1. Ukubuka Kwenziwa (Product Overview) 1.1 Incazelo eziyisisekelo I-colloidal silica dioxide iyisilicon dioxide esiphezulu esilungiswe ngezinqubo ezithuthukisiwe, ibonakala njengothuli oluphaphathekile, oluwhite. Umkhiqizo unikeza isakhiwo se-nano-network esiyinhloko, unikeza izinzuzo ezifana nosayizi wezakhi ezifanayo, ukusabalala okuhle, kanye nokuzinza kwezemithi 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 kwezinhlelo zokwelapha. Itholakala ezinhlelweni zemithi, ukudla, ukudla kwezilwane, kanye nezinkambu ezihlobene, ngenkathi isekela izixazululo zokusebenza ezenziwe ngezifiso. 1.2 Izinzuzo eziyisisekelo Njengomkhiqizo wemithi onemisebenzi eminingi, i-Zhongqi Colloidal Silica ixazulula kahle izinselelo zezimboni ezifana nokungabi namathuba okuhamba kahle ezimweni zokwelapha eziqinile kanye nezinkinga zokuhlala ezilungisweni ze-liquid. Ngokulawula ikhwalithi ngokuphelele kuyo yonke i-chain yokukhiqiza, 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 kahle kwakhe ekuhlangabezaneni nezidingo ezihlukahlukene zokulawula. 2. Izici Zomkhiqizo (Product Characteristics) •Isakhiwo se-nano: usayizi wezithako 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. •Ukuhlala okuhle kokusabalala: ingakha i-colloid ezinzile ohlelweni lwamanzi, 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 zokulungiselela iziphuzo. •I-impurity residue ephansi kakhulu: I-SiO₂ iqukethe ngaphezu kwe-99.0%, inani le-heavy metal liphansi kune-25ppm, inani le-arsenic liphansi kune-8ppm, umkhawulo wezinto eziphilayo uphansi kune-1000CFU/g, kude kakhulu nezinga lezimboni. 4. Izinkambu Zokusebenza 4.1 Izimo zokwelapha eziqinile Amathablethi, ama-capsules, kanye nothuli: Lezi zingasabalala ngokufanayo zisebenzisa imishini yokuxuba ejwayelekile. Uhlelo lusebenza njengovimbela ukuze lunciphise ukuxhumana phakathi kwezithako, kuthuthukisa ukuhamba kahle, futhi kuvinjeze ukuhlanganiswa. Iphakamisa isivinini sokucindezela amathablethi ngenkathi ithuthukisa izinqubo zokukhiqiza ukuze kube nokuhamba kahle kwezothuli. I-material yokumunca/ukuphuma kwamanzi ilawula kahle umswakama nokuqukethwe kwamanzi (ukuguqulwa kuncike kumthamo). Lokhu kunciphisa izinkinga zokuhambisana phakathi kwezithako zemithi, kukhuthaza ukusabalala okufanayo kwezithako zothuli, futhi kuthuthukisa isivinini sokuphuka kwamathablethi. •I-Tablet/capsule: Engeza u-0.1-0.5% njengomsebenzi wokuhamba, onganciphisa i-angle yokuphumula yothuli ngama-20-30%, unciphise umehluko wesisindo enqubweni ye-tablet, futhi uthuthukise ubunzima bamathablethi ngama-15-20% futhi unciphise ubrittleness. •Inqubo ye-tablet eqondile: thuthukisa ukuhamba kwemathiriyeli, 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, ivumela ukujula ibe yi-paste noma ibe mncane ukuze kube lula ukuyisebenzisa. Ivimbela ukuhlanganiswa okuqinile, ukuhlangana, nokuhamba, ngenkathi ithuthukisa ukujula kwe-gel nokuhambisana kwezinto zokwakha. Ithuthukisa ukuhlala kwe-suspension futhi ivimbela ukuhlanganiswa kwe-aerosol (idinga imishini ephezulu yokuhamba ukuze kuqinisekiswe ukusabalala okuhle). •I-Oral suspension: Njengomsebenzi wokuphakela nokujula, ukwengeza u-0.5-2.0% kungakwenza kube ne-sediment volume ratio ye-API> 95%, ivimbele ukuhlanganiswa kwemithi, futhi ithuthukise ukunemba kokuthola. •Izithako/izilungiselelo zamehlo: kuhambisana nezindinganiso zokukhiqiza ezihlanzekile ze-IPEC-GMP, kungathuthukisa ukuzinza kwesixazululo, kunciphise ingozi yokwakheka kwezithako, futhi kuhlangabezane nezidingo zezilungiselelo ezithambile. 4.3 Izithako zokudla •Umthwali wezithako ezisebenzayo: umunca ama-vitamins, ama-probiotics nezinye izithako ukuze wandise isikhathi sokuphila kwemikhiqizo futhi wandise isilinganiso sokugcina sokusebenza kwezinto eziphilayo ngaphezu kwe-30%, efanelekile ku-protein powder, nutritional powder nezinye izinto. •Umsebenzi wokuvimbela ukuhlanganiswa: emkhathini we-humidity ≤60%, impahla yothuli ingagcinwa isikhathi esingaphezu kwezinyanga eziyi-6 ngaphandle kokuhlanganiswa ukuze kuqinisekiswe ukuhamba kwemikhiqizo. 4.4 Izicelo zokudla: Njengomkhiqizo wokudla oqondile, uthuthukisa ukuhamba kahle kwezithako zokudla (kuhlanganisa nothuli lwe-organic oluthambile), ivimbela ukuhlanganiswa kokugcina ngenkathi igcina umswakama; umunca umswakama, efanelekile ku-damp/hygroscopic powders; isebenza njengomthuli wezithako zokudla ezinjengama-pickling juices kanye nama-oyili ezitshalo, futhi isebenza njengomsebenzi we-thixotropic kumafutha okubilisa nokupheka; futhi ithuthukisa ukuhlanzeka kwemishini ngesikhathi sokugaya izinto zokwakha. 4.5 Ukusebenza emkhakheni wokudla kwezilwane: Thuthukisa ukusebenza kokudla nezobuchwepheshe bokucubungula ukuze kuqinisekiswe ukuhamba kahle nokumelana nokugcina kwe-powder yokwengeza, futhi unikeze izakhiwo ezinhle zokulungisa umswakama ezithakeni; thuthukisa inqubo yokugaya nokugaya ukuze uvimbele umkhiqizo ekunamathelweni kwemishini. 5. Izindinganiso nezimfuneko (Standards & Regulations) •Uhlangabezana nezindinganiso eziningi ze-international pharmacopoeia: USP-NF, European Pharmacopoeia (Ph. Eur.), Japanese Pharmacopoeia (JP), kanye ne-China Pharmacopoeia (ChP 2025). •Thola ubufakazi obuhambelanayo: i-FDA inactive ingredient database collection, i-EU E551 food additive certification. •Landela iziqondiso zokuhambisana zomhlaba: uhambisana nezindinganiso zokukhiqiza ze-GMP nezimfuneko ze-HACCP food safety system. 6. Imiyalelo Yokusebenzisa 6.1 Umthamo ohlongozwayo Uhlobo lokulungiselela Inhloso yokusebenza Umthamo ohlongozwayo Tablet/capsule umkhiqizo wokuhamba 0.1-0.5% Oral suspension Umsebenzi wokuphakela/Ujula 0.5-2.0% Nutrient powder umkhiqizo wokuvimbela ukuhlanganiswa 0.2-1.0% Active ingredient carrier Umunca 5-15% 6.2 Iziphakamiso ezibalulekile zokusebenza nokugcina •Ukusetshenziswa kokulungiselela okuqinile: kunconywa ukwengeza ngemuva kokuxuba i-API kanye ne-diluent, futhi usebenzise ukuxuba okuphezulu okungaphezu kwemizuzu engama-30 ukuze uqinisekise ukusabalala okufanayo. •Ukusetshenziswa kokulungiselela kwe-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: 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 nokuthola kufanele kulungiswe ngokuya ngempela. 7. Izinzuzo Zomkhiqizo (PA) •Ukuhambisana kwesimo esiphelele: inezici zokuhamba komkhiqizo wokulungiselela okuqinile kanye nokuzinza kokulungiselela kwe-liquid, yehlisa uhlobo lwezinto ezisizayo futhi ilungiselele umklamo wefomula. •Ukuqinisekiswa kokuhambisana komhlaba: ukuhlinzekwa kwe-multi-pharmaceutical code certification, ukweseka ukubhaliswa kwemithi yasekhaya naphakathi, yehlisa izingozi zokufinyelela emakethe. •Isevisi eyenziwe ngezifiso: ngokuya ngezidingo zamakhasimende, usayizi wezithako nezilinganiso zesikhala esithile zingalungiswa ukuze kuhanjiswe izixazululo zobuchwepheshe ezikhethekile. •Ukuphakelwa okuqhubekayo: inqubo yokukhiqiza isebenzisa ukuphinda kusebenze amandla, futhi iphakheji isebenzisa amabhakede ephepha angasetshenziswa kabusha ukuze kuhlangabezane nezidingo zokusebenza nokuvikelwa kwemvelo. 8. Ukuqinisekiswa kwesistimu yeNkampani kanye nezindondo •FSSC22000 •ISO22000：2018 •ISO9001：2015 •SHC HALAL •OU KOSHER •I-FDA attestation •FAMI-QS •SEDEX •Ilayisensi yokukhiqiza yokwengeza ukudla •Ilayisensi yokukhiqiza yokwengeza ukudla kwezilwane •I-National high-tech enterprise •Izinkampani ezikhethekile, ezithuthukile nezintsha eGuangzhou •Amalungelo angu-52 avela kwi-Office of State Intellectual Property