1. Ukubuka Kwamkhiqizo (Product Overview) 1.1 Incazelo eziyisisekelo I-colloidal silica dioxide iyisilicon dioxide esiphezulu sokuhlanzeka esilungiswe ngezinqubo advanced, ibonakala njengeph powder elimhlophe, elikhululekile. Umkhiqizo unama-structure e-nano-network ayinhloko, unikeza izinzuzo ezifana nosayizi wezinhlayiya ofanayo, ukusabalala okuhle, kanye nokuzinza kwezem kemikhakha. 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 kokwakhiwa kwemithi. Ithola izicelo emithini, ekudleni, ekudleni, nasemkhakheni ofanele, ngenkathi isekela izixazululo zokusebenza ezenziwe ngokwezifiso. 1.2 Izinzuzo eziyisisekelo Njengomkhiqizo wemithi onemisebenzi eminingi, i-Zhongqi Colloidal Silica ibhekana kahle nezinselelo zezimboni ezifana nokungahambi kahle kwezinto ezithile ezimweni zokupakisha eziqinile kanye nezinkinga zokuhlala emikhiqizweni ye-liquid. Ngokusebenzisa ukulawula ikhwalithi okuphelele kulo lonke uchungechunge lokukhiqiza, lo mkhiqizo uqinisekisa ukuhlanzeka nokusebenza okuqhubekayo, uvumela abakhiqizi bemithi ukuba bathuthukise ukusebenza kahle kokukhiqiza kanye nokuncintisana komkhiqizo. Uhlangabezana nezidingo zokubhaliswa kwemithi zasekhaya nezamazwe omhlaba, ubonisa ukuhamba phambili ekuhlangabezaneni nezidingo ezihlukahlukene zokulawula. 2. Izici Zomkhiqizo (Product Characteristics) • I-Nanostructure: usayizi wezinhlayiya ungaphansi kokulawulwa ku-12-20nm, udala i-network structure eyinhlobonhlobo, kanti i-BET specific surface area ingafinyelela ku-175-380m²/g, inikeza isisekelo sokumunca kahle nokusabalala. • Ukuzinza 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 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 nezinga lezimboni. 4. Iziqhingi Zokusebenza 4.1 Izimo zokupakisha eziqinile Amathebhu, ama-capsule, kanye ne-powder: Lezi zingasabalala kahle zisetshenziswa ngezinsiza zokuxuba ezijwayelekile. Uhlelo lusebenza njengovimbela ukunciphisa ukuxhumana phakathi kwezinhlayiya, kuthuthukisa ukuhamba okukhululekile, futhi kuvimbele ukuhlanganiswa. Iphushisa ijubane lokucindezela amathebhu ngenkathi ithuthukisa izinqubo zokukhiqiza zokuhamba kahle kwe-powder. I-adsorbent/umkhiqizo opholile ulawula kahle umswakama kanye nomthamo we-liquid (ukuguqulwa kuncike kumthamo). Lokhu kunciphisa izinkinga zokuhambisana phakathi kwezithako zemithi, kukhuthaza ukusabalala okufanayo kwezinto ze-powder, futhi kuthuthukisa ijubane lokuphuka kwamathathu. • I-Tablet/capsule: Engeza u-0.1-0.5% njengomsebenzi wokuhamba, onganciphisa i-angle yokuphumula kwe-powder ngo-20-30%, unciphise umehluko wesisindo emsebenzini we-tablet, futhi uthuthukise ubunzima bamathathu ngo-15-20% futhi unciphise ubrittleness. • Inqubo ye-tablet eqondile: thuthukisa ukuhamba kwezinto, unciphise inani le-lubricant, yehlisa isikhathi sokukhiqiza, efanelekile ku-acetaminophen, 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, kanye nezimpawu zokuhlukaniswa ngenkathi ithuthukisa ukujula kwe-gel kanye nokusabalala kwezinto zokwakha. Ithuthukisa ukuzinza kokuphuma futhi ivimbela ukuhamba kwe-aerosol (idinga izinsiza ezinamandla zokuhamba ukuze kufezwe ukusebenza okuhle). • I-Oral suspension: Njengomkhiqizo wokuphuma kanye nomkhiqizo opholile, ukwengeza u-0.5-2.0% kungakwenza kube nesilinganiso sokuhlala kwe-API> 95%, ivimbela ukuhamba kwemithi, futhi ithuthukisa ukunemba kokuthola. • Izinjongo/izinhlelo zokubuka: zihambisana nezindinganiso zokukhiqiza ezihlanzekile ze-IPEC-GMP, zingathuthukisa ukuzinza kwesixazululo, zinciphise ingozi yokwakheka kwezinhlayiya, futhi zifanele izidingo 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%, efanelekile ku-protein powder, nutritional powder nezinye izinto. • Umkhiqizo opholile: emkhathini we-humidity ≤60%, umkhiqizo we-powder ungagcinwa isikhathi esingaphezu kwezinyanga eziyi-6 ngaphandle kokuhlanganiswa ukuze kuqinisekiswe ukuhamba komkhiqizo. 4.4 Izicelo zokudla: Njengomkhiqizo wokudla oqondile, uthuthukisa ukuhamba kwe-powder yokudla (kubandakanya ama-powder amakhanda), ivimbela ukuhamba kokugcina ngenkathi igcina umswakama; umunca umswakama, efanelekile kuma-powder amanzi/ahamba phambili; isebenza njengomkhiqizo opholile wemikhiqizo ye-liquid efana nezinsiza zokupheka nezithako ze-oyela, 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 ezinhlelweni; thuthukisa inqubo yokugaya nokugaya ukuze uvimbele umkhiqizo ukuthi ungabambeki ezinsizeni. 5. Izindinganiso nezimfuneko (Standards & Regulations) • Uhlangabezana nezindinganiso eziningi ze-international pharmacopoeia: USP-NF, European Pharmacopoeia (Ph. Eur.), Japanese Pharmacopoeia (JP), kanye ne-China Pharmacopoeia (ChP 2025). • Thola ubufakazi obufanele bokufaneleka: 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 Inhloso yokusebenza Umthamo ohlongozwayo I-Tablet/capsule umkhiqizo wokuhamba 0.1-0.5% I-Oral suspension Umkhiqizo wokuphuma/Umkhiqizo opholile 0.5-2.0% I-Nutrient powder umkhiqizo opholile 0.2-1.0% Umthwali wezithako ezisebenzayo Umunca 5-15% 6.2 Iziqondiso ezibalulekile zokusebenza nokugcina • Ukusebenza kwemikhiqizo eqinile: kunconywa ukwengeza ngemuva kokuxuba i-API kanye ne-diluent, futhi usebenzise ukuxuba okuphezulu okungaphezu kwemizuzu engama-30 ukuze uqinisekise ukusabalala okufanayo. • Ukusebenza kwemikhiqizo ye-liquid: kufanele kusabalale 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, ivule futhi usebenzise ngokushesha. Le mininingwane engenhla iyisikhumbuzo kuphela, futhi ukusetshenziswa kwangempela kanye nomthamo kufanele kulungiswe ngokuya ngempela yakho. 7. Izinzuzo Zomkhiqizo (PA) • Ukuhambisana kwesimo esiphelele: inezici zomkhiqizo wokuhamba kwemikhiqizo eqinile kanye nokuzinza kwemikhiqizo ye-liquid, kunciphisa uhlobo lwezinto ezisizayo futhi kulungiselela ukwakhiwa kwefomula. • Ukuqinisekiswa kokuhambisana komhlaba: ukuvuma izitifiketi eziningi ze-pharmaceutical code, ukweseka ukubhaliswa kwemithi yasekhaya nezamazwe, kunciphisa izingozi zokufinyelela emakethe. • Insiza ezenziwe ngokwezifiso: ngokuya ngezidingo zamakhasimende, usayizi wezinhlayiya kanye nezici ezithile zesikhala zingalungiswa ukuze kuhanjiswe izixazululo zobuchwepheshe ezikhethekile. • Ukuhlinzekwa okuqhubekayo: 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 • Ilayisensi yokukhiqiza yokudla • Ilayisensi yokukhiqiza yokudla • I-National high-tech enterprise • Iziqu ezikhethekile, ezithuthukisiwe nezintsha eGuangzhou • Amalayisense angu-33 avela kwi-Office of State Intellectual Property