1. Ukubuka KweMikhiqizo (Product Overview) 1.1 Incazelo eziyisisekelo I-colloidal silica dioxide iyisilicon dioxide esiphezulu esilungiswe ngokuqhubekayo, ibonakala njengepudingi eliphuzi, elithambile. Umkhiqizo unomkhiqizo we-nano-network oyisisekelo, unikeza izinzuzo ezifana nosayizi wezinhlayiya ofanayo, ukusabalala okuhle, kanye nokuzinza kwemichiza okuqinile. Ayiphenduli nezithako ezisebenzayo zemithi. Ngobubanzi bayo obuphezulu besikhala esithile kanye nokuxhumana okuqinile phakathi kwezinhlayiya, i-silica dioxide iyinsiza ebalulekile yemithi yokwandisa ikhwalithi nokuzinza kokwakhiwa kwemithi. Ithola izicelo emithini, ekudleni, ekudleni, nasemikhakheni efanele, ngenkathi isekela izixazululo zokusebenza ezenziwe ngokwezifiso. 1.2 Izinzuzo eziyisisekelo Njengomkhiqizo we-multifunctional pharmaceutical excipient, i-Zhongqi Colloidal Silica ixazulula kahle izinselelo zezimboni ezifana nokungabi namandla okuhamba kahle ezimweni zokuphakelwa eziqinile kanye nezinkinga zokuhlala ezilwazini. Ngokusebenzisa ukulawula ikhwalithi okuphelele kulo lonke uchungechunge lokukhiqiza, lo mkhiqizo uqinisekisa ubuqotho obuhambisanayo 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) •I-Nanostructure: usayizi wezinhlayiya wendawo ulawulwa ku-12-20nm, udala isakhiwo esihlangene se-three-dimensional, kanti isikhala esithile se-BET singafinyelela ku-175-380m²/g, sinikeza isisekelo sokumunca kahle nokusabalala. •Ukuvikeleka okuhle kokusabalala: ingakha 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 zokwakhiwa kwezinto ezilwazini. •I-impurity residue ephansi kakhulu: I-SiO₂ iqukethe ngaphezu kwe-99.0%, inani le-heavy metal liphansi kune-25ppm, inani le-arsenic liphansi kune-8ppm, umkhawulo we-microbial uphansi kune-1000CFU/g, kude kakhulu nezinga lezimboni. 4. Izindawo Zokusebenza 4.1 Izimo zokuphakelwa eziqinile Amathablethi, ama-capsules, kanye ne-powders: Lezi zingasabalala kahle zisetshenziswa ngezinsiza zokuxuba ezijwayelekile. Uhlelo lusebenza njengovimbela ukunciphisa ukuxhumana phakathi kwezinhlayiya, kuthuthukisa ukuhamba kahle, futhi kuvimbele ukuhlanganiswa. Iphakamisa isivinini sokucindezela amathablethi ngenkathi ithuthukisa izinqubo zokukhiqiza ukuze kube nokuhamba kahle kwepudingi. I-adsorbent/umkhiqizo opholile ulawula kahle umswakama nokuhamba kwamanzi (ukuguqulwa kuncike kumthamo). Lokhu kunciphisa izinkinga zokuhambisana phakathi kwezingxenye zemithi, kukhuthaza ukusabalala okufanayo kwezingxenye ze-powder, futhi kuthuthukisa isivinini sokuphuka kwamathablethi. •I-Tablet/capsule: Engeza u-0.1-0.5% njengomsizi wokuhamba, onganciphisa i-angle yokuphumula kwepudingi ngo-20-30%, unciphise umehluko wesisindo enqubweni yamathablethi, futhi uthuthukise ubunzima bamathablethi ngo-15-20% futhi unciphise ubrittleness. •Inqubo ye-tablet eqondile: thuthukisa ukuhamba kwemikhiqizo, unciphise inani le-lubricant, yehlise isikhathi sokukhiqiza, efanelekile ku-acetaminophen, aspirin nezinye izinhlelo ze-API. 4.2 Ukulungiswa kweLiquid Izinto ezilwazini (ama-gels, ama-creams, ama-suspensions, njll.): I-viscosity iyahluka ngokuhamba, ivumela ukujula ibe yi-paste noma ibe mncane ukuze kube lula ukuyisebenzisa. Ivimbela ukuwa okuqinile, ukuhamba, nokuhamba ngenkathi ithuthukisa ukujula kwe-gel nokuhambisana kwezingxenye zokwakha. Ithuthukisa ukuzinza kokuhamba futhi ivimbela ukuhamba kwe-aerosol (idinga izinsiza eziphezulu zokuhamba ukuze kufezwe ukusebenza okuhle). •I-Oral suspension: Njengomkhiqizo wokuphakamisa nokujula, ukwengeza u-0.5-2.0% kungakwenza kube ne-sediment volume ratio ye-API> 95%, ivimbele ukuhamba kwemithi, futhi ithuthukise ukunemba kokuthola. •Izithako/izinto zokubona: kuhambisana nezindinganiso zokukhiqiza ezihlanzekile ze-IPEC-GMP, kungathuthukisa ukuzinza kwesixazululo, kunciphise ingozi yokwakheka kwezinhlayiya, futhi kuhlangabezane nezidingo zokwakhiwa kwezinto ezilwazini ezithambile. 4.3 Izithako zokudla •Umthwali wezithako ezisebenzayo: umuncu ama-vitamins, ama-probiotics nezinye izingxenye ukuze wandise isikhathi sokugcina kwemikhiqizo futhi wandise izinga lokugcina le-biological activity ngaphezu kwe-30%, efanelekile 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 oqondile wokudla, uthuthukisa ukuhamba kwepudingi yokudla (kuhlanganisa ne-powder soft organic), ivimbela ukuhlanganiswa kokugcina ngenkathi igcina umswakama; umuncu umswakama, efanelekile ku-powder damp/hygroscopic; isebenza njengomkhiqizo opholile wezinto ezilwazini ezifana ne-pickling juices kanye ne-vegetable oils, futhi isebenza njengomkhiqizo we-thixotropic ezinsizeni zokupheka ezisekelwe ku-oyela; 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 kwe-powder yokwengeza, futhi unikeze izici ezinhle zokulungisa umswakama kumaphakethe; thuthukisa inqubo yokugaya nokugaya ukuze uvimbele umkhiqizo ukuthi ungabambeki 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 obuhambisanayo: 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 lokulungiswa Umsebenzi ohlosiwe Umthamo ohlongozwayo Tablet/capsule umsizi wokuhamba 0.1-0.5% Oral suspension Umkhiqizo wokuphakamisa/Umkhiqizo opholile 0.5-2.0% Nutrient powder umkhiqizo ophikisana nokuhlanganiswa 0.2-1.0% Active ingredient carrier Umuncu 5-15% 6.2 Iziphakamiso ezibalulekile zokusebenza nokugcina •Ukusebenza kokulungiswa okuqinile: kunconywa ukwengeza ngemva kokuxuba i-API kanye ne-diluent, futhi usebenzise ukuxuba okuphezulu okungaphezu kwemizuzu engama-30 ukuze uqinisekise ukusabalala okufanayo. •Ukusebenza kokulungiswa kwe-liquid: kufanele kusabalale ngaphansi kwezimo ze-pH 4-6, futhi ugweme ukuxhumana isikhathi eside ne-asidi eqinile kanye ne-alkali ukuze uvimbele ukonakala kwesakhiwo se-colloid. •Izimo zokugcina: iphakheji evaliwe, igcinwe endaweni eyomile nepholile (15-25℃, umswakama ophakathi <60%), isebenza iminyaka emibili, ivule futhi usebenzise ngokushesha. Le mininingwane engenhla iyisikhumbuzo kuphela, futhi ukusetshenziswa kwangempela nokuthola kufanele kulungiswe ngokuya ngempela yakho. 7. Izinzuzo Zomkhiqizo (PA) •Ukufanisa kwesimo sonke: inezici zokuhamba komkhiqizo wokulungiswa okuqinile kanye nokuzinza kokulungiswa kwe-liquid, kunciphisa uhlobo lwezinto ezisizayo futhi kulungiselela umklamo wefomula. •Ukuqinisekiswa kokuhambisana komhlaba: ukuvuma kwe-multi-pharmaceutical code certification, ukweseka ukubhaliswa kwemithi yasekhaya naphesheya, kunciphisa izingozi zokufinyelela emakethe. •Isevisi eyenziwe ngokwezifiso: ngokwezidingo zamakhasimende, usayizi wezinhlayiya nezici ezithile zesikhala 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 •I-licence yokukhiqiza yokudla •I-licence yokukhiqiza yokudla •I-National high-tech enterprise •Izinkampani ezikhethekile, ezihlukile nezintsha eGuangzhou •88 patents ezivela kwiNkantolo Yezimpahla Zombuso