1. Isithombe Somkhiqizo (Product Overview) 1.1 Incazelo eziyisisekelo I-colloidal silica dioxide iyisilicon dioxide esiphezulu sokuhlanzeka esilungiswe ngezinqubo advanced, ibonakala njengeph powder elimhlophe, elikhululekile. Umkhiqizo ubonisa isakhiwo se-nano-network esiyinhloko, unikeza izinzuzo ezifana nosayizi wezakhi ezifanayo, ukusabalala okuhle, kanye nokuzinza okuqinile kwezemithi. Ayiphenduli nezithako ezisebenzayo zemithi. Ngobubanzi bayo obuphezulu besikhala esithile kanye nokuxhumana okuqinile phakathi kwezithako, i-silica dioxide iyinsiza ebalulekile yokwelapha ukuze kuthuthukiswe ikhwalithi nokuzinza kokwakhiwa kwemithi. Ithola izicelo emithini, ekudleni, ekudleni, nasemikhakheni efanele, ngenkathi ixhasa izixazululo zokusebenza ezenziwe ngokwezifiso. 1.2 Izinzuzo eziyisisekelo Njengomkhiqizo wezemithi onemisebenzi eminingi, i-Zhongqi Colloidal Silica ixazulula kahle izinselelo zezimboni ezifana nokungabi namathuba okuhamba kahle ezithakweni eziqinile kanye nezinkinga zokuhlala emithini ye-liquid. Ngokusebenzisa ukulawula ikhwalithi okuphelele kuyo yonke imikhakha yokukhiqiza, lo mkhiqizo uqinisekisa ukuhamba kahle nokusebenza okujwayelekile, uvumela abakhiqizi bemithi ukuba bathuthukise ukusebenza kahle kokukhiqiza 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 se-network esihlangene, futhi indawo ethile ye-BET ingafinyelela ku-175-380m²/g, inikeza isisekelo sokumunca kahle nokusabalala. •Ukuhlala okuhle kokusabalala: ingakha i-colloid ezinzile ohlelweni lwe-aqueous, futhi inani le-pH ligcinwa ku-3.5-5.5, elihambisana nezinhlelo eziningi ze-API. Akukho phenomene yokuhlukaniswa eyenzeka ngemuva kwezinsuku eziyi-30 zokuma ku-25℃, ihlangabezana nezidingo zokugcina isikhathi eside zemithi ye-liquid. •Ukuphuma okuphansi kwe-impurity: 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. Iziqu Zokusebenza 4.1 Izinhlobo zokwakhiwa eziqinile Amathablethi, ama-capsule, kanye ne-powder: Lezi zingasabalala kahle zisetshenziswa ngezinsiza zokuxuba ezijwayelekile. Uhlelo lusebenza njengovimbelo lokunciphisa ukuxhumana phakathi kwezithako, kuthuthukisa ukuhamba kahle, futhi kuvimbele ukuhlanganiswa. Iphakamisa isivinini sokucindezela amathablethi ngenkathi ithuthukisa izinqubo zokukhiqiza ukuze kube nokuhamba kahle kwe-powder. I-adsorbent/imathiriyeli yokumunca amanzi ilawula kahle umswakama nokuhamba kwamanzi (ukuguqulwa kuncike kumthamo). Lokhu kunciphisa izinkinga zokuhambisana phakathi kwezithako zemithi, kuthuthukisa ukusabalala okujwayelekile kwezakhi ze-powder, futhi kuthuthukisa isivinini sokuphuka kwamathablethi. •I-Tablet/capsule: Engeza u-0.1-0.5% njengomsebenzi wokuhamba, okunganciphisa i-angle yokuphumula kwe-powder ngo-20-30%, kunciphise umehluko wesisindo ohlelweni lwamathablethi, futhi kuthuthukise ubunzima bamathablethi ngo-15-20% kunciphise ubrittleness. •Inqubo ye-tablet eqondile: thuthukisa ukuhamba kwemathiriyeli, kunciphise inani le-lubricant, kunciphise isikhathi sokukhiqiza, kufanelekile ku-acetaminophen, aspirin nezinye izinhlelo ze-API. 4.2 Izinhlelo ze-liquid Imithi ye-liquid (ama-gels, ama-creams, ama-suspensions, njll.): I-viscosity iyahluka ngokuhamba, ivumela ukujula ibe yi-paste noma ibe mncane ukuze kube lula ukuyisebenzisa. Ivimbela ukuhlanganiswa okuqinile, ukwehla, nokuhamba okuphakeme ngenkathi ithuthukisa ukujula kwe-gel nokuhambisana kwezinto zokwakha. Ithuthukisa ukuzinza kokuhlala futhi ivimbela ukuhamba kwe-aerosol (idinga imishini ephezulu yokuhamba ukuze kufinyelelwe ukusebenza okuhle). •I-suspension yokudla: Njengomsebenzi wokuphakamisa nokujula, ukwengeza u-0.5-2.0% kungenza ubukhulu bokuhlala kwe-API> 95%, kuvimbele ukuhluza kwemithi, futhi kuthuthukise ukunemba kokuthola. •Izithako/izinhlelo zokubona: kuhambisana nezindinganiso zokukhiqiza ezihlanzekile ze-IPEC-GMP, kungathuthukisa ukuzinza kwesixazululo, kunciphise ingozi yokwakheka kwezithako, futhi kulungele izidingo zemithi ye-liquid ezithambile. 4.3 Izithako zokudla •Umthwalo wezithako ezisebenzayo: umunca ama-vitamins, ama-probiotics nezinye izinto ukuze wandise isikhathi sokuphila kwemikhiqizo futhi wandise izinga lokugcina le-biological activity ngaphezu kuka-30%, kufanelekile ku-protein powder, nutritional powder nezinye izinto. •Umsebenzi wokuvimbela ukuhlanganiswa: emkhakheni we-humidity ≤60%, impahla ye-powder ingagcinwa isikhathi esingaphezu kwezinyanga eziyi-6 ngaphandle kokuhlanganiswa ukuze kuqinisekiswe ukuhamba kwemikhiqizo. 4.4 Izicelo zokudla: Njengomkhiqizo wokudla oqondile, uthuthukisa ukuhamba kwemikhiqizo yokudla (kuhlanganise ne-powder ye-organic ethambile), ivimbela ukuhlanganiswa ngesikhathi igcina umswakama; umunca umswakama, ufanelekile kuma-powder amanzi/ahamba phambili; isebenza njengomsebenzi wokujula kwemikhiqizo ye-liquid efana nezinsalela zokupheka nezithako ze-oyili, futhi isebenza njengomsebenzi we-thixotropic ezinhlelweni zokupheka ezisekelwe ku-oyili; ngaphezu kwalokho ithuthukisa ukuhlanzeka kwemishini ngesikhathi sokugaya izinto zokwakha. 4.5 Ukusebenza emkhakheni wokudla: Thuthukisa ukusebenza kokudla kanye nobuchwepheshe bokucubungula ukuze kuqinisekiswe ukuhamba kahle nokumelana nokugcina kwe-powder yokwengeza, futhi unikeze izakhiwo ezinhle zokulungisa umswakama ezithakweni; thuthukisa inqubo yokugaya nokugaya ukuze kuvinjelwe umkhiqizo ukuthi ungalungiseki kumishini. 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 ubufakazi obufanele bokufaneleka: i-FDA inactive ingredient database collection, EU E551 food additive certification. •Landela iziqondiso zokuhambisana zomhlaba: hlangabezana nezindinganiso zokukhiqiza ze-GMP nezidingo ze-HACCP food safety system. 6. Imiyalelo Yokusebenzisa 6.1 Umthamo ophakanyisiwe Uhlobo lokwakhiwa Umsebenzi ophakanyisiwe Umthamo ophakanyisiwe Tablet/capsule umkhiqizo wokuhamba 0.1-0.5% Oral suspension Umsebenzi wokuphakamisa/ujula 0.5-2.0% Nutrient powder umkhiqizo wokuvimbela ukuhlanganiswa 0.2-1.0% Active ingredient carrier Umunca 5-15% 6.2 Iziqondiso ezibalulekile zokusebenza nokugcina •Ukusetshenziswa kokwakhiwa okuqinile: kunconywa ukwengeza ngemuva kokuxuba i-API kanye ne-diluent, futhi usebenzise ukuxuba okuphezulu okungaphezu kwemizuzu engama-30 ukuze kuqinisekiswe ukusabalala okujwayelekile. •Ukusetshenziswa kokwakhiwa kwe-liquid: kufanele kusabalale ngaphansi kwezimo ze-pH 4-6, futhi kugwenywe ukuxhumana isikhathi eside ne-asidi eqinile kanye ne-alkali ukuze kuvinjelwe ukonakaliswa kwesakhiwo se-colloid. •Izimo zokugcina: iphakheji evaliwe, igcinwe endaweni eyomile nepholile (15-25℃, umswakama ophakathi <60%), ivumelekile iminyaka emibili, ivule futhi usebenzise ngokushesha. Le mininingwane engenhla iyisikhumbuzo kuphela, futhi ukusetshenziswa kwangempela nokuthola kufanele kulungiswe ngokuhambisana ne-formula yakho. 7. Izinzuzo Zomkhiqizo (PA) •Ukufaneleka kwesimo esiphelele: inezici zokuhamba komkhiqizo we-solid preparation kanye nezokuzinza kokwakhiwa kwe-liquid, kunciphisa uhlobo lwezinto ezisizayo futhi kulula ukuklama ifomula. •Ukuqinisekiswa kokuhambisana komhlaba: ukuvuma izitifiketi eziningi ze-pharmaceutical code, ukweseka ukubhaliswa kwemithi yasekhaya naphesheya, kunciphisa izingozi zokufinyelela emakethe. •Isevisi eyenziwe ngokwezifiso: ngokwezidingo zamakhasimende, usayizi wezithako kanye nezici ezithile zingalungiswa ukuze kuhanjiswe izixazululo zobuchwepheshe ezikhethekile. •Ukuphakelwa okuqhubekayo: inqubo yokukhiqiza isebenzisa ukuvuselelwa kwamandla, futhi ukupakisha kusebenzisa amabhakede ephepha angasetshenziswa kabusha ukuze kuhlangabezane nezidingo zokusebenza kanye nezokuvikelwa kwemvelo. 8. Ukuqinisekiswa kwesistimu ye-Enterprise 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 •Izinkampani eziphakeme ze-high-tech •Izinkampani ezikhethekile, ezihlelekile nezintsha eGuangzhou •Amalungelo angu-69 avela kwi-Office of State Intellectual Property