1. Ukubuka kweMikhiqizo (Product Overview) 1.1 Incazelo eziyisisekelo I-colloidal silica dioxide iyisilicon dioxide esiphezulu sokuhlanzeka esilungiswe ngezinqubo advanced, ibonakala njengothuli oluphakathi, olukhululekile. Umkhiqizo unikeza isakhiwo se-nano-network esiyinhloko, unikeza izinzuzo ezifana nosayizi wezakhi ezifanayo, ukusabalala okuhle, kanye nokuzinza okuqinile kwezokhemikhali. Ayiphenduli nezithako ezisebenzayo zemithi. Nge-surface area ethile ephezulu kanye nokuxhumana okuqinile phakathi kwezakhi, i-silica dioxide isebenza njengomkhiqizo obalulekile wezokwelapha ukuze kuthuthukiswe ikhwalithi nokuzinza kokwakhiwa kwemithi. Itholakala ezindaweni zokwelapha, ukudla, ukudla kwezilwane, kanye nezinye izinkambu ezihlobene, ngenkathi isekela izixazululo zokusebenza ezenziwe ngokwezifiso. 1.2 Izinzuzo eziyisisekelo Njengomkhiqizo wezokwelapha onemisebenzi eminingi, i-Zhongqi Colloidal Silica ixazulula kahle izinselelo zezimboni ezifana nokungabi namandla okuhamba kahle ezimweni zokwelapha eziqinile kanye nezinkinga zokuhlala ezilungisweni ze-liquid. Ngokusebenzisa ukulawula ikhwalithi okuphelele kuyo yonke i-chain yokukhiqiza, lo mkhiqizo uqinisekisa ukuhlanzeka nokusebenza okuqhubekayo, uvumela abakhiqizi bezokwelapha ukuba bathuthukise ukusebenza kahle kokukhiqiza kanye nokuncintisana komkhiqizo. Uhlangabezana nezidingo zokubhaliswa kwemithi zasekhaya nezamazwe ngamazwe, ubonisa ukuhamba phambili ekuhlangabezaneni nezidingo ezihlukahlukene zokulawula. 2. Izici zomkhiqizo (Product Characteristics) •I-Nanostructure: usayizi wezakhi wendawo uqondile ku-12-20nm, udala isakhiwo esihlangene se-three-dimensional, futhi i-BET specific surface area ingafinyelela ku-175-380m²/g, inikeza isisekelo sokumunca kahle nokusabalala. •Ukuhlala okuhle kokusabalala: ingakha i-colloid ezinzile ohlelweni lwe-aqueous, futhi inani le-pH ligcinwa ku-3.5-5.5, elihambisana nezinhlelo eziningi ze-API. Akukhona ukuhlehla okukhona ngemva kwezinsuku eziyi-30 zokuma ku-25℃, kuhambisana nezidingo zokugcina isikhathi eside zokulungiselela iziphuzo. •I-Impurity residue ephansi kakhulu: I-SiO₂ content ingaphezu 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. Izinkambu Zokusebenza 4.1 Izimo zokwelapha eziqinile Amathablethi, ama-capsule, kanye nothuli: Lezi zingasabalala kahle zisebenzisa imishini yokuxuba ejwayelekile. Uhlelo lusebenza njengovimbela ukuze lunciphise ukuxhumana phakathi kwezakhi, kuthuthukise ukuhamba kahle, futhi kuvinjeze ukuhlanganiswa. Iphakamisa isivinini sokucindezela amathablethi ngenkathi ithuthukisa izinqubo zokukhiqiza ukuze kube nokuhamba kahle kotuli. I-adsorbent/umkhiqizo opholile ulawula kahle umswakama kanye nomthamo wamanzi (ukuguqulwa kuncike kumthamo). Lokhu kunciphisa izinkinga zokuhambisana phakathi kwezithako zemithi, kukhuthaza ukusabalala okufanayo kwezakhi zotuli, futhi kuthuthukisa isivinini sokuphuka kwamathablethi. •I-Tablet/capsule: Engeza u-0.1-0.5% njengomsebenzi wokuhamba, onganciphisa i-angle yokuphumula kotuli ngo-20-30%, unciphise umehluko wesisindo ohlelweni lwamathablethi, futhi uthuthukise ubunzima bamathablethi ngo-15-20% futhi unciphise ubrittleness. •Inqubo ye-tablet eqondile: thuthukisa ukuhamba kwemikhiqizo, 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 ukuhamba okuqinile, ukuhlela, nokuhamba okukhanyayo ngenkathi ithuthukisa ukujula kwe-gel kanye nokusabalala kwezinto zokwakha. Ithuthukisa ukuzinza kokuhlala futhi ivimbela ukuhamba kwe-aerosol (idinga imishini ephezulu yokuhamba ukuze kufinyelelwe ukusebenza okuhle). •I-Oral suspension: Njengomkhiqizo wokuphakamisa nokujula, ukwengeza u-0.5-2.0% kungenza umthamo we-sediment ratio ye-API> 95%, ivimbele ukuhlela kwemithi, futhi ithuthukise ukunemba kokuthola. •Izithako/izilungiselelo zamehlo: kuhambisana nezindinganiso zokukhiqiza ezihlanzekile ze-IPEC-GMP, kungathuthukisa ukuzinza kwesixazululo, kunciphise ingozi yokwakheka kwezakhi, futhi kuhlangabezane nezidingo zezilungiselelo ze-liquid ezithambile. 4.3 Izithako zokudla •Umthwali wezithako ezisebenzayo: adsorb izithako ezinjenge-vitamins, probiotics nezinye ukuze wandise isikhathi sokuphila kwemikhiqizo futhi wandise umphumela wokugcina we-biological activity ngaphezu kuka-30%, efanelekile ku-protein powder, nutritional powder nezinye. •I-Anti-caking agent: 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 kwemikhiqizo yokudla (kuhlanganise nothuli lwe-organic oluthambile), uvimbela ukuhlela ngesikhathi sokugcina ngenkathi ugcina umswakama; adsorbs umswakama, efanelekile nothuli olumnyama/oluhambayo; isebenza njengomkhiqizo wokujula wezidlo ezinjenge-pickling juices kanye ne-vegetable oils, futhi isebenza njengomkhiqizo we-thixotropic ezinsizeni zokubhaka ezisekelwe ku-oyela; ngaphezu kwalokho ithuthukisa ukuhlanzeka kwemishini ngesikhathi sokugaya izinto zokwakha. 4.5 Ukusebenza emkhakheni wokudla: Thuthukisa ukusebenza kokudla kanye nobuchwepheshe bokucubungula ukuze kuqinisekiswe ukuhamba okukhululekile nokumelana nokugcina kotuli, futhi unikeze izici ezinhle zokulungisa umswakama ezakhiweni; thuthukisa inqubo yokugaya nokugaya ukuze uvimbele umkhiqizo ukuthi ungeniswe emshinini. 5. Izindinganiso nezimiso (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: uhambe 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/ukujula 0.5-2.0% I-Nutrient powder umkhiqizo wokuvimbela ukuhlela 0.2-1.0% Umthwali wezithako ezisebenzayo I-adsorbent 5-15% 6.2 Amathiphu abalulekile okusebenza nokugcina •Ukusebenza kokulungiselela okuqinile: kunconywa ukwengeza ngemva 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 kugwenywe ukuxhumana isikhathi eside ne-asidi eqinile kanye ne-alkali ukuze kuvinjezelwe ukuwohloka kwesakhiwo se-colloid. •Izimo zokugcina: iphakheji evaliwe, igcinwe endaweni eyomile nepholile (15-25℃, umswakama ophakathi <60%), isebenza iminyaka emibili, ivuliwe futhi isetshenziswe ngokushesha. Le mininingwane engenhla iyisikhumbuzo kuphela, futhi ukusetshenziswa kwangempela kanye nomthamo kufanele kulungiswe ngokuya ngempela. 7. Izinzuzo zomkhiqizo (PA) •Ukuzivumelanisa kwazo zonke izimo: inezici zomkhiqizo wokuhamba kokulungiselela okuqinile kanye nezimo zokulungiselela kwe-liquid, inciphisa uhlobo lwezinto ezisizayo futhi ilungiselela umklamo wefomula. •Ukuqinisekiswa kokuhambisana komhlaba: ukuvuma kwe-multi-pharmaceutical code certification, ukweseka ukubhaliswa kwemithi yasekhaya nezamazwe, kunciphisa izingozi zokufinyelela emakethe. •Isevisi ezenziwe ngokwezifiso: ngokuya ngezidingo zamakhasimende, usayizi wezakhi kanye nezici ze-surface area 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 kohlelo lwezinkampani 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, ezithuthukile nezintsha eGuangzhou •Amalungelo angu-56 avela kwi-Office of State Intellectual Property