1. Ukubuka KweMikhiqizo (Product Overview) 1.1 Incazelo eziyisisekelo I-colloidal silica dioxide iyisilicon dioxide esinobukhulu obuphezulu esilungiswe ngokuqhubekayo, ibonakala njengepudingi elimhlophe, elikhululekile. Umkhiqizo ubonisa isakhiwo se-nano-network esiyinhloko, unikeza izinzuzo ezifana nosayizi wezinhlayiya obumbene, ukusabalala okuhle, kanye nokuzinza kwamakhemikhali okuqinile. Ayiphenduli nezithako ezisebenzayo zemithi. Ngobubanzi bayo obuphezulu besikhala esithile kanye nokuxhumana okuqinile phakathi kwezinhlayiya, i-silica dioxide isebenza njengomkhiqizo obalulekile wemithi ukuze ithuthukise ikhwalithi nokuzinza kwemikhiqizo yemithi. Ithola izicelo emithini, ekudleni, ekudleni kwezilwane, nasemikhakheni efanele, ngenkathi isekela izixazululo zokusebenza ezenziwe ngezifiso. 1.2 Izinzuzo eziyisisekelo Njengomkhiqizo wemithi onemisebenzi eminingi, i-Zhongqi Colloidal Silica ixazulula kahle izinselelo zezimboni ezifana nokungabi nokuhamba kahle kwezinhlayiya ezimweni zokuphakelwa eziqinile kanye nezinkinga zokuhlala emikhiqizweni ye-liquid. Ngokusebenzisa ukulawula ikhwalithi okuphelele kuyo yonke imikhakha yokukhiqiza, lo mkhiqizo uqinisekisa ukuhlala kwe-purity nokusebenza, uvumela abakhiqizi bemithi ukuba bathuthukise ukusebenza kahle kokukhiqiza kanye nokuncintisana komkhiqizo. Uhlangabezana nezidingo zokubhaliswa kwemithi ezweni nasemhlabeni jikelele, ubonisa ukujula kwawo ekuhlangabezaneni nezidingo ezihlukahlukene zokulawula. 2. Izici Zomkhiqizo (Product Characteristics) •Isakhiwo se-Nano: usayizi wezinhlayiya uqondiswa ku-12-20nm, udala isakhiwo se-network esiyinhlangothi ezintathu esihambisanayo, 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 phenomenu yokuhlukaniswa eyenzeka ngemva kwezinsuku eziyi-30 zokuma ku-25℃, ihlangabezana nezidingo zokugcina isikhathi eside zemikhiqizho 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 neziqondiso zezimboni. 4. Izindawo Zokusebenza 4.1 Izimo zokuphakelwa eziqinile Amathablethi, ama-capsules, kanye nepudingi: Lezi zingasabalala kahle zisetshenziswa imishini yokuxuba ejwayelekile. Uhlelo lusebenza njengovimbelo lokunciphisa ukuxhumana phakathi kwezinhlayiya, kuthuthukisa ukuhamba kahle, futhi kuvimbele ukuhlanganiswa. Iphakamisa isivinini sokucindezela amathablethi ngenkathi ithuthukisa izinqubo zokukhiqiza ukuze kube nokuhamba kwepudingi okuhle. I-adsorbent/imathiriyeli emunca amanzi ikwazi kahle ukulawula umswakama nokuhamba kwamanzi (ukuguqulwa kuncike kumthamo). Lokhu kunciphisa izinkinga zokuhambisana phakathi kwezithako zemithi, kukhuthaza ukusabalala okujwayelekile kwezakhi ze-pudingi, futhi kuthuthukisa isivinini sokuphuka kwamathablethi. •Ithablethi/icapusule: Engeza u-0.1-0.5% njengomsizi 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 kwemathiriyeli, kunciphise inani le-lubricant, kunciphise isikhathi sokukhiqiza, kufanelekile kumasistimu e-acetaminophen, i-aspirin nezinye izinhlelo ze-API. 4.2 Imikhiqizo ye-liquid Imikhiqizo yemithi (ama-gels, ama-creams, ama-suspensions, njll.): I-viscosity iyahluka ngokushintsha, 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 kokuhlanganiswa futhi ivimbela ukuhamba kwe-aerosol (idinga imishini ye-high-shear ukuze kuqinisekiswe ukusabalala okuhle ukuze kufinyelelwe ekusebenzeni okuhle). •I-suspension yokudla: Njengomsebenzi wokuphakamisa kanye nomthuthukisi, ukwengeza u-0.5-2.0% kungenza ubukhulu bokuhlala kwe-API> 95%, kuvimbele ukuhamba kwemithi, futhi kuthuthukise ukunemba kokuthola. •Izithako/izinhlelo zokubona: kuhambisana nezindinganiso zokukhiqiza ezihlanzekile ze-IPEC-GMP, kungathuthukisa ukuzinza kwesixazululo, kunciphise ingozi yokwakheka kwezinhlayiya, 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 izinga lokugcina le-biological activity ngaphezu kuka-30%, kufanelekile kumapowder e-protein, amaphowder okudla nezinye izinto. •Umsebenzi wokuvimbela ukuhlanganiswa: emkhathini wezinga lokushisa ≤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 ama-powder anokwakheka okuthambile), uvimbela ukuhlanganiswa kokugcina ngenkathi ugcina umswakama; umunca umswakama, ufanelekile kumapowder anomswakama/okuhamba; isebenza njengomthuthukisi wezinto zokudla ezinjengezikhukhula zokupheka kanye namafutha emifino, futhi isebenza njengomsebenzi we-thixotropic kumaspray wokupheka namafutha; 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 kwepudingi yokwengeza, futhi inikeze izakhiwo ezinhle zokulungisa umswakama ezinhle; thuthukisa inqubo yokugaya nokugaya ukuze kuvinjelwe umkhiqizo ukuthi ungeniswe kumishini. 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: 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 Ithablethi/icapusule umsizi wokuhamba 0.1-0.5% I-suspension yokudla Umsebenzi/Umthuthukisi 0.5-2.0% I-powder yokudla umphumela wokuvimbela ukuhlanganiswa 0.2-1.0% Umthwali wezithako ezisebenzayo Umunca 5-15% 6.2 Iziphakamiso ezibalulekile zokusebenza nokugcina •Ukusebenza kwemikhiqizo eqinile: kunconywa ukuthi engezwe ngemva kokuxuba i-API kanye ne-diluent, futhi kusetshenziswe ukuxuba okuphezulu okungaphezu kwemizuzu engama-30 ukuze kuqinisekiswe ukusabalala okujwayelekile. •Ukusebenza kwemikhiqizo ye-liquid: kufanele isabalale ngaphansi kwezimo ze-pH 4-6, futhi ugweme ukuxhumana isikhathi eside ne-asidi eqinile kanye ne-alkali ukuze uvimbele ukonakaliswa kwesakhiwo se-colloid. •Izimo zokugcina: iphakheji evaliwe, igcinwe endaweni eyomile nepholile (15-25℃, umswakama ophakathi <60%), iyasebenza iminyaka emibili, ivuliwe futhi isetshenziswe ngokushesha. Ulwazi olungaphezulu lungumhlahlandlela kuphela, futhi ukusetshenziswa kwangempela nokuthola kufanele kulungiswe ngokuya ngombhalo wakho. 7. Izinzuzo Zomkhiqizo (PA) •Ukufaneleka kwesimo esiphelele: inezici zokusebenza kwemikhiqizo eqinile kanye nokuzinza kwemikhiqizo ye-liquid, kunciphisa uhlobo lwezinto ezisizayo futhi kulula ukuklama umkhiqizo. •Ukuqinisekiswa kokuhambisana komhlaba: ukuvuma izitifiketi eziningi ze-pharmaceutical code, ukweseka ukubhaliswa kwemithi yasekhaya naphesheya, kunciphisa izingozi zokufinyelela emakethe. •Isevisi eyenziwe ngezifiso: ngokuya ngezidingo zamakhasimende, usayizi wezinhlayiya kanye nezici ezithile zesikhala zingalungiswa ukuze kuhanjiswe izixazululo zobuchwepheshe ezikhethekile. •Ukuhlinzekwa okungapheli: inqubo yokukhiqiza isebenzisa ukuvuselelwa kwamandla, futhi iphakheji isebenzisa amabhakede ephepha angasetshenziswa kabusha ukuze kuhlangatshezwane 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 yokudla •I-licence yokukhiqiza yokudla kwezilwane •I-National high-tech enterprise •Izinkampani ezikhethekile, ezithuthukile nezintsha eGuangzhou •Amalungelo angu-60 avela kwi-Office of State Intellectual Property