1. Ukubuka KweMikhiqizo (Product Overview) 1.1 Incazelo eziyisisekelo I-colloidal silica dioxide iyisilicon dioxide esiphezulu esilungiswe ngezinqubo ezithuthukisiwe, ibonakala njengepudingi emhlophe, elula. Umkhiqizo unikeza isakhiwo se-nano-network esiyinhloko, unikeza izinzuzo ezifana nosayizi wezakhiwo ofanayo, ukusabalala okuhle, kanye nokuzinza kwemichiza okuqinile. Ayiphenduli nezithako ezisebenzayo zemithi. Ngobubanzi bayo obuphezulu besikhala esithile kanye nokuxhumana okuqinile phakathi kwezakhi, 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 ngokwezifiso. 1.2 Izinzuzo eziyisisekelo Njengomkhiqizo wemithi onemisebenzi eminingi, i-Zhongqi Colloidal Silica ixazulula kahle izinselelo zezimboni ezifana nokungabi nokuhamba kahle kwezinhlobo zokwelapha eziqinile kanye nezinkinga zokuhlala emikhiqizweni ye-liquid. Ngokusebenzisa ukulawula ikhwalithi okuphelele kuzo zonke izigaba zokukhiqiza, lo mkhiqizo uqinisekisa ubuqotho obufanayo 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 ezihlukahlukene zokulawula. 2. Izici Zomkhiqizo (Product Characteristics) •Isakhiwo se-Nano: usayizi wezakhiwo uqondiswa ku-12-20nm, udala isakhiwo se-network esihlangene, futhi indawo ethile ye-BET ingafinyelela ku-175-380m²/g, inikeza isisekelo sokumunca kahle nokusabalala. •Ukuzinza kokusabalala okuhle: ingakha i-colloid ezinzile ohlelweni lwamanzi, futhi inani le-pH ligcinwa ku-3.5-5.5, elihambisana nezinhlelo eziningi ze-API. Akukho phenomenu yokuhlukaniswa eyenzeka ngemuva kwezinsuku eziyi-30 zokuma ku-25℃, ihlangabezana nezidingo zokugcina isikhathi eside zemikhiqizweni 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 nezinga lezimboni. 4. Iziqukathi Zokusebenza 4.1 Izinhlobo zokwelapha eziqinile Amathablethi, ama-capsule, namapudingi: Lezi zingasabalala kahle zisetshenziswa ngezinsiza zokuxuba ezijwayelekile. Uhlelo lusebenza njengovimba ukuze lunciphise ukuxhumana phakathi kwezakhi, kuthuthukise ukuhamba kahle, futhi kuvinjeze ukuhlanganiswa. Iphusha ijubane lokucindezela amathablethi ngenkathi ithuthukisa izinqubo zokukhiqiza ukuze kube nokuhamba kahle kwepudingi. I-adsorbent/umkhiqizo opholile ulawula kahle umswakama kanye nomthamo we-liquid (ukuguqulwa kuncike kumthamo). Lokhu kunciphisa izinkinga zokuhambisana phakathi kwezithako zemithi, kuthuthukisa ukusabalala okufanayo kwezakhi ze-pudingi, futhi kuthuthukisa ijubane lokuphuka kwamathablethi. •I-Tablet/capsule: Engeza u-0.1-0.5% njengomsebenzi wokuhamba, okunganciphisa i-angle yokuphumula kwepudingi ngo-20-30%, kunciphise umehluko wesisindo enqubweni ye-tablet, futhi kuthuthukise ubunzima bamathablethi ngo-15-20% futhi kunciphise ubrittleness. •Inqubo ye-tablet eqondile: thuthukisa ukuhamba kwemikhiqizo, kunciphise inani le-lubricant, kunciphise isikhathi sokukhiqiza, kufanelekile ku-acetaminophen, aspirin nezinye izinhlelo ze-API. 4.2 Imikhiqizo ye-liquid Imikhiqizo yemithi (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, ukuhamba, nokuhamba ngenkathi ithuthukisa ukujula kwe-gel kanye nokusabalala kwezinto zokwakha. Ithuthukisa ukuzinza kwe-suspension futhi ivimbela ukuhamba kwe-aerosol (idinga imishini ephezulu yokuhamba ukuze kuqinisekiswe ukusabalala okuhle ukuze kufezwe ukusebenza okuhle). •I-suspension yokudla: Njengomkhiqizo wokuphakamisa kanye nomjovo, ukwengeza u-0.5-2.0% kungenza umthamo we-sediment ratio ye-API> 95%, ivimbele ukuhamba kwemithi, futhi ithuthukise ukunemba kokudla. •Izithako/izinhlelo zokubuka: kuhambisana nezindinganiso zokukhiqiza ezihlanzekile ze-IPEC-GMP, kungathuthukisa ukuzinza kwesixazululo, kunciphise ubungozi bokwakheka kwezakhi, futhi kuhlangabezane nezidingo zemikhiqizo ye-liquid ezithambile. 4.3 Izithako zokudla •Umthwali wezithako ezisebenzayo: adsorb ama-vitamins, ama-probiotics nezinye izithako ukuze wandise isikhathi sokugcina kwemikhiqizo futhi wandise isilinganiso sokugcina sokusebenza kwemvelo ngaphezu kuka-30%, kufanelekile kumapudingi e-protein, amaphudingi okudla nezinye izinto. •Umkhiqizo ophikisana nokuhlanganiswa: emkhathini wokungabi namanzi ≤60%, impahla ye-powder ingagcinwa isikhathi eside ngaphezu kwezinyanga eziyi-6 ngaphandle kokuhlanganiswa ukuze kuqinisekiswe ukuhamba komkhiqizo. 4.4 Izicelo zokudla: Njengomkhiqizo wokudla oqondile, uthuthukisa ukuhamba kwepudingi yokudla (kuhlanganisa amapudingi e-organic), ivimbela ukuhlanganiswa kokugcina ngenkathi igcina umswakama; adsorbs umswakama, ifanelekile kumapudingi anomswakama/okuhambisana; isebenza njengomjovo wezinto eziphilayo ezifana nezinsipho zokupheka nezamafutha ezitshalo, futhi isebenza njengomkhiqizo we-thixotropic kumaspray wokupheka nezokupheka ezisekelwe kumafutha; ngaphezu kwalokho ithuthukisa ukuhlanzeka kwemishini ngesikhathi sokugaya izinto zokwakha. 4.5 Ukusebenza emkhakheni wezokudla: Thuthukisa ukusebenza kokudla kanye nobuchwepheshe bokucubungula ukuze kuqinisekiswe ukuhamba okukhululekile nokumelana nokugcina kwepudingi yokwengeza, futhi unikeze izici ezinhle zokulungisa umswakama kumapudingi; thuthukisa inqubo yokugaya nokugaya ukuze uvimbele umkhiqizo ukuthi ungabambeki kumishini. 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 ubufakazi obufanele bokufaneleka: I-FDA inactive ingredient database collection, EU E551 food additive certification. •Landela iziqondiso zokuhambisana zomhlaba: uhambisana nezindinganiso zokukhiqiza ze-GMP 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 Umjovo/Umjovo 0.5-2.0% I-Nutrient powder umkhiqizo ophikisana nokuhlanganiswa 0.2-1.0% Umthwali wezithako ezisebenzayo Umkhiqizo wokumunca 5-15% 6.2 Iziqondiso ezibalulekile zokusebenza nokugcina •Ukusetshenziswa kwemikhiqizo eqinile: kunconywa ukuthi engezwe ngemva kokuxuba i-API kanye ne-diluent, futhi kusetshenziswe ukuxuba okuphezulu okungaphezu kwemizuzu engama-30 ukuze kuqinisekiswe ukusabalala okufanayo. •Ukusetshenziswa kwemikhiqizo ye-liquid: kufanele kusabalalise ngaphansi kwezimo ze-pH 4-6, futhi kugwenywe ukuxhumana isikhathi eside ne-asidi eqinile kanye ne-alkali ukuze kuvinjwe ukonakala kwesakhiwo se-colloid. •Izimo zokugcina: iphakheji evaliwe, igcinwe endaweni eyomile nepholile (15-25℃, umswakama ophakathi <60%), isebenza iminyaka emibili, ivule futhi usebenzise ngokushesha. Ulwazi olukhuluma ngenhla lungumhlahlandlela kuphela, futhi ukusetshenziswa kwangempela kanye nomthamo kufanele kulungiswe ngokuya ngempela. 7. Izinzuzo Zomkhiqizo (PA) •Ukwenza kahle kuzo zonke izimo: inezici zokuhamba kwemikhiqizo eqinile kanye nezokuzinza kwemikhiqizo ye-liquid, kunciphisa uhlobo lwezinto ezisizayo futhi kulungiselela ukuklama kwefomula. •Ukuqinisekiswa kokuhambisana komhlaba: ukuvuma kwe-multi-pharmaceutical code certification, ukweseka ukubhaliswa kwemithi yasekhaya nakwamanye amazwe, kunciphisa ubungozi bokufinyelela emakethe. •Isevisi eyenziwe ngokwezifiso: ngokuya ngezidingo zamakhasimende, usayizi wezakhiwo 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 •I-licence yokukhiqiza yokwengeza ukudla •I-licence yokukhiqiza yokwengeza ukudla kwezilwane •I-National high-tech enterprise •Izinkampani ezikhethekile, ezithuthukisiwe nezintsha eGuangzhou •Amalungelo angu-50 avela kwi-Office of State Intellectual Property