1. Ukubuka KweMikhiqizo (Product Overview) 1.1 Incazelo eziyisisekelo I-colloidal silica dioxide iyisilicon dioxide esinokuphuma okuphezulu esilungiswe ngokuqhubekayo, ibonakala njengothuli oluphaphathekile, oluwhite. Umkhiqizo unikeza isakhiwo se-nano-network esiyinhloko, unikeza izinzuzo ezifana nosayizi wezakhi ezifanayo, ukusabalala okuhle, kanye nokuzinza kwezem kemikhakha. Ayiphenduli nezithako ezisebenzayo zemithi. Ngobubanzi bayo obuphezulu besikhala esithile kanye nokuxhumana okuqinile phakathi kwezakhi, i-silica dioxide isebenza njenge-excipient ebalulekile yemithi ukuze ithuthukise ikhwalithi nokuzinza kwezinhlelo zokwelapha. Ithola izicelo emithini, ekudleni, ekudleni kwezilwane, nasemkhakheni ofanayo, ngenkathi isekela izixazululo zokusebenza ezikhethekile. 1.2 Izinzuzo eziyisisekelo Njengomkhiqizo we-excipient wemithi onemisebenzi eminingi, i-Zhongqi Colloidal Silica ixazulula kahle izinselelo zezimboni ezifana nokungahambi kahle kwezinhlayiya ezimweni zokwelapha ezinzima kanye nezinkinga zokuhlala emanzini. Ngokulawula ikhwalithi ngokuphelele kuyo yonke imikhakha yokukhiqiza, lo mkhiqizo uqinisekisa ukuhamba kahle nokusebenza, uvumela abakhiqizi bemithi ukuba bathuthukise ukusebenza kahle kokukhiqiza kanye nokuncintisana komkhiqizo. Uhlangabezana nezidingo zokubhaliswa kwemithi ezweni nasemhlabeni jikelele, ubonisa ukuhamba kahle ekuhlangabezaneni nezidingo ezihlukahlukene zokulawula. 2. Izici Zomkhiqizo (Product Characteristics) •Isakhiwo se-Nano: usayizi wezakhi wendawo uqondiswa ku-12-20nm, udala isakhiwo esihlangene se-three-dimensional, futhi indawo ethile ye-BET ingafinyelela ku-175-380m²/g, inikeza isisekelo sokumunca kahle nokusabalala. •Ukuzinza kokusabalala okuhle: ingakha i-colloid ezinzile ohlelweni lwamanzi, futhi inani le-pH ligcinwa ku-3.5-5.5, elihambisana nezinhlelo eziningi ze-API. Akukho phutha lokuhlukaniswa olwenziwa ngemuva kwezinsuku eziyi-30 zokuma ku-25℃, kuhambisana nezidingo zokugcina isikhathi eside kwezinhlelo zokwelapha. •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 we-microbial uphansi kuka-1000CFU/g, kude kakhulu neziqondiso zezimboni. 4. Izindawo Zokusebenza 4.1 Izinhlobo zokwelapha eziqinile Amathablethi, ama-capsule, kanye nothuli: Lezi zingasabalala kahle zisetshenziswa ngezinsiza zokuxuba ezijwayelekile. Uhlelo lusebenza njengovimbelo lokunciphisa ukuxhumana phakathi kwezakhi, kuthuthukisa ukuhamba kahle, futhi kuvimbele ukuhlanganiswa. Iphakamisa isivinini sokucindezela amathablethi ngenkathi ithuthukisa izinqubo zokukhiqiza ukuze kube nokuhamba kahle kothuli. I-adsorbent/umkhiqizo opholile ulawula kahle umswakama kanye nomthamo wamanzi (ukuguqulwa kuncike kumthamo). Lokhu kunciphisa izinkinga zokuhambisana phakathi kwezithako zemithi, kuthuthukisa ukusabalala okufanayo kwezithako zothuli, futhi kuthuthukisa isivinini sokuphuka kwamathablethi. •I-Tablet/capsule: Engeza u-0.1-0.5% njengomsizi wokuhamba, okunganciphisa i-angle yokuphumula kothuli ngo-20-30%, kunciphise umehluko wesisindo ohlelweni lwamathablethi, futhi kuthuthukise ubunzima bamathablethi ngo-15-20% futhi 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 Izinhlelo zokwelapha ezimanzini Izinkambo 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 kanye nokusabalala kwezinto zokwakha. Ithuthukisa ukuzinza kokuhamba futhi ivimbela ukuhamba kwe-aerosol (idinga imishini ephezulu yokuhamba ukuze kufezwe ukusebenza okuhle). •I-suspension yokudla: Njengomkhiqizo wokuphakamisa kanye nomjovo, ukwengeza u-0.5-2.0% kungakwenza kube ne-sediment volume ratio ye-API> 95%, ivimbele ukuhamba kwemithi, futhi ithuthukise ukunembile kokudla. •Izithako/izinhlelo zokwelapha zamehlo: kuhambisana nezindinganiso zokukhiqiza ezihlanzekile ze-IPEC-GMP, kungathuthukisa ukuzinza kwesixazululo, kunciphise ingozi yokwakheka kwezakhi, futhi kulungele izidingo zokwelapha ezithambile. 4.3 Izithako zokudla •Umthwali wezithako ezisebenzayo: adsorb vitamins, probiotics nezinye izithako ukuze wandise isikhathi sokuphila kwemikhiqizo futhi wandise umphumela wokugcina we-biological activity ngaphezu kuka-30%, kufanelekile ku-protein powder, nutritional powder nezinye izinto. •Umkhiqizo ophikisanayo: emkhathini we-umswakama ≤60%, impahla yothuli ingagcinwa isikhathi eside ngaphezu kwezinyanga eziyi-6 ngaphandle kokuhlanganiswa ukuze kuqinisekiswe ukuhamba komkhiqizo. 4.4 Izicelo zokudla: Njengomkhiqizo wokudla oqondile, ithuthukisa ukuhamba kwezithako zokudla (kuhlanganise nothuli lwe-organic oluthambile), ivimbela ukuhlanganiswa kokugcina ngenkathi igcina umswakama; ithola umswakama, ifanelekile kumathuli amanzi/ahambayo; isebenza njengomjovo wezithako ezimanzini ezifana nezinsipho zokupheka kanye namafutha ezitshalo, futhi isebenza njengomkhiqizo we-thixotropic emikhiqizweni yokupheka ne-baking; futhi ithuthukisa ukuhlanzeka kwemishini ngesikhathi sokugaya izinto zokwakha. 4.5 Ukusebenza emkhakheni wezokudla: Thuthukisa ukusebenza kokudla kanye nobuchwepheshe bokucubungula ukuze uqinisekise ukuhamba kahle nokumelana nokugcina kwe-powder yokwengeza, futhi unikeze izakhiwo ezinhle zokulungisa umswakama kumathuli; 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 isitifiketi esihlobene: I-FDA inactive ingredient database collection, 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 umsizi wokuhamba 0.1-0.5% I-Oral suspension Umjovo/Umjovo 0.5-2.0% I-Nutrient powder umkhiqizo ophikisanayo 0.2-1.0% Umthwali wezithako ezisebenzayo I-adsorbent 5-15% 6.2 Iziqondiso ezibalulekile zokusebenza nokugcina •Ukusebenza kokulungiselela okuqinile: kunconywa ukwengeza ngemuva kokuxuba i-API kanye ne-diluent, futhi usebenzise ukuxuba okuphezulu okungaphezu kwemizuzu engama-30 ukuze uqinisekise ukusabalala okufanayo. •Ukusebenza kokulungiselela okumanzi: kufanele kusabalale ngaphansi kwezimo ze-pH 4-6, futhi kugwenywe ukuxhumana isikhathi eside ne-asidi eqinile kanye ne-alkali ukuvimbela ukonakaliswa kwesakhiwo se-colloid. •Izimo zokugcina: iphakheji evaliwe, igcinwe endaweni eyomile nepholile (15-25℃, umswakama ophakathi <60%), ivumelekile iminyaka emibili, ivuliwe futhi isetshenziswe ngokushesha. Le mininingwane engenhla iyisikhumbuzo kuphela, futhi ukusetshenziswa kwangempela nokuthamo kufanele kulungiswe ngokuhambisana ne-formula yakho. 7. Izinzuzo Zomkhiqizo (PA) •Ukuzivumelanisa kwesimo sonke: inezici zokuhamba komkhiqizo wokulungiselela okuqinile kanye nokuzinza kokulungiselela okumanzi, kunciphisa uhlobo lwezinto ezisizayo futhi kulula ukuklama ifomula. •Ukuqinisekiswa kokuhambisana komhlaba: ukuvikelwa kwe-multi-pharmaceutical code certification, ukweseka ukubhaliswa kwemithi yasekhaya nakwamanye amazwe, kunciphisa izingozi zokufinyelela emakethe. •Isevisi eyenziwe ngokwezifiso: ngokuhambisana nezidingo zamakhasimende, usayizi wezakhi kanye nezici ezithile ze-surface zingalungiswa ukuze kuhanjiswe izixazululo zobuchwepheshe ezikhethekile. •Ukuhlinzekwa 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 yokwengeza ukudla •I-licence yokukhiqiza yokwengeza ukudla kwezilwane •I-National high-tech enterprise •Izinkampani ezikhethekile, ezithuthukile nezintsha eGuangzhou •Amalungelo angu-94 avela kwi-Office of State Intellectual Property