1. Ukubuka KweMikhiqizo (Product Overview) 1.1 Incazelo eziyisisekelo I-colloidal silica dioxide iyisilicon dioxide esiphezulu sokuhlanzeka esilungiswe ngokuqhubekayo, ibonakala njengothuli oluphaphathekile, oluwhite. Umkhiqizo unama-nano-network structure ayisisekelo, unikeza izinzuzo ezifana nosayizi wezinhlayiya ofanayo, ukusabalala okuhle, kanye nokuzinza kwezemikhakha. Ayiphenduli nezithako ezisebenzayo zemithi. Ngobubanzi bayo obuphezulu besikhala esithile kanye nokuxhumana okuqinile phakathi kwezinhlayiya, i-silica dioxide isebenza njenge-excipient ebalulekile yemithi ukuze ithuthukise ikhwalithi nokuzinza kwemikhiqizo yemithi. Itholakala ezindaweni zemithi, ukudla, ukudla kwezilwane, kanye nezinye izinkambu ezihlobene, ngenkathi isekela izixazululo zokusebenza ezikhethekile. 1.2 Izinzuzo eziyisisekelo Njenge-excipient yemithi enezinhloso eziningi, i-Zhongqi Colloidal Silica ibhekana kahle nezinselelo zezimboni ezifana nokungabi nempilo kahle kwezinhlobo zokuphakela eziqinile kanye nezinkinga zokuhlala ezilungisweni ze-liquid. Ngokusebenzisa ukulawula ikhwalithi okuphelele kulo lonke uchungechunge lokukhiqiza, lo mkhiqizo uqinisekisa ukuhlanzeka nokusebenza okuqhubekayo, uvumela abakhiqizi bemithi ukuba bathuthukise ukusebenza kahle kokukhiqiza kanye nokuncintisana komkhiqizo. Uhlangabezana nezidingo zokubhaliswa kwemithi ezweni nasemhlabeni jikelele, ubonisa ubuchwepheshe bayo bokuhlangabezana nezidingo ezihlukahlukene zokulawula. 2. Izici Zomkhiqizo (Product Characteristics) •I-Nanostructure: usayizi wezinhlayiya wendawo uqondiswa ku-12-20nm, udala isakhiwo esihlangene se-three-dimensional, futhi indawo ethile ye-BET ingafinyelela ku-175-380m²/g, inikeza isisekelo sokumunca kahle nokusabalala. •Ukwesekwa 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 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 neziqondiso zezimboni. 4. Izinkambu Zokusebenza 4.1 Izinhlobo zokuphakela eziqinile Amathablethi, ama-capsule, kanye nothuli: Lezi zingasabalala kahle zisebenzisa imishini yokuxuba ejwayelekile. Uhlelo lusebenza njengovimbelo lokunciphisa ukuxhumana phakathi kwezinhlayiya, kuthuthukisa ukuhamba okukhululekile, futhi kuvimbele ukuhlanganiswa. Iphakamisa isivinini sokucindezela amathablethi ngenkathi ithuthukisa izinqubo zokukhiqiza ukuze kube nokuhamba okukhululekile kotuli. I-adsorbent/umkhiqizo opholile ulawula kahle umswakama nokuhamba kwamanzi (ukuguqulwa kuncike kumthamo). Lokhu kunciphisa izinkinga zokuhambisana phakathi kwezingxenye zemithi, kukhuthaza ukusabalala okufanayo kwezingxenye zotuli, futhi kuthuthukisa isivinini sokuphuka kwamathablethi. •I-Tablet/capsule: Engeza u-0.1-0.5% njengomsizi wokuhamba, onganciphisa i-angle yokuphumula kotuli 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 Izilungiselelo ze-liquid Izilungiselelo zemithi (ama-gels, ama-creams, ama-suspensions, njll.): I-viscosity iyahluka ngokuhamba kwe-shear, ivumela ukujula ibe iphesti noma ibe mncane ukuze kube lula ukuyisebenzisa. Ivimbela ukuhlanganiswa okuqinile, ukuhamba, kanye nezimpawu zokuhamba ngenkathi ithuthukisa ukujula kwe-gel nokuhambisana kwezinto zokwakha. Ithuthukisa ukuzinza kokuhamba futhi ivimbela ukuhamba kwe-aerosol (idinga imishini ye-high-shear ukuze kuqinisekiswe ukusabalala okuhle ukuze kufezwe ukusebenza okuhle). •I-Oral suspension: Njenge-agent yokuphakamisa kanye nomjovo, ukwengeza u-0.5-2.0% kungakwenza kube ne-sediment volume ratio ye-API> 95%, ivimbele ukuhamba kwemithi, futhi ithuthukise ukunemba kokuthola. •Izithako/izilungiselelo zamehlo: kuhambisana nezindinganiso zokukhiqiza ezihlanzekile ze-IPEC-GMP, kungathuthukisa ukuzinza kwesixazululo, kunciphise ingozi yokwakheka kwezinhlayiya, futhi kulungele izidingo zezinto ezithambile. 4.3 Izithasiselo zokudla •Umthwali wezithako ezisebenzayo: umunca ama-vitamins, ama-probiotics nezinye izinto ukuze wandise isikhathi sokuphila kwemikhiqizo futhi wandise isilinganiso sokugcina sokusebenza kwezinto eziphilayo ngaphezu kuka-30%, efanelekile kumathuli e-protein, uthuli lokudla nezinye izinto. •I-Anti-caking agent: emkhathini we-humidity ≤60%, impahla yothuli ingagcinwa isikhathi eside ngaphezu kwezinyanga eziyi-6 ngaphandle kokuhlanganiswa ukuze kuqinisekiswe ukuhamba komkhiqizo. 4.4 Izicelo zokudla: Njenge-additive yokudla eqondile, ithuthukisa ukuhamba kwezithako zokudla (kuhlanganisa nothuli lwe-organic oluthambile), ivimbela ukuhlanganiswa kokugcina ngenkathi igcina umswakama; umunca umswakama, efanelekile kumathuli amanzi/ahamba; isebenza njengomjovo wezithako zokudla ezinjengama-pickling juices kanye nama-oyili ezitshalo, futhi isebenza njengomkhiqizo we-thixotropic kumaspray wokubhaka nokupheka; 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 kotuli, futhi unikeze izakhiwo ezinhle zokulungisa umswakama ezinhle; thuthukisa inqubo yokugaya nokugaya ukuze uvimbele umkhiqizo ekunamathelweni kwemishini. 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 bokufaneleka: i-FDA inactive ingredient database collection, i-EU E551 food additive certification. •Landela iziqondiso zokuhambisana zomhlaba: uhambe 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 umsizi wokuhamba 0.1-0.5% Oral suspension Umjovo/Umjovo 0.5-2.0% Nutrient powder umkhiqizo opholile 0.2-1.0% Active ingredient carrier Umunca 5-15% 6.2 Iziphakamiso ezibalulekile zokusebenza 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 kusabalale ngaphansi kwezimo ze-pH 4-6, futhi ugweme ukuxhumana isikhathi eside ne-asidi eqinile kanye ne-alkali ukuze uvimbele 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 kanye nomthamo kufanele kulungiswe ngokuya ngempela yakho. 7. Izinzuzo Zomkhiqizo (PA) •Ukufaneleka kwesimo esiphelele: inezici zokuhamba kokulungiselela okuqinile kanye nokuzinza kokulungiselela i-liquid, kunciphisa uhlobo lwezinto ezisizayo futhi kulungiselela ukuklama ifomula. •Ukuqinisekiswa kokuhambisana komhlaba: ukuvuma izitifiketi eziningi zephakheji yemithi, ukweseka ukubhaliswa kwemithi yasekhaya naphakathi, kunciphisa izingozi zokufinyelela emakethe. •Insiza eyenziwe ngezifiso: ngokuya ngezidingo zamakhasimende, usayizi wezinhlayiya kanye nezici ezithile zendawo 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 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 i-food additive •I-licence yokukhiqiza i-feed additive •I-National high-tech enterprise •Izinkampani ezikhethekile, ezihlelekile nezintsha eGuangzhou •Amalungelo angama-22 avela kwi-Office of State Intellectual Property