USP-Ezihambisanayo iColloidal Silica yePharmaceuticals
USP-Ezihambisanayo iColloidal Silica yePharmaceuticals
USP-Ezihambisanayo iColloidal Silica yePharmaceuticals
USP-Ezihambisanayo iColloidal Silica yePharmaceuticals
USP-Ezihambisanayo iColloidal Silica yePharmaceuticals
USP-Ezihambisanayo iColloidal Silica yePharmaceuticals
FOB
Imininingwane yemithombo
Imibuzo evamile
Ukubonisa umlingani
1. Ukubuka KweMikhiqizo (Product Overview) 1.1 Incazelo eziyisisekelo I-colloidal silica dioxide iyisilicon dioxide esiphezulu esilungiswe ngezindlela advanced, ibonakala njengepowder emhlophe, ethambile. Umkhiqizo ubonisa isakhiwo se-nano-network esiyinhloko, unikeza izinzuzo ezifana nosayizi wezinhlayiya ofanayo, ukusabalala okuhle, kanye nokuzinza kwemichiza okuqinile. Ayiphenduli nezithako ezisebenzayo zemithi. Nge-surface area ethile ephezulu kanye nokuxhumana okuqinile phakathi kwezinhlayiya, i-silica dioxide isebenza njengomkhiqizo obalulekile wemithi ukuze ithuthukise ikhwalithi nokuzinza kwemikhiqizo yemithi. Ithola izicelo emithini, ekudleni, ekudleni kwezilwane, nasemkhakheni ofanayo, ngenkathi isekela izixazululo zokusebenza ezenziwe ngezifiso. 1.2 Izinzuzo eziyisisekelo Njengomkhiqizo wemithi onemisebenzi eminingi, i-Zhongqi Colloidal Silica ixazulula kahle izinselelo zezimboni ezifana nokungabi nokuhamba kahle ezimfuthweni eziqinile kanye nezinkinga zokuhlala emikhiqizweni ye-liquid. Ngokusebenzisa ukulawula ikhwalithi okuphelele kulo lonke uchungechunge lokukhiqiza, lo mkhiqizo uqinisekisa ukuhlala kwe-purity nokusebenza, uvumela abakhiqizi bemithi ukuba bathuthukise ukusebenza kahle kokukhiqiza nokuncintisana komkhiqizo. Uhlangabezana nezidingo zokubhaliswa kwemithi zasekhaya nezamazwe, ubonisa ukuhamba phambili ekuhlangabezaneni nezidingo ezihlukahlukene zokulawula. 2. Izici Zomkhiqizo (Product Characteristics) •Isakhiwo se-Nano: usayizi wezinhlayiya uqondiswa ku-12-20nm, udala isakhiwo esihlangene se-three-dimensional, futhi i-BET specific surface area ingafinyelela ku-175-380m²/g, inikeza isisekelo sokumunca kahle nokusabalala. •Ukuzinza 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 zemikhiqizho 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 neziqondiso zezimboni. 4. Izindawo Zokusebenza 4.1 Imikhiqizo ye-Dosage eziqinile Amathablethi, ama-capsule, kanye nepowder: Lezi zingasabalala kahle zisetshenziswa imishini yokuxuba ejwayelekile. Uhlelo lusebenza njengovimbelo lokunciphisa ukuxhumana phakathi kwezinhlayiya, kuthuthukisa ukuhamba kahle, futhi kuvinjeze i-caking. Iph ускоряет isivinini sokucindezela amathablethi ngenkathi ithuthukisa izinqubo zokukhiqiza ukuze kube nokuhamba kahle kwepowder. I-adsorbent/umkhiqizo opholile ulawula kahle umswakama kanye nomthamo we-liquid (ukuguqulwa kuncike kumthamo). Lokhu kunciphisa izinkinga zokuhambisana phakathi kwezithako zemithi, kuthuthukisa ukusabalala okujwayelekile kwezingxenye ze-powder, futhi kuthuthukisa isivinini sokuphuka kwamathablethi. •I-Tablet/capsule: Engeza u-0.1-0.5% njengomsebenzi wokuhamba, okunganciphisa i-angle yokuphumula kwepowder ngo-20-30%, kunciphise umehluko wesisindo enqubweni ye-tablet, futhi kuthuthukise ubunzima bamathablethi ngo-15-20% 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 ukuhamba okuqinile, ukwehla, nokuhamba okuphakeme ngenkathi ithuthukisa ukujula kwe-gel nokuhambisana kwezinto zokwakha. Ithuthukisa ukuzinza kwe-suspension futhi ivimbela ukuhamba kwe-aerosol (idinga imishini ye-high-shear ukuze kuqinisekiswe ukusabalala okuhle ukuze kufinyelelwe ukusebenza okuhle). •I-Oral suspension: Njengomkhiqizo wokuphakamisa kanye nomjovo, ukwengeza u-0.5-2.0% kungenza umthamo we-sediment ratio ye-API> 95%, ivimbele ukuhamba kwemithi, futhi ithuthukise ukunemba kokuthola. •Izinjini/izinhlelo zokubuka: kuhambisana nezindinganiso zokukhiqiza ezihlanzekile ze-IPEC-GMP, kungathuthukisa ukuzinza kwesixazululo, kunciphise ingozi yokwakheka kwezinhlayiya, futhi kuhlangabezane nezidingo zemikhiqizo ye-liquid ezithambile. 4.3 Izithako zokudla •Umthwali wezithako ezisebenzayo: umunca ama-vitamins, ama-probiotics nezinye izithako ukuze wandise isikhathi sokugcina kwemikhiqizo futhi wandise umphumela wokugcina we-biological activity ngaphezu kuka-30%, kufanelekile ku-protein powder, nutritional powder nezinye imikhiqizo. •Umkhiqizo ophikayo: emkhathini we-umswakama ≤60%, umkhiqizo we-powder ungagcinwa isikhathi esingaphezu kwezinyanga eziyi-6 ngaphandle kokuhlanganiswa ukuze kuqinisekiswe ukuhamba komkhiqizo. 4.4 Izicelo zokudla: Njengomkhiqizo wokudla oqondile, uthuthukisa ukuhamba kwepowder yokudla (kuhlanganisa ama-powder amakhanda), uvimbela i-caking yokugcina ngenkathi ugcina umswakama; umunca umswakama, ufanelekile kuma-powder amanzi/ahamba phambili; isebenza njengomjovo wezinto eziphilayo ezifana nezinsipho zokupheka nezithako zezithelo, futhi isebenza njengomkhiqizo we-thixotropic emikhiqizweni yokupheka ne-baking; ngaphezu kwalokho ithuthukisa ukuhlanzeka kwemishini ngesikhathi sokugaya izinto zokwakha. 4.5 Ukusebenza emkhakheni wezokudla: Thuthukisa ukusebenza kwe-feed kanye nobuchwepheshe bokucubungula ukuze uqinisekise ukuhamba kahle nokumelana nokugcina kwepowder yokwengeza, futhi unikeze izici ezinhle zokulungisa umswakama ezinhle; thuthukisa inqubo yokugaya nokugaya ukuze uvimbele 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 ubufakazi obuhambisanayo: i-FDA inactive ingredient database collection, i-EU E551 food additive certification. •Landela iziqondiso zokuhambisana zomhlaba: uhambisana nezindinganiso zokukhiqiza ze-GMP kanye nezidingo ze-HACCP food safety system. 6. Imiyalelo Yokusebenzisa 6.1 Umthamo ohlongozwayo Uhlobo lokulungiselela Inhloso yokusebenza Umthamo ohlongozwayo I-Tablet/capsule umkhiqizo wokuhamba 0.1-0.5% I-Oral suspension Umjovo/Umjovo 0.5-2.0% I-Nutrient powder umkhiqizo ophikayo 0.2-1.0% Umthwali wezithako ezisebenzayo Umunca 5-15% 6.2 Amaphuzu abalulekile okusebenza nokugcina •Ukusebenza kwemikhiqizo eqinile: kunconywa ukwengeza ngemva kokuxuba i-API ne-diluent, futhi usebenzise ukuxuba okuphezulu okungaphezu kwemizuzu engama-30 ukuze uqinisekise ukusabalala okujwayelekile. •Ukusebenza 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 nokuthola kufanele kulungiswe ngokuya ngempela yakho. 7. Izinzuzo Zomkhiqizo (PA) •Ukuhambisana kwazo zonke izimo: inezici zokuhamba kwemikhiqizo eqinile kanye nezokuzinza kwemikhiqizo ye-liquid, kunciphisa uhlobo lwezinto ezisizayo futhi kulungiselela ukwakhiwa kwefomula. •Ukuqinisekiswa kokuhambisana komhlaba: ukuvuma kwe-multi-pharmaceutical code certification, ukweseka ukubhaliswa kwemithi yasekhaya nezamazwe, kunciphisa izingozi zokufinyelela emakethe. •Isevisi ezenziwe ngezifiso: ngokuya ngezidingo zamakhasimende, usayizi wezinhlayiya 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 ibalansise ukusebenza nezidingo zokuvikelwa 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 angu-19 avela kwi-Office of State Intellectual Property
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