1. Ukubuka KweMikhiqizo (Product Overview) 1.1 Incazelo eziyisisekelo I-colloidal silica dioxide iyisilicon dioxide esinokuphuma okuphezulu okwenziwe ngokuqhubekayo, ibonakala njengothuli oluphaphathekile, oluwhite. Umkhiqizo unama-nano-network structure ayisisekelo, anikeza izinzuzo ezifana nosayizi wezakhi ezihlangene, ukuhamba kahle okuhle, kanye nokuzinza kwemichiza okuqinile. Ayiphenduli nezithako ezisebenzayo zemithi. Ngenxa yesikhala sayo esikhulu esithile kanye nokuxhumana okuqinile phakathi kwezithako, i-silica dioxide isebenza njenge-excipient ebalulekile yemithi ukuze ithuthukise ikhwalithi nokuzinza kwemikhiqizo yemithi. Itholakala ezindaweni zemithi, ukudla, ukudla kwezilwane, kanye nezinye izinkambu ezihlobene, ngenkathi isekela izixazululo zokusebenza ezikhethekile. 1.2 Izinzuzo eziyisisekelo Njengoba i-excipient yemithi enezinhloso eziningi, i-Zhongqi Colloidal Silica ixazulula kahle izinselelo zezimboni ezifana nokungahambi kahle kwezakhi ezinzima ezimithini ezithile kanye nezinkinga zokuhlala ezilwazini. Ngokusebenzisa ukulawula ikhwalithi okuphelele kulo lonke uchungechunge lokukhiqiza, lo mkhiqizo uqinisekisa ukuhamba kahle nokusebenza okujwayelekile, uvumela abakhiqizi bemithi ukuthi 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) •I-Nanostructure: usayizi wezithako uqondiswa ku-12-20nm, udala isakhiwo esihlangene esijwayelekile, futhi indawo ethile ye-BET ingafinyelela ku-175-380m²/g, inikeza isisekelo sokumunca kahle nokuhamba. •Ukuhamba kahle 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 zemikhiqizo ye-liquid. •I-impurity residue ephansi kakhulu: I-SiO₂ iqukethe ngaphezulu 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. Izinkambu Zokusebenza 4.1 Izinhlobo zemithi ezinzima Amathablethi, ama-capsule, kanye nothuli: Lezi zingahlukaniswa kahle zisebenzisa imishini yokuxuba ejwayelekile. Uhlelo lusebenza njengovimbela ukunciphisa ukuxhumana phakathi kwezithako, kuthuthukisa ukuhamba kahle, futhi kuvimbele ukuhlanganiswa. Kwandisa isivinini sokucindezela amathablethi ngenkathi kuthuthukiswa izinqubo zokukhiqiza ukuze kube nokuhamba kahle kotuli. I-adsorbent/imathiriyeli yokumunca amanzi ikwazi kahle ukulawula umswakama nokuhamba kwamanzi (ukuguqulwa kuncike kumthamo). Lokhu kunciphisa izinkinga zokuhambisana phakathi kwezithako zemithi, kuthuthukisa ukusabalalisa okujwayelekile kwezakhi zotuli, futhi kuthuthukisa isivinini sokuphuka kwamathablethi. •I-Tablet/capsule: Engeza u-0.1-0.5% njengosizo lokuhamba, okunganciphisa i-angle yokuphumula kotuli ngo-20-30%, kunciphise umehluko wesisindo enqubweni yamathablethi, futhi kuthuthukise ubunzima bamathablethi ngo-15-20% kunciphise ubrittleness. •Inqubo ye-tablet eqondile: thuthukisa ukuhamba kwemathiriyeli, kunciphise inani le-lubricant, kanciphisa isikhathi sokukhiqiza, kufanelekile ku-acetaminophen, aspirin nezinye izinhlelo ze-API. 4.2 Imikhiqizo ye-liquid Izixazululo zemithi (ama-gel, ama-creams, ama-suspensions, njll.): I-viscosity iyahluka ngokuhamba, ivumela ukujula ibe i-paste noma ibe mncane ukuze kube lula ukuyisebenzisa. Ivimbela ukuhamba okuqinile, ukuhamba, nokuhamba ngenkathi ithuthukisa ukujula kwe-gel nokuhambisana kwezinto zokwakha. Ithuthukisa ukuzinza kokuhlanganiswa futhi ivimbela ukuhamba kwe-aerosol (idinga imishini ye-high-shear ukuze kuqinisekiswe ukuhamba kahle ukuze kufezwe 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 kokuthola. •Izithako/izixazululo zamehlo: kuhambisana nezindinganiso zokukhiqiza ezihlanzekile ze-IPEC-GMP, kungathuthukisa ukuzinza kwesixazululo, kunciphise ingozi yokwakheka kwezithako, futhi kulungele izidingo zemikhiqizo ye-liquid ezithambile. 4.3 Izithako zokudla •Umthwalo wezithako: umuncu ama-vitamins, ama-probiotics nezinye izithako ukuze wandise isikhathi sokuphila kwemikhiqizo futhi wandise isilinganiso sokugcina sokusebenza kwezinto ngaphezu kuka-30%, kufanelekile ku-protein powder, nutritional powder nezinye izinto. •I-Anti-caking agent: emkhathini we- humidity ≤60%, impahla yothuli ingagcinwa ngaphezu kwezinyanga eziyi-6 ngaphandle kokuhlanganiswa ukuze kuqinisekiswe ukuhamba komkhiqizo. 4.4 Izicelo zokudla: Njengomkhiqizo wokudla oqondile, uthuthukisa ukuhamba kwezakhi zokudla (kuhlanganise nothuli lwe-organic oluthambile), ivimbela ukuhlanganiswa kokugcina ngenkathi igcina umswakama; umunca umswakama, ifanele nothuli olumanzi/oluhambayo; isebenza njengomjovo wezinto eziphilayo ezifana nezikhukhula zokupheka nezamafutha ezitshalo, futhi isebenza njengomjovo we-thixotropic ezinhlelweni zokupheka ezisekelwe kumafutha; ngaphezu kwalokho ithuthukisa ukuhlanzeka kwemishini ngesikhathi sokugaya izinto zokwakha. 4.5 Ukusebenza emkhakheni wokudla kwezilwane: Thuthukisa ukusebenza kokudla kwezilwane kanye nobuchwepheshe bokucubungula ukuze kuqinisekiswe ukuhamba kahle nokumelana nokugcina kwe-powder yokwengeza, futhi unikeze izakhiwo ezinhle zokulungisa umswakama kumaphakethe; thuthukisa inqubo yokugaya nokugaya ukuze uvimbele umkhiqizo ukuthi ungabambeki kumishini. 5. Izindinganiso nezimfuneko (Standards & Regulations) •Uhambisana nezindinganiso eziningi ze-pharmacopoeia zomhlaba: USP-NF, European Pharmacopoeia (Ph. Eur.), Japanese Pharmacopoeia (JP), kanye ne-China Pharmacopoeia (ChP 2025). •Thola isitifiketi esihlobene: i-FDA inactive ingredient database collection, i-EU E551 food additive certification. •Landela iziqondiso zokuhambisana zomhlaba: uhambisana nezindinganiso zokukhiqiza ze-GMP nezidingo ze-HACCP zokuphepha kokudla. 6. Imiyalelo Yokusebenzisa 6.1 Umthamo ohlongozwayo Uhlobo lokulungiselela Umsebenzi ohlosiwe Uhlaka lokwengeza oluhlongozwayo Tablet/capsule usizo lokuhamba 0.1-0.5% Oral suspension Umsebenzi/Umjovo 0.5-2.0% Nutrient powder umjovo wokungabambeki 0.2-1.0% Active ingredient carrier Umuncu 5-15% 6.2 Izinqumo ezibalulekile zokusebenza nokugcina •Ukusebenza kwemikhiqizo ezinzima: kunconywa ukwengeza ngemuva kokuxuba i-API kanye ne-diluent, futhi usebenzise ukuxuba okuphezulu okungaphezu kwemizuzu engama-30 ukuze kuqinisekiswe ukuhamba kahle. •Ukusebenza kwemikhiqizo ye-liquid: kufanele ihlukaniswe ngaphansi kwezimo ze-pH 4-6, futhi ugweme 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%), iyasebenza iminyaka emibili, ivuliwe futhi isetshenziswe ngokushesha. Le mininingwane engenhla iyisikhumbuzo kuphela, futhi ukusetshenziswa kwangempela nokuthola kufanele kulungiswe ngokuya ngempela. 7. Izinzuzo Zomkhiqizo (PA) •Ukufaneleka kwesimo esiphelele: inezici zokuhamba kwemikhiqizo ezinzima kanye nokuzinza kwemikhiqizo ye-liquid, kunciphisa uhlobo lwezinto ezisizayo futhi kulula ukwakha ifomula. •Ukuqinisekiswa kokuhambisana komhlaba: ukuvuma izitifiketi eziningi ze-pharmaceutical code, ukweseka ukubhaliswa kwemithi yasekhaya nakwamanye amazwe, kunciphisa izingozi zokufinyelela emakethe. •Isevisi eyenziwe ngezifiso: ngokuya ngezidingo zamakhasimende, usayizi wezithako nezici ezithile zendawo zingalungiswa ukuze kuhanjiswe izixazululo zobuchwepheshe ezikhethekile. •Ukuphakelwa okuqhubekayo: inqubo yokukhiqiza isebenzisa ukuvuselelwa kwamandla, futhi ukupakisha kusebenzisa amabhakede ephepha angasetshenziswa kabusha ukuze kuhlangabezane nezidingo zokusebenza 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 yokwengeza kokudla •Ilayisensi yokukhiqiza yokwengeza kokudla kwezilwane •I-National high-tech enterprise •Izinkampani ezikhethekile, ezithuthukile nezintsha eGuangzhou •Amalungelo angama-70 avela kwi-Office of State Intellectual Property