1. Ukubuka Kwenkanyezi (Product Overview) 1.1 Incazelo eziyisisekelo I-colloidal silica dioxide iyisilicon dioxide esiphezulu esilungiswe ngokuqhubekayo, ibonakala njengepudingi elimhlophe, elikhululekile. 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 njenge-excipient ebalulekile yemithi ukuze ithuthukise ikhwalithi nokuzinza kwezithako zemithi. Ithola izicelo emithini, ekudleni, ekudleni kwezilwane, nasemkhakheni ofanele, ngenkathi ixhasa izixazululo zokusebenza ezikhethekile. 1.2 Izinzuzo eziyisisekelo Njenge-excipient yemithi enezinhloso eziningi, i-Zhongqi Colloidal Silica ixazulula kahle izinselelo zezimboni ezifana nokungabi nempilo kahle ezakhiweni ezinzima zokuphakela kanye nezinkinga zokuhlala emithini ye-liquid. Ngokulawula ikhwalithi ngokuphelele kulo lonke uhlelo lokukhiqiza, lo mkhiqizo uqinisekisa ubuqotho obufanayo nokusebenza, uvumela abakhiqizi bemithi ukuba bathuthukise ukusebenza kahle kokukhiqiza kanye nokuncintisana komkhiqizo. Uhlangabezana nezidingo zokubhaliswa kwemithi ezweni nasemhlabeni jikelele, ubonisa ukuhamba phambili ekuhlangabezaneni nezidingo ezahlukene zokulawula. 2. Izici Zomkhiqizo (Product Characteristics) •I-Nanostructure: usayizi wezakhi wendawo uqondiswa ku-12-20nm, udala isakhiwo esihlangene esinobukhulu obufanayo, futhi indawo ethile ye-BET ingafinyelela ku-175-380m²/g, inikeza isisekelo sokumunca kahle nokusabalala. •Ukwesekwa okuhle kokusabalala: ingakwazi ukudala i-colloid ezinzile ohlelweni lwe-aqueous, 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 zemithini 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 neziqondiso zezimboni. 4. Izindawo Zokusebenza 4.1 Izakhiwo ezinzima Amathablethi, ama-capsule, namapudingi: Lezi zingasabalala kahle zisetshenziswa ngezinsiza zokuxuba ezijwayelekile. Uhlelo lusebenza njengezithiyo zokunciphisa ukuxhumana phakathi kwezakhi, kuthuthukisa ukuhamba okukhululekile, futhi kuvimbele ukuhlanganiswa. Kwandisa isivinini sokucindezela amathablethi ngenkathi kuthuthukiswa izinqubo zokukhiqiza zokuhamba kwepudingi. I-adsorbent/umkhiqizo opholile ulawula kahle umswakama nokuhamba kwamanzi (ukuguqulwa kuncike kumthamo). Lokhu kunciphisa izinkinga zokuhambisana phakathi kwezithako zemithi, kukhuthaza ukusabalala okufanayo kwezakhi ze-powder, futhi kuthuthukisa isivinini sokuphuka kwamathablethi. •I-Tablet/capsule: Engeza u-0.1-0.5% njengomsizi wokuhamba, onganciphisa i-angle yokuphumula kwepudingi ngo-20-30%, unciphise umehluko wesisindo enqubweni ye-tablet, futhi uthuthukise ubunzima bamathablethi ngo-15-20% futhi unciphise ubrittleness. •Inqubo ye-tablet eqondile: thuthukisa ukuhamba kwezinto, unciphise inani le-lubricant, yehlisa isikhathi sokukhiqiza, efanelekile ku-acetaminophen, aspirin nezinye izinhlelo ze-API. 4.2 Izinhlelo ze-liquid Imithi ye-liquid (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, ukuhamba, nokuhamba ngenkathi ithuthukisa ukujula kwe-gel nokuhambisana kwezinto zokwakha. Ithuthukisa ukuzinza kokuhlala futhi ivimbela ukuhamba kwe-aerosol (idinga imishini ye-high-shear ukuze kuqinisekiswe ukusabalala okuhle ukuze kufinyelelwe ukusebenza okuhle). •I-Oral suspension: Njenge-agent yokuhlala kanye nomjikelezo, ukwengeza u-0.5-2.0% kungenza ubuningi bokuhlala kwe-API> 95%, kuvimbele ukuhamba kwemithi, futhi kuthuthukise ukunemba kokutholakala. •Izithako/izinhlelo zokubuka: kuhambisana nezindinganiso zokukhiqiza ezihlanzekile ze-IPEC-GMP, kungathuthukisa ukuzinza kwesixazululo, kunciphise ingozi yokwakheka kwezakhi, futhi kuhlangabezane nezidingo ze-liquid ezithambile. 4.3 Izithako zokudla •I-active ingredient carrier: adsorb vitamins, probiotics nezinye izithako ukuze wandise isikhathi sokuphila kwemikhiqizo futhi wandise isilinganiso sokugcina sokusebenza kwe-biological ngaphezu kuka-30%, efanelekile ku-protein powder, nutritional powder nezinye izinto. •I-anti-caking agent: emkhathini we- humidity ≤60%, impahla ye-powder ingagcinwa isikhathi esingaphezu kwezinyanga eziyi-6 ngaphandle kokuhlanganiswa ukuze kuqinisekiswe ukuhamba komkhiqizo. 4.4 Izicelo zokudla: Njengezithako zokudla ezithile, ithuthukisa ukuhamba kwepudingi yokudla (kuhlanganisa ama-powder amakhanda), ivimbela ukuhlanganiswa kokugcina ngenkathi igcina umswakama; adsorbs umswakama, efanelekile kumapudingi amanzi/ahambayo; isebenza njengomjikelezo wezithako zokudla ezinjengezikhukhula zokupheka nezithako zezithelo, futhi isebenza njenge-agent ye-thixotropic ezithakeni zokupheka ezisekelwe ku-oyela; ngaphezu kwalokho ithuthukisa ukuhlanzeka kwemishini ngesikhathi sokugaya izinto zokwakha. 4.5 Ukusebenza emkhakheni wezokudla: Thuthukisa ukusebenza kokudla kanye nobuchwepheshe bokucubungula ukuze kuqinisekiswe ukuhamba okukhululekile nokumelana nokugcina kwepudingi yokwengeza, futhi unikeze izakhiwo ezinhle zokulungisa umswakama kumapudingi; thuthukisa inqubo yokugaya nokugaya ukuze kuvinjelwe umkhiqizo ukuthi ungeniswe 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 nezidingo ze-HACCP food safety system. 6. Imiyalelo Yokusebenzisa 6.1 Umthamo ophakanyisiwe Uhlobo lokulungiselela Umsebenzi ophakanyisiwe Umthamo ophakanyisiwe Tablet/capsule umsizi wokuhamba 0.1-0.5% Oral suspension Umsebenzi/Umjikelezo 0.5-2.0% Nutrient powder umjikelezo wokungahambisani 0.2-1.0% Active ingredient carrier Adsorbent 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 kwe-liquid: kufanele kusabalale ngaphansi kwezimo ze-pH 4-6, futhi ugweme ukuxhumana isikhathi eside ne-asidi eqinile kanye ne-alkali ukuvimbela ukuwohloka 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 sonke: inezici zokuhamba kokulungiselela okuqinile kanye nokuzinza kokulungiselela kwe-liquid, inciphisa uhlobo lwezinto ezisizayo futhi ilungiselele umklamo wefomula. •Ukuqinisekiswa kokuhambisana komhlaba: ukuhlinzeka nge-multi-pharmaceutical code certification coverage, ukweseka ukubhaliswa kwemithi yasekhaya naphakathi, kunciphisa izingozi zokufinyelela emakethe. •Isevisi eyenziwe ngezifiso: ngokuya ngezidingo zamakhasimende, usayizi wezakhi nezici ezithile zingalungiswa ukuze kuhanjiswe izixazululo zobuchwepheshe ezikhethekile. •Ukuphakelwa okuqhubekayo: inqubo yokukhiqiza isebenzisa ukuvuselelwa kwamandla, futhi iphakheji isebenzisa amabhakede ephepha angasetshenziswa kabusha ukuze ibalansise ukusebenza nezidingo zokuvikelwa kwemvelo. 8. Ukuqinisekiswa kwesistimu yeNkampani kanye nezindondo •FSSC22000 •ISO22000：2018 •ISO9001：2015 •SHC HALAL •OU KOSHER •I-FDA attestation •FAMI-QS •SEDEX •Imvume yokukhiqiza izithako zokudla •Imvume yokukhiqiza izithako zokudla kwezilwane •I-National high-tech enterprise •Izinkampani ezikhethekile, ezihlukile nezintsha eGuangzhou •Amalungelo angama-40 avela kwi-Office of State Intellectual Property