1. Ukubuka KweMikhiqizo (Product Overview) 1.1 Incazelo eziyisisekelo I-colloidal silica dioxide iyisilicon dioxide esiphezulu sokuhlanzeka esilungiswe ngokuqhubekayo, ibonakala njengothuli oluphaphathekile, oluwhite. Umkhiqizo ubonisa isakhiwo se-nano-network esiyinhloko, unikeza izinzuzo ezifana nosayizi wezinhlayiya obumbene, ukusabalala okuhle, kanye nokuzinza kwezemikhemisi okuqinile. Awuphenduli nezithako ezisebenzayo zemithi. Ngobubanzi bayo obuphezulu besikhala esithile kanye nokuxhumana okuqinile phakathi kwezinhlayiya, i-silica dioxide isebenza njengomkhiqizo obalulekile wemithi ukuze kuthuthukiswe ikhwalithi nokuzinza kwezinhlelo zokwelapha. Ithola izicelo emithini, ekudleni, ekudleni kwezilwane, nasemikhakheni ehlobene, ngenkathi ixhasa izixazululo zokusebenza ezenziwe ngezifiso. 1.2 Izinzuzo eziyisisekelo Njengomkhiqizo wemithi onemisebenzi eminingi, i-Zhongqi Colloidal Silica ibhekana kahle nezinselelo zezimboni ezifana nokungahambi kahle kwezinto ezithile ezibhalwe phansi kanye nezinkinga zokuhlala ezilungisweni ze-liquid. Ngokusebenzisa ukulawula ikhwalithi okuphelele kulo lonke uchungechunge lokukhiqiza, lo mkhiqizo uqinisekisa ukuhlanzeka nokusebenza okujwayelekile, uvumela abakhiqizi bemithi ukuthi bathuthukise ukusebenza kahle kokukhiqiza kanye nokuncintisana komkhiqizo. Uhlangabezana nezidingo zokubhaliswa kwemithi ezweni nasemazweni aphesheya, ubonisa ukuhamba phambili ekuhlangabezaneni nezidingo ezihlukahlukene zokulawula. 2. Izici Zomkhiqizo (Product Characteristics) •Isakhiwo se-Nano: usayizi wezinhlayiya 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. •Ukuhlala okuhle kokusabalala: ingakha i-colloid ezinzile ohlelweni lwamanzi, futhi inani le-pH ligcinwa ku-3.5-5.5, elihambisana nezinhlelo eziningi ze-API. Akukhona ukuhluza okwenziwa ngemva kwezinsuku eziyi-30 zokuma ku-25℃, kuhambisana nezidingo zokugcina isikhathi eside zokulungiselela iziphuzo. •I-impurity residue ephansi kakhulu: I-SiO₂ iqukethe ngaphezu kwe-99.0%, inani le-heavy metal liphansi kwe-25ppm, inani le-arsenic liphansi kwe-8ppm, umkhawulo wezinto eziphilayo uphansi kwe-1000CFU/g, kude kakhulu nezinga lezimboni. 4. Izinkambu Zokusebenza 4.1 Izinhlobo zokwelapha eziqinile Amathablethi, ama-capsule, kanye nothuli: Lezi zingasabalala kahle zisetshenziswa ngezinsiza zokuxuba ezijwayelekile. Uhlelo lusebenza njengovimbelo lokunciphisa ukuxhumana phakathi kwezinhlayiya, kuthuthukisa ukuhamba okukhululekile, futhi kuvimbele ukwakheka. Kwandisa isivinini sokucindezela amathablethi ngenkathi kuthuthukiswa izinqubo zokukhiqiza ukuze kube nokuhamba okuphumelelayo kotuli. I-adsorbent/umkhiqizo opholile ulawula kahle umswakama nokuhamba kwamanzi (ukuguqulwa kuncike kumthamo). Lokhu kunciphisa izinkinga zokuhambisana phakathi kwezithako zemithi, kuthuthukisa ukusabalala okujwayelekile kwezinto zotuli, futhi kuthuthukisa isivinini sokuphuka kwamathablethi. •I-Tablet/capsule: Engeza i-0.1-0.5% njengomsebenzi wokuhamba, okunganciphisa i-angle yokuphumula kotuli ngama-20-30%, kunciphise umehluko wesisindo enqubweni yamathablethi, futhi kuthuthukise ubunzima bamathablethi ngama-15-20% futhi kunciphise ukwephuka. •Inqubo ye-tablet eqondile: thuthukisa ukuhamba kwezinto, kunciphise inani le-lubricant, kunciphise isikhathi sokukhiqiza, kufanelekile 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 ukuhluza okuqinile, ukuhluza, nokuhluza ngenkathi ithuthukisa ukujula kwe-gel kanye nokusabalala kwezinto zokwakha. Ithuthukisa ukuzinza kokuhluza futhi ivimbela ukuhluza kwe-aerosol (idinga izinsiza eziphakeme zokuhamba ukuze kufezwe ukusebenza okuhle). •I-Suspension yokudla: Njengomsebenzi wokuhluza kanye nomthuthukisi, ukwengeza i-0.5-2.0% kungenza umthamo we-sediment we-API> 95%, ivimbele ukuhluza kwemithi, futhi ithuthukise ukunemba kokutholakala. •Izithako/izilungiselelo zamehlo: kuhambisana nezindinganiso zokukhiqiza ezihlanzekile ze-IPEC-GMP, kungathuthukisa ukuzinza kwesixazululo, kunciphise ubungozi bokwakheka kwezinhlayiya, 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 izinga lokugcina le-biological activity ngaphezu kwe-30%, kufanelekile kumathuli e-protein, uthuli lwezokudla nezinye izinto. •Umsebenzi wokuvimbela ukuhluza: emkhathini we-humidity ≤60%, impahla yothuli ingagcinwa isikhathi esingaphezu kwezinyanga eziyi-6 ngaphandle kokuhluza ukuze kuqinisekiswe ukuhamba komkhiqizo. 4.4 Izicelo zokudla: Njengomkhiqizo owengeziwe wokudla, ithuthukisa ukuhamba kwezithako zokudla (kuhlanganisa nothuli lwe-organic oluthambile), ivimbela ukuhluza ngesikhathi sokugcina ngenkathi igcina umswakama; umunca umswakama, ufanelekile kumathuli amanzi/ahluzi; isebenza njengomthuthukisi wezithako zokudla ezinjengama-pickling juices kanye nama-oyili ezitshalo, futhi isebenza njengomsebenzi we-thixotropic ezinsizeni zokubhaka ezisekelwe ku-oyili; ngaphezu kwalokho ithuthukisa ukuhlanzeka kwezinsiza 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 kumaparticles; thuthukisa inqubo yokugaya nokugaya ukuze uvimbele umkhiqizo ukuthi ungalungi ezinsizeni. 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 kanye nezidingo ze-HACCP food safety system. 6. Imiyalelo Yokusebenzisa 6.1 Umthamo ohlongozwayo Uhlobo lokulungiselela Umsebenzi ohlongozwayo Umthamo ohlongozwayo Tablet/capsule umthuthukisi wokuhamba 0.1-0.5% Oral suspension Umsebenzi wokuhluza/Umthuthukisi 0.5-2.0% Nutrient powder umkhiqizo wokuvimbela ukuhluza 0.2-1.0% Active ingredient carrier Umunca 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 okujwayelekile. •Ukusebenza kokulungiselela i-liquid: 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: iphakethe elivaliwe, ligcinwe endaweni eyomile nepholile (15-25℃, umswakama ophakathi <60%), lilungile iminyaka emibili, vula futhi usebenzise ngokushesha. Le mininingwane engenhla iyisikhumbuzo kuphela, futhi ukusetshenziswa kwangempela nomthamo kufanele kulungiswe ngokuya ngempela. 7. Izinzuzo Zomkhiqizo (PA) •Ukuhambisana kwazo zonke izimo: inezici zomsebenzi wokuhamba kokulungiselela okuqinile kanye nokuzinza kokulungiselela i-liquid, kunciphisa uhlobo lwezinto ezisizayo futhi kulungiselela ukuklama ifomula. •Ukuqinisekiswa kokuhambisana komhlaba: ukuvuma izitifiketi eziningi ze-pharmaceutical code, ukweseka ukubhaliswa kwemithi yasekhaya naphakathi, kunciphisa ubungozi bokufinyelela emakethe. •Isevisi eyenziwe ngezifiso: ngokuya ngezidingo zamakhasimende, usayizi wezinhlayiya kanye nezici ezithile zendawo zingalungiswa ukuze kuhanjiswe izixazululo zobuchwepheshe ezikhethekile. •Ukuhlinzekwa 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 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, ezithuthukisiwe nezintsha eGuangzhou •Amalungelo angu-81 avela kwi-Office of State Intellectual Property