1. Ukubuka Kwenkampani (Product Overview) 1.1 Incazelo eziyisisekelo I-colloidal silica dioxide iyisilicon dioxide esiphezulu esilungiswe ngokuqhubekayo, ibonakala njengepudingi emhlophe, elula. Umkhiqizo unikeza isakhiwo se-nano-network esiyinhloko, unikeza izinzuzo ezifana nosayizi wezakhi ezifanayo, ukusabalala okuhle, kanye nokuzinza okuqinile kwezemithi. Ayiphenduli nezithako ezisebenzayo zemithi. Ngobubanzi bayo obuphezulu besikhala esithile kanye nokuxhumana okuqinile phakathi kwezithako, i-silica dioxide isebenza njengomkhiqizo obalulekile wemithi ukuze kuthuthukiswe ikhwalithi nokuzinza kwezinhlelo zokwelapha. Isebenza emithini, ukudla, ukudla kwezilwane, kanye nezinkambu ezihlobene, ngenkathi isekela izixazululo zokusebenza ezenziwe ngokwezifiso. 1.2 Izinzuzo eziyisisekelo Njengomkhiqizo wemithi onemisebenzi eminingi, i-Zhongqi Colloidal Silica ixazulula kahle izinselelo zezimboni ezifana nokungabi ne-flowability ezakhiweni ezinzima zokwelapha kanye nezinkinga zokuhlala emaphaketheni amanzi. Ngokusebenzisa ukulawula ikhwalithi okuphelele kulo lonke uchungechunge lokukhiqiza, lo mkhiqizo uqinisekisa ubuqotho obufanayo nokusebenza, uvumela abakhiqizi bemithi ukuba bathuthukise ukusebenza kahle kokukhiqiza nokuncintisana komkhiqizo. Uhlangabezana nezidingo zokubhaliswa kwemithi ezweni nasemhlabeni jikelele, ubonisa ukuhamba phambili ekuhlangabezaneni nezidingo ezihlukahlukene zokulawula. 2. Izici Zomkhiqizo (Product Characteristics) •Isakhiwo se-Nano: usayizi wezithako 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, kanti 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 zokulungiselela amanzi. •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. Izinkambu Zokusebenza 4.1 Izakhiwo ezinzima Amathablethi, ama-capsule, kanye nepudingi: Lezi zingasabalala kahle zisetshenziswa ngezinsiza zokuxuba ezijwayelekile. Uhlelo lusebenza njengovimbelo lokunciphisa ukuxhumana phakathi kwezithako, kuthuthukisa i-flowability yamahhala, futhi kuvinjezele ukwakheka. Iphakamisa isivinini sokucindezela amathablethi ngenkathi ithuthukisa izinqubo zokukhiqiza ukuze kube nokuhamba kwepudingi okuhle. I-adsorbent/umkhiqizo owamukelayo ulawula kahle umswakama kanye nenani lamanzi (ukuguqulwa kuncike kumthamo). Lokhu kunciphisa izinkinga zokuhambisana phakathi kwezithako zemithi, kuthuthukisa ukusabalala okufanayo kwezithako 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 Ukulungiselela amanzi Amathuluzi emithi (ama-gels, ama-creams, ama-suspensions, njll.): I-viscosity iyahluka ngokuhamba kwesikhathi, ivumela ukujula ibe yi-paste noma ibe mncane ukuze kube lula ukuyisebenzisa. Ivimbela ukuwa okuqinile, ukungena, nokuhamba phambili ngenkathi ithuthukisa ukujula kwe-gel nokuhambisana kwezinto zokwakha. Ithuthukisa ukuzinza kokuhlala futhi ivimbela ukuwa kwe-aerosol (idinga izinsiza ezinamandla zokuhamba ukuze kufezwe ukusebenza okuhle). •I-suspension yokudla: Njengomkhiqizo wokuphakamisa nokujula, ukwengeza u-0.5-2.0% kungenza ubuningi bokuhlala kwe-API> 95%, kuvimbele ukuhlukaniswa kwemithi, futhi kuthuthukise ukunemba kokuthola. •Izithako/ukulungiselela amehlo: kuhambisana nezindinganiso zokukhiqiza ezihlanzekile ze-IPEC-GMP, kungathuthukisa ukuzinza kwesixazululo, kunciphise ingozi yokwakheka kwezithako, futhi kuhlangabezane nezidingo zokulungiselela amanzi ezithambile. 4.3 Izithako zokudla •Umthwali wezithako ezisebenzayo: umuncu ama-vitamins, ama-probiotics nezinye izinto ukuze wandise isikhathi sokuphila kwemikhiqizo futhi wandise isilinganiso sokugcina sokusebenza kwe-biological ngaphezu kuka-30%, efanelekile ku-protein powder, nutritional powder nezinye izinto. •Umkhiqizo ophikisana nokwakheka: emkhathini wezinga lokushisa ≤60%, impahla ye-powder ingagcinwa isikhathi esingaphezu kwezinyanga eziyi-6 ngaphandle kokwakheka ukuze kuqinisekiswe ukuhamba komkhiqizo. 4.4 Izicelo zokudla: Njengomkhiqizo wokudla oqondile, uthuthukisa i-flowability yezithako zokudla (kuhlanganisa ama-powder amakhanda), ivimbela ukwakheka ngesikhathi sokugcina ngenkathi igcina umswakama; umuncu umswakama, efanelekile kuma-powder amanzi/ahambayo; isebenza njengomkhiqizo ophikisana nokwakheka kwezithako ezinjengezikhukhula zokupheka nezithako ze-oyela, futhi isebenza njengomkhiqizo we-thixotropic ezithako zokupheka 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 kwepudingi, futhi unikeze izakhiwo ezinhle zokulungisa umswakama ezithakweni; thuthukisa inqubo yokugaya nokugaya ukuze kuvinjezelwe umkhiqizo ekubambeni kwezinsiza. 5. Izindinganiso nezimfuneko (Standards & Regulations) •Uhambisana nezindinganiso eziningi zepharmacopoeia zomhlaba: USP-NF, European Pharmacopoeia (Ph. Eur.), Japanese Pharmacopoeia (JP), kanye neChina Pharmacopoeia (ChP 2025). •Thola isitifiketi esihlobene: I-FDA inactive ingredient database collection, EU E551 food additive certification. •Landela iziqondiso zokuhambisana zomhlaba: ulandela izindinganiso zokukhiqiza ze-GMP nezimfuneko ze-HACCP zokuphepha kokudla. 6. Imiyalelo Yokusebenzisa 6.1 Umthamo ohlongozwayo Uhlobo lokulungiselela Inhloso yokusebenza Umthamo ohlongozwayo Tablet/capsule umsizi wokuhamba 0.1-0.5% Oral suspension Umkhiqizo wokuphakamisa/Umkhiqizo wokujula 0.5-2.0% Nutrient powder umkhiqizo ophikisana nokwakheka 0.2-1.0% Active ingredient carrier Umuncu 5-15% 6.2 Amathiphu abalulekile okusebenza 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 amanzi: kufanele kusabalale ngaphansi kwezimo ze-pH 4-6, futhi kugwenywe ukuxhumana isikhathi eside ne-asidi eqinile kanye ne-alkali ukuze kuvinjezelwe ukonakaliswa kwesakhiwo se-colloid. •Izimo zokugcina: iphakheji evaliwe, igcinwe endaweni eyomile nepholile (15-25℃, umswakama ophakathi <60%), iyasebenza iminyaka emibili, ivule futhi usebenzise ngokushesha. Le mininingwane engenhla iyisikhumbuzo kuphela, futhi ukusetshenziswa kwangempela nokuthola kufanele kulungiswe ngokuya ngempela yakho. 7. Izinzuzo Zomkhiqizo (PA) •Ukufaneleka kwazo zonke izimo: inezici zokuhamba komkhiqizo wokulungiselela okuqinile kanye nokuzinza kokulungiselela amanzi, yehlisa uhlobo lwezinto ezisizayo futhi ilungiselela ukwakhiwa kwefomula. •Ukuqinisekiswa kokuhambisana komhlaba: ukuvuma izitifiketi eziningi zepharmaceutical code, ukweseka ukubhaliswa kwemithi yasekhaya naphakathi, kunciphisa izingozi zokufinyelela emakethe. •Isevisi eyenziwe ngokwezifiso: ngokuya ngezidingo zamakhasimende, usayizi wezithako kanye nezici ezithile 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 nezokuvikelwa kwemvelo. 8. Ukuqinisekiswa kwesistimu yeNkampani kanye neziqinisekiso •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 kwezilwane •I-National high-tech enterprise •Izinkampani ezikhethekile, ezithuthukisiwe nezintsha eGuangzhou •Amalungelo angama-72 avela kwi-Office of State Intellectual Property