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mapa strony: Start. arrow Wszechnica arrow 10.2008 - "Alkohol etylowy w recepturze."


 


10.2008 - "Alkohol etylowy w recepturze." Drukuj Email
10.2008, nr 26/4 online

 ALKOHOL ETYLOWY
 
W RECEPTURZE

   „Spiritus Vini” – duch wina, jego odkrycie przypisuje się alchemikowi arabskiemu Geberowi (XIV w.). Nazwę „alkohol” nadał spirytusowi Paracelsus w XVII wieku. Duży autorytet Paracelsusa przyczynił się do powszechnego przyjęcia tego terminu [4].
   Nazewnictwo alkoholu etylowego zmieniało się w kolejnych farmakopeach. Farmakopea Polska II zawiera 3 monografie:
-    Spiritus 95o (synonimy: Alkohol 95o, Spirytus stężony, Spiritus concentratus, Spiritus fortior),
-    Spiritus (syn.: Alkohol 90o, Spiritus Vini rectificatus, Wyskok)
-    Spiritus 70 stopniowy.
   FP III zawiera analogiczne nazewnictwo dla alkoholu etylowego. Na uwagę zasługuje fakt powszechnego stosowania w recepturze spirytusu 90o. Postępowanie to było podyktowane niedostatkiem na rynku spirytusu 95o, większość zakładów rektyfikacyjnych nie wytwarzała spirytusu o tak wysokim stężeniu. FP IV zawiera już tylko jedną monografię – Aethanolum 95o (syn.: Spiritus Vini rectificatus). FP V zmienia nazwę na Ethanolum 760 g/l (syn. Aethanolum 95o). Farmakopea Polska VI zamieszcza monografię – Ethanolum 96%, (syn.: Ethanolum 760 g/l, Ethanolum 96o, Alkohol etylowy, Etanol 760 g/l, Spiritus Vini rectificatus). Nazwa chemiczna - etanol, C2H5OH. Zawartość etanolu w temp. 20oC nie powinna być mniejsza niż 95,1% (v/v) (92,6 m/m) i większa niż 96,9% (v/v) (95,2% m/m). Etanol jest bezbarwną, przezroczystą, lotną, łatwopalną i higroskopijną cieczą o swoistym zapachu, mieszającą się z wodą i chlorkiem metylenu.

 Zastosowanie alkoholu etylowego
   Alkohol etylowy ze względu na właściwości odwadniające, rumieniące, hemostatyczne, ściągające, chłodzące, jest stosowany w preparatach leczących niektóre zaburzenia skórne. Można go stosować do znoszenia bólu chronicznego i spastycznego, jak również w zatruciach glikolem etylenowym lub alkoholem metylowym (podanie dożylne) [3].
   W praktyce aptecznej alkohol etylowy ma zastosowanie jako rozpuszczalnik i środek konserwujący w preparatach farmaceutycznych. Roztwory zawierające alkohol o stężeniu poniżej 40o określa się jako roztwory alkoholowe (Solutiones spirituosae), roztwory o wyższym stężeniu niż 40o to spirytusy lecznicze (Spirituosa medicata). FP VI zawiera szczegółowe monografie spirytusów leczniczych, są to: spirytus kamforowy, spirytus mrówkowy, spirytus salicylowy, spirytus mydlany, spirytus mydlano-kamforowy, krople anyżowe, spirytusowy roztwór jodu, spirytus gorczyczny. Ponadto FP III zawiera monografie spirytusu lawendowego, spirytusu miętowego. Spirytusy te otrzymuje się przez rozpuszczenie olejków eterycznych w rozcieńczonym alkoholu. Zastosowanie – korygowanie smaku, zapachu, obecnie już mało używane.
   Alkohol etylowy powszechnie jest stosowany jako rozpuszczalnik dla preparatów roślinnych. Nalewki i wyciągi roślinne są stosowane jako składniki do przyrządzania preparatów farmaceutycznych, natomiast alkoholatury stabilizowane częściej spotyka się jako gotowe preparaty do sprzedaży odręcznej ( Intractum Visci albi, Intractum Crataegi).
   Mając na uwadze działanie bakteriobójcze etanolu 70o, można go wykorzystać jako środek odkażający w recepturze aseptycznej do przygotowania miejsca pracy (loża z nawiewem laminarnym), dezynfekcji wstępnej pracownika (dezynfekcja rąk), czy też przygotowanie sprzętu do pracy.

Problemy z alkoholem etylowym
   Stężenie procentowe etanolu można zapisać objętościowo (v/v),  wagowo (m/m) lub wagowo – objętościowo (g/l). Zapis objętościowy, powszechnie stosowany, może doprowadzić do pomyłki, gdy będziemy chcieli rozcieńczyć alkohol wodą. Zachodzi tu bowiem zjawisko kontrakcji, czyli zmniejszenia objętości powstałej mieszaniny. Dla przykładu mieszając 95 litrów alkoholu bezwodnego i 6,2 litra wody otrzymujemy 100 litrów roztworu alkoholowego. Kontrakcja przy mieszaniu wody z alkoholem w różnych stosunkach jest zmienna i obliczenie objętości otrzymanej mieszaniny jest niemożliwe. Można tylko empirycznie ustalić jaką objętość zajmie mieszanina. Dlatego wygodniej posługiwać się stężeniem wagowym alkoholu, które jest niezależne od kontrakcji.
   Korzystając z tabeli gęstości (d20) mieszanin etanolu z wodą [1], można odczytać procenty objętościowe i odpowiadające mu procenty wagowe. Dla przykładu, rozcieńczając etanol 96o do etanolu 70o możemy posłużyć się następującym równaniem:
x =  100 * % wagowy etanolu słabszego  /  % wagowy etanolu silniejszego,
gdzie x – ilość gramów etanolu silniejszego jaki trzeba użyć aby otrzymać 100 g etanolu słabszego.
96,03o – 93,89% wag.
70o – 62,40% wag.
x = 100 * 62,40 / 93,89 = 66,46 g etanolu 96o i woda do 100 g

    Dla ułatwienia pracy można również skorzystać z poniższej tabeli, zawierającej części wagowe etanolu 96o i wody, którą należy zmieszać, aby otrzymać roztwory o zawartości od 30o do 90o etanolu w temp 20 oC [1].
 
 Tabela 1. Rozcieńczenia etanolu
 

Końcowe stężenie etanolu

Etanol 96o

Woda

30o

262

738

40 o

355

 645

50 o

452

548

60 o

555

445

70 o

665

335

80 o

783

217

90 o

913

87



   W przypadku, kiedy potrzebujemy odmierzyć kroplami etanol bądź roztwory alkoholowe, warto zwrócić uwagę na masę pojedynczej kropli lub ilość kropli, jaka przypada na 1 gram [2]. Przykładowe dane zawiera tabela 2.
 
Tabela 2. Ciężar kropli roztworów alkoholowych.
 

 Nazwa składnika

1 g zawiera ilość kropli

Masa 1 kropli (mg)

Etanol 96o

65

15

Ammonii anisatus spirytus

58

17

Iodi solutio spirituosa

55

18



   Podczas przygotowywania preparatów z alkoholem należy zwrócić uwagę na niezgodności, które mogą wpłynąć na wygląd gotowego preparatu, jego trwałość lub aktywność poszczególnych składników. W mieszankach z enzymami (pepsyna) dochodzi do ich inaktywacji. Obecność kwasu solnego jeszcze bardziej potęguje działanie alkoholu (np. 52% stężenie alkoholu w obecności 0,66% kwasu solnego powoduje całkowitą inaktywację pepsyny w przeciągu kilku godzin) [5]. Alkohol z białkami i śluzami roślinnymi tworzy osady. Natomiast substancje utleniające niszczą i utleniają alkohol [6].
   Niejednokrotnie zdarza się, że lekarz wystawiając receptę na lek robiony, zapisuje alkohol etylowy bez podania jego stężenia. Farmaceuta mając na uwadze monografię FP VI powinien zastosować etanol 96o, jeżeli monografia szczegółowe nie określa inaczej. Ponadto farmakopea zaleca stosować etanol do celów odkażających, którego stężenie w przygotowywanym preparacie powinno być na poziomie 70% (v/v). Wobec powyższego, łatwo o pomyłkę – czy użyć etanolu 96o czy 70o? Jeżeli alkohol jest zapisany wraz z innymi rozpuszczalnikami (np. woda, roztwór 3% kwasu borowego) wówczas nie mamy wątpliwości co do zastosowania etanolu 96o. W praktyce aptecznej często spotyka się następującą receptę:

Rp.

Detreomycini          3.0
Spir. Vini        ad 100.0
M. f. sol.
D.S. zewnętrznie

 
   W tym przypadku, alkohol etylowy stanowi podstawowy (jedyny) rozpuszczalnik w recepcie, a jego stężenie nie jest określone przez autora. Farmaceuta powinien mieć na uwadze przede wszystkim dobro pacjenta. Pacjent stosując roztwór etanolowy 96% (v/v), mógłby poparzyć skórę twarzy, dlatego końcowe stężenie etanolu w przygotowanym preparacie należałoby przygotować na poziomie 70% (v/v). Niestety do aptek trafiają czasami błędnie wypisane recepty, które uniemożliwiają zachowanie powyższych wskazań stężeń procentowych, wówczas pozostaje nam skontaktować się z lekarzem w celu ustalenia prawidłowego składu recepty.

Piśmiennictwo
1.    Farmakopea Polska VI, Warszawa 2002,
2.    Krówczyński L., Jachowicz R.: Ćwiczenia z receptury. Wydawnictwo Uniwersytetu Jagiellońskiego 2000,
3.    Martindale: The complete drug reference 32nd edition 1999,
4.    Modrzejewski F.: Farmacja stosowana. PZWL Warszawa 1961,
5.    Modrzejewski F.: Niezgodności recepturowe. PZWL Warszawa 1964,
6.    Supniewski J.: Receptura. PZWL Warszawa 1957.

dr farm. Piotr Belniak
Katedra i Zakład Farmacji Stosowanej
Uniwersytet Medyczny w Lublinie

Fot. BigStockPhoto
 
 
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