1. Ukubuka KweMikhiqizo (Product Overview) 1.1 Incazelo eziyisisekelo I-colloidal silica dioxide iyisilicon dioxide esinokuhlanzeka okuphezulu esilungiswe ngezinqubo advanced, ibonakala njengophawu oluphaphathekile, oluhlaza. Umkhiqizo unama-nano-network structure ayisisekelo, unikeza izinzuzo ezifana nosayizi wezakhi ezihlangene, ukuhamba kahle okuhle, kanye nokuzinza kwezemikhiqizo. Ayiphenduli nezithako ezisebenzayo zemithi. Ngobubanzi bayo obuphezulu besikhala esithile kanye nokuxhumana okuqinile phakathi kwezithako, i-silica dioxide isebenza njenge-excipient ebalulekile yemithi ukuze ithuthukise ikhwalithi nokuzinza kwemikhiqizo yemithi. Ithola izicelo emithini, ekudleni, ekudleni kwezilwane, nasemikhakheni ehlobene, ngenkathi isekela izixazululo zokusebenza ezenziwe ngezifiso. 1.2 Izinzuzo eziyisisekelo Njengomkhiqizo we-excipient wemithi onemisebenzi eminingi, i-Zhongqi Colloidal Silica ibhekana kahle nezinselelo zezimboni ezifana nokungahambi kahle kwezinto ezithile ezimweni zokuphakela ezinzima kanye nezinkinga zokuhlala emikhiqizweni ye-liquid. Ngokusebenzisa ukulawula ikhwalithi okuphelele kulo lonke uchungechunge lokukhiqiza, lo mkhiqizo uqinisekisa ukuhamba kahle nokusebenza okujwayelekile, uvumela abakhiqizi bemithi ukuba bathuthukise ukusebenza kahle kokukhiqiza kanye nokuncintisana komkhiqizo. Uhlangabezana nezidingo zokubhaliswa kwemithi zasekhaya nezamazwe omhlaba, ubonisa ukuhamba kahle ekuhlangabezaneni nezidingo ezihlukahlukene zokulawula. 2. Izici Zomkhiqizo (Product Characteristics) •I-Nanostructure: usayizi wezithako uqondiswa ku-12-20nm, udala isakhiwo esihlangene esingama-3D, kanti isikhala esithile se-BET singafinyelela ku-175-380m²/g, sinikeza isisekelo sokumunca kahle nokuhamba. •Ukuhamba kahle 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 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 zokuphakelwa ezinzima Amathablethi, ama-capsule, namaphudingi: Lezi zingahlukaniswa kahle zisebenzisa imishini yokuhlanganisa ejwayelekile. Uhlelo lusebenza njengovimbela ukuze lunciphise ukuxhumana phakathi kwezithako, kuthuthukise ukuhamba kahle, futhi kuvinjeze ukuhlanganiswa. Iphakamisa isivinini sokucindezela amathablethi ngenkathi ithuthukisa izinqubo zokukhiqiza ukuze kube nokuhamba kahle kwamaphudingi. I-adsorbent/umkhiqizo opholile ulawula kahle umswakama nokuhamba kwamanzi (ukuguqulwa kuncike kumthamo). Lokhu kunciphisa izinkinga zokuhambisana phakathi kwezithako zemithi, kukhuthaza ukusabalala okujwayelekile kwezithako zamaphudingi, futhi kuthuthukisa isivinini sokuphuka kwamathablethi. •I-Tablet/capsule: Engeza u-0.1-0.5% njengomsizi wokuhamba, okunganciphisa i-angle yokuphumula kwamaphudingi ngo-20-30%, kunciphise umehluko wesisindo enqubweni yamathablethi, futhi kuthuthukise ubunzima bamathablethi ngo-15-20% futhi kunciphise ubrittleness. •Inqubo ye-tablet eqondile: thuthukisa ukuhamba kwemikhiqizo, 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 ukuhlanganiswa okuqinile, ukuhlangana, nokuhamba ngenkathi ithuthukisa ukujula kwe-gel nokuhambisana kwezinto zokwakha. Ithuthukisa ukuzinza kokuhlala futhi ivimbela ukuhlanganiswa kwe-aerosol (idinga imishini ephezulu yokuhlanganisa ukuze kufezwe ukusebenza okuhle). •I-Oral suspension: Njengomkhiqizo wokuhlala kanye nomjovo, ukwengeza u-0.5-2.0% kungakwenza kube nesilinganiso sokuhlala se-API> 95%, kuvimbele ukuhlanganiswa kwemithi, futhi kuthuthukise ukunemba kokuthola. •Izithako/izinhlelo zokubuka: 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: umunca ama-vitamins, ama-probiotics nezinye izithako ukuze wandise isikhathi sokuphila kwemikhiqizo futhi wandise isilinganiso sokugcina sokusebenza kwe-biological ngaphezu kuka-30%, kufanelekile kumaphudingi e-protein, amaphudingi okudla nezinye izinto. •Umkhiqizo ophikisana nokuhlanganiswa: emkhathini we-umswakama ≤60%, umkhiqizo ophudingi ungagcinwa isikhathi esingaphezu kwezinyanga eziyi-6 ngaphandle kokuhlanganiswa ukuze kuqinisekiswe ukuhamba kahle komkhiqizo. 4.4 Izicelo zokudla: Njengomkhiqizo wokudla oqondile, uthuthukisa ukuhamba kahle kwamaphudingi okudla (kuhlanganisa amaphudingi e-organic apholile), uvimbela ukuhlanganiswa ngesikhathi sokugcina ngenkathi kugcinwa umswakama; umunca umswakama, ufanelekile kumaphudingi anomswakama/ahambayo; usebenza njengomjovo wezinto eziphilayo ezifana nezinsalela zokupheka nezamafutha ezitshalo, futhi usebenza njengomkhiqizo we-thixotropic ezinsizeni zokupheka ezisekelwe kumafutha; futhi uthuthukisa ukuhlanzeka kwemishini ngesikhathi sokugaya izinto zokwakha. 4.5 Ukusebenza emkhakheni wokudla: Thuthukisa ukusebenza kokudla kanye nobuchwepheshe bokucubungula ukuze kuqinisekiswe ukuhamba kahle nokumelana nokugcina kwephudingi, futhi unikeze izakhiwo ezinhle zokulungisa umswakama kumaphudingi; thuthukisa inqubo yokugaya nokugaya ukuze kuvinjezelwe umkhiqizo ekubambeni kwemishini. 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 isitifiketi esihlobene: I-FDA inactive ingredient database collection, EU E551 food additive certification. •Landela iziqondiso zokuhambisana zomhlaba: ulandela izindinganiso zokukhiqiza ze-GMP nezidingo ze-HACCP food safety system. 6. Imiyalelo Yokusebenzisa 6.1 Umthamo ophakanyisiwe Uhlobo lokulungiselela Inhloso yokusebenza Umthamo ophakanyisiwe Tablet/capsule umsizi wokuhamba 0.1-0.5% Oral suspension Umjovo/Umjovo 0.5-2.0% Nutrient powder umkhiqizo ophikisana nokuhlanganiswa 0.2-1.0% Active ingredient carrier Umunca 5-15% 6.2 Iziphakamiso ezibalulekile zokusebenza nokugcina •Ukusebenza kwemikhiqizo eqinile: kunconywa ukwengeza ngemva kokuhlanganisa i-API kanye ne-diluent, futhi usebenzise ukuhlanganisa okuphezulu okungaphezu kwemizuzu engama-30 ukuze kuqinisekiswe ukuhamba kahle. •Ukusebenza kwemikhiqizo ye-liquid: kufanele ihlukaniswe 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%), isebenza iminyaka emibili, ivuliwe futhi isetshenziswe ngokushesha. Le mininingwane engenhla iyisikhumbuzo kuphela, futhi ukusetshenziswa kwangempela nokuthola kufanele kulungiswe ngokuya ngombhalo wakho. 7. Izinzuzo Zomkhiqizo (PA) •Ukwenza kahle kwazo zonke izimo: inezici zokuhamba kwemikhiqizo eqinile kanye nezokuzinza kwemikhiqizo ye-liquid, kunciphisa uhlobo lwezinto ezisizayo futhi kulungiselela umklamo wombhalo. •Ukuqinisekiswa kokuhambisana komhlaba: ukuvikelwa kwe-multi-pharmaceutical code certification, ukweseka ukubhaliswa kwemithi yasekhaya nezamazwe omhlaba, kunciphisa izingozi zokufinyelela emakethe. •Isevisi ezenziwe ngezifiso: ngokuya ngezidingo zamakhasimende, usayizi wezithako nezici ezithile zesikhala zingalungiswa ukuze kuhanjiswe izixazululo zobuchwepheshe ezikhethekile. •Ukuphakelwa okuqhubekayo: inqubo yokukhiqiza ithatha amandla, futhi ukupakisha kusebenzisa amabhakede ephepha angasetshenziswa kabusha ukuze kuhlangabezane nezidingo zokusebenza kanye nezokuvikela imvelo. 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, ezihlukile nezintsha eGuangzhou •Amalungelo angu-51 avela kwi-Office of State Intellectual Property