1. Ukubuka KweMikhiqizo (Product Overview) 1.1 Incazelo eziyisisekelo I-colloidal silica dioxide iyisilicon dioxide esiphezulu sokuhlanzeka esilungiswe ngezinqubo advanced, ibonakala njengepowder emhlophe, ethambile. Umkhiqizo ubonisa isakhiwo se-nano-network esiyinhloko, unikeza izinzuzo ezifana nosayizi wezinhlayiya obumbene, ukusabalala okuhle, kanye nokuzinza kwemichiza okuqinile. Ayiphenduli nezithako ezisebenzayo zemithi. Ngobubanzi bayo obuphezulu besikhala esithile kanye nokuxhumana okuqinile phakathi kwezinhlayiya, i-silica dioxide isebenza njengomkhiqizo obalulekile wemithi ukuze ithuthukise ikhwalithi nokuzinza kwemikhiqizo yemithi. Ithola izicelo emithini, ekudleni, ekudleni, nasemikhakheni ehlobene, ngenkathi ixhasa izixazululo zokusebenza ezenziwe ngokwezifiso. 1.2 Izinzuzo eziyisisekelo Njengomkhiqizo wemithi onemisebenzi eminingi, i-Zhongqi Colloidal Silica ixazulula kahle izinselelo zezimboni ezifana nokungabi ne-flowability ezimweni zokudla eziqinile kanye nezinkinga zokuhlala emikhiqizweni ye-liquid. Ngokusebenzisa ukulawula ikhwalithi okuphelele kuyo yonke i-chain yokukhiqiza, lo mkhiqizo uqinisekisa ukuhlanzeka nokusebenza okuhambisanayo, uvumela abakhiqizi bemithi ukuba bathuthukise ukusebenza kahle kokukhiqiza kanye nokuncintisana komkhiqizo. Uhlangabezana nezidingo zokubhaliswa kwemithi ezweni nasemhlabeni jikelele, ubonisa ubuchwepheshe bayo bokuhlangabezana nezidingo ezihlukahlukene zokulawulwa. 2. Izici Zomkhiqizo (Product Characteristics) •Isakhiwo se-Nano: usayizi wezinhlayiya uqondiswa ku-12-20nm, udala isakhiwo esihlangene se-three-dimensional, kanti indawo ethile ye-BET 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. Akukho phenomenu yokuhlukaniswa eyenzeka ngemuva kwezinsuku eziyi-30 zokuma ku-25℃, ihlangabezana nezidingo zokugcina isikhathi eside zemikhiqizweni ye-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 lezimboni. 4. Izindawo Zokusebenza 4.1 Izimo zokudla eziqinile Amathablethi, ama-capsule, kanye ne-powder: Lezi zingasabalala kahle zisetshenziswa ngempahla yokuxuba ejwayelekile. Uhlelo lusebenza njengovimbelo ukuze lunciphise ukuxhumana phakathi kwezinhlayiya, kuthuthukise i-flowability yamahhala, futhi kuvinjeze i-caking. Iphumelela ngesivinini sokucindezela amathablethi ngenkathi ithuthukisa izinqubo zokukhiqiza ukuze kube nokuhamba kwepowder okuhle. I-adsorbent/umkhiqizo opholile ulawula kahle umswakama kanye nomthamo wamanzi (ukuguqulwa kuncike kumthamo). Lokhu kunciphisa izinkinga zokuhambisana phakathi kwezingxenye zemithi, kuthuthukisa ukusabalala okujwayelekile kwezingxenye ze-powder, futhi kuthuthukisa isivinini sokuphuka kwamathablethi. •I-Tablet/capsule: Engeza u-0.1-0.5% njengomsebenzi wokusiza ukuhamba, okunganciphisa i-angle yokuphumula kwepowder ngo-20-30%, kunciphise umehluko wesisindo emsebenzini wamathablethi, futhi kuthuthukise ubunzima bamathablethi ngo-15-20% futhi kunciphise ubrittleness. •Inqubo ye-tablet eqondile: thuthukisa ukuhamba kwemikhiqizo, kunciphise inani le-lubricant, kunciphise isikhathi sokukhiqiza, kufanelekile ku-acetaminophen, aspirin nezinye izinhlelo ze-API. 4.2 Imikhiqizo ye-liquid Imikhiqizo yemithi (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, kanye nezimpawu zokuhlukaniswa ngenkathi ithuthukisa ukujula kwe-gel kanye nokusabalala kwezinto zokwakha. Ithuthukisa ukuzinza kokuhlala futhi ivimbela ukuhamba kwe-aerosol (idinga imishini ephezulu yokuhamba ukuze kuqinisekiswe ukusabalala okuhle ukuze kufinyelelwe ukusebenza okuhle). •I-Oral suspension: Njengomkhiqizo wokuphakamisa kanye nomkhiqizo opholile, ukwengeza u-0.5-2.0% kungenza umthamo we-sediment ratio ye-API> 95%, ivimbele ukuhlukaniswa kwemithi, futhi ithuthukise ukunembile kokuthola. •Izithako/imikhiqizo ye-ophthalmic: ehambisana nezindinganiso zokukhiqiza ezihlanzekile ze-IPEC-GMP, ingathuthukisa ukuzinza kwesixazululo, kunciphise ingozi yokwakheka kwezinhlayiya, futhi ilungiselele izidingo zemikhiqizo ye-liquid ezithambile. 4.3 Izithako zokudla •Umthwali wezithako ezisebenzayo: adsorb vitamins, probiotics nezinye izithako ukuze wandise isikhathi sokuphila kwemikhiqizo futhi wandise umphumela wokugcina we-biological activity ngaphezu kuka-30%, kufanelekile ku-protein powder, nutritional powder nezinye izinto. •Umkhiqizo ophikisana ne-caking: emkhathini we-humidity ≤60%, impahla ye-powder ingagcinwa isikhathi esingaphezu kwezinyanga eziyi-6 ngaphandle kokuhlangana ukuze kuqinisekiswe ukuhamba komkhiqizo. 4.4 Izicelo zokudla: Njengomkhiqizo wokudla oqondile, ithuthukisa i-flowability ye-powder yokudla (kuhlanganise ne-powder ye-organic ethambile), ivimbela i-caking yokugcina ngenkathi igcina umswakama; adsorbs umswakama, ifanelekile kuma-powder amanzi/hygroscopic; isebenza njengomkhiqizo opholile wezokudla ezinjengezikhukhula zokupheka nezithako ze-vegetable oils, futhi isebenza njengomkhiqizo we-thixotropic ezithako zokupheka ezisekelwe ku-oyela; ngaphezu kwalokho ithuthukisa ukuhlanzeka kwemishini ngesikhathi sokugaya izinto zokwakha. 4.5 Ukusebenza emkhakheni we-feed: Thuthukisa ukusebenza kwe-feed kanye nobuchwepheshe bokucubungula ukuze kuqinisekiswe ukuhamba okukhululekile nokumelana nokugcina kwe-powder yokwengeza, futhi unikeze izakhiwo ezinhle zokulungisa umswakama ezinhle; thuthukisa inqubo yokugaya nokugaya ukuze uvimbele umkhiqizo ukuthi ungabambeki kumishini. 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: 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 I-Tablet/capsule umkhiqizo wokuhamba 0.1-0.5% I-Oral suspension Umkhiqizo wokuphakamisa/opholile 0.5-2.0% I-Nutrient powder umkhiqizo ophikisana ne-caking 0.2-1.0% Umthwali wezithako ezisebenzayo Umkhiqizo opholile 5-15% 6.2 Iziphakamiso ezibalulekile zokusebenza nokugcina •Ukusebenza kwemikhiqizo eqinile: kunconywa ukuthi engezwe ngemuva kokuxuba i-API kanye ne-diluent, futhi kusetshenziswe ukuxuba okuphezulu okungaphezu kwemizuzu engama-30 ukuze kuqinisekiswe ukusabalala okujwayelekile. •Ukusebenza kwemikhiqizo ye-liquid: kufanele kusabalalise 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: iphakethe elivaliwe, ligcinwe endaweni eyomile nepholile (15-25℃, umswakama ophakathi <60%), lisebenza iminyaka emibili, livule futhi usebenzise ngokushesha. Le mininingwane engenhla iyisikhumbuzo kuphela, futhi ukusetshenziswa kwangempela kanye nomthamo kufanele kulungiswe ngokuya ngempela yakho. 7. Izinzuzo Zomkhiqizo (PA) •Ukufaneleka kwazo zonke izimo: inezici zokuhamba kwemikhiqizo eqinile kanye nezokusebenza kwe-liquid, kunciphisa uhlobo lwezinto ezisizayo futhi kulungiselela ukuklama ifomula. •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 wezinhlayiya kanye nezici ezithile zendawo 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 •I-licence yokukhiqiza izithako zokudla •I-licence yokukhiqiza izithako zokudla •I-National high-tech enterprise •Izinkampani ezikhethekile, ezithuthukisiwe nezintsha eGuangzhou •Amalungelo angama-28 avela kwi-Office of State Intellectual Property