1. Ukubuka Kwenkambo (Product Overview) 1.1 Incazelo eziyisisekelo I-colloidal silica dioxide iyisilicon dioxide esihlanzekile kakhulu esilungiswe ngezinqubo advanced, ibonakala njengothuli oluphaphathekile, olumhlophe. Umkhiqizo unama-structure e-nano-network ayisisekelo, anikeza izinzuzo ezifana nosayizi wezakhi ezihambisanayo, ukusabalala okuhle, kanye nokuzinza okuqinile kwezemikhakha. Ayiphenduli nezithako ezisebenzayo zemithi. Ngenxa yesikhala sayo esikhulu sokusebenza kanye nokuxhumana okuqinile phakathi kwezithako, i-silica dioxide isebenza njengomkhiqizo obalulekile wemithi ukuze kuthuthukiswe ikhwalithi nokuzinza kwemikhiqizo yemithi. Itholakala ezinhlelweni zemithi, ukudla, ukudla kwezilwane, kanye nezinye izindawo ezihlobene, ngenkathi isekela izixazululo zokusebenza ezenziwe ngokwezifiso. 1.2 Izinzuzo eziyisisekelo Njengomkhiqizo wemithi onemisebenzi eminingi, i-Zhongqi Colloidal Silica ixazulula kahle izinselelo zezimboni ezifana nokungahambi kahle kwezinto ezithile ezimweni zokuphakela ezinzima kanye nezinkinga zokuhlala ezilwazini. Ngokusebenzisa ukulawula ikhwalithi okuphelele kuyo yonke imikhakha yokukhiqiza, lo mkhiqizo uqinisekisa ukuhamba kahle nokusebenza okujwayelekile, uvumela abakhiqizi bemithi ukuba bathuthukise ukusebenza kahle kokukhiqiza nokuncintisana komkhiqizo. Uhlangabezana nezidingo zokubhaliswa kwemithi ezweni nasemhlabeni jikelele, ubonisa ukuhamba kahle ekufezekiseni izidingo ezihlukahlukene zokulawula. 2. Izici Zomkhiqizo (Product Characteristics) •I-Nanostructure: usayizi wezithako uqondiswa ku-12-20nm, udala i-structure ye-network emithathu ehambisanayo, futhi indawo ethile ye-BET ingafinyelela ku-175-380m²/g, inikeza isisekelo sokumunca kahle nokusabalala. •Ukuhamba kahle kokusabalala: ingakha i-colloid ezinzile ohlelweni lwe-aqueous, 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 zemikhiqizo 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. Izindawo Zokusebenza 4.1 Izimo zokuphakela ezinzima Amathablethi, ama-capsules, kanye nothuli: Lezi zingasabalala kahle zisetshenziswa ngezinsiza zokuxuba ezijwayelekile. Uhlelo lusebenza njengovimbelo lokunciphisa ukuxhumana phakathi kwezithako, kuthuthukisa ukuhamba kahle, futhi kuvimbele ukuhlanganiswa. Iphakamisa isivinini sokucindezela amathablethi ngenkathi ithuthukisa izinqubo zokukhiqiza ukuze kube nokuhamba kahle kokuthutha uthuli. I-adsorbent/okumunca amanzi ikwazi kahle ukulawula umswakama nokuhamba kwamanzi (ukuguqulwa kuncike kumthamo). Lokhu kunciphisa izinkinga zokuhambisana phakathi kwezithako zemithi, kukhuthaza ukusabalala okujwayelekile kwezithako zothuli, futhi kuthuthukisa isivinini sokuphuka kwamathablethi. •I-Tablet/capsule: Engeza u-0.1-0.5% njengomsebenzi wokuhamba, onganciphisa i-angle yokuphumula uthuli ngo-20-30%, unciphise umehluko wesisindo enqubweni yamathablethi, futhi uthuthukise ubunzima bamathablethi ngo-15-20% futhi unciphise ubrittleness. •Inqubo ye-tablet eqondile: thuthukisa ukuhamba kwezinto, unciphise inani le-lubricant, yehlise isikhathi sokukhiqiza, efanelekile ku-acetaminophen, aspirin nezinye izinhlelo ze-API. 4.2 Izinhlelo ze-liquid Izinto zemithi (ama-gels, ama-creams, ama-suspensions, njll.): I-viscosity iyahluka ngokuhamba, ivumela ukujula kube yipasta noma kube mncane ukuze kube lula ukufaka. Ivimbela ukuhlanganiswa okuqinile, ukuhamba, nokuhamba ngenkathi ithuthukisa ukujula kwe-gel nokusabalala kwezinto zokwakha. Ithuthukisa ukuzinza kokuhamba futhi ivimbela ukuhamba kwe-aerosol (idinga izinsiza ezinamandla okukhulisa ukuze kufezwe ukusebenza okuhle). •I-Oral suspension: Njengomsebenzi wokuphakela kanye nomthuthukisi, ukwengeza u-0.5-2.0% kungakwenza kube nesilinganiso sokuhamba kwe-API> 95%, kuvimbele ukuhamba kwemithi, futhi kuthuthukise ukunemba kokuthola. •Izithako/izinhlelo zokubuka: zihambisana nezindinganiso zokukhiqiza ezihlanzekile ze-IPEC-GMP, zingathuthukisa ukuzinza kwesixazululo, zinciphise ingozi yokwakheka kwezithako, futhi zifanele izidingo ze-liquid ezithambile. 4.3 Izithako zokudla •Umthwali wezithako ezisebenzayo: ukumunca ama-vitamins, ama-probiotics nezinye izithako ukuze wandise isikhathi sokuphila kwemikhiqizo futhi wandise isilinganiso sokugcina sokusebenza kwezinto eziphilayo ngaphezu kuka-30%, ezifanele uthuli lwe-protein, uthuli lwezokudla nezinye izinto. •Umsebenzi wokuvimbela ukuhlanganiswa: emkhathini wezinga lokushisa ≤60%, uthuli lungagcinwa ngaphezu kwezinyanga eziyi-6 ngaphandle kokuhlanganiswa ukuze kuqinisekiswe ukuhamba komkhiqizo. 4.4 Izicelo zokudla: Njengomkhiqizo wokudla oqondile, uthuthukisa ukuhamba kahle kwezithako zokudla (kuhlanganisa uthuli lwe-organic oluthambile), ivimbela ukuhlanganiswa kokugcina ngenkathi igcina umswakama; imunca umswakama, ifanele uthuli olumnyama/oluhambisanayo; isebenza njengomthuthukisi wezithako zokudla ezinjengezikhukhula zokupheka nezithako zezithelo, futhi isebenza njengomsebenzi we-thixotropic ezithakeni zokupheka ezisekelwe ku-oyela; ngaphezu kwalokho ithuthukisa ukuhlanzeka kwezinsiza ngesikhathi sokugaya izinto zokwakha. 4.5 Ukusebenza emkhakheni wezokudla: Thuthukisa ukusebenza kokudla kanye nobuchwepheshe bokucubungula ukuze kuqinisekiswe ukuhamba okukhululekile nokumelana nokugcina uthuli, futhi unikeze izakhiwo ezinhle zokulungisa umswakama kumaphakheji; 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 obufanele: i-FDA inactive ingredient database collection, i-EU E551 food additive certification. •Landela iziqondiso zokuhambisana zomhlaba: uhambe nezindinganiso zokukhiqiza ze-GMP nezidingo ze-HACCP food safety system. 6. Imiyalelo Yokusebenzisa 6.1 Umthamo ohlongozwayo Uhlobo lokulungiselela Umsebenzi ohlosiwe Umthamo ohlongozwayo Tablet/capsule umkhiqizo wokuhamba 0.1-0.5% Oral suspension Umsebenzi wokuphakela/Umthuthukisi 0.5-2.0% Nutrient powder umkhiqizo wokuvimbela ukuhlanganiswa 0.2-1.0% Active ingredient carrier Umthwali 5-15% 6.2 Izinqumo 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 kusabalalise ngaphansi kwezimo ze-pH 4-6, futhi ugweme ukuxhumana isikhathi eside ne-asidi eqinile kanye ne-alkali ukuze uvimbele ukuwohloka 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 kanye nomthamo kufanele kulungiswe ngokuya ngempela yakho. 7. Izinzuzo Zomkhiqizo (PA) •Ukuhambisana kwesimo esiphelele: inezici zokuhamba komkhiqizo wokulungiselela okuqinile kanye nokuzinza kokulungiselela kwe-liquid, kunciphisa uhlobo lwezinto ezisizayo futhi kulula ukuhlela ifomula. •Ukuqinisekiswa kokuhambisana komhlaba: ukuvuma izitifiketi eziningi zepharamaceutical code, ukweseka ukubhaliswa kwemithi yasekhaya nangaphandle, kunciphisa izingozi zokufinyelela emakethe. •Isevisi eyenziwe ngokwezifiso: ngokuya ngezidingo zamakhasimende, usayizi wezithako kanye nezici ezithile zokusebenza 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 •I-licence yokukhiqiza yokudla •I-licence yokukhiqiza yokudla kwezilwane •I-National high-tech enterprise •Izinkampani ezikhethekile, ezithuthukile nezintsha eGuangzhou •Amalungelo angama-35 avela kwi-Office of State Intellectual Property