1. Ukubuka Kwamkhiqizo (Product Overview) 1.1 Incazelo eziyisisekelo I-colloidal silica dioxide iyisilicon dioxide esiphezulu esilungiswe ngezinqubo advanced, ibonakala njengepowder emhlophe, ethambile. Umkhiqizo unikeza isakhiwo se-nano-network esiyinhloko, uhlinzeka ngezinsiza ezifana nosayizi wezakhi ezihambisanayo, ukusabalala okuhle, kanye nokuzinza kwemichilo eqinile. Ayiphenduli nezithako ezisebenzayo zemithi. Nge-surface area yayo ethile ephezulu kanye nokuxhumana okuqinile phakathi kwezakhi, i-silica dioxide isebenza njenge-excipient ebalulekile yemithi ukuze ithuthukise ikhwalithi nokuzinza kwemikhiqizo yemithi. Ithola izicelo emithini, ekudleni, ekudleni kwezilwane, nasemikhakheni ehlobene, ngenkathi ixhasa izixazululo zokusebenza ezenziwe ngezifiso. 1.2 Izinzuzo eziyisisekelo Njengomkhiqizo we-excipient wemithi onemisebenzi eminingi, i-Zhongqi Colloidal Silica ixazulula kahle izinselelo zezimboni ezifana nokungahambi kahle kwezakhi ezinzima ezimithini ezinzima kanye nezinkinga zokuhlala emikhiqizweni ye-liquid. Ngokulawula ikhwalithi ngokuphelele kuyo yonke i-chain yokukhiqiza, lo mkhiqizo uqinisekisa ubuqotho obuhambisanayo nokusebenza, uvumela abakhiqizi bemithi ukuba bathuthukise ukusebenza kahle kokukhiqiza kanye nokuncintisana komkhiqizo. Uhlangabezana nezidingo zokubhaliswa kwemithi zasekhaya nezamazwe omhlaba, ubonisa ubuchwepheshe bawo bokuhlangabezana nezidingo ezihlukahlukene zokulawulwa. 2. Izici Zomkhiqizo (Product Characteristics) •Isakhiwo se-Nano: usayizi wezakhi wendawo uqondiswa ku-12-20nm, udala isakhiwo esihambisanayo se-three-dimensional, kanti i-BET specific surface area ingafinyelela ku-175-380m²/g, ihlinzeka ngesisekelo sokumunca kahle nokusabalala. •Ukuhlala okuhle kokusabalala: ingakha i-colloid ezinzile ohlelweni lwe-aqueous, futhi inani le-pH ligcinwa ku-3.5-5.5, elihambelana nezinhlelo eziningi ze-API. Akukho phenomene yokuhlukaniswa eyenzeka ngemuva kwezinsuku eziyi-30 zokuma ku-25℃, ihlangabezana nezidingo zokugcina isikhathi eside zemikhiqizweni ye-liquid. •Ukungcola okuphansi 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 ne-standards zezimboni. 4. Iziqu Zokusebenza 4.1 Imikhiqizo ezinzima Amathablethi, ama-capsule, namapowder: Lezi zingasabalala kahle zisebenzisa imishini yokuxuba ejwayelekile. Uhlelo lusebenza njengovimbelo lokunciphisa ukuxhumana phakathi kwezakhi, kuthuthukisa ukuhamba okukhululekile, futhi kuvinjeze i-caking. Iphakamisa isivinini sokucindezela amathablethi ngenkathi ithuthukisa izinqubo zokukhiqiza ukuze kube nokuhamba okuphelele kwepowder. I-adsorbent/umkhiqizo owamukelayo ulawula kahle umswakama nokuqukethwe kwamanzi (ukuguqulwa kuncike kumthamo). Lokhu kunciphisa izinkinga zokuhambelana phakathi kwezithako zemithi, kuthuthukisa ukusabalala okuhambisanayo kwezakhi ze-powder, futhi kuthuthukisa isivinini sokuphuka kwamathablethi. •I-Tablet/capsule: Engeza u-0.1-0.5% njengomsizi wokuhamba, onganciphisa i-angle yokuphumula kwepowder ngo-20-30%, unciphise umehluko wesisindo enqubweni ye-tablet, futhi uthuthukise ubunzima bamathablethi 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 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 ukuhlala kwe-suspension futhi ivimbela ukuwa kwe-aerosol (idinga imishini ye-high-shear ukuze kuqinisekiswe ukusabalala okuhle ukuze kufinyelelwe ukusebenza okuhle). •I-Oral suspension: Njengomkhiqizo wokuphakamisa nokujula, ukwengeza u-0.5-2.0% kungakwenza kube nesilinganiso sokuhlala kwe-API> 95%, kuvimbele ukuhlukaniswa kwemithi, futhi kuthuthukise ukunemba kokutholwa. •Izithako/izinhlelo zokubheka: kuhambisana nezindinganiso zokukhiqiza ezihlanzekile ze-IPEC-GMP, kungathuthukisa ukuzinza kwesixazululo, kunciphise ingozi yokwakheka kwezakhi, futhi kuhlangabezane nezidingo zemikhiqizo ye-liquid ezithambile. 4.3 Izithako zokudla •Umthwali wezithako ezisebenzayo: umuncu ama-vitamins, ama-probiotics nezinye izithako ukuze wandise isikhathi sokuphila kwemikhiqizo futhi wandise isilinganiso sokugcina sokusebenza kwezinto eziphilayo ngaphezu kuka-30%, efanelekile ku-protein powder, nutritional powder nezinye izinto. •Umkhiqizo ophikisana ne-caking: emkhathini we- humidity ≤60%, umkhiqizo we-powder ungagcinwa isikhathi esingaphezu kwezinyanga eziyi-6 ngaphandle kokuhlangana ukuze kuqinisekiswe ukuhamba komkhiqizo. 4.4 Izicelo zokudla: Njengomkhiqizo owengeziwe wokudla, uthuthukisa ukuhamba kwepowder yokudla (kuhlanganise ne-powder soft organic), ivimbela i-caking yokugcina ngenkathi igcina umswakama; umuncu umswakama, efanelekile kumapowder amanzi/hygroscopic; isebenza njengomkhiqizo ophikisana ne-caking emikhiqizweni ye-liquid efana nezinsalela zokupheka nezamafutha ezitshalo, futhi isebenza njengomkhiqizo we-thixotropic emikhiqizweni yokupheka ne-baking; ngaphezu kwalokho ithuthukisa ukuhlanzeka kwemishini ngesikhathi sokugaya izinto zokwakha. 4.5 Ukusetshenziswa emkhakheni wezokudla: Thuthukisa ukusebenza kokudla nezobuchwepheshe bokucubungula ukuze uqinisekise ukuhamba okukhululekile nokumelana nokugcina kwepowder yokwengeza, futhi unikeze izakhiwo ezinhle zokulungisa umswakama ezakhiweni; thuthukisa inqubo yokugaya nokugaya ukuze uvimbele umkhiqizo ukuthi ungeniswe kumishini. 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, i-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 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 ophikisana ne-caking 0.2-1.0% Umthwali wezithako ezisebenzayo Umuncu 5-15% 6.2 Amathiphu abalulekile okusebenza nokugcina •Ukusetshenziswa kwemikhiqizo ezinzima: kunconywa ukwengeza ngemuva kokuxuba i-API kanye ne-diluent, futhi usebenzise i-high shear mixing isikhathi esingaphezu kwemizuzu engama-30 ukuze uqinisekise ukusabalala okuhambisanayo. •Ukusetshenziswa kwemikhiqizo ye-liquid: kufanele kusabalalise 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 nokuthamo kufanele kulungiswe ngokuya ngefomula yakho. 7. Izinzuzo Zomkhiqizo (PA) •Ukufaneleka kwesimo esiphelele: inezici zokuhamba kwemikhiqizo ezinzima kanye nezokuzinza kwemikhiqizo ye-liquid, inciphisa uhlobo lwezinto ezisizayo futhi ilungiselela umklamo wefomula. •Ukuqinisekiswa kokuhambisana komhlaba: ukuvuma izitifiketi eziningi ze-pharmaceutical code, ukweseka ukubhaliswa kwemithi yasekhaya nezamazwe omhlaba, kunciphisa izingozi zokufinyelela emakethe. •Isevisi eyenziwe ngezifiso: ngokuya ngezidingo zamakhasimende, usayizi wezakhi 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 ibalansise ukusebenza nezidingo zokuvikelwa kwemvelo. 8. Ukuqinisekiswa kwesistimu yeNkampani nezihlonipho •FSSC22000 •ISO22000：2018 •ISO9001：2015 •SHC HALAL •OU KOSHER •I-FDA attestation •FAMI-QS •SEDEX •Ilayisensi yokukhiqiza yokwengeza ukudla •Ilayisensi yokukhiqiza yokwengeza ukudla kwezilwane •I-National high-tech enterprise •Izinkampani ezikhethekile, ezithuthukile nezintsha eGuangzhou •Amalungelo angu-48 avela kwi-Office of State Intellectual Property