1. Ukubuka KweMikhiqizo (Product Overview) 1.1 Incazelo eziyisisekelo I-colloidal silica dioxide iyisilicon dioxide esiphezulu sokuhlanzeka esilungiswe ngezinqubo ezithuthukisiwe, ibonakala njengephowder emhlophe, ethambile. Umkhiqizo ubonisa isakhiwo se-nano-network esiyinhloko, unikeza izinzuzo ezifana nosayizi wezinhlayiya ophumelelayo, ukusabalala okuhle, kanye nokuzinza kwemichiza okuqinile. Ayiphenduli nezithako ezisebenzayo zemithi. Ngobubanzi bayo obuphezulu besikhala esithile kanye nokuxhumana okuqinile phakathi kwezinhlayiya, i-silica dioxide isebenza njengomkhiqizo obalulekile wemithi ukuze kuthuthukiswe ikhwalithi nokuzinza kwezinhlelo zokwelapha. Itholakala ezindaweni zemithi, ukudla, ukudla kwezilwane, kanye nezinkambu ezihlobene, ngenkathi isekela izixazululo zokusebenza ezenziwe ngokwezifiso. 1.2 Izinzuzo eziyisisekelo Njengomkhiqizo wemithi onemisebenzi eminingi, i-Zhongqi Colloidal Silica ixazulula kahle izinselelo zezimboni ezifana nokungabi ne-flowability ezimweni zokwelapha eziqinile kanye nezinkinga zokuhlala ezilungisweni ze-liquid. Ngokusebenzisa ukulawula ikhwalithi okuphelele kuyo yonke imikhakha yokukhiqiza, lo mkhiqizo uqinisekisa ukuhlanzeka nokusebenza okuqhubekayo, 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) •Isakhiwo se-Nano: usayizi wezinhlayiya uqondiswa ku-12-20nm, udala isakhiwo esihlangene se-three-dimensional, kanti indawo ethile ye-BET ingafinyelela ku-175-380m²/g, inikeza isisekelo sokumunca kahle nokusabalala. •Ukuqina kokusabalala okuhle: ingakha i-colloid ezinzile ohlelweni lwe-aqueous, futhi inani le-pH ligcinwa ku-3.5-5.5, elihambisana nezinhlelo eziningi ze-API. Akukho phenomenu yokuhlukana eyenzeka ngemuva kwezinsuku eziyi-30 zokuma ku-25℃, ihlangabezana nezidingo zokugcina isikhathi eside zokulungiselela iziphuzo. •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. Izinkambu Zokusebenza 4.1 Izimo zokwelapha eziqinile Amathablethi, ama-capsules, kanye ne-powders: Lezi zingasabalala ngokulinganayo zisetshenziswa ngezinsiza zokuxuba ezijwayelekile. Uhlelo lusebenza njengovimbelo lokunciphisa ukuxhumana phakathi kwezinhlayiya, kuthuthukisa i-flowability yamahhala, futhi kuvinjezelwe ukuhlanganiswa. Iphakamisa isivinini sokucindezela amathablethi ngenkathi ithuthukisa izinqubo zokukhiqiza ukuze kube nokuhamba kahle kwepowder. I-adsorbent/umkhiqizo opholile ulawula kahle umswakama kanye nomthamo we-liquid (umkhiqizo wokuguqula uncike kumthamo). Lokhu kunciphisa izinkinga zokuhambisana phakathi kwezithako zemithi, kukhuthaza ukusabalala okujwayelekile kwezingxenye ze-powder, futhi kuthuthukisa isivinini sokuphuka kwamathablethi. •I-Tablet/capsule: Engeza u-0.1-0.5% njengomsebenzi wokunceda ukuhamba, okunganciphisa i-angle yokuphumula kwepowder ngo-20-30%, kunciphise umehluko wesisindo enqubweni yamathablethi, futhi kuthuthukise ubhardness bamathablethi 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 Izilungiselelo ze-liquid Izilungiselelo zemithi (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, ukuhlangana, nokuhamba okungafanele ngenkathi ithuthukisa ukujula kwe-gel nokuhambisana kwezinto zokwakha. Ithuthukisa ukuzinza kokuhlala futhi ivimbela ukuhamba kwe-aerosol (idinga imishini ephezulu yokuhamba ukuze kufezwe ukusebenza okuhle). •I-Oral suspension: Njengomkhiqizo wokuphakamisa kanye nomjovo, ukwengeza u-0.5-2.0% kungenza ubuningi bokuhlala kwe-API> 95%, kuvimbele ukuhlukana kwemithi, futhi kuthuthukise ukunemba kokuthola. •Izithako/izilungiselelo zamehlo: kuhambisana nezindinganiso zokukhiqiza ezihlanzekile ze-IPEC-GMP, kungathuthukisa ukuzinza kwesixazululo, kunciphise ingozi yokwakheka kwezinhlayiya, futhi kuhlangabezane nezidingo zezilungiselelo ze-liquid ezibucayi. 4.3 Izithako zokudla •Umthwali wezithako ezisebenzayo: adsorb vitamins, probiotics nezinye izithako ukuze wandise isikhathi sokugcina kwemikhiqizo futhi wandise inani lokugcina le-biological activity ngaphezu kuka-30%, kufanelekile ku-protein powder, nutritional powder nezinye izinto. •Umkhiqizo ophikisana nokuhlanganiswa: emkhathini we-umswakama ≤60%, impahla ye-powder ingagcinwa isikhathi esingaphezu kwezinyanga eziyi-6 ngaphandle kokuhlanganiswa ukuze kuqinisekiswe ukuhamba komkhiqizo. 4.4 Izicelo zokudla: Njengomkhiqizo wokudla oqondile, uthuthukisa i-flowability ye-powder yokudla (kuhlanganise ne-powder soft organic), ivimbela ukuhlanganiswa ngesikhathi sokugcina ngenkathi igcina umswakama; adsorbs umswakama, ifanelekile kuma-powder amanzi/hygroscopic; isebenza njengomjovo wezinto eziphathekayo ezifana nezikhukhula zokupheka nezithako ze-vegetable oils, futhi isebenza njengomkhiqizo we-thixotropic ezikhukhuleni 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 unikeze izakhiwo ezinhle zokulungisa umswakama ezinhlelweni; thuthukisa inqubo yokugaya nokugaya ukuze kuvinjezelwe umkhiqizo ukuthi ungenzi umkhiqizo ufinyelele 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 nesikhumbuzo: 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 Umsebenzi ohlosiwe Umthamo ohlongozwayo Tablet/capsule umkhiqizo wokunceda ukuhamba 0.1-0.5% Oral suspension Umjovo/Umjovo ophakeme 0.5-2.0% Nutrient powder umkhiqizo ophikisana nokuhlanganiswa 0.2-1.0% Active ingredient carrier Umkhiqizo opholile 5-15% 6.2 Iziphakamiso ezibalulekile zokusebenza nokugcina •Ukusetshenziswa kokulungiselela okuqinile: kunconywa ukwengeza ngemuva kokuxuba i-API kanye ne-diluent, futhi usebenzise ukuxuba okuphezulu okungaphezu kwemizuzu engama-30 ukuze uqinisekise ukusabalala okujwayelekile. •Ukusetshenziswa kokulungiselela kwe-liquid: kufanele kusabalale ngaphansi kwezimo ze-pH 4-6, futhi kugwenywe ukuxhumana isikhathi eside ne-asidi eqinile kanye ne-alkali ukuze kuvinjezelwe 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 lungumqondo kuphela, futhi ukusetshenziswa kwangempela kanye nomthamo kufanele kulungiswe ngokuya ngempela. 7. Izinzuzo Zomkhiqizo (PA) •Ukufaneleka kwazo zonke izimo: inezici zomkhiqizo wokunceda ukuhamba kokulungiselela okuqinile kanye nezilungiselelo ze-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 wezinhlayiya kanye nezici ezithile ze-surface zingalungiswa ukuze kuhanjiswe izixazululo zobuchwepheshe ezikhethekile. •Ukuphakelwa 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 •Ilayisensi yokukhiqiza yokudla •Ilayisensi yokukhiqiza yokudla kwezilwane •I-National high-tech enterprise •Izinkampani ezikhethekile, ezithuthukisiwe nezintsha eGuangzhou •Amalungelo angama-32 avela kwi-Office of State Intellectual Property