BP-Ezihambisana Nezidingo I-Sterile Colloidal Silica
BP-Ezihambisana Nezidingo I-Sterile Colloidal Silica
BP-Ezihambisana Nezidingo I-Sterile Colloidal Silica
BP-Ezihambisana Nezidingo I-Sterile Colloidal Silica
BP-Ezihambisana Nezidingo I-Sterile Colloidal Silica
BP-Ezihambisana Nezidingo I-Sterile Colloidal Silica
FOB
Imininingwane yemithombo
Imibuzo evamile
Ukubonisa umlingani
1. Ukubuka Kwenkambo (Product Overview) 1.1 Incazelo eziyisisekelo I-colloidal silica dioxide iyisilicon dioxide esiphezulu sokuhlanzeka esilungiswe ngezinqubo ezithuthukisiwe, ibonakala njengepudingi emhlophe, elula. Umkhiqizo unama-structure e-nano-network ayinhloko, unikeza izinzuzo ezifana nosayizi wezakhi ezifanayo, ukusabalala okuhle, kanye nokuzinza okuqinile kwezemikhakha. Ayiphenduli nezithako ezisebenzayo zemithi. Ngobubanzi bayo obuphezulu besikhala esithile kanye nokuxhumana okuqinile phakathi kwezithako, i-silica dioxide isebenza njengomkhiqizo obalulekile wezokwelapha ukuze ithuthukise ikhwalithi nokuzinza kwemikhiqizo yemithi. Itholakala ezinhlelweni zokwelapha, ukudla, ukudla kwezilwane, kanye nezinye izindawo ezihlobene, ngenkathi ixhasa izixazululo zokusebenza ezenziwe ngezifiso. 1.2 Izinzuzo eziyisisekelo Njengomkhiqizo wezokwelapha onemisebenzi eminingi, i-Zhongqi Colloidal Silica ixazulula kahle izinselelo zezimboni ezifana nokungabi nokuhamba kahle ezimweni zokwelapha ezinzima kanye nezinkinga zokuhlala ezilungisweni ze-liquid. Ngokusebenzisa ukulawula ikhwalithi okuphelele kuyo yonke i-chain yokukhiqiza, lo mkhiqizo uqinisekisa ukuhlanzeka nokusebenza okuqhubekayo, uvumela abakhiqizi bemithi ukuba bathuthukise ukusebenza kahle kokukhiqiza kanye nokuncintisana komkhiqizo. Uhlangabezana nezidingo zokubhaliswa kwemithi zasekhaya nezamazwe, ubonisa ukuhamba phambili ekuhlangabezaneni nezidingo ezihlukahlukene zokulawula. 2. Izici Zomkhiqizo (Product Characteristics) •I-Nanostructure: usayizi wezakhi wendawo ulawulwa ku-12-20nm, udala i-structure ye-network eyinhlangothi ezintathu efanayo, futhi indawo ethile ye-BET ingafinyelela ku-175-380m²/g, inikeza isisekelo sokumunca kahle nokusabalala. •Ukuzinza kokusabalala okuhle: ingakha i-colloid ezinzile ohlelweni lwe-aqueous, 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 ezilungisweni ze-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 zokwelapha ezinzima Amathablethi, ama-capsules, kanye nepudingi: Lezi zingasabalala kahle zisebenzisa imishini yokuxuba ejwayelekile. Uhlelo lusebenza njengovimbelo ukuze lunciphise ukuxhumana phakathi kwezithako, kuthuthukise ukuhamba kahle, futhi kuvinjeze ukuhlanganiswa. Iphakamisa isivinini sokucindezela amathablethi ngenkathi ithuthukisa izinqubo zokukhiqiza ukuze kube nokuhamba kahle kwepudingi. I-adsorbent/imathiriyeli yokumunca amanzi ilawula kahle umswakama nokuqukethwe kwamanzi (ukuguqulwa kuncike kumthamo). Lokhu kunciphisa izinkinga zokuhambisana phakathi kwezithako zemithi, kukhuthaza ukusabalala okufanayo kwezakhi ze-powder, futhi kuthuthukisa isivinini sokuphuka kwamathablethi. •I-Tablet/capsule: Engeza u-0.1-0.5% njengomsebenzi wokuhamba, onganciphisa i-angle yokuphumula kwepudingi 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 kwemathiriyeli, unciphise inani le-lubricant, yehlisa isikhathi sokukhiqiza, ifanele i-acetaminophen, i-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, ukwehla, nokuhamba okuphakeme ngenkathi ithuthukisa ukujula kwe-gel nokuhambisana kwezinto zokwakha. Ithuthukisa ukuzinza kokuhlala futhi ivimbela ukuhamba kwe-aerosol (idinga imishini yokuhamba ephezulu ukuze kuqinisekiswe ukusabalala okuhle ukuze kufinyelelwe ukusebenza okuhle). •I-Oral suspension: Njengomsebenzi wokuphakamisa nokujula, ukwengeza u-0.5-2.0% kungenza ubuningi bokuhlala kwe-API> 95%, kuvimbele ukuhamba kwemithi, futhi kuthuthukise ukunemba kokutholwa. •Izithako/izilungiselelo zokubuka: kuhambisana nezindinganiso zokukhiqiza ezihlanzekile ze-IPEC-GMP, kungathuthukisa ukuzinza kwesixazululo, kunciphise ubungozi bokwakheka kwezithako, futhi kuhlangabezane nezidingo zezilungiselelo 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%, ifanele i-protein powder, i-nutritional powder nezinye imikhiqizo. •Umsebenzi wokuvimbela ukuhlanganiswa: emkhathini we-umswakama ≤60%, impahla ye-powder ingagcinwa isikhathi esingaphezu kwezinyanga eziyi-6 ngaphandle kokuhlanganiswa ukuze kuqinisekiswe ukuhamba komkhiqizo. 4.4 Izicelo zokudla: Njengomkhiqizo oqondile wokudla, ithuthukisa ukuhamba kwepudingi yokudla (kuhlanganise ne-powder ye-organic ethambile), ivimbela ukuhlanganiswa kokugcina ngenkathi igcina umswakama; umunca umswakama, ifanele ama-powder amanzi/ahamba phambili; isebenza njengomsebenzi wokujula kwezokudla ezinjengama-pickling juices kanye nama-oyili ezitshalo, futhi isebenza njengomsebenzi we-thixotropic emikhiqizweni yokubhaka ne-cooking sprays; futhi ithuthukisa ukuhlanzeka kwemishini ngesikhathi sokugaya izinto zokwakha. 4.5 Ukusebenza emkhakheni wokudla: Thuthukisa ukusebenza kokudla kanye nobuchwepheshe bokucubungula ukuze kuqinisekiswe ukuhamba okukhululekile nokumelana nokugcina kwepudingi yokwengeza, futhi unikeze izici ezinhle zokulungisa umswakama kumaparticles; thuthukisa inqubo yokugaya nokugaya ukuze kuvinjezelwe umkhiqizo ekubambeni kwemishini. 5. Izindinganiso nezimfuneko (Standards & Regulations) •Uhlangabezana nezindinganiso eziningi ze-international pharmacopoeia: USP-NF, European Pharmacopoeia (Ph. Eur.), Japanese Pharmacopoeia (JP), kanye ne-China Pharmacopoeia (ChP 2025). •Thola isitifiketi sokufaneleka esihlobene: 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 lwezilungiselelo Umsebenzi ohlosiwe Umthamo ohlongozwayo Tablet/capsule umkhiqizo wokuhamba 0.1-0.5% Oral suspension Umsebenzi wokuphakamisa/ukujula 0.5-2.0% Nutrient powder umkhiqizo wokuvimbela ukuhlanganiswa 0.2-1.0% Active ingredient carrier Umunca 5-15% 6.2 Amaphuzu abalulekile okusebenza nokugcina •Ukusebenza kwezilungiselelo ezinzima: kunconywa ukwengeza ngemva kokuxuba i-API kanye ne-diluent, futhi usebenzise ukuxuba okuphezulu okungaphezu kwemizuzu engama-30 ukuze uqinisekise ukusabalala okufanayo. •Ukusebenza kwezilungiselelo ze-liquid: kufanele kusabalale ngaphansi kwezimo ze-pH 4-6, futhi kugwenywe ukuxhumana isikhathi eside ne-asidi eqinile kanye ne-alkali ukuze kuvinjezelwe 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 nokuthamo kufanele kulungiswe ngokuya ngempela yakho. 7. Izinzuzo Zomkhiqizo (PA) •Ukufanisa isimo esiphelele: inezici zomkhiqizo wokuhamba wezinto ezinzima kanye nokuzinza kwezilungiselelo ze-liquid, kunciphisa uhlobo lwezinto ezisizayo futhi kulungiselela ukwakhiwa kwefomula. •Ukuqinisekiswa kokuhambisana komhlaba: ukuvuma kwe-multi-pharmaceutical code certification, ukweseka ukubhaliswa kwemithi yasekhaya nezamazwe, kunciphisa ubungozi bokufinyelela emakethe. •Isevisi ezenziwe ngezifiso: ngokuya ngezidingo zamakhasimende, usayizi wezakhi kanye nezici ezithile zendawo 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 nezindondo •FSSC22000 •ISO22000:2018 •ISO9001:2015 •SHC HALAL •OU KOSHER •I-FDA attestation •FAMI-QS •SEDEX •Ilayisensi yokukhiqiza yokwengeza ukudla •Ilayisensi yokukhiqiza yokwengeza ukudla kwezilwane •Inkampani ye-high-tech kazwelonke •Izinhlangano ezikhethekile, ezithuthukisiwe nezintsha eGuangzhou •Amalungelo angu-54 avela kwi-Office of State Intellectual Property
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