1. Ukubuka KweMikhiqizo (Product Overview) 1.1 Incazelo eziyisisekelo I-colloidal silica dioxide iyisilicon dioxide esiphezulu esenziwe ngokuqhubekayo, ibonakala njengepowder emhlophe, ethambile. Umkhiqizo unama-nano-network structure ayisisekelo, unikeza izinzuzo ezifana nosayizi wezakhi ezihambisanayo, ukusabalala okuhle, kanye nokuzinza kwezemikhiqizo. Ayiphenduli nezithako ezisebenzayo zemithi. Ngobubanzi bayo obuphezulu besikhala esithile kanye nokuxhumana okuqinile phakathi kwezithako, i-silica dioxide iyisithako esiyinhloko semithi ukuze ithuthukise ikhwalithi nokuzinza kwemikhiqizo yemithi. Isetshenziswa emithini, ekudleni, ekudleni kwezilwane, nasemkhakheni ofanele, ngenkathi ixhasa izixazululo zokusebenza ezikhethekile. 1.2 Izinzuzo eziyisisekelo Njengesisekelo semithi esisebenza ngezindlela eziningi, i-Zhongqi Colloidal Silica ibhekana kahle nezinselelo zezimboni ezifana nokungahambi kahle kokugeleza kwezinhlobo ezithile zemithi ezinzima kanye nezinkinga zokuhlala emikhiqizweni ye-liquid. Ngokusebenzisa ukulawula ikhwalithi okujule 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 phambili ekuhlangabezaneni nezidingo ezihlukahlukene zokulawula. 2. Izici Zomkhiqizo (Product Characteristics) •I-Nanostructure: usayizi wezithako uqondiswa ku-12-20nm, udala isakhiwo esihlangene esiyindilinga, futhi indawo ethile ye-BET ingafinyelela ku-175-380m²/g, inikeza isisekelo sokumunca kahle nokusabalala. •Ukuqina 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. Izindawo Zokusebenza 4.1 Izinhlobo zemithi ezinzima Amathebhu, ama-capsule, kanye nepowder: Lezi zingasabalala kahle zisetshenziswa ngezinsiza zokuxuba ezijwayelekile. Uhlelo lusebenza njengovimbelo lokunciphisa ukuxhumana phakathi kwezithako, kuthuthukisa ukuhamba okukhululekile, futhi kuvimbele ukuhlanganiswa. Iphusha ijubane lokucindezela amathebhu ngenkathi ithuthukisa izinqubo zokukhiqiza ukuze kube nokuhamba kwepowder okuhle. I-adsorbent/umkhiqizo opholile ulawula kahle umswakama kanye nomthamo wamanzi (ukuguqulwa kuncike kumthamo). Lokhu kunciphisa izinkinga zokuhambisana phakathi kwezithako zemithi, kukhuthaza ukusabalala okufanayo kwezithako ze-powder, futhi kuthuthukisa ijubane lokuphuka kwamatebhu. •I-Tablet/capsule: Engeza u-0.1-0.5% njengomsizi wokuhamba, okunganciphisa i-angle yokuphumula kwepowder ngo-20-30%, kunciphise umehluko wesisindo enqubweni ye-tablet, futhi kuthuthukise ubunzima bamatebhu ngo-15-20% futhi kunciphise ubrittleness. •Inqubo ye-tablet eqondile: thuthukisa ukuhamba kwezinto, 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 ukuhlanganiswa okuqinile, ukuhamba, nokuhamba ngenkathi ithuthukisa ukujula kwe-gel kanye nokusabalala kwezinto zokwakha. Ithuthukisa ukuzinza kwe-suspension futhi ivimbela ukuhamba kwe-aerosol (idinga izinsiza ezinamandla zokuhamba ukuze kufezwe ukusebenza okuhle). •I-Oral suspension: Njengomkhiqizo opholile kanye nomjovo, ukwengeza u-0.5-2.0% kungakwenza kube ne-sediment volume ratio ye-API> 95%, ivimbele ukuhamba kwemithi, futhi ithuthukise ukunemba kokutholwa. •Izithako/izinhlelo zokubuka: kuhambisana nezindinganiso zokukhiqiza ezihlanzekile ze-IPEC-GMP, kungathuthukisa ukuzinza kwesixazululo, kunciphise ingozi yokwakheka kwezithako, futhi kuhlangabezane nezidingo zemikhiqizo 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 kwe-biological ngaphezu kuka-30%, kufanelekile ku-protein powder, nutritional powder nezinye izinto. •Umkhiqizo ophikisana nokuhlanganiswa: emkhathini we-humidity ≤60%, impahla ye-powder ingagcinwa isikhathi esingaphezu kwezinyanga eziyi-6 ngaphandle kokuhlanganiswa ukuze kuqinisekiswe ukuhamba komkhiqizo. 4.4 Izicelo zokudla: Njengomkhiqizo wokudla oqondile, ithuthukisa ukuhamba kwepowder yokudla (kuhlanganise ne-powder ezithambile), ivimbela ukuhlanganiswa ngesikhathi igcina umswakama; umunca umswakama, ufanelekile kuma-powder anomswakama/ahambayo; isebenza njengomjovo wezinto zokudla ezinjengama-pickling juices kanye ne-vegetable oils, futhi isebenza njengomkhiqizo we-thixotropic ezinsizeni zokubhaka ezisekelwe ku-oyela; ngaphezu kwalokho ithuthukisa ukuhlanzeka kwezinsiza ngesikhathi sokugaya izinto zokwakha. 4.5 Ukusebenza 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 kuvinjwe umkhiqizo ukuthi ungeniswe ezinsizeni. 5. Izindinganiso nezimfuneko (Standards & Regulations) •Uhambisana nezindinganiso eziningi ze-pharmacopoeia zomhlaba: USP-NF, European Pharmacopoeia (Ph. Eur.), Japanese Pharmacopoeia (JP), kanye ne-China Pharmacopoeia (ChP 2025). •Thola isitifiketi esihlobene: 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 umsizi wokuhamba 0.1-0.5% I-Oral suspension Umjovo/Umjovo opholile 0.5-2.0% I-Nutrient powder umkhiqizo ophikisana nokuhlanganiswa 0.2-1.0% Umthwali wezithako ezisebenzayo Umunca 5-15% 6.2 Iziqondiso ezibalulekile zokusebenza nokugcina •Ukusebenza kwemikhiqizo ezinzima: kunconywa ukuthi engezwe ngemuva kokuxuba i-API kanye ne-diluent, futhi usebenzise ukuxuba okukhulu okungaphezu kwemizuzu engama-30 ukuze uqinisekise ukusabalala okufanayo. •Ukusebenza kwemikhiqizo ye-liquid: kufanele kusabalalise ngaphansi kwezimo ze-pH 4-6, futhi kugwenywe ukuxhumana isikhathi eside ne-asidi eqinile kanye ne-alkali ukuze kuvinjwe ukonakaliswa kwesakhiwo se-colloid. •Izimo zokugcina: iphakheji evaliwe, igcinwe endaweni eyomile nepholile (15-25℃, umswakama ophakathi <60%), iyasebenza iminyaka emibili, ivule futhi usebenzise ngokushesha. Le mininingwane engenhla iyisikhumbuzo kuphela, futhi ukusetshenziswa kwangempela kanye nomthamo kufanele kulungiswe ngokuya ngempela. 7. Izinzuzo Zomkhiqizo (PA) •Ukufanisa isimo esiphelele: inezici zomkhiqizo ezinzima zokuhamba kanye nezokusebenza kwe-liquid, kunciphisa uhlobo lwezinto ezisizayo futhi kulungiselela ukwakhiwa kwefomula. •Ukuqinisekiswa kokuhambisana komhlaba: ukuvuma izitifiketi eziningi ze-pharmaceutical code, ukweseka ukubhaliswa kwemithi yasekhaya nakwamanye amazwe, kunciphisa izingozi zokufinyelela emakethe. •Isevisi eyenziwe ngokwezifiso: ngokuya ngezidingo zamakhasimende, usayizi wezithako kanye nezici ezithile 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 kwezinqubo zezimboni kanye neziqinisekiso •FSSC22000 •ISO22000：2018 •ISO9001：2015 •SHC HALAL •OU KOSHER •I-FDA attestation •FAMI-QS •SEDEX •Ilayisensi yokukhiqiza yokudla •Ilayisensi yokukhiqiza yokudla kwezilwane •I-High-tech enterprise kazwelonke •Izinkampani ezikhethekile, ezithuthukisiwe nezintsha eGuangzhou •Amalungelo angu-92 avela kwi-Office of State Intellectual Property