Iziqu ezenziwe ngokwezifiso kunye nee-Ointments ziNinzi zeMichiza
Ukusetyenziswa kweziyobisi ezingaqhelekanga ngumgaqo-milleniya wokulungiselela amachiza amachiza athile ukusela, ukugwinya, ukungenisa okanye ukufaka isicelo esikhumbeni. Luhlobo oluthile oluqhelekileyo lwezonyango eziqulunqwe ngabagqirha kunye nochwepheshe bee-pharmacy kwii-pharmacy zasekuhlaleni nasezibhedlele. Kwaye nangona i-"nonsterile" yayo ibhalwe, ukwenza iifayili ezenziwe ngokwezifiso ngokwemigangatho yomthetho kunye nezobugcisa kudinga ukuhambelana nemithetho eqinile yokuqinisekisa nokugcina isilathisi esisebenzayo sokuxutywa kwamachiza kunye nokuphucula; ukuqinisekisa ukuchaneka kokuxuba; ukubonelela ngokupakishwa okufanelekileyo, ukugcinwa, kunye neelayibhile; kunye nokugcina yonke indawo yokusebenza kunye nezixhobo zicocekile ngokunokwenzeka.
Ulwahlulo olukhulu phakathi kokungabikho komzimba okungaxakaliyo kunye nobunzima bokuxhatshazwa kwezidakamizwa. Amachiza ayenzelwe ukujova, ukumnika okanye ukufaka isicelo kwiso kufuneka kuhlanganiswe ngokwemiqathango nemigangatho yokubambisa oyinyumba kuba iibhaktheriya okanye iifungi ezikhoyo kwiindawo-kwi-trillion ububanzi zingafaka ubomi bezilwelomngcipheko emngciphekweni. Ukuthintela ukucoceka kubalulekile xa ukwenziwa kokungahambisani nendawo, kodwa abaqulunqwayo akudingeki basebenze kwiindawo ezizinzileyo ezinjengeendawo zokuhlambulula.
Yintoni eyenziwa ngu-Nonsterile Compounding?
Inkcazo eqhelekileyo yokuhlanganiswa okungekho emfutshane eyenziwa yiwebhusayithi i-Quizlet ichaza umkhwa "njengendlela yokuvelisa izisombululo, ukumiswa, i-ointment kunye nama-creams, powders, suppositories, capsules, and tablets." Ingcaciso epheleleyo ngakumbi iya kuchaza ukuwa kwamanzi okungaqhelekanga kumacandelo alula, aphantsi kwaye anzima.
Ukwahlula kuxhomekeke ekubeni kunzima kangakanani ukulungiselela ifom ye-dosage ekhoyo, ingozi imveliso ibangela isigulane kunye nomxube, kunye nendlela ifomu eligqityiweyo kufuneka lilawulwe ngayo kwaye ligcinwe.
Ukudibanisa okungaqhelekanga kokubandakanya ukuxuba imichiza ngokwemiqathango echanekileyo, okanye "zokupheka" kunye nokwenza iinguqulelo zamanzi eziqhelekileyo zithengiswa nje kuphela njengeipilisi okanye iifomsile.
Ootitshala bezilwanyana nabagqirha bezilwanyana bavame ukucela le ntlobo yeemveliso kwiintsana kunye nezilwanyana ezingenako ukugwinya iipilisi okanye zidinga amanani amancinci kunezo kwimveliso evezwe ngentengiso.
I- US Pharmacopeia ifomula ekhoyo ikhona kwi-125 e-nonsterile ekhoyo. Iiresiphi zichaza ukuba yeyiphi i-APIs kunye nezithako ezingekho kwemida ezisebenzisayo, kunye nendlela yokulinganisa nokudibanisa izithako, ilebula umkhiqizo weziyobisi ogqityiweyo kwaye umise umhla wokuphelelwa yisikhathi, othi, ngolwimi lwe-pharmacy, "lingaphaya komhla wokusetyenziswa." Amachiza amabini e-USP e-nonsterile elula ayimiso yokumiswa ngomlomo (umzekelo, iipilisi ze-Xanax ezivela kwi-Pfizer) kunye ne-generic-release release-morphine sulfate suppositories.
Ukuhlanganiswa okungafaniyo okungafaniyo kubandakanya ukwenza ama-dosage aneemichiza ezinokulimaza okanye amalungiselelo adinga ukuphathwa okukhethekileyo. Iifentanyl, ezithandwa kangcono njenge-lollipops, kunye namafutha anokusetyenziswa kuphela ngokukhuselekileyo kunye neiglavu ziwela kule nqanaba. Amagqirha wamazinyo, i-oncologists, kunye nama-dermatologists bathambelela ukuhlawula amayeza afuna ukulungelelanisa okungaqhelekanga. Idatha enamandla kwiimimiselo ezingcono kunye nemini yokuphelelwa yisikhathi ayizange ishicilelwe kwizinto ezininzi.
Zimbalwa iifomasta zenza i-nonsterile eyinkimbinkimbi, efuna ukuqeqeshwa okuphambili kunye nezixhobo ezikhethekileyo ukwenza iimveliso ezinjengeepsulesi ezikhutshwe ngokubanzi kunye neentambo ezijikelezayo.
Yiyiphi Imigaqo Ekhoyo Kukho Ukungabonakali?
I-USP 795 "Amayeza okuQinisekisa ---- Ukulungiswa kweNdawo engaHlengiyo" idibanisa imigaqo yamachiza kunye neekhemikhali zeekhmikhali kufuneka zilandele xa zilungiselela iifom ezenzelwe ukuba zithathwe ngomlomo, zifakwe ngokusemthethweni okanye zifakwe kwisimo somlomo. Isahluko sahlaziywa, sandiswa kwaye sashicilelwa ngo-Meyi 2011 ukugxininisa ukubaluleka kokubhalisa zonke iinkqubo eziqulunqayo, ukubhalisa ngokuchanekileyo izidakamizwa ezichanekileyo kunye nama-API kunye nangaphezulu kwemihla yokusetyenziswa, kunye nokusebenzisa amanzi ahlambulukileyo kuwo wonke ukuxuba kunye nokucocwa okunxulumene nokuhlanganiswa okungenanto.
Iinqwelo kule mhlathi zibonelela ngeenkcukacha ezingakumbi kwi-USP 795 efunayo, kodwa iimbini ezimbini zibonisa ukugqamisa.
Okokuqala, njengelungu leKomidi leComputering Expert Committee, uPatricia Kienle, uRhh, MPA, FASHP, watshela i- Pharmacy Purchasing & Products , "Nokuba iinkqubo ezilula, ezifana nokuvuselela i-antibiotic suspension, zibonisa ukuba zidibeneyo kwaye, ngoko, zihlanganiswe kwesi sahluko."
Okwesibini, i-USP 795 ithatha amandla omthetho. Amalungiselelo ayo angabikho, kwaye aqinisekiswe ngabaphathi be-US Food and Drug Administration kunye nebhodi likarhulumente lamagosa e-pharmacy. Zonke iifom zamkele i-USP 795 njengesiqalo sokukhuseleka komgaqo-nkqubo osisigxina kunye nomthetho, kwaye abanye baye baphula eminye imigaqo yabasebenzi. Ngamafutshane, ukulandela imilinganiselo ye-USP 795 ibeka oomachiza kunye neengcali kwicala lasekunene lomsebenzi wokunakekelwa kwempilo kunye nomthetho.