1. Ukubuka Kwenkanyezi (Product Overview) 1.1 Incazelo eziyisisekelo I-colloidal silica dioxide iyisilicon dioxide esinokuphuma okuphezulu okwenziwe ngokuqhubekayo, ibonakala njengepudingi emhlophe, elula. Umkhiqizo unama-nano-network structure ayisisekelo, unikeza izinzuzo ezifana nosayizi wezakhi ezihlangene, ukusabalala okuhle, kanye nokuzinza okuqinile kwezemithi. Ayiphenduli nezithako ezisebenzayo zemithi. Ngobubanzi bayo obuphezulu besikhala esithile kanye nokuxhumana okuqinile phakathi kwezithako, i-silica dioxide isebenza njengomkhiqizo obalulekile wokwakha imithi ukuze kuthuthukiswe ikhwalithi nokuzinza kwezinhlelo zokwelapha. Ithola izicelo emithini, ekudleni, ekudleni kwezilwane, nasemkhakheni ofanayo, ngenkathi isekela izixazululo zokusebenza ezikhethekile. 1.2 Izinzuzo eziyisisekelo Njengomkhiqizo wezemithi onemisebenzi eminingi, i-Zhongqi Colloidal Silica ibhekana kahle nezinselelo zezimboni ezifana nokungabi ne-flowability ezakhiweni ezinzima zokwelapha kanye nezinkinga zokuhlala emaphaketheni amanzi. Ngokusebenzisa ukulawula ikhwalithi okuphelele kuyo yonke imikhakha yokukhiqiza, lo mkhiqizo uqinisekisa ukuhamba okujwayelekile nokusebenza, uvumela abakhiqizi bemithi ukuba bathuthukise ukusebenza kokukhiqiza kanye nokuncintisana komkhiqizo. Uhlangabezana nezidingo zokubhaliswa kwemithi ezweni nasemhlabeni jikelele, ubonisa ukuhamba kahle ekuhlangabezaneni nezidingo ezihlukahlukene zokulawula. 2. Izici Zomkhiqizo (Product Characteristics) •I-Nanostructure: usayizi wezithako uqondiswa ku-12-20nm, udala isakhiwo esihlangene se-three-dimensional, kanti i-BET specific surface area ingafinyelela ku-175-380m²/g, inikeza isisekelo sokumunca kahle nokusabalala. •Ukuzinza okuhle kokusabalala: ingakha i-colloid ezinzile ohlelweni lwamanzi, kanti 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 zokuhlala emaphaketheni amanzi. •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 Izakhiwo ezinzima Amathablethi, ama-capsules, kanye nepudingi: Lezi zingasabalala kahle zisetshenziswa ngezinsiza zokuxuba ezijwayelekile. Uhlelo lusebenza njengovimbelo lokunciphisa ukuxhumana phakathi kwezithako, kuthuthukisa i-flowability yamahhala, futhi kuvimbele i-caking. Iphakamisa isivinini sokucindezela amathablethi ngenkathi ithuthukisa izinqubo zokukhiqiza ukuze kube nokuthuthwa kwepudingi okuhle. I-adsorbent/umkhiqizo opholile ulawula kahle umswakama kanye nomthamo wamanzi (ukuguqulwa kuncike kumthamo). Lokhu kunciphisa izinkinga zokuhambisana phakathi kwezithako zemithi, kukhuthaza ukusabalala okujwayelekile kwezithako ze-powder, futhi kuthuthukisa isivinini sokuphuka kwamathablethi. •I-Tablet/capsule: Engeza u-0.1-0.5% njengomsebenzi wokunceda ukuhamba, okunganciphisa i-angle yokuphumula ye-powder ngo-20-30%, kunciphise umehluko wesisindo enqubweni yamathablethi, futhi kuthuthukise ubunzima bamathablethi ngo-15-20% futhi kunciphise ubrittleness. •Inqubo ye-tablet eqondile: thuthukisa ukuhamba kwezinto, kunciphise inani le-lubricant, kunciphise isikhathi sokukhiqiza, kufanelekile ku-acetaminophen, aspirin nezinye izinhlelo ze-API. 4.2 Izinhlelo zamanzi Izinto zokwelapha (ama-gels, ama-creams, ama-suspensions, njll.): I-viscosity iyahluka ngokuhamba kwesikhathi, ivumela ukujula ibe iphesto noma ibe mncane ukuze kube lula ukuyisebenzisa. Ivimbela ukuhamba okuqinile, ukuhlangana, nokuhamba okungafanele ngenkathi ithuthukisa ukujula kwe-gel kanye nokusabalala kwezinto zokwakha. Ithuthukisa ukuzinza kokuhlala futhi ivimbela ukuhamba kwe-aerosol (idinga izinsiza ezinamandla ukuze kuqinisekiswe ukusabalala okuhle ukuze kufezwe ukusebenza okuhle). •I-Oral suspension: Njengomkhiqizo wokuphakamisa nokujula, ukwengeza u-0.5-2.0% kungenza umthamo we-sediment ratio ye-API> 95%, ivimbele ukuhlukaniswa kwemithi, futhi ithuthukise ukunemba kokutholwa. •Izithako/izinhlelo zokubuka: kuhambisana nezindinganiso zokukhiqiza ezihlanzekile ze-IPEC-GMP, kungathuthukisa ukuzinza kwesixazululo, kunciphise ingozi yokwakheka kwezithako, futhi kuhlangabezane nezidingo zezinqubo zokwelapha ezithambile. 4.3 Izithako zokudla •Umthwali wezithako ezisebenzayo: umuncu ama-vitamins, ama-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 ophikisana ne-caking: emkhathini we-humidity ≤60%, impahla ye-powder ingagcinwa isikhathi esingaphezu kwezinyanga eziyi-6 ngaphandle kokuhlangana ukuze kuqinisekiswe ukuhamba komkhiqizo. 4.4 Izicelo zokudla: Njengomkhiqizo wokudla oqondile, uthuthukisa i-flowability ye-powder yokudla (kuhlanganise ne-powder ye-organic ethambile), ivimbela i-caking yokugcina ngenkathi igcina umswakama; umuncu umswakama, ufanelekile ku-powder ezimanzi/hygroscopic; isebenza njengomkhiqizo opholile wezinto zokudla ezinjengezikhukhula zokupheka nezinhlanzi, futhi isebenza njengomkhiqizo we-thixotropic kumaspray wokupheka nezokubhaka ezisekelwe ku-oyela; ngaphezu kwalokho ithuthukisa ukuhlanzeka kwezinsiza ngesikhathi sokugaya izinto zokwakha. 4.5 Ukusebenza emkhakheni wokudla: Thuthukisa ukusebenza kokudla kanye nobuchwepheshe bokucubungula ukuze kuqinisekiswe ukuhamba okukhululekile nokumelana nokugcina kwepudingi, futhi unikeze izakhiwo ezinhle zokulungisa umswakama ezithakeni; thuthukisa inqubo yokugaya nokugaya ukuze uvimbele umkhiqizo ukuthi ungabambeki ezinsizeni. 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, EU E551 food additive certification. •Landela iziqondiso zokuhambisana zomhlaba: ulandela izindinganiso zokukhiqiza ze-GMP kanye nezidingo ze-HACCP zokuphepha kokudla. 6. Imiyalelo Yokusebenzisa 6.1 Umthamo ohlongozwayo Uhlobo lokulungiselela Umsebenzi ohlongozwayo Umthamo ohlongozwayo Tablet/capsule umkhiqizo wokunceda ukuhamba 0.1-0.5% Oral suspension Umkhiqizo wokuphakamisa/Umkhiqizo opholile 0.5-2.0% Nutrient powder umkhiqizo ophikisana ne-caking 0.2-1.0% Active ingredient carrier Umuncu 5-15% 6.2 Iziphakamiso ezibalulekile zokusebenza nokugcina •Ukusebenza kokulungiselela okwenziwe: kunconywa ukwengeza ngemuva kokuxuba i-API kanye ne-diluent, futhi usebenzise ukuxuba okuphezulu okungaphezu kwemizuzu engama-30 ukuze kuqinisekiswe ukusabalala okujwayelekile. •Ukusebenza kokulungiselela okwenziwe: kufanele kusabalalise ngaphansi kwezimo ze-pH 4-6, futhi kugwenywe ukuxhumana isikhathi eside ne-asidi eqinile kanye ne-alkali ukuze kuvinjwe 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 kanye nomthamo kufanele kulungiswe ngokuya ngempela yakho. 7. Izinzuzo Zomkhiqizo (PA) •Ukuhambisana kwesimo esiphelele: inezici zomkhiqizo wokunceda ukuhamba kokulungiselela okwenziwe kanye nezimo zokugcina ezinzima, kunciphisa uhlobo lwezinto ezisizayo futhi kulula ukuklama ifomula. •Ukuqinisekiswa kokuhambisana komhlaba: ukuhlinzeka ngokuqinisekiswa kwe-multi-pharmaceutical code, ukweseka ukubhaliswa kwemithi yasekhaya naphakathi, kunciphisa izingozi zokufinyelela emakethe. •Isevisi eyenziwe ngokwezifiso: ngokuya ngezidingo zamakhasimende, usayizi wezithako kanye nezimo ezithile zesikhala 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 yeNkampani kanye neziqinisekiso •FSSC22000 •ISO22000：2018 •ISO9001：2015 •SHC HALAL •OU KOSHER •I-FDA attestation •FAMI-QS •SEDEX •Ilayisensi yokukhiqiza yokudla •Ilayisensi yokukhiqiza yokudla kwezilwane •I-National high-tech enterprise •Izinkampani ezikhethekile, ezithuthukile nezintsha eGuangzhou •Amalungelo angu-53 avela kwi-Office of State Intellectual Property