1. Ukubuka KweMikhiqizo (Product Overview) 1.1 Incazelo eziyisisekelo I-colloidal silica dioxide iyisilicon dioxide esiphezulu esilungiswe ngezinqubo advanced, ibonakala njengepowder emhlophe, ethambile. Umkhiqizo unama-structure e-nano-network, unikeza izinzuzo ezifana nosayizi wezakhiwo ofanayo, ukwakheka okuhle, kanye nokuzinza okuqinile kwezemikhakha. Ayiphenduli nezithako ezisebenzayo zemithi. Ngobubanzi bayo obuphezulu besikhala esithile kanye nokuxhumana okuqinile phakathi kwezakhi, i-silica dioxide isebenza njenge-excipient ebalulekile yemithi ukuze ithuthukise ikhwalithi nokuzinza kwemikhiqizo yemithi. Itholakala ezinhlelweni zemithi, ukudla, ukudla kwezilwane, kanye nezinye izindawo ezihlobene, ngenkathi isekela izixazululo zokusebenza ezenziwe ngokwezifiso. 1.2 Izinqubomgomo eziyisisekelo Njenge-excipient yemithi enezinhloso eziningi, i-Zhongqi Colloidal Silica ibhekana kahle nezinselelo zemboni ezifana nokungabi ne-flowability ezakhiweni ezinzima zokuphakela kanye nezinkinga zokuhlala ezilungisweni ze-liquid. Ngokusebenzisa ukulawulwa kwekhwalithi okuphelele kuyo yonke i-chain yokukhiqiza, 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 ekuhlangabezaneni nezidingo ezihlukahlukene zokulawula. 2. Izici Zomkhiqizo (Product Characteristics) •I-Nanostructure: usayizi wezakhiwo ungaphansi kokulawulwa ku-12-20nm, udala i-network structure ye-three-dimensional efanayo, futhi indawo ethile ye-BET ingafinyelela ku-175-380m²/g, inikeza isisekelo sokumunca kahle nokwakheka. •Ukwakheka okuhle kokuhlakazeka: ingakwazi ukudala i-colloid ezinzile ohlelweni lwe-aqueous, futhi inani le-pH ligcinwa ku-3.5-5.5, elihambisana nezinhlelo eziningi ze-API. Akukho phenomene yokuhlukaniswa eyenzeka ngemva kwezinsuku eziyi-30 zokuma ku-25℃, ihlangabezana nezidingo zokugcina isikhathi eside ezilungisweni ze-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 we-microbial uphansi kuka-1000CFU/g, kude kakhulu nezinga le-emboni. 4. Iziqu Zokusebenza 4.1 Izinhlobo zokuphakela ezinzima Amathablethi, ama-capsules, kanye ne-powders: Lezi zingahlakazeka kahle zisetshenziswa ngempahla yokuxuba ejwayelekile. Uhlelo lusebenza njengovimbelo lokunciphisa ukuxhumana phakathi kwezakhi, kuthuthukisa i-flowability, futhi kuvinjeze i-caking. Iphakamisa isivinini sokucindezela amathablethi ngenkathi ithuthukisa izinqubo zokukhiqiza ukuze kube nokuhamba kahle kwe-powder. I-adsorbent/umkhiqizo opholile ulawula kahle umswakama kanye nenani le-liquid (ukuguqulwa kuncike kumthamo). Lokhu kunciphisa izinkinga zokuhambisana phakathi kwezithako zemithi, kuthuthukisa ukusabalalisa okufanayo kwezakhi ze-powder, futhi kuthuthukisa isivinini sokuphuka kwamathablethi. •I-Tablet/capsule: Engeza u-0.1-0.5% njengomsizi wokuhamba, okunganciphisa i-angle yokuphumula kwe-powder ngo-20-30%, kunciphise umehluko wesisindo ohlelweni lwamathablethi, futhi kuthuthukise ubhardness bamathablethi ngo-15-20% futhi kunciphise i-brittleness. •Inqubo ye-tablet eqondile: thuthukisa ukuhamba kwemikhiqizo, 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 kwe-shear, ivumela ukujula ibe yi-paste noma ibe mncane ukuze kube lula ukuyisebenzisa. Ivimbela ukuhamba okhard, ukuhlangana, nokuhamba okuphakeme ngenkathi ithuthukisa ukujula kwe-gel kanye nokuhambisana kwezinto zokwakha. Thuthukisa ukuzinza kokuhlala futhi ivimbele ukuhamba kwe-aerosol (idinga imishini ye-high-shear ukuze kuhlakazeke kahle ukuze kufinyelelwe ekusebenzeni okuhle). •I-Oral suspension: Njengomsizi wokuhlala kanye nomjovo, ukwengeza u-0.5-2.0% kungenza ubuningi bokuhlala kwe-API> 95%, ivimbele ukuhlukaniswa kwemithi, futhi ithuthukise ukunemba kokuphakela. •Izithako/izilungiselelo zamehlo: kuhambisana nezindinganiso zokukhiqiza ezihlanzekile ze-IPEC-GMP, kungathuthukisa ukuzinza kwesixazululo, kunciphise ingozi yokwakheka kwezakhi, futhi kuhlangabezane nezidingo zezilungiselelo ze-liquid ezibucayi. 4.3 Izithako zokudla •Umthwali wezithako ezisebenzayo: adsorb vitamins, probiotics nezinye izithako ukuze wandise isikhathi sokuphila kwemikhiqizo futhi wandise isilinganiso sokugcina sokusebenza kwe-biological ngaphezu kuka-30%, kufanelekile ku-protein powder, nutritional powder nezinye izithako. •Umkhiqizo ophikisana ne-caking: emkhathini we-humidity ≤60%, impahla ye-powder ingagcinwa isikhathi esingaphezu kwezinyanga eziyi-6 ngaphandle kokuhlangana ukuze kuqinisekiswe ukuhamba komkhiqizo. 4.4 Izicelo zokudla: Njenge-additive yokudla eqondile, ithuthukisa i-flowability ye-powder yokudla (kuhlanganisa ne-powder soft organic), ivimbele i-caking yokugcina ngenkathi igcina umswakama; adsorbs umswakama, ifanelekile kuma-powder damp/hygroscopic; isebenza njengomjovo wezinto eziphilayo ezifana nezikhukhula zokupheka nezithako ze-vegetable oils, futhi isebenza njenge-agent ye-thixotropic ezithakeni zokupheka ezisekelwe ku-oyili; 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 kwe-powder yokwengeza, futhi inikeze izici ezinhle zokulungisa umswakama ezakhiweni; thuthukisa inqubo yokugaya nokuhlanza ukuze kuvinjeze umkhiqizo ukuthi ungabambeki 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, 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 Inhloso yokusebenza Umthamo ohlongozwayo Tablet/capsule umsizi wokuhamba 0.1-0.5% Oral suspension Umsizi/Umjovo 0.5-2.0% Nutrient powder umkhiqizo ophikisana ne-caking 0.2-1.0% Active ingredient carrier Umthwali 5-15% 6.2 Iziphakamiso ezibalulekile zokusebenza nokugcina •Ukusebenza kokulungiselela okuqinile: kunconywa ukwengeza ngemva kokuxuba i-API kanye ne-diluent, futhi usebenzise ukuxuba okuphezulu isikhathi esingaphezu kwemizuzu engama-30 ukuze uqinisekise ukuhamba okufanayo. •Ukusebenza kokulungiselela kwe-liquid: kufanele kuhlakazeke ngaphansi kwezimo ze-pH 4-6, futhi kugwenywe ukuxhumana isikhathi eside ne-asidi eqinile kanye ne-alkali ukuze kuvinjeze ukuwohloka kwesakhiwo se-colloid. •Izimo zokugcina: iphakheji evaliwe, igcinwe endaweni eyomile nepholile (15-25℃, umswakama ophakathi <60%), isebenza isikhathi esiyiminyaka emibili, ivule futhi usebenzise ngokushesha. Le mininingwane engenhla iyisikhumbuzo kuphela, futhi ukusetshenziswa kwangempela kanye nomthamo kufanele kulungiswe ngokuya ngempela yakho. 7. Izinzuzo Zomkhiqizo (PA) •Ukuzivumelanisa kwesimo sonke: inezici zokusebenza zokuhamba kwe-preparation eqinile kanye nezokuzinza kwe-preparation ye-liquid, kunciphisa uhlobo lwezinto ezisizayo futhi kulungiselela ukwakhiwa kwefomula. •Ukuqinisekiswa kokuhambisana komhlaba: ukuvuma izitifiketi eziningi ze-pharmaceutical code, ukweseka ukubhaliswa kwemithi yasekhaya naphakathi, kunciphisa izingozi zokufinyelela emakethe. •Isevisi eyenziwe ngokwezifiso: ngokuya ngezidingo zamakhasimende, usayizi wezakhiwo kanye nezici ezithile zendawo 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 kwesistimu yeNkampani kanye neziqinisekiso •FSSC22000 •ISO22000：2018 •ISO9001：2015 •SHC HALAL •OU KOSHER •I-FDA attestation •FAMI-QS •SEDEX •Ilayisensi yokukhiqiza i-food additive •Ilayisensi yokukhiqiza i-feed additive •I-National high-tech enterprise •Izinkampani ezikhethekile, ezithuthukile nezintsha eGuangzhou •Amalungelo angu-57 avela kwi-Office of State Intellectual Property