablet/capsule: Engeza u-0.1-0.5% njengensiza yokuhamba, enganciphisa i-angle yokuphumula kothuli ngama-20-30%, yehlise umehluko wesisindo enqubweni yamathablethi, futhi ithuthukise ubunzima bamathablethi ngama-15-20% futhi yehlise ubrittleness. •Inqubo ye-tablet eqondile: thuthukisa ukuhamba kwezinto, yehlise inani le-lubricant, yehlise isikhathi sokukhiqiza, efanelekile ku-acetaminophen, aspirin nezinye izinhlelo ze-API. 4.2 Izinhlelo ezimanzi Izinto ezimanzi 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 ukuhlanganiswa okuqinile, ukuhamba, nokuhlukana ngenkathi ithuthukisa ukujula kwe-gel nokuhambisana kwezinto ezisemqoka. Ithuthukisa ukuzinza kokuhlanganiswa futhi ivimbela ukuhamba kwe-aerosol (idinga imishini yokuhamba ephezulu ukuze kuqinisekiswe ukuhamba kahle ukuze kufezwe ukusebenza okuhle). •I-Oral suspension: Njengensiza yokuhlanganisa kanye ne-thickener, ukwengeza u-0.5-2.0% kungakwenza kube khona umthamo we-sediment ratio ye-API> 95%, ivimbele ukuhluza kwemithi, futhi ithuthukise ukunemba kokuthola. •Izithako/izinhlelo zokubuka: zihambisana nezindinganiso zokukhiqiza ezihlanzekile ze-IPEC-GMP, zingathuthukisa ukuzinza kwesixazululo, zinciphise ingozi yokwakheka kwezithako, futhi zihlale zihambisana nezidingo zemikhiqizo emanzi ezibucayi. 4.3 Izithako zokudla •Umthwali wezithako ezisebenzayo: ukumunca ama-vitamins, ama-probiotics nezinye izithako ukuze wandise isikhathi sokuphila kwemikhiqizo futhi wandise umphumela wokugcina we-biological activity ngaphezu kuka-30%, efanelekile ku-protein powder, nutritional powder nezinye izinto. •I-Anti-caking agent: emkhathini we-humidity ≤60%, impahla yothuli ingagcinwa isikhathi esingaphezu kwezinyanga eziyi-6 ngaphandle kokuhlanganiswa ukuze kuqinisekiswe ukuhamba komkhiqizo. 4.4 Izicelo zokudla: Njengokudla okuqondile, kuthuthukisa ukuhamba kahle kwezithako zokudla (kuhlanganisa nothuli lwe-organic oluthambile), ivimbela ukuhlanganiswa kokugcina ngenkathi igcina umswakama; ukumunca umswakama, efanelekile ku-damp/hygroscopic powders; isebenza njenge-thickener yezinto ezimanzi zokudla ezifana nezikhukhula zokupheka nezithako zezithelo, futhi isebenza njenge-thixotropic agent ezindaweni zokupheka ezisekelwe ku-oyela; ngaphezu kwalokho ithuthukisa ukuhlanzeka kwemishini ngesikhathi sokugaya izinto ezisemqoka. 4.5 Ukusetshenziswa emkhakheni wokudla: Thuthukisa ukusebenza kokudla kanye nobuchwepheshe bokucubungula ukuze uqinisekise ukuhamba kahle nokumelana nokugcina kwe-powder yokwengeza, futhi unikeze izakhiwo ezinhle zokulungisa umswakama ezithakweni; thuthukisa inqubo yokugaya nokugaya ukuze uvimbele umkhiqizo ekubambeni kwemishini. 5. Izindinganiso nezimfuneko (Standards & Regulations) •Uhambisana nezindinganiso eziningi ze-pharmacopoeia zomhlaba: USP-NF, European Pharmacopoeia (Ph. Eur.), Japanese Pharmacopoeia (JP), kanye ne-China Pharmacopoeia (ChP 2025). •Thola isitifiketi esihlobene: I-FDA inactive ingredient database collection, EU E551 food additive certification. •Landela iziqondiso zokuhambisana zomhlaba: 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 Tablet/capsule insiza yokuhamba 0.1-0.5% Oral suspension Insiza yokuhlanganisa/Thickening agent 0.5-2.0% Nutrient powder insiza yokuvimbela ukuhlanganiswa 0.2-1.0% Active ingredient carrier Adsorbent 5-15% 6.2 Izinhloso ezibalulekile zokusebenza nokugcina •Ukusetshenziswa kokulungiselela okuqinile: kunconywa ukwengeza ngemuva kokuxuba i-API kanye ne-diluent, futhi usebenzise ukuxuba okuphezulu okungaphezu kwemizuzu engama-30 ukuze uqinisekise ukusabalala okujwayelekile. •Ukusetshenziswa kokulungiselela okumanzi: kufanele kuhlukaniswe ngaphansi kwezimo ze-pH 4-6, futhi ugweme ukuxhumana isikhathi eside ne-asidi eqinile kanye ne-alkali ukuvimbela ukonakaliswa kwesakhiwo se-colloid. •Izimo zokugcina: iphakheji evaliwe, igcinwe endaweni eyomile nepholile (15-25℃, umswakama ophakathi <60%), iyasebenza iminyaka emibili, ivule futhi usebenzise ngokushesha. Ulwazi olungaphezulu lungumqondo kuphela, futhi ukusetshenziswa kwangempela nokuthola kufanele kulungiswe ngokuya ngempela yakho. 7. Izinzuzo Zomkhiqizo (PA) •Ukufaneleka kwazo zonke izimo: inezinhloso zokuhamba komkhiqizo okuqinile kanye nokuzinza kokulungiselela okumanzi, yehlisa uhlobo lwezinto ezisizayo futhi ilungiselele umklamo wefomula. •Ukuqinisekiswa kokuhambisana komhlaba: ukuvuma izitifiketi eziningi ze-pharmaceutical code, ukweseka ukubhaliswa kwemithi yasekhaya nakwamanye amazwe, yehlisa izingozi zokufinyelela emakethe. •Insiza ezenziwe ngezifiso: ngokuya ngezidingo zamakhasimende, usayizi wezinto kanye nezimo ezithile zendawo zingalungiswa ukuze kuhanjiswe izixazululo zobuchwepheshe ezikhethekile. •Ukuphakelwa okuqhubekayo: inqubo yokukhiqiza isebenzisa ukuvuselelwa kwamandla, futhi iphakheji isebenzisa amabhakede ephepha aphindaphindwayo 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 •I-licence yokukhiqiza yokudla •I-licence yokukhiqiza yokudla kwezilwane •I-National high-tech enterprise •Izinkampani ezikhethekile, ezithuthukisiwe nezintsha eGuangzhou •Amalungelo angu-90 avela kwi-Office of State Intellectual Property