1. Ukubuka KweMikhiqizo (Product Overview) 1.1 Incazelo eziyisisekelo I-colloidal silica dioxide iyisilicon dioxide esinobukhulu obuphezulu esilungiswe ngezinqubo ezithuthukile, ibonakala njengothuli oluphuma, oluhlaza. Umkhiqizo unama-nano-network structure ayisisekelo, unikeza izinzuzo ezifana nosayizi wezakhi ezifanayo, ukusabalala okuhle, kanye nokuzinza kwezemikhiqizo. Ayiphenduli nezithako ezisebenzayo zemithi. Ngenxa yesikhala esikhulu esithile kanye nokuxhumana okuqinile phakathi kwezithako, i-silica dioxide isebenza njengomkhiqizo obalulekile we-pharmaceutical excipient ukuze ithuthukise ikhwalithi nokuzinza kwemikhiqizo yemithi. Isebenza emithini, ukudla, ukudla kwezilwane, kanye nezinkambu ezihlobene, ngenkathi isekela izixazululo zokusebenza ezenziwe ngokwezifiso. 1.2 Izinzuzo eziyisisekelo Njengomkhiqizo we-pharmaceutical excipient onemisebenzi eminingi, i-Zhongqi Colloidal Silica ixazulula kahle izinselelo zezimboni ezifana nokungabi namaflow okuhle ezithako ezinzima kanye nezinkinga zokuhlala emikhiqizweni ye-liquid. Ngokusebenzisa ukulawula ikhwalithi okuphelele kuzo zonke izigaba zokukhiqiza, 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 phambili ekuhlangabezaneni nezidingo ezihlukahlukene zokulawula. 2. Izici Zomkhiqizo (Product Characteristics) •I-Nanostructure: usayizi wezithako uqondiswa ku-12-20nm, udala isakhiwo esihlangene se-three-dimensional, futhi indawo ethile ye-BET ingafinyelela ku-175-380m²/g, inikeza isisekelo sokumunca kahle nokusabalala. •Ukuzinza 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 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 kwe-99.0%, inani le-heavy metal liphansi kune-25ppm, inani le-arsenic liphansi kune-8ppm, umkhawulo wezinto eziphilayo uphansi kune-1000CFU/g, kude kakhulu nezinga lezimboni. 4. Izinkambu Zokusebenza 4.1 Izinhlobo zokupakisha ezinzima Amathablethi, ama-capsule, kanye nothuli: Lezi zingasabalala kahle zisetshenziswa ngezinsiza zokuxuba ezijwayelekile. Uhlelo lusebenza njengovimbela ukuze lunciphise ukuxhumana phakathi kwezithako, kuthuthukise ukuhamba okukhululekile, futhi kuvimbele ukuhlanganiswa. Iphusha isivinini sokucindezela amathablethi ngenkathi ithuthukisa izinqubo zokukhiqiza zokuhamba kahle kothuli. I-adsorbent/umkhiqizo opholile ulawula kahle umswakama kanye nomthamo we-liquid (ukuguqulwa kuncike kumthamo). Lokhu kunciphisa izinkinga zokuhambelana phakathi kwezithako zemithi, kuthuthukisa ukusabalala okufanayo kwezithako zothuli, futhi kuthuthukisa isivinini sokuphuka kwamathablethi. •I-Tablet/capsule: Engeza i-0.1-0.5% njengomsebenzi wokuhamba, okunganciphisa i-angle yokuphumula kothuli ngama-20-30%, kunciphise umehluko wesisindo kuhlelo lwamathablethi, futhi kuthuthukise ubunzima bamathablethi ngama-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 Imikhiqizo ye-liquid Imikhiqizo yemithi (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, ukuhlela, nokuhamba ngenkathi ithuthukisa ukujula kwe-gel kanye nokusabalala kwezinto zokwakha. Ithuthukisa ukuzinza kokuphuma futhi ivimbela ukuhlela kwe-aerosol (idinga izinsiza eziphezulu zokuhamba ukuze kufezwe ukusebenza okuhle). •I-Oral suspension: Njengomkhiqizo wokuphakamisa nokujula, ukwengeza i-0.5-2.0% kungenza umthamo we-sediment ratio ye-API> 95%, ivimbela ukuhlela kwemithi, futhi ithuthukise ukunemba kokuthola. •Izithako/izinhlelo zokubona: kuhambisana nezindinganiso zokukhiqiza ezihlanzekile ze-IPEC-GMP, kungathuthukisa ukuzinza kwesixazululo, kunciphise ingozi yokwakheka kwezithako, futhi kuhlangabezane nezidingo zemikhiqizo ye-liquid ezithambile. 4.3 Izithako zokudla •Umthwali wezithako ezisebenzayo: adsorbivita, ama-probiotics nezinye izinto ukuze wandise isikhathi sokugcina kwemikhiqizo futhi wandise umphumela wokugcina we-biological activity ngaphezu kwe-30%, kufanelekile ku-protein powder, nutritional powder nezinye izinto. •Umkhiqizo ophikisanayo: endaweni yokuphuma ≤60%, umkhiqizo uthuli ungagcinwa ngaphezu kwezinyanga eziyi-6 ngaphandle kokuhlanganiswa ukuze kuqinisekiswe ukuhamba komkhiqizo. 4.4 Izicelo zokudla: Njengomkhiqizo wokudla oqondile, uthuthukisa ukuhamba kwezithako zokudla (kuhlanganisa nothuli lwe-organic oluthambile), ivimbela ukuhlanganiswa kokugcina ngenkathi igcina umswakama; adsorbs moisture, ifanelekile kumathuli/water-absorbing powders; isebenza njengomkhiqizo ophikisanayo wezithako zokudla ezinjenge-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 inikeze izici ezinhle zokulungisa umswakama kumathuli; thuthukisa inqubo yokugaya nokugaya ukuze kuvinjelwe umkhiqizo ukuhamba ezinsizeni. 5. Izindinganiso nezimfuneko (Standards & Regulations) •Ihamba phambili 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: hamba phambili 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 umkhiqizo wokuhamba 0.1-0.5% Oral suspension Umkhiqizo wokuphakamisa/ukujula 0.5-2.0% Nutrient powder umkhiqizo ophikisanayo 0.2-1.0% Active ingredient carrier Umkhiqizo opholile 5-15% 6.2 Amathiphu abalulekile okusebenza nokugcina •Ukusebenza kwemikhiqizo ezinzima: 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 kugwenywe ukuxhumana isikhathi eside ne-asidi eqinile kanye ne-alkali ukuze kuvinjelwe ukonakaliswa kwesakhiwo se-colloid. •Izimo zokugcina: iphakheji evaliwe, igcinwe endaweni eyomile nepholile (15-25℃, umswakama ophakathi <60%), isebenza iminyaka emibili, ivuliwe futhi isetshenziswe ngokushesha. Le mininingwane engenhla iyisikhumbuzo kuphela, futhi ukusetshenziswa kwangempela kanye nomthamo kufanele kulungiswe ngokuya ngempela. 7. Izinzuzo Zomkhiqizo (PA) •Ukufanisa isimo esiphelele: inezici zomkhiqizo wokuhamba wezinto ezinzima kanye nokuzinza kwemikhiqizo ye-liquid, kunciphisa uhlobo lwezinto ezisizayo futhi kulula ukuklama ifomula. •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 wezithako kanye nezici ezithile ze-surface 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 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, ezithuthukisiwe nezintsha eGuangzhou •Amalungelo angama-75 avela kwi-Office of State Intellectual Property