1. Ukubuka Kwenkambo (Product Overview) 1.1 Incazelo eziyisisekelo I-colloidal silica dioxide iyisilicon dioxide esiphezulu esenziwe ngezinqubo ezithuthukile, ibonakala njengepowder emhlophe, ethambile. Umkhiqizo ubonisa isakhiwo se-nano-network esiyinhloko, unikeza izinzuzo ezifana nosayizi wezakhi ezihlangene, ukusabalala okuhle, kanye nokuzinza kwemichiza okuqinile. Ayiphenduli nezithako ezisebenzayo zemithi. Nge-surface area yayo ethile ephezulu kanye nokuxhumana okuqinile phakathi kwezithako, i-silica dioxide isebenza njenge-excipient ebalulekile yemithi ukuze ithuthukise ikhwalithi nokuzinza kwezinhlaka zemithi. Ithola izicelo emithini, ekudleni, ekudleni kwezilwane, nasemikhakheni ehlobene, ngenkathi isekela izixazululo zokusebenza ezikhethekile. 1.2 Izinzuzo eziyisisekelo Njenge-excipient yemithi enezinhloso eziningi, i-Zhongqi Colloidal Silica ibhekana kahle nezinselelo zezimboni ezifana nokungahambi kahle kwezinto ezinzima ezimweni zokuphakela ezinzima kanye nezinkinga zokuhlala emiphumeleni ye-liquid. Ngokusebenzisa ukulawula ikhwalithi okuhlelekile kuzo zonke izigaba zokukhiqiza, lo mkhiqizo uqinisekisa ubuqotho obuhambisanayo 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) •Isakhiwo se-Nano: usayizi wezithako 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 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 ngemuva kwezinsuku eziyi-30 zokuma ku-25℃, ihlangabezana nezidingo zokugcina isikhathi eside zemiphumela 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 nezinga lezimboni. 4. Izindawo Zokusebenza 4.1 Izinhlobo zokuphakela ezinzima Amathablethi, ama-capsule, kanye nepowder: Lezi zingasabalala kahle zisetshenziswa ngezinsiza zokuxuba ezijwayelekile. Uhlelo lusebenza njengovimbelo lokunciphisa ukuxhumana phakathi kwezithako, kuthuthukisa ukuhamba okukhululekile, futhi kuvimbele ukuhlanganiswa. Iphusha isivinini sokucindezela amathablethi ngenkathi ithuthukisa izinqubo zokukhiqiza ukuze kube nokuhamba kwepowder okuphumelelayo. I-adsorbent/umkhiqizo opholile ulawula kahle umswakama kanye nomthamo we-liquid (umsebenzi wokuguqula uncike kumthamo). Lokhu kunciphisa izinkinga zokuhambisana phakathi kwezithako zemithi, kuthuthukisa ukusabalala okujwayelekile kwezithako ze-powder, futhi kuthuthukisa isivinini sokuphuka kwamathablethi. •Ithablethi/ama-capsule: Engeza u-0.1-0.5% njengomsebenzi wokuhamba, onganciphisa i-angle yokuphumula kwepowder 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 kwezinto, unciphise inani le-lubricant, yehlisa isikhathi sokukhiqiza, efanelekile kumasistimu e-acetaminophen, i-aspirin nezinye izinhlelo ze-API. 4.2 Imiphumela ye-liquid Imiphumela 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, ukuhamba, nokuhamba ngenkathi ithuthukisa ukujula kwe-gel kanye nokusabalala kwezinto zokwakha. Ithuthukisa ukuzinza kokuhamba futhi ivimbela ukuhamba kwe-aerosol (idinga imishini yokuhamba ephezulu ukuze kuqinisekiswe ukusabalala okuhle ukuze kufinyelelwe ukusebenza okuhle). •I-suspension yokudla: Njenge-agent yokuphakela kanye nomthuthukisi, ukwengeza u-0.5-2.0% kungenza umthamo we-sediment ratio ye-API> 95%, ivimbele ukuhamba kwemithi, futhi ithuthukise ukunemba kokuphakelwa. •Izithako/izinhlelo zokubuka: zihambisana nezindinganiso zokukhiqiza ezihlanzekile ze-IPEC-GMP, zingathuthukisa ukuzinza kwesixazululo, zinciphise ingozi yokwakheka kwezithako, futhi zifanele izidingo zemiphumela ye-liquid ezithambile. 4.3 Izithako zokudla •Umthwalo wezithako ezisebenzayo: adsorb ama-vitamins, ama-probiotics nezinye izinto ukuze wandise isikhathi sokugcina kwemikhiqizo futhi wandise umthamo wokugcina we-biological activity ngaphezu kuka-30%, efanelekile kumapowder e-protein, amapowder okudla nezinye izinto. •I-agent yokuvimbela ukuhlanganiswa: emkhathini we-humidity ≤60%, impahla ye-powder ingagcinwa isikhathi esingaphezu kwezinyanga eziyi-6 ngaphandle kokuhlanganiswa ukuze kuqinisekiswe ukuhamba komkhiqizo. 4.4 Izicelo zokudla: Njenge-additive yokudla eqondile, ithuthukisa ukuhamba kwepowder yokudla (kuhlanganisa ama-powder amakhanda), ivimbela ukuhlanganiswa kokugcina ngenkathi igcina umswakama; adsorbs umswakama, efanelekile kumapowder amanzi/ahambayo; isebenza njenge-thickener yemikhiqizo yokudla efana nezikhukhula zokupheka kanye namafutha ezitshalo, futhi isebenza njenge-agent ye-thixotropic kumaspray wokupheka nokubhaka; ngaphezu kwalokho ithuthukisa ukuhlanzeka kwemishini ngesikhathi sokugaya izinto zokwakha. 4.5 Ukusebenza emkhakheni wezokudla: Thuthukisa ukusebenza kokudla kanye nobuchwepheshe bokucubungula ukuze kuqinisekiswe ukuhamba okukhululekile nokumelana nokugcina kwepowder yokwengeza, futhi inikeze izakhiwo ezinhle zokulungisa umswakama kumaparticles; thuthukisa inqubo yokugaya nokugaya ukuze kuvinjelwe umkhiqizo ukuthi ungabambeki emshinini. 5. Izindinganiso nezimfuneko (Standards & Regulations) •Ihamba phambili nezindinganiso eziningi ze-international pharmacopoeia: USP-NF, European Pharmacopoeia (Ph. Eur.), Japanese Pharmacopoeia (JP), kanye neChina Pharmacopoeia (ChP 2025). •Thola ubufakazi obufanele bokufaneleka: i-FDA inactive ingredient database collection, i-EU E551 food additive certification. •Landela iziqondiso zokuhambisana zomhlaba: hamba phambili nezindinganiso zokukhiqiza ze-GMP kanye nezidingo ze-HACCP food safety system. 6. Imiyalelo Yokusebenzisa 6.1 Umthamo ohlongozwayo Uhlobo lokulungiselela Inhloso yokusebenza Umthamo ohlongozwayo Ithablethi/ama-capsule umkhiqizo wokuhamba 0.1-0.5% I-suspension yokudla Umphumela/Umthuthukisi 0.5-2.0% I-powder yokudla umkhiqizo wokuvimbela ukuhlanganiswa 0.2-1.0% Umthwalo wezithako ezisebenzayo Umkhiqizo opholile 5-15% 6.2 Amaphuzu abalulekile okusebenza nokugcina •Ukusebenza kokulungiselela okuqinile: kunconywa ukwengeza ngemuva kokuxuba i-API kanye ne-diluent, futhi usebenzise ukuxuba okuphezulu okungaphezu kwemizuzu engama-30 ukuze kuqinisekiswe ukusabalala okujwayelekile. •Ukusebenza kokulungiselela kwe-liquid: kufanele kusabalale ngaphansi kwezimo ze-pH 4-6, futhi kugwenywe ukuxhumana isikhathi eside ne-asidi eqinile kanye ne-alkali ukuze kuvinjelwe ukuwohloka kwesakhiwo se-colloid. •Izimo zokugcina: iphakheji evaliwe, igcinwe endaweni eyomile nepholile (15-25℃, umswakama ophakathi <60%), isebenza isikhathi esiyiminyaka emibili, ivuliwe futhi isetshenziswe ngokushesha. Le mininingwane engenhla iyisikhumbuzo kuphela, futhi ukusetshenziswa kwangempela kanye nomthamo kufanele kulungiswe ngokuya ngempela. 7. Izinzuzo Zomkhiqizo (PA) •Ukufaneleka kwazo zonke izimo: inezici zokuhamba komkhiqizo wokulungiselela okuqinile kanye nezokuzinza kwemikhiqizo ye-liquid, inciphisa uhlobo lwezinto ezisizayo futhi ilungiselela umklamo wefomula. •Ukuqinisekiswa kokuhambisana komhlaba: ukuvuma izitifiketi eziningi ze-pharmaceutical code, ukweseka ukubhaliswa kwemithi yasekhaya naphakathi, kunciphisa izingozi zokufinyelela emakethe. •Isevisi eyenziwe ngokwezifiso: ngokuya ngezidingo zamakhasimende, usayizi wezithako 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 kuhlangatshezwane 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 •I-licence yokukhiqiza additive yokudla •I-licence yokukhiqiza additive yokudla kwezilwane •I-National high-tech enterprise •Izinkampani ezikhethekile, ezithuthukile nezintsha eGuangzhou •Amalungelo angama-73 avela kwi-Office of State Intellectual Property