1. Ukubuka Kwenkambo (Product Overview) 1.1 Incazelo eziyisisekelo I-colloidal silica dioxide iyisilicon dioxide esiphezulu esilungiswe ngokuqhubekayo, ibonakala njengepudingi emhlophe, elula. Umkhiqizo unama-nano-network structure ayisisekelo, unikeza izinzuzo ezifana nosayizi wezakhi ezifanayo, ukusabalala okuhle, kanye nokuzinza kwezemikhakha. Ayiphenduli nezithako ezisebenzayo zemithi. Ngobubanzi bayo obuphezulu besikhala esithile kanye nokuxhumana okuqinile phakathi kwezakhi, i-silica dioxide isebenza njengomkhiqizo obalulekile wemithi ukuze ithuthukise ikhwalithi nokuzinza kwemikhiqizo yemithi. Itholakala ezindaweni zemithi, ukudla, ukudla kwezilwane, kanye nezinye izinkambu ezihlobene, ngenkathi ixhasa izixazululo zokusebenza ezenziwe ngezifiso. 1.2 Izinzuzo eziyisisekelo Njengomkhiqizo wemithi onemisebenzi eminingi, i-Zhongqi Colloidal Silica ibhekana kahle nezinselelo zezimboni ezifana nokungabi namandla kokuhamba ezimfuthweni ezinzima kanye nezinkinga zokuhlala ezilungisweni ze-liquid. Ngokusebenzisa ukulawula ikhwalithi okuhlanganisiwe kuyo yonke imikhakha yokukhiqiza, lo mkhiqizo uqinisekisa ubuqotho obufanayo nokusebenza, uvumela abakhiqizi bemithi ukuthi 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) •Uhlaka lwe-nano: usayizi wezakhi wendawo uqondiswa ku-12-20nm, udala uhlaka lwezinhlelo ezintathu ezifanayo, futhi indawo ethile ye-BET ingafinyelela ku-175-380m²/g, inikeza isisekelo sokumunca kahle nokusabalala. •Ukuqina kokusabalala 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 ngemva kwezinsuku eziyi-30 zokuma ku-25℃, ihlangabezana nezidingo zokugcina isikhathi eside zokulungiselela iziphuzo. •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. Izinkambu Zokusetshenziswa 4.1 Izimo zokuphakelwa eziqinile Amathablethi, ama-capsule, kanye nepudingi: Lezi zingasabalala kahle zisebenzisa imishini yokuxuba ejwayelekile. Uhlelo lusebenza njengovimbelo lokunciphisa ukuxhumana phakathi kwezakhi, kuthuthukisa ukuhamba okukhululekile, futhi kuvimbele ukuhlanganiswa. Iphusha ijubane lokucindezela amathablethi ngenkathi ithuthukisa izinqubo zokukhiqiza ukuze kube nokuhamba kwepudingi okukhululekile. I-adsorbent / impahla emunca amanzi ikwazi kahle ukulawula umswakama nokuhamba kwamanzi (ukuguqulwa kuncike kumthamo). Lokhu kunciphisa izinkinga zokuhambisana phakathi kwezingxenye zemithi, kuthuthukisa ukusabalala okufanayo kwezakhi ze-pudingi, futhi kuthuthukisa ijubane lokuphuka kwamathablethi. •I-Tablet / capsule: Engeza u-0.1-0.5% njengomsizi wokuhamba, okunganciphisa i-angle yokuphumula kwepudingi ngo-20-30%, kunciphise umehluko wesisindo enqubweni yamathablethi, futhi kuthuthukise ubunzima bamathablethi ngo-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 Izilungiselelo ze-liquid Izilungiselelo zemithi (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, ukuhamba, nokuhamba ngenkathi ithuthukisa ukujula kwe-gel nokusabalala kwezinto zokwakha. Ithuthukisa ukuzinza kokuhlala futhi ivimbela ukuhamba kwe-aerosol (idinga imishini yokuhamba ephezulu ukuze kuqinisekiswe ukusabalala okuhle ukuze kufezwe ukusebenza okuhle). •I-Oral suspension: Njengomkhiqizo wokuphakamisa nokujula, ukwengeza u-0.5-2.0% kungakwenza kube ne-sediment volume ratio ye-API> 95%, ivimbele ukuhamba kwemithi, futhi ithuthukise ukunemba kokuthola. •Izithako / izilungiselelo zamehlo: kuhambisana nezindinganiso zokukhiqiza ezihlanzekile ze-IPEC-GMP, kungathuthukisa ukuzinza kwesixazululo, kunciphise ingozi yokwakheka kwezinto, futhi kuhlangabezane nezidingo zezilungiselelo ezibucayi. 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 ku-protein powder, nutritional powder nezinye izinto. •Umkhiqizo ophikisana nokuhlanganiswa: emkhathini wokuhamba ≤60%, impahla ye-powder ingagcinwa isikhathi eside ngaphezu kwezinyanga eziyi-6 ngaphandle kokuhlanganiswa ukuze kuqinisekiswe ukuhamba komkhiqizo. 4.4 Izicelo zokudla: Njengomkhiqizo wokudla oqondile, ithuthukisa ukuhamba kwepudingi yokudla (kuhlanganise ne-powder ye-organic ethambile), ivimbela ukuhlanganiswa kokugcina ngenkathi igcina umswakama; umunca umswakama, kufanelekile ku-powder ezimanzi / ezithambile; isebenza njengomkhiqizo ojulile wezokudla ezinjengezikhukhula zokupheka nezithako zezithelo, futhi isebenza njengomkhiqizo we-thixotropic emikhiqizweni yokubhaka nezokupheka ezisekelwe ku-oyela; futhi ithuthukisa ukuhlanzeka kwemishini ngesikhathi sokugaya izinto zokwakha. 4.5 Ukusetshenziswa emkhakheni wokudla: Thuthukisa ukusebenza kokudla nobuchwepheshe bokucubungula ukuze uqinisekise ukuhamba okukhululekile nokumelana nokugcina kwepudingi yokwengeza, futhi unikeze izakhiwo ezinhle zokulungisa umswakama ezakhiweni; thuthukisa inqubo yokugaya nokugaya ukuze uvimbele umkhiqizo ukuthi ungabambeki kumishini. 5. Izindinganiso nezimfuneko (Standards & Regulations) •Uhambisana nezindinganiso eziningi ze-pharmacopoeia zomhlaba: 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: uhambisana nezindinganiso zokukhiqiza ze-GMP nezidingo ze-HACCP food safety system. 6. Imiyalelo Yokusebenzisa 6.1 Umthamo ohlongozwayo Uhlobo lokulungiselela Inhloso yokusebenza Umthamo ohlongozwayo Tablet/capsule umsizi wokuhamba 0.1-0.5% Oral suspension Umsizi / Umkhiqizo ojulile 0.5-2.0% Nutrient powder umkhiqizo ophikisana nokuhlanganiswa 0.2-1.0% Active ingredient carrier Umunca 5-15% 6.2 Iziqondiso ezibalulekile zokusebenza nokugcina •Ukusetshenziswa kokulungiselela okuqinile: kunconywa ukuthi engezwe ngemuva kokuxuba i-API kanye ne-diluent, futhi kusetshenziswe ukuxuba okuphezulu okungaphezu kwemizuzu engama-30 ukuze kuqinisekiswe ukusabalala okufanayo. •Ukusetshenziswa kokulungiselela kwe-liquid: kufanele kusabalale ngaphansi kwezimo ze-pH 4-6, futhi kugwenywe ukuxhumana isikhathi eside ne-asidi eqinile kanye ne-alkali ukuze kuvinjwe 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) •Ukuhambisana kwesimo esiphelele: inezici zokuhamba kwemikhiqizo eqinile kanye nokuzinza kokulungiselela kwe-liquid, kunciphisa uhlobo lwezinto ezisizayo futhi kulula ukuklama ifomula. •Ukuqinisekiswa kokuhambisana komhlaba: ukuvuma kwe-multi-pharmaceutical code certification, ukweseka ukubhaliswa kwemithi yasekhaya naphakathi, kunciphisa izingozi zokufinyelela emakethe. •Insizakalo ezenziwe ngezifiso: ngokuya ngezidingo zamakhasimende, usayizi wezakhi kanye nezinga elithile lesikhala singalungiswa ukuze kuhanjiswe izixazululo zobuchwepheshe ezikhethekile. •Ukuphakelwa okuqhubekayo: inqubo yokukhiqiza isebenzisa ukuvuselelwa kwamandla, futhi iphakheji isebenzisa amabhakede ephepha angasetshenziswa kabusha ukuze kuhlangabezane nezidingo zokusebenza nokuvikelwa kwemvelo. 8. Ukuqinisekiswa kohlelo lwezinkampani 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-Enterprise ye-high-tech kazwelonke •Izinkampani ezikhethekile, ezithuthukisiwe nezintsha eGuangzhou •Amalungelo angama-30 avela kwi-Office of State Intellectual Property