Uyini Umehluko Phakathi kwe-Apis kanye Nezimaphakathi Zemithi?
Kokubili ama-intermediate emithi kanye nama-API ayingxenye yamakhemikhali amahle. Okumaphakathi kuyizinto ezikhiqizwa ezinyathelweni zenqubo yama-API okumele abhekane nezinye izinguquko zamangqamuzana noma ukucwengwa ukuze abe ama-API. Abaphakathi bangahlukaniswa noma bangahlukaniswa. (Qaphela: Lo mhlahlandlela uhlanganisa kuphela izimaphakathi ezichazwa yinkampani njengezikhiqizwe ngemuva kokuqala kokukhiqizwa kwe-API.)
Isithako esisebenzayo somuthi (i-API): Noma iyiphi into noma ingxube yezinto ezihloselwe ukusetshenziswa lapho kukhiqizwa umuthi futhi, lapho kukhiqizwa umuthi, iba yisithako esisebenzayo emthini. Izinto ezinjalo zinomsebenzi we-pharmacological noma eminye imiphumela eqondile ekuxilongweni, ekwelapheni, ekunciphiseni izimpawu, ekulawuleni noma ekuvimbeleni izifo, noma zingathinta imisebenzi nezakhiwo zomzimba. Ama-API ayimikhiqizo esebenzayo eqede indlela yokuhlanganisa, kuyilapho okumaphakathi kuyimikhiqizo ndawana thize endleleni yokuhlanganisa. Ama-API angalungiselelwa ngokuqondile, kuyilapho okuphakathi kungasetshenziswa kuphela ukuhlanganisa isinyathelo esilandelayo somkhiqizo. Kuphela ngama-intermediates lapho ama-API enziwa khona.
Kungabonakala encazelweni yokuthi abaphakathi bayimikhiqizo esemqoka enqubweni yangaphambili yokwenza ama-API futhi banezakhiwo ezihlukile kuma-API. Ngaphezu kwalokho, kunezindlela zokuhlola zezinto ezingavuthiwe ku-Pharmacopoeia, kodwa hhayi zabaphakathi. Ikhuluma ngesitifiketi, okwamanje i-FDA idinga abaphakathi ukuthi babhaliswe, kodwa i-COS ayifuni. Kodwa-ke, ifayela le-CTD kufanele libe nencazelo enemininingwane yenqubo emaphakathi. E-China, azikho izidingo eziphoqelekile ze-GMP zabaphakathi.
Abaphakathi kwezemithi abadingi amalayisense okukhiqiza njengama-API. Izithiyo zokungena ziphansi futhi ukuncintisana kushubile. Ngakho-ke, izinga, izinga kanye nezinga lokuphatha kuvame ukuba yisisekelo sokuphila nokuthuthukiswa kwamabhizinisi. Ingcindezi ekhulayo ekuvikelweni kwemvelo nayo idale ukuthi izinkampani eziningi ezincane zihoxe kancane kancane esigabeni sokuncintisana, futhi ukugxilwa kwezimboni kulindeleke ukuthi kukhule ngokushesha.