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04.2012 - "Repetytorium do specjalizacji. Proszki w recepturze." Drukuj Email
kwiecień 2012, nr 68/46 online
 
PROSZKI W RECEPTURZE


    Proszki są stałą postacią leku składającą się z homogennych cząstek o określonym stopniu rozdrobnienia. W zależności od przeznaczenia wyróżniamy:
- proszki do użytku wewnętrznego (Pulveres perorales) - wielkość cząstek nie większa niż 0,5 mm;
- proszki do użytku zewnętrznego, tzw. pudry lecznicze lub zasypki (Pulveres ad usum dermicum) stosowane na skórę lub błony śluzowe - wielkość cząstek nie większa niż 0,16 mm.     
   Proszki mogą być podawane w formie stałej lub po rozpuszczeniu w formie roztworów czy zawiesin. Jeżeli stosowane są do sporządzania płynnych preparatów do oczu lub płynów infuzyjnych, muszą spełniać wymagania farmakopealne dotyczące danej postaci leku.

   Jeżeli postać leku stanowi jedna sproszkowana substancja lecznicza są to proszki proste (Pulveres simplices), a jeżeli jest to mieszanina sproszkowanych substancji, to są to proszki złożone (Pulveres compositi, Pulveres mixti).

   Wśród proszków do receptury wyróżniamy proszki rozcieńczane (Pulveres triturati) zwane również rozcierkami. Proszki rozcieńczane sporządza się poprzez roztarcie substancji bardzo silnie działającej z laktozą w stosunku 1+1 (1:2), 1+9 (1:10), 1+99 (1:100). Proszki takie przygotowuje się w celu dokładnego odważenia substancji bardzo silnie działających.  Najczęściej są to: Atropini sulfas trituratio 1:10, Strichnini nitras trituratio 1:10, Scopolamini hydrobromidum trituratio 1:100. Przykładem rozcierki sporządzonej w celu zmniejszenia higroskopijności proszku jest Belladonnae extractum siccum trituratio 1:2.
   Podstawową zasadą sporządzania proszków jest zachowanie właściwej kolejności dodawania składników. Polega to na zatarciu porów moździerza substancją, której jest najwięcej, a następnie dodawaniu substancji od najmniejszej ilości do największej. Należy pamiętać o dokładnym mieszaniu po każdym dodaniu kolejnego składnika. Nigdy nie zacieramy porów moździerza talkiem.

   Jeżeli w skład proszków wchodzi substancja lecznicza, która nie jest dostępna w postaci pro receptura, a tylko w postaci tabletek, to sporządzanie proszku należy rozpocząć od obliczenia liczby tabletek jaka będzie potrzebna do wykonania preparatu oraz zważenia ich. W takim przypadku tabletki należy miałko sproszkować przed dodaniem i wymieszaniem z następnymi składnikami.

   Trudność może sprawiać recepta z propranololem dla dziecka o masie ciała 10 kg:

Rp.                    
Propranoli 0,001
Lactosi 0,1
M.f. pulv.

D.t.d. No XX
D.S. 1 x dziennie proszek

    Propranolol nie występuje jako proszek do receptury, a jedynie jest dostępny w postaci tabletek w dawce 10 mg i 40 mg. Przed przystąpieniem należy sprawdzić, czy nie została przekroczona dawka maksymalna propranololu obliczając ją według wzoru Clarka.

Dj max = 0,08     wg. FP IX
Dd max = 0,48

dawka dla dziecka = 0,01, a zatem dawki jednorazowa jak i dobowa dla dziecka nie zostały przekroczone.
   Aby wykonać powyższą receptę należy użyć 20 mg substancji leczniczej (2 tabletki w dawce 10 mg) i 2 g laktozy. Wybrane tabletki zważyć, sproszkować w moździerzu i wymieszać z laktozą. Po dokładnym wymieszaniu wyliczyć masę pojedynczego proszku. W tym celu należy dodać masę dwóch tabletek 0,234 g do 2 g laktozy i podzielić na 20 proszków, wówczas otrzymamy masę pojedynczego proszka równą 0,112 g. Odważyć każdą pojedynczą dawkę do kapsułki skrobiowej o odpowiedniej wielkości. Napełnione kapsułki umieścić w białej torebce z odpisem recepty.
Rp.
Ephedrini hydrochloridi  0,01
Clemastini 0,0005
Calcii lactatis 0,3

M.f. pulv. D.t.d. No XV
D.S. 3 x dziennie proszek
   Do sporządzenia 15 proszków należy użyć 0,15 g chlorowodorku efedryny, 4,5 g mleczanu wapnia oraz 0,0075 g klemastyny. W aptece klemastyna znajduje sie w postaci tabletek w dawce 1 mg o masie 0,12 g. Chociaż z obliczeń wynika, że należałoby użyć 7,5 tabletki to należy jednak przygotować 8 tabletek. Zważona masa 8 tabletek wynosi 0,96 g o zawartości substancji leczniczej 0,008 g. Jeżeli 0,96 g sproszkowanych tabletek zawiera 0,008 g substancji to potrzebne 0,0075 g znajduje sie w:

0,96   - 0,008
  x       - 0,0075
x = 0,9 g sproszkowanych tabletek
    
    Do wykonania preparatu należy sproszkować w moździerzu 8 tabletek klemastyny. W oddzielnym moździerzu należy zatrzeć pory częścią mleczanu wapnia, dodać 0,15 g chlorowodorku efedryny, następnie dodać 0,9 g sproszkowanych tabletek oraz resztę mleczanu wapnia mieszając po każdym dodaniu nowej porcji proszku. Odważyć masę 1 proszku 0,37 g do kapsułki skrobiowej i według odważki wzorcowej rozsypać do pozostałych kapsułek skrobiowych.

   Innym problemem może być przekroczenie dawki maksymalnej. W składzie recepty występuje Pabialgina P w postaci tabletek. Chociaż nie jest ona już dostępna w aptece, to nadal jest opisywana w obowiązujących podręcznikach.

Rp.
Atropini sulfatis 0,0005
Propyphenazoni  0,3
Papaverini hydrochloridi 0,04
Pabialgini P 0,3

M.f. pulv. D.t.d. No XX
D.S. 2 x dziennie proszek

    Siarczan atropiny należy do wykazu A. Do wykonania proszków zawierających tę substancję używa się wcześniej sporządzonego proszku rozcieńczonego Atropini sulfatis trituratio 1:10. W omawianej recepcie należy odważyć dziesięciokrotną ilość (tzn. 0,005 g) rozcierki z atropiny na jeden proszek. Pabialgina P w postaci tabletek składa się z propyfenazonu  220 mg oraz allobarbitalu 30 mg (220 mg + 30 mg = 250 mg) o masie 320 mg. W celu obliczenia, czy nie została przekroczona dawka maksymalna dla propyfenazonu należy obliczyć ilość propyfenazonu występującego w Pabialginie P.

   Jeżeli 250 mg (1 tabletka) Pabialginy P zawiera 220 mg propyfenazonu to w 300 mg (0,3 g) jest:

250 - 220
300 - x
x = 264 mg ≈ 0,26 g  propyfenazonu

   A zatem należy zsumować ilość propyfenazonu z Pabialginy P w ilości 0,26 g  oraz 0,3 g propyfenazonu per se: 0,26 + 0,3 = 0,56 g, co odpowiada dawce jednorazowej, natomiast dawka dobowa wynosi 2 x 0,56 = 1,12 g.

   Dawka maksymalna dobowa dla propyfenazonu wg. FP IX wynosi 0,8. Dawka maksymalna dobowa została przekroczona, należy zmniejszyć ilość propyfenazonu do dawki maksymalnej. Zatem należy podzielić dawkę dobową na 2 dawki jednorazowe: 0,8 g : 2 = 0,4 g, i zmniejszyć ilość propyfenazonu do dawki 0,4 g w następujący sposób: 0,4 - 0,26 (propyfenazon z Pabialginy P) = 0,14 g.  Jak wynika z obliczeń należy użyć na 1 proszek  propyfenazonu per se 0,14 g i Pabialginy P 0,3 g.

     Do sporządzenia 20 proszków należy użyć 0,1 g atropiny w postaci rozcierki (0,0005 x 10 x 20 = 0,1 g), 0,8g chlorowodorku papaweryny, 2,8 g propyfenazonu (0,14 g x 20 proszków = 2,8 g) oraz 24 tabletki Pabialginy P. Masa sproszkowanych 24 tabletek  wynosi 7,68 g.

   Pory moździerza zatrzeć częścią sproszkowanej Pabialginy P, następnie dodawać według kolejności 0,1 atropiny w rozcierce, 0,8 g papaweryny, 2,8 g propyfenazonu, oraz resztę Pabialginy P mieszając pistlem po każdym dodaniu nowej porcji proszku. Odważyć masę 1 proszka  0,569 g do kapsułki skrobiowej i według odważki wzorcowej rozsypać do pozostałych. Napełnione kapsułki umieścić w białej torebce z odpisem recepty.

   Innym przykładem może być niezgodność polegająca na hydrolizie kwasu acetylosalicylowego.
Rp.     
Belladonae extr. sicci 0,02
Acidi acetylosalicylici 0,3
Methenamini 0,5

M.f. pulv. D.t.d. No XX
D.S. 2 x dziennie proszek

    Metanamina w obecności niewielkiej ilości wody jaka znajduje się w wyciągu daje alkaliczny odczyn w którym następuje hydroliza kwasu acetylosalicylowego. Powstaje higroskopijny kwas octowy i cały proszek wilgotnieje. Należy rozdzielić składniki wydzielając kwas acetylosalicylowy. Osobno wykonuje się proszki z wyciągiem z pokrzyku i metenaminą, a osobno z kwasem acetylosalicylowym.


dr n. farm. Katarzyna Świąder
Katedra i Zakład Farmacji Stosowanej
Uniwersytet Medyczny w Lublinie

Piśmiennictwo:
Farmakopea Polska IX. PTF Warszawa 2011.
Farmakopea Polska IV PTF Warszawa 1970.
Jachowicz R.: Receptura apteczna. Warszawa PZWL 2010.
Jachowicz R.: Farmacja praktyczna. PZWL 2010.
Janicki S. i wsp.: Farmacja stosowana. Warszawa PZWL 2002.
Krówczyński L, Jachowicz R.: Ćwiczenia z receptury. Wydawnictwo UJ 2000.
Fot. Fotolia.com
 
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