1. Ukubuka KweMikhiqizo (Product Overview) 1.1 Incazelo eziyisisekelo I-colloidal silica dioxide iyisilicon dioxide esiphezulu sokuhlanzeka esilungiswe ngokuqhubekayo, ibonakala njengepudingi elimhlophe, elikhululekile. Umkhiqizo ubonisa isakhiwo se-nano-network esiyinhloko, unikeza izinzuzo ezifana nosayizi wezakhi ezifanayo, ukusabalala okuhle, kanye nokuzinza kwezemikhemisi okuqinile. Ayiphenduli nezithako ezisebenzayo zemithi. Nge-surface area yayo ethile ephezulu kanye nokuxhumana okuqinile phakathi kwezithako, i-silica dioxide isebenza njengomkhiqizo obalulekile wemithi ukuze ithuthukise ikhwalithi nokuzinza kwemikhiqizo yemithi. Ithola izicelo emithini, ekudleni, ekudleni kwezilwane, nasemikhakheni ehlobene, ngenkathi ixhasa izixazululo zokusebenza ezenziwe ngokwezifiso. 1.2 Izinzuzo eziyisisekelo Njengomkhiqizo wemithi onemisebenzi eminingi, i-Zhongqi Colloidal Silica ixazulula kahle izinselelo zezimboni ezifana nokungabi ne-flowability ezakhiweni ezinzima zokuphakela kanye nezinkinga zokuhlala emikhiqizweni ye-liquid. Ngokusebenzisa ukulawula ikhwalithi okuphelele kuyo yonke imikhakha yokukhiqiza, lo mkhiqizo uqinisekisa ukuhlanzeka nokusebenza okuqhubekayo, uvumela abakhiqizi bemithi ukuba bathuthukise ukusebenza kahle kokukhiqiza kanye nokuncintisana komkhiqizo. Uhlangabezana nezidingo zokubhaliswa kwemithi zasekhaya nezamazwe omhlaba, ubonisa ubuchwepheshe bawo bokuhlangabezana 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. •Ukuhlala okuhle kokusabalala: 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 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 ne-standards zezimboni. 4. Izinkambu Zokusebenza 4.1 Izakhiwo ezinzima Amathablethi, ama-capsule, namapudingi: Lezi zingasabalala kahle zisetshenziswa ngezinsiza zokuxuba ezijwayelekile. Uhlelo lusebenza njengovimbelo ukuze lunciphise ukuxhumana phakathi kwezithako, kuthuthukise i-flowability yamahhala, futhi kuvinjeze ukuhlanganiswa. Iphucula isivinini sokucindezela amathablethi ngenkathi ithuthukisa izinqubo zokukhiqiza ukuze kube nokuhamba okuphelele kwepudingi. I-adsorbent/imathiriyeli emunca amanzi ilawula kahle umswakama nokuhamba kwamanzi (ukuguqulwa kuncike kumthamo). Lokhu kunciphisa izinkinga zokuhambisana phakathi kwezithako zemithi, kuthuthukisa ukusabalala okufanayo kwezithako ze-powder, futhi kuthuthukisa isivinini sokuphuka kwamathablethi. •I-Tablet/capsule: Engeza u-0.1-0.5% njengomsebenzi wokunceda ukuhamba, okunganciphisa i-angle yokuphumula kwepudingi ngo-20-30%, kunciphise umehluko wesisindo ohlelweni lwamathablethi, futhi kuthuthukise ubunzima bamathablethi ngo-15-20% futhi 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 Imikhiqizo ye-liquid Imikhiqizo 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 ukuhlanganiswa okuqinile, ukuhamba, nokuhamba ngenkathi ithuthukisa ukujula kwe-gel nokuhambisana kwezinto zokwakha. Ithuthukisa ukuzinza kokuhamba futhi ivimbela ukuhamba kwe-aerosol (idinga izinsiza ezinamandla ukuze kuqinisekiswe ukusabalala okuhle 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/izinhlelo zokubheka: 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 •Umthwali wezithako ezisebenzayo: umunca ama-vitamins, ama-probiotics nezinye izithako ukuze wandise isikhathi sokuphila kwemikhiqizo futhi wandise isilinganiso sokugcina sokusebenza kwe-biological ngaphezu kuka-30%, kufanelekile kumapowder e-protein, amaphilisi okudla nezinye izinto. •Umsebenzi wokuvimbela ukuhlanganiswa: emkhathini we-humidity ≤60%, impahla ye-powder ingagcinwa ngaphezu kwezinyanga eziyi-6 ngaphandle kokuhlanganiswa ukuze kuqinisekiswe ukuhamba komkhiqizo. 4.4 Izicelo zokudla: Njengomkhiqizo wokudla oqondile, uthuthukisa i-flowability yamapowder okudla (kuhlanganise namapowder soft organic), uvimbela ukuhlanganiswa kokugcina ngenkathi ugcina umswakama; umunca umswakama, ufanelekile kumapowder amanzi/ahamba; isebenza njengomsebenzi wokujula emikhiqizweni ye-liquid efana nezinsalela zokupheka nezithako ze-oyela, futhi isebenza njengomsebenzi we-thixotropic emikhiqizweni yokupheka ne-baking; futhi ithuthukisa ukuhlanzeka kwezinsiza ngesikhathi sokugaya izinto zokwakha. 4.5 Ukusebenza emkhakheni wezokudla: Thuthukisa ukusebenza kokudla kanye nobuchwepheshe bokucubungula ukuze uqinisekise ukuhamba okukhululekile nokumelana nokugcina kwepudingi yokwengeza, futhi unikeze izakhiwo ezinhle zokulungisa umswakama ezithakeni; thuthukisa inqubo yokugaya nokugaya ukuze uvimbele umkhiqizo ukuthi ungeniswe ezinsizeni. 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 ubufakazi obuhambisanayo: i-FDA inactive ingredient database collection, i-EU E551 food additive certification. •Landela iziqondiso zokuhambisana zomhlaba: uhambe nezindinganiso 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 Umsebenzi wokuphakamisa/ukujula 0.5-2.0% Nutrient powder umkhiqizo wokuvimbela ukuhlanganiswa 0.2-1.0% Active ingredient carrier Umunca 5-15% 6.2 Amathiphu abalulekile wokusebenza nokugcina •Ukusebenza kwemikhiqizo eqinile: kunconywa ukwengeza ngemuva kokuxuba i-API kanye ne-diluent, futhi usebenzise ukuxuba okukhulu okungaphezu kwemizuzu engama-30 ukuze uqinisekise ukusabalala okufanayo. •Ukusebenza kwemikhiqizo ye-liquid: kufanele kusabalale ngaphansi kwezimo ze-pH 4-6, futhi kugwenywe ukuxhumana isikhathi eside ne-asidi eqinile kanye ne-alkali ukuze kuvinjeze 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 nokuthola kufanele kulungiswe ngokuya ngombhalo wakho. 7. Izinzuzo Zomkhiqizo (PA) •Ukufaneleka kwazo zonke izimo: inezici zokunceda ukuhamba kwemikhiqizo eqinile kanye nokuzinza kwemikhiqizo ye-liquid, kunciphisa uhlobo lwezinto ezisizayo futhi kulula ukuklama umkhiqizo. •Ukuqinisekiswa kokuhambisana komhlaba: ukuvuma izitifiketi eziningi ze-pharmaceutical code, ukweseka ukubhaliswa kwemithi yasekhaya nezamazwe, kunciphisa izingozi zokufinyelela emakethe. •Isevisi eyenziwe ngokwezifiso: ngokuya ngezidingo zamakhasimende, usayizi wezithako kanye nezici ze-surface area zingalungiswa ukuze kuhanjiswe izixazululo zobuchwepheshe ezikhethekile. •Ukuphakelwa okuqhubekayo: inqubo yokukhiqiza ithatha amandla, futhi iphakheji isebenzisa amabhakede ephepha angasetshenziswa kabusha ukuze ibalansi ukusebenza nezidingo zokuvikelwa kwemvelo. 8. Ukuqinisekiswa kwesistimu yeNkampani kanye nezindondo •FSSC22000 •ISO22000：2018 •ISO9001：2015 •SHC HALAL •OU KOSHER •Ubufakazi be-FDA •FAMI-QS •SEDEX •Ilayisensi yokukhiqiza yokwengeza kokudla •Ilayisensi yokukhiqiza yokwengeza kokudla kwezilwane •Inkampani ye-high-tech kazwelonke •Izinkampani ezikhethekile, ezihlukile nezintsha eGuangzhou •Amalungelo angu-41 avela kwiHhovisi leZimpahla Zobuhlakani ZaseMelika