1. Ukubuka Kwenkampani (Product Overview) 1.1 Incazelo eziyisisekelo I-colloidal silica dioxide iyisilicon dioxide esihlanzekile kakhulu esilungiswe ngezinqubo advanced, ibonakala njengothuli oluphaphathekile, oluwhite. Umkhiqizo unama-nano-network structure ayisisekelo, unikeza izinzuzo ezifana nosayizi wezakhi ezihlanganisiwe, ukusabalala okuhle, kanye nokuzinza kwemichiza okuqinile. 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 kokwakhiwa kwemithi. Ithola izicelo emithini, ekudleni, ekudleni kwezilwane, nasemkhakheni oxhumene, ngenkathi isekela izixazululo zokusebenza ezenziwe ngokwezifiso. 1.2 Izinzuzo eziyisisekelo Njengomkhiqizo wemithi onemisebenzi eminingi, i-Zhongqi Colloidal Silica ixazulula kahle izinselelo zezimboni ezifana nokungabi namathuba okuhamba kahle ezithakweni eziqinile kanye nezinkinga zokuhlala emithini ye-liquid. Ngokusebenzisa ukulawula ikhwalithi okuphelele kulo lonke uchungechunge lokukhiqiza, lo mkhiqizo uqinisekisa ukuhlala kwekhwalithi nokusebenza, uvumela abakhiqizi bemithi ukuba bathuthukise ukusebenza kahle kokukhiqiza kanye nokuncintisana komkhiqizo. Uhlangabezana nezidingo zokubhaliswa kwemithi ezweni nasemhlabeni jikelele, ubonisa ukuhamba kahle kwakhe ekuhlangabezaneni nezidingo ezahlukene zokulawula. 2. Izici Zomkhiqizo (Product Characteristics) •I-Nanostructure: usayizi wezithako uqondiswa ku-12-20nm, udala isakhiwo esihlangene se-three-dimensional, kanti i-BET specific surface area 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 zemithi 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. Iziqu Zokusebenza 4.1 Izinhlobo zokwakhiwa eziqinile Amathablethi, ama-capsule, kanye nothuli: Lezi zingasabalala kahle zisetshenziswa ngempahla yokuxuba ejwayelekile. Uhlelo lusebenza njengovimbelo lokunciphisa ukuxhumana phakathi kwezithako, kuthuthukisa ukuhamba kahle, futhi kuvimbele ukuhlanganiswa. Iphakamisa isivinini sokucindezela amathablethi ngenkathi ithuthukisa izinqubo zokukhiqiza ukuze kube nokuhamba kahle kotuli. I-adsorbent/okumunca amanzi okwakhiwa kahle kulawula umswakama nokuqukethwe kwamanzi (ukuguqulwa kuncike kumthamo). Lokhu kunciphisa izinkinga zokuhambisana phakathi kwezithako zemithi, kuthuthukisa ukusabalala okujwayelekile kwezithako zotuli, futhi kuthuthukisa isivinini sokuphuka kwamathablethi. •I-Tablet/capsule: Engeza u-0.1-0.5% njengomsebenzi wokuhamba, okunganciphisa i-angle yokuphumula kotuli ngo-20-30%, kunciphise umehluko wesisindo enqubweni yokwenza amathablethi, futhi kuthuthukise ubhardness bamathablethi ngo-15-20% futhi kunciphise ubrittleness. •Inqubo ye-tablet eqondile: thuthukisa ukuhamba kwezinto, kunciphise inani le-lubricant, kunciphise 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 yipasta noma ibe mncane ukuze kube lula ukuyisebenzisa. Ivimbela ukuhlanganiswa okuqinile, ukuhamba, nokuhamba ngenkathi ithuthukisa ukujula kwe-gel nokuhambisana kwezinto zokwakha. Ithuthukisa ukuzinza kokuhamba futhi ivimbela ukuhamba kwe-aerosol (idinga imishini ephezulu yokuhamba ukuze kufezwe ukusebenza okuhle). •I-Oral suspension: Njengomsebenzi wokuphakamisa nokujula, ukwengeza u-0.5-2.0% kungenza ubuningi bokuhlala kwe-API> 95%, kuvimbele ukuhamba kwemithi, futhi kuthuthukise ukunemba kokuphuma. •Izithako/izinhlelo zokubuka: kuhambisana nezindinganiso zokukhiqiza ezihlanzekile ze-IPEC-GMP, kungathuthukisa ukuzinza kwesixazululo, kunciphise ingozi yokwakheka kwezithako, futhi kuhlangabezane nezidingo zemithi ye-liquid ezithambile. 4.3 Izithako 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 ku-protein powder, nutritional powder nezinye izinto. •Umsebenzi wokuvimbela ukuhlanganiswa: endaweni yokungabi namanzi ≤60%, impahla yothuli ingagcinwa isikhathi eside ngaphezu kwezinyanga eziyi-6 ngaphandle kokuhlanganiswa ukuze kuqinisekiswe ukuhamba komkhiqizo. 4.4 Izicelo zokudla: Njengokudla okungeziwe okuqondile, kuthuthukisa ukuhamba kwezithako zokudla (kuhlanganise nothuli lwe-organic oluthambile), kuvimbele ukuhlanganiswa kokugcina ngenkathi kugcinwa umswakama; umunca umswakama, efanelekile ku-powder ezimanzi/hygroscopic; isebenza njengomsebenzi wokujula ezidleni ezinjengama-pickling juices kanye nama-oyili ezitsha, futhi isebenza njengomsebenzi we-thixotropic ezindaweni zokupheka ezisekelwe ku-oyili; ngaphezu kwalokho ithuthukisa ukuhlanzeka kwemishini ngesikhathi sokugaya izinto zokwakha. 4.5 Ukusetshenziswa emkhakheni wezokudla: Thuthukisa ukusebenza kokudla kanye nobuchwepheshe bokucubungula ukuze kuqinisekiswe ukuhamba okukhululekile nokumelana nokugcina kwe-powder yokwengeza, futhi inikeze izakhiwo ezinhle zokulungisa umswakama ezithakweni; 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 izitifiketi ezifanele: 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 lokwakhiwa Umsebenzi ohlongozwayo Umthamo ohlongozwayo Tablet/capsule umkhiqizo wokuhamba 0.1-0.5% Oral suspension Umsebenzi wokuphakamisa/ujula 0.5-2.0% Nutrient powder umkhiqizo wokuvimbela ukuhlanganiswa 0.2-1.0% Active ingredient carrier Umunca 5-15% 6.2 Amathiphu abalulekile okusebenza nokugcina •Ukusetshenziswa kokwakhiwa okuqinile: kunconywa ukwengeza ngemuva kokuxuba i-API kanye ne-diluent, futhi usebenzise ukuxuba okuphezulu okungaphezu kwemizuzu engama-30 ukuze uqinisekise ukusabalala okujwayelekile. •Ukusetshenziswa kokwakhiwa kwe-liquid: kufanele kusabalale ngaphansi kwezimo ze-pH 4-6, futhi kugwenywe ukuxhumana isikhathi eside ne-asidi eqinile kanye ne-alkali ukuze kuvinjelwe ukonakala kwesakhiwo se-colloid. •Izimo zokugcina: iphakheji evaliwe, igcinwe endaweni eyomile nepholile (15-25℃, umswakama ophakathi <60%), iyasebenza iminyaka emibili, ivuliwe futhi isetshenziswe ngokushesha. Le mininingwane engenhla iyisikhumbuzo kuphela, futhi ukusetshenziswa kwangempela nokuthamo kufanele kulungiswe ngokuya ngempela yakho. 7. Izinzuzo Zomkhiqizo (PA) •Ukufaneleka kwesimo esiphelele: inezici zokuhamba komkhiqizo wokwakhiwa okuqinile kanye nokuzinza kokwakhiwa kwe-liquid, kunciphisa uhlobo lwezinto ezisizayo futhi kulula ukwakha ifomula. •Ukuqinisekiswa kokuhambisana komhlaba: ukuvuma kwe-multi-pharmaceutical code certification, ukweseka ukubhaliswa kwemithi yasekhaya nakwamanye amazwe, kunciphisa izingozi zokufinyelela emakethe. •Isevisi eyenziwe ngokwezifiso: ngokuya ngezidingo zamakhasimende, usayizi wezithako nezici ezithile zokwakha zingalungiswa ukuze kuhanjiswe izixazululo zobuchwepheshe ezikhethekile. •Ukuphakelwa okuqhubekayo: inqubo yokukhiqiza isebenzisa ukuvuselelwa kwamandla, futhi iphakheji isebenzisa 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 yokudla •I-licence yokukhiqiza yokudla kwezilwane •I-National high-tech enterprise •Izinkampani ezikhethekile, ezithuthukile nezintsha eGuangzhou •Amalungelo angu-62 avela kwi-Office of State Intellectual Property