1. Ukubuka Kwamkhiqizo (Product Overview) 1.1 Incazelo eziyisisekelo I-colloidal silica dioxide iyisilicon dioxide esiphezulu sokuhlanzeka esilungiswe ngokuqhubekayo, ibonakala njengepudingi emhlophe, elula. Umkhiqizo unikeza isakhiwo se-nano-network esiyinhloko, unikeza izinzuzo ezifana nosayizi wezakhi ezifanayo, ukusabalala okuhle, kanye nokuzinza kwemichiza okuqinile. Ayiphenduli nezithako ezisebenzayo zemithi. Nge-surface area yayo ethile ephezulu kanye nokuxhumana okuqinile phakathi kwezithako, i-silica dioxide isebenza njenge-excipient ebalulekile yemithi ukuze ithuthukise ikhwalithi nokuzinza kwezinhlelo zemithi. Ithola izicelo emithini, ekudleni, ekudleni kwezilwane, nasemkhakheni ofanele, 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 nokungabi nokuhamba kahle kwezinhlobo zokuphakelayo eziqinile kanye nezinkinga zokuhlala emaphaketheni amanzi. Ngokulawula ikhwalithi ngokuphelele kuyo yonke inqubo yokukhiqiza, lo mkhiqizo uqinisekisa ukuhlanzeka nokusebenza okuhambisanayo, uvumela abakhiqizi bemithi ukuba bathuthukise ukusebenza kahle kokukhiqiza nokuncintisana komkhiqizo. Uhambisana kakhulu nezidingo zokubhaliswa kwemithi zasekhaya nezamazwe, ubonisa ukuhamba phambili ekuhlangabezaneni nezidingo ezihlukahlukene zokulawula. 2. Izici Zomkhiqizo (Product Characteristics) •Isakhiwo se-Nano: usayizi wezithako uqondiswa ku-12-20nm, udala isakhiwo esihlangene se-three-dimensional, kanti i-BET specific surface area ingafinyelela ku-175-380m²/g, inikeza isisekelo sokumunca kahle nokusabalala. •Ukuhlala okuhle kokusabalala: 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 ngemva kwezinsuku eziyi-30 zokuma ku-25℃, ihlangabezana nezidingo zokugcina isikhathi eside zokuhlala kwemikhiqizo emanzini. •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 Izinhlobo zokuphakelayo eziqinile Amathablethi, ama-capsule, namapudingi: Lezi zingasabalala kahle zisetshenziswa ngempahla yokuxuba ejwayelekile. Uhlelo lusebenza njengovimbelo lokunciphisa ukuxhumana phakathi kwezithako, kuthuthukisa ukuhamba okukhululekile, futhi kuvimbele ukwakheka. Iphakamisa isivinini sokucindezela amathablethi ngenkathi ithuthukisa izinqubo zokukhiqiza ukuze kube nokuhamba okukhululekile kwepudingi. I-adsorbent/imathiriyeli yokumunca amanzi ikwazi kahle ukulawula umswakama nokuhamba kwamanzi (ukuguqulwa kuncike kumthamo). Lokhu kunciphisa izinkinga zokuhambisana phakathi kwezithako zemithi, kuthuthukisa ukusabalala okufanayo kwezakhi ze-powder, futhi kuthuthukisa isivinini sokuphuka kwamathablethi. •I-Tablet/capsule: Engeza u-0.1-0.5% njengomsizi wokuhamba, okunganciphisa i-angle yokuphumula kwepudingi ngo-20-30%, kunciphise umehluko wesisindo enqubweni ye-tablet, futhi kuthuthukise ubhardness bamathablethi ngo-15-20% futhi kunciphise ubrittleness. •Inqubo ye-tablet eqondile: thuthukisa ukuhamba kwemathiriyeli, kunciphise inani le-lubricant, kunciphise isikhathi sokukhiqiza, kufanelekile ku-acetaminophen, aspirin nezinye izinhlelo ze-API. 4.2 Izinhlelo zamanzi 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 ukuwa okuqinile, ukuhlangana, nokuhamba ngenkathi ithuthukisa ukujula kwe-gel nokuhambisana kwezinto zokwakha. Ithuthukisa ukuzinza kokuhlala futhi ivimbela ukuwa kwe-aerosol (idinga imishini ephezulu yokuhamba ukuze kufezwe ukusebenza okuhle). •I-suspension yokudla: Njengomkhiqizo wokuphakamisa nokujula, ukwengeza u-0.5-2.0% kungenza ubukhulu bokuhlala kwe-API> 95%, kuvimbele ukuhlukaniswa kwemithi, futhi kuthuthukise ukunemba kokuphakelayo. •Izithako/izinhlelo zokubuka: kuhambisana nezindinganiso zokukhiqiza ezihlanzekile ze-IPEC-GMP, kungathuthukisa ukuzinza kwesixazululo, kunciphise ingozi yokwakheka kwezithako, futhi kulungele izidingo zokuhlala ezithambile. 4.3 Izithako zokudla •Umthwali wezithako ezisebenzayo: umunca ama-vitamini, ama-probiotics nezinye izithako ukuze wandise isikhathi sokuphila kwemikhiqizo futhi wandise umphumela wokugcina wokuphila ngaphezu kuka-30%, kufanelekile kumapowder e-protein, amaphowder okudla nezinye izinto. •Umkhiqizo wokuvimbela ukuwa: emkhathini wokungabi namanzi ≤60%, impahla ye-powder ingagcinwa isikhathi esingaphezu kwezinyanga eziyi-6 ngaphandle kokwakheka ukuze kuqinisekiswe ukuhamba komkhiqizo. 4.4 Izicelo zokudla: Njengomkhiqizo wokudla oqondile, uthuthukisa ukuhamba kwepudingi yokudla (kuhlanganise namapowder e-organic alula), uvimbela ukuwa kokugcina ngenkathi ugcina umswakama; umunca umswakama, ufanelekile kumapowder anomswakama/ahamba phambili; usebenza njengomkhiqizo wokujula ezidleni ezinjengama-pickling juices kanye namafutha emifino, futhi usebenza njengomkhiqizo we-thixotropic kumaspray wokupheka nokubhaka; futhi uthuthukisa ukuhlanzeka kwemishini ngesikhathi sokugaya izinto zokwakha. 4.5 Ukusebenza emkhakheni wokudla: Thuthukisa ukusebenza kokudla kanye nobuchwepheshe bokucubungula ukuze uqinisekise ukuhamba okukhululekile nokumelana nokugcina kwepudingi yokwengeza, futhi unikeze izakhiwo ezinhle zokulungisa umswakama kumaparticles; thuthukisa inqubo yokugaya nokugaya ukuze uvimbele umkhiqizo ukuthi ungalungiseki kumishini. 5. Izindinganiso nezimfuneko (Standards & Regulations) •Uhambisana nezindinganiso eziningi ze-pharmacopoeia zomhlaba: USP-NF, European Pharmacopoeia (Ph. Eur.), Japanese Pharmacopoeia (JP), ne-China Pharmacopoeia (ChP 2025). •Thola ubufakazi obufanele: i-FDA inactive ingredient database collection, i-EU E551 food additive certification. •Landela iziqondiso zokuhambisana zomhlaba: ulandela izindinganiso zokukhiqiza ze-GMP nezimfuneko ze-HACCP zokuphepha kokudla. 6. Imiyalelo Yokusebenzisa 6.1 Umthamo ohlongozwayo Uhlobo lokulungiselela Inhloso yokusebenza Umthamo ohlongozwayo I-Tablet/capsule umsizi wokuhamba 0.1-0.5% I-oral suspension Umkhiqizo wokuphakamisa/ukujula 0.5-2.0% I-nutrient powder umkhiqizo wokuvimbela ukuwa 0.2-1.0% Umthwali wezithako ezisebenzayo Umunca 5-15% 6.2 Amathiphu abalulekile okusebenza nokugcina •Ukusetshenziswa kokulungiselela okuqinile: kunconywa ukwengeza ngemva kokuxuba i-API kanye ne-diluent, futhi usebenzise ukuxuba okuphezulu okungaphezu kwemizuzu engama-30 ukuze uqinisekise ukusabalala okufanayo. •Ukusetshenziswa kokulungiselela okukhanyayo: kufanele kusabalale ngaphansi kwezimo ze-pH 4-6, futhi ugweme ukuxhumana isikhathi eside ne-asidi eqinile kanye ne-alkali ukuvimbela ukonakaliswa kwesakhiwo se-colloid. •Izimo zokugcina: iphakheji evaliwe, igcinwe endaweni ehlanzekile nepholile (15-25℃, umswakama ophakathi <60%), iyasebenza iminyaka emibili, ivule futhi usebenzise ngokushesha. Le mininingwane engenhla iyisikhumbuzo kuphela, futhi ukusetshenziswa kwangempela nokuthamo kufanele kulungiswe ngokuhambisana ne-formula yakho. 7. Izinzuzo Zomkhiqizo (PA) •Ukulungiswa kwesimo sonke: inezici zokuhamba kwezinhlobo zokuphakelayo eziqinile kanye nezokuhlala ezinzile, kunciphisa uhlobo lwezinto ezisizayo futhi kulula ukudizayina ifomula. •Ukuqinisekiswa kokuhambisana komhlaba: ukuvuma kwe-multi-pharmaceutical code certification, ukweseka ukubhaliswa kwemithi yasekhaya nezamazwe, kunciphisa izingozi zokufinyelela emakethe. •Insizakalo ezenziwe ngezifiso: ngokuhambisana nezidingo zamakhasimende, usayizi wezithako kanye nezici ze-surface area 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 neziqinisekiso •FSSC22000 •ISO22000：2018 •ISO9001：2015 •SHC HALAL •OU KOSHER •I-FDA attestation •FAMI-QS •SEDEX •Ilayisensi yokukhiqiza yokwengeza kokudla •Ilayisensi yokukhiqiza yokwengeza kokudla kwezilwane •I-National high-tech enterprise •Izinkampani ezikhethekile, ezithuthukisiwe nezintsha eGuangzhou •Amalungelo angu-61 avela kwi-Office of State Intellectual Property