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mapa strony: Start. arrow Wszechnica arrow 09.2009 - RECEPTARIUSZ - "Sporządzanie jałowych maści recepturowych."


09.2009 - RECEPTARIUSZ - "Sporządzanie jałowych maści recepturowych." Drukuj Email
wrzesień 2009, nr 37/15 online


   Od leków zaliczanych przez farmakopeę do I kategorii jakości mikrobiologicznej wymaga się bezwzględnej jałowości. Należą do nich preparaty pozajelitowe, do oczu, na rany i rozległe oparzenia. Jałowe muszą być również różne postacie leków z antybiotykami. Wynika to stąd, że antybiotyki są wrażliwe na działanie enzymów i metabolitów bakteryjnych, gdyż pod ich wpływem ulegają inaktywacji. Dzięki jałowości zapewnia się nie tylko trwałość antybiotykowi, ale również chroni się pacjenta przed dodatkowym zakażeniem.
   Recepturowe leki jałowe mogą być sporządzane w aptekach posiadających odpowiednie wyposażenie, które pozwoli wysterylizować surowce, przyrządy, opakowania itp., a następnie wykonać jałowy lek w warunkach aseptycznych. Niezbędne są: szafka z laminarnym nawiewem jałowego powietrza (w chwili obecnej rzadkością są w aptekach otwartych boksy aseptyczne), sterylizator powietrzny, autoklaw, aparat Kocha, puszki sterylizacyjne (tzw. puszki Schimmelbuscha) i inny drobny sprzęt, np. sączki klarujące i wyjaławiające.
   Jałowe maści uzyskuje się w warunkach aseptycznych z jałowych podłoży, rozpuszczalników, roztworów, jałowych substancji stałych, korzystając z wysterylizowanych przyrządów i wydając gotowy lek w jałowej tubie.
   Składniki podłoży lipofilowych i absorpcyjnych oraz podłoża o powyższym charakterze (np. wazelina, parafina, lanolina, euceryna, maść cholesterolowa), a także oleje roślinne (np. olej rzepakowy, rycynowy, lniany), po uprzednim przesączeniu na ciepło przez bibułę, wyjaławia się w sterylizatorze powietrznym z termoregulatorem w temperaturze 160ºC przez 1 godzinę. Substancje półstałe i stałe umieszcza się w parowniczkach, a płynne w szklanych zlewkach. W sterylizatorze kładzie się obok parowniczek i zlewek płytki Petriego odpowiedniej wielkości, którymi przykrywa się wyjałowione substancje podczas przenoszenia ze sterylizatora do loży.
   Parametry sterylizacji substancji stałych zależą od ich właściwości fizykochemicznych, np. kwas borowy sterylizuje się w temperaturze 170ºC przez 1,5 godziny, sulfacetamid w 140ºC przez 2 godz., chloramfenikol w 100ºC przez 2 godz., kwas salicylowy w 120ºC także przez 2 godz. Substancje stałe rozprowadza się cienką warstwą na płytce Petriego. Po wstawieniu do sterylizatora powietrznego kładzie się obok płytki z substancją płytkę o większej średnicy. Jest ona niezbędna do zabezpieczenia substancji wyjałowionej przed zainfekowaniem w czasie przenoszenia ze sterylizatora do loży.
   Jeśli w skład wykonywanej jałowej maści wchodzi woda, można użyć ampułkowaną wodę do wstrzykiwań (Aqua pro iniectione) lub wodę do sporządzania leków do oczu (Aqua pro usu ophthalmico), albo w specjalnych butelkach ciśnieniowych wyjałowić wodę w autoklawie w 122ºC przez 20 minut.
   Niektórych substancji nie wyjaławia się termicznie z powodu ich dużej wrażliwości na wysoką temperaturę. Do takich substancji należą m. in. witaminy A i E, będące silnymi antyoksydantami.
   Moździerze, pistle, szklane zlewki, bagietki, łopatki metalowe itp., po dokładnym umyciu i wypłukaniu jałową wodą, należy umieścić w puszce Schimmelbuscha z odsłoniętymi bocznymi przewietrznikami i sterylizować w sterylizatorze powietrznym w temp. 170ºC przez 1 godzinę. Po sterylizacji należy przesunąć przesłonę puszki tak, aby otwory przewietrzników były zamknięte.
   Tuby aluminiowe wewnątrz nielakierowane lub lakierowane poddaje się sterylizacji, po zdjęciu nakrętek i włożeniu do puszki Schimmelbuscha, w autoklawie w 122ºC przez 20 minut. Ewentualnie można je przepłukać 70º etanolem. Na rynku farmaceutycznym dostępne są jałowe opakowania-tuby z ruchomym dnem, wykonane z tworzywa sztucznego. Wprawdzie są one dostosowane do sporządzania maści przy użyciu miksera recepturowego – Unguatora, ale również można do nich przekładać maści wykonane ręcznie. Jałowe opakowania-tuby, po rozcięciu folii w którą były fabrycznie zapakowane, należy przełożyć do puszki Schimmelbuscha umieszczonej w loży z laminarnym nawiewem jałowego powietrza.

        Lini Olei                 60,0
        Retinoli palmitatis (Vit. A)    0,1
        Cholesteroli                            4,1
        Vaselini albi                          25,2
        Lanolini anhydrici                 89,6
        Paraffini solidi                       21,0

        D.S. Maść na rozległe oparzenie

    Przed przystąpieniem do realizacji recepty należy w pierwszej kolejności przygotować lożę, a więc: włączyć przepływ jałowego powietrza, ścianki wewnętrzne i blat loży umyć roztworem detergentu, a następnie przetrzeć środkiem dezynfekującym, np. 70º etanolem lub innym dostępnym na rynku preparatem odkażającym. Odkazić należy również wagę elektroniczną stanowiącą stałe wyposażenie loży. Następnie trzeba umieścić w loży puszkę Schimmelbuscha z wyjałowionymi naczyniami recepturowymi, opakowanie do którego będzie przełożona gotowa maść oraz substancje niezbędne do sporządzenia leku. Po upływie 30 minut można rozpocząć wykonywanie leku.
   Kliszą przetartą 70º etanolem przenieść z parowniczki do moździerza 139,9 g wyjałowionego podłoża, będącego mieszaniną 4,1 g cholesterolu, 25,2 g wazeliny białej, 89,6 g lanoliny bezwodnej i 21 g parafiny stałej. Do jałowej zlewki odważyć 60 g wysterylizowanego oleju lnianego i 0,1 g witaminy A. Roztwór olejowy witaminy A dokładnie wymieszać z podłożem. Gotową maść przenieść do tuby.
   Powyższą maść można wykonać również przy użyciu Unguatora. W loży, bezpośrednio do odpowiedniej wielkości opakowania-tuby, należy odważyć podłożę, olej lniany i witaminę A. Na wyjałowiony w sterylizatorze powietrznym (170ºC/1 godz.) trzpień nałożyć jednorazowe jałowe mieszadło i umieścić je w składnikach maści, zamknąć opakowanie-tubę nakrętką i podłączyć do unguatora stojącego w pomieszczeniu, w którym jest loża. Ustawić ilość obrotów i czas mieszania. Po wymieszaniu odłączyć opakowanie-tubę od aparatu i pod lożą wyciągnąć trzpień (mieszadło pozostaje w opakowaniu-tubie) i małą nakrętką zamknąć tubę.

                                                           dr n. farm.Grażyna Samczewska
                                                                            Katedra Farmacji Stosowanej UM w Łodzi
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