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03.2013 - "Krople w recepturze aptecznej - nie takie straszne jak myślimy!" Drukuj Email
marzec 2013, nr 79/57 online
 
   W poprzednim artykule odpowiedzieliśmy sobie na pytanie, kiedy przeliczanie dawek nie jest potrzebne, a wręcz nie ma sensu. Należałoby wobec tego przyjrzeć się teraz sprawie kiedy dawki należy sprawdzać i przeliczać.

   Zgodnie z FP IX, lekarz przepisując dawkę przekraczającą dawkę maksymalną zobowiązany jest ten fakt oznaczyć na recepcie. W przypadku, gdy z treści recepty wynika zastosowanie przez lekarza dawki przekraczającej dawkę maksymalną, a brak jest właściwego oznaczenia dawki na recepcie, farmaceuta wydający lek powinien porozumieć się z lekarzem, który wystawił receptę, w celu potwierdzenia świadomego przekroczenia przepisanej dawki. W przypadku niemożności wyjaśnienia celowości przekroczenia maksymalnej dawki jednorazowej lub dobowej, farmaceuta wykonuje lub wydaje lek w dawce odpowiadającej dawce maksymalnej z uwzględnieniem przepisanej drogi podania leku i częstotliwości podawania.

   Jednocześnie należy pamiętać, iż ustalone w Farmakopei dawki maksymalne są to największe dawki stosowane w lecznictwie i mogą być przekroczone tylko w sposób świadomy i to w określonych przypadkach. Z kolei dawki zwykle stosowane są to dawki przeciętne, mające charakter orientacyjny i wywołujące określone działanie zapobiegawcze, diagnostyczne lub lecznicze.

   Konkludując, należy sprawdzać i obliczać dawki maksymalne dla substancji aktywnej biologicznie używanej wewnętrznie, która należy do wykazu A, B i N i dla tych z wykazu C, dla których jest ustalona dawka maksymalna. Takim przykładem są sole bromu, zwane potocznie „bromkami” stosowane w różnej formie w leku recepturowym, zarówno w postaciach oficynalnych, jak i kompozycjach autorskich lekarzy. Problem dawkowania soli bromu scharakteryzowano w tabeli 1.

Tabela 1. Tabela dawkowania najczęściej stosowanych w recepturze aptecznej soli bromu według FP IX.

*kliknij, aby powiększyć
 
UWAGA: dla preparatów zawierających więcej niż jedną sól bromkową maksymalna łączna dawka dobowa wynosi 1,0 gram (w tym bromku amonowego  maksymalnie 0,5 grama).
 
   Z powyższego zestawienia jasno wynika, iż mamy określoną z góry sumaryczną dawkę dobową soli bromu na poziomie 1,0 grama, w tym bromku amonowego nie więcej niż 0,5 grama. Z oczywistych względów nie ma podanych w tabeli dawek pozostałych, ponieważ wynikają one bezpośrednio ze sposobu dawkowania porcji leku określonego przez lekarza.

    Sprawdzanie i przeliczanie dawkowania nie dotyczy jedynie substancji dla których dawki znajdują się tylko w FP IX. Należy sprawdzić także dawki substancji o których wiemy że są z wykazu A, B lub N, a z różnych przyczyn nie znalazły się w aktualnej Farmakopei. To że ich tam nie ma, nie zmienia ich siły działania. Dawek maksymalnych dla takich substancji należy szukać w starszych wydaniach Farmakopei.

   Pierwszym krokiem przy sprawdzaniu poprawności dawkowania powinno być ustalenie farmakopealnej dawki maksymalnej, czy to dobowej czy to jednorazowej. Bardzo często przy odpowiedniej wprawie już to pozwala nam na określenie czy dawka została czy nie została przekroczona. Nie wolno oczywiście zapominać o pacjencie tzn. czy jest osobą dorosłą czy dzieckiem, bo w tym drugim przypadku jesteśmy zobowiązani do odpowiedniej weryfikacji (przeliczenia), zgodnie z zasadami rozliczania dawek dla dzieci. Każdy z farmaceutów ma zapewne swoje sposoby czytelnego przeliczania dawkowania w oparciu o farmakopealny „Wykaz Dawek”, ale z doświadczenia dydaktycznego możemy podpowiedzieć, że wygodnie jest porównywać dawki przeliczone z normą również w postaci prostej tabelki z podziałem na dawki zwykle stosowane i maksymalne, jednorazowe i dobowe. Schemat taki sprawdza się szczególnie jeśli do rozliczenia pozostaje dawkowanie dla dzieci.

   Kolejnym etapem jest ustalenie, jaką parcjalną ilość całej postaci leku – syropu, proszku, mieszanki, czy kropli przyjmie pacjent jednorazowo, a ile dobowo. Ten element przeliczania dawkowania, choć wydaje się banalnie prosty może nastręczyć dużo trudności zwłaszcza, kiedy brakuje dokładnego rozeznania w kwestii tzw. „miar domowych”.

   Problem ten nabiera szczególnego wymiaru, jeżeli postać leku tworzą różne roztwory pod względem charakterystyki fizykochemicznej, na przykład mieszanka roztworu wodnego i syropu lub syropu i nalewki. Gdy ilość leku recepturowego, jaką przyjmie pacjent została w sposób poprawny wyliczona, możemy obliczyć ile w tej ilości znajduje się faktycznie substancji biologicznie czynnej. Ilość tę porównujemy z odczytanymi z Farmakopei dawkami i możemy w sposób jasny i czytelny odpowiedzieć czy dawki maksymalne zostały bądź nie zostały przekroczone.

       Spośród preparatów podawanych wewnętrznie najwięcej obaw związanych jest z obliczaniem dawkowania w kroplach. Nie jest to jednak takie trudne. Prześledźmy cały proces na podstawie hipotetycznej recepty – celowo skomplikowanej obliczeniowo.
 
 
Rp.
Nicethamidi sol. 6,0
Adonidis vern. Trae 6,0    
Kalii Bromidi
Aquae aa 4,0
Luminali natrici 2,0
Chlorali hydrati 1,0

M.f. guttae, S. 3 razy dziennie po 20 kropli

 
   Pierwszą czynnością, zarazem kluczową jest ustalenie ilości gotowej formy leku wyrażonej w gramach jaką pacjent zażyje jednorazowo i dobowo. Żeby tego dokonać, należy pogrupować składniki recepty ze względu na rozpuszczalność w składnikach płynnych lub rozpuszczalnikach stanowiących również składniki recepty. W omawianym przypadku Nicethamid jest roztworem i ma sobie właściwy ciężar jednej kropli, podobnie nalewka z miłka wiosennego. Ale co zrobić z solą sodową luminalu, bromkiem potasu i wodzianem chloralu? Otóż związki te rozpuszczają się w wodzie, dlatego należy wziąć pod uwagę iż ilości tych substancji zwiększą nam masę roztworu wodnego. Zgodnie z powyższym otrzymamy:
 
Nicethamidi sol. - 6,0 grama roztworu
Adonidis vern. Trae - 6,0 grama roztworu
Wodny roztwór bromku potasu, luminalu sodowego i wodzianu chloralu – 11,0
 
   Krople są w jakiś sposób pewną konkretną, ściśle ustaloną objętością – oczywiście na wielkość kropli ma wpływ rodzaj naczynia z którego ta kropla powstaje. Niemniej jednak jeśli mówimy o kroplach recepturowych zawsze mamy na myśli tzw. kroplomierz normalny. Standardowe kroplomierze są wykonane ze szkła praktycznie bezbarwnego. Dolny koniec ma okrągły otwór o płaskiej powierzchni i kącie prostym wobec osi. Mogą być stosowane inne kroplomierze, pod warunkiem, że spełniają wymagania następującego badania wg FP IX. Dwadzieścia kropli wody w temperaturze 20+/-1C wypływających swobodnie z kroplomierza utrzymywanego w położeniu pionowym, przy stałym wypływie 1 kropli na sekundę, waży 1000+/-50mg. Kroplomierz musi być starannie oczyszczony przed użyciem. Należy wykonać trzy oznaczenia z każdym kroplomierzem. Żaden wynik nie może różnić się o więcej niż 5% od średniej z 3 oznaczeń.

   Reasumując, z kroplomierzem normalnym jest tak jak z farmakopealnym pacjentem, według którego wylicza się dawki zwykle stosowane i maksymalne - czyli jest znormalizowany. W myśl definicji kroplomierza normalnego jest to taki kroplomierz z którego 1,0 gram wody wypływa 20 kroplami w temperaturze pokojowej 20°C z kapilary o średnicy u dołu 3mm. O wielkości kropli decyduje: napięcie powierzchniowe cieczy, średnica kroplomierza, wysokość słupa cieczy, czystość powierzchni szkła, temperatura itp.

   Niemniej jednak jesteśmy w dalszy ciągu w kategoriach objętościowych i pojawia się wtedy problem powiązania masy pojedynczej kropli z ilością wagową preparatu farmaceutycznego jaką ma spożyć pacjent. Aby realnie przeliczyć objętość na masę potrzebujemy oczywiście dodatkowej wielkości fizycznej – gęstości w myśl równania:


   I w dalszym ciągu jesteśmy w tak zwanej kropce. Oczywiście moglibyśmy po wykonaniu recepty dokonać pomiaru gęstości otrzymanej cieczy chociażby metodą piknometryczną, ale my potrzebujemy dokonać przeliczeń przed wykonaniem recepty tak, aby w przypadku jakiejkolwiek pomyłki lekarskiej dokonać jeszcze odpowiedniej korekty. Należy tu jeszcze nadmienić, że objętość kropli jest uzależniona od napięcia powierzchniowego cieczy. Z pomocą przychodzi nam tu znowu kroplomierz normalny, a ściślej sporządzone na jego podstawie doświadczenia stabelaryzowane w FP IV podające masę jednej kropli wybranych cieczy a także ilość kropli która mieści się w jednym gramie.
 
Tabela 2. Ilość kropli cieczy zawartych w gramie i ciężary 1 kropli według FP IV.

*kliknij, aby powiększyć

   W rubryce 2 podano ilość kropli, wypływających z kroplomierza normalnego z 1,0 grama różnych cieczy w temperaturze 15-200C. W rubryce 3 podano ciężary kropli różnych cieczy, wypływających z kroplomierza normalnego w temp. 15-200C. Dokładność danych jest na poziomie +/-5%.

   Dla cieczy czy też roztworów nie występujących w tej tabeli możemy dokonać prostego pomiaru w aptece, korzystając po prostu z kroplomierza normalnego, odważając dokładnie jeden gram danej cieczy i licząc jednocześnie ilość kropli.

   Oczywiście chcielibyśmy wykonywać leki jak najdokładniej w myśl powszechnie używanego sformułowania „dokładnie jak w aptece”. Niemniej jednak do prawidłowego wykonania recepty wystarczą nam pewne przybliżenia. Jesteśmy tak naprawdę ograniczani dopuszczalnym odchyleniem od zawartości substancji czynnej w pojedynczej dawce preparatu, która nie może przekroczyć średnio 5%.

   W związku z powyższym w oparciu o tabelę 2 z FP IV obliczamy masę porcji jednorazowej lub dobowej przyjmowanej przez pacjenta w oparciu o średni ciężar jednej kropli. Problem może pojawić się wówczas gdy w skład recepty na krople wchodzą dwie różne ciecze – o różnym napięciu powierzchniowym i różnej gęstości i dodatkowo jakieś substancje stałe. Gdyby pominąć substancje stałe, ciężar kropli cieczy obliczylibyśmy jako średnią arytmetyczną. Dla substancji stałej nie mamy siłą rzeczy określonej masy kropli. Przyjmujemy wówczas, że substancja stała tworzy z odpowiednią cieczą roztwór, dla którego mamy już określone potrzebne parametry jak ciężar kropli czy ilość kropli w gramach. Do ustalenia - i jest to niejako kluczowy element - pozostaje jaki roztwór utworzy dana substancja stała. Musimy tutaj odnieść się do jej rozpuszczalności i przyjmujemy zasadę, że substancja tworzy roztwór z tą cieczą, w której jest lepiej rozpuszczalna. Ma to zresztą przecież wpływ na samo wykonanie – najpierw substancje rozpuszczamy w odpowiednim rozpuszczalniku, a dopiero później łączymy roztwory.

   Podobne rozważania, dotyczące takich samych kwestii powinniśmy przeprowadzić dla innych postaci leku płynnego ad usum internum. W takich postaciach leku, zamiast kroplami posługujemy się miarami domowymi takimi jak łyżka czy łyżeczka. Różnice w masach dla tych miar domowych są zależne od gęstości cieczy (napięcie powierzchniowe nie odgrywa tu najważniejszej roli) i są dość spore. Ale tym zajmiemy się w kolejnym artykule.

dr n. farm. Michał Krzysztof Kołodziejczyk
Specjalista Farmacji Aptecznej
Starszy Wykładowca
Zakład Technologii Postaci Leku
Katedra Farmacji Stosowanej
Uniwersytet Medyczny w Łodzi

dr n. farm. Michał J. Nachajski
adiunkt
Zakład Technologii Postaci Leku,
Uniwersytet Medyczny w Łodzi
 
Fot. Fotolia.pl

Piśmiennictwo:
[1]    Farmakopea Polska IX, tom II, URPL, WMiPB, 2011, Warszawa, Polskie Towarzystwo Farmaceutyczne.
[2]    Farmakopea Polska IV, tom II, PZWL, 1970, Warszawa.
[3]    Krówczyński L.: Ćwiczenia z receptury, Collegium Medicum UJ, 1994, Kraków
[4]    Krówczyński L., Jachowicz R.: Ćwiczenia z receptury, Wydawnictwo Uniwersytetu Jagiellońskiego, 2000, Kraków

 
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