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12.2012 - "Przykłady niezgodności chemicznych w mieszankach i roztworach." Drukuj Email
grudzień 2012, nr 76/54 online

   W praktyce aptecznej farmaceuta niekiedy spotyka się z możliwością wystąpienia niezgodności w składzie recept. Niezgodności chemiczne powstają wskutek oddziaływania pomiędzy składnikami leku. W wyniku reakcji zachodzących pomiędzy kwasami i zasadami, reakcji podwójnej wymiany, reakcji red-ox oraz hydrolizy mogą powstać nowe związki co prowadzi do zaniku, zmiany lub zmniejszania działania leczniczego. Powstające niezgodności mogą być widoczne między innymi w postaci tworzenia się osadów lub zmiany zabarwienia. Niekorzystne zmiany ujawniają się od razu, stopniowo lub dopiero po pewnym czasie.

   Znajomość rozpuszczalności substancji, odczynu pH danej substancji, przestrzeganie właściwej kolejności dodawania składników oraz właściwy sposób przechowywania pozwala na uniknięcie niezgodności.
   Po zauważeniu wystąpienia niezgodności farmaceuta może:
- częściowo zamienić rozpuszczalnik np. poprzez dodanie etanolu (max do 5% w stosunku do całej ilości leku);
- zamienić formę nierozpuszczalną na rozpuszczalną lub odwrotnie po uwzględnieniu różnic w masie cząsteczkowej, np. zamiana fenobarbitalu na fenobarbital sodowy, kodeiny na fosforan kodeiny, teofiliny na aminofilinę;
- dodać środek obojętny w celu zawieszenia osadu;
- dodać środek rozcieńczający, na przykład laktozę;
- wydać osobno niezgodny składnik;
- zastosować odpowiednią kolejność mieszania składników.
   Farmaceuta samodzielnie może wydać lek z osadem, jeżeli ilość osadu jest niewielka i nie zawiera składników silnie działających, zaopatrując butelkę w etykietę "Zmieszać przed użyciem".
Ephedrini hydrochloridi 0,5
Phenobarbitali natrici 0,2
Tussipect sir. 30,0
Aquae ad 100,0

M.f. mixt.
D.S. 3 x dziennie łyżkę


   W recepcie tej występuje niezgodność pozorna, należy więc oddzielić maksymalną ilością wody chlorowodorek efedryny od fenobarbitalu sodowego alkalizującego środowisko. Przepisany syrop zawiera w swoim składzie chlorowodorek efedryny (0,07g substancji/100g syropu) co należy uwzględnić przy obliczaniu dawek. Według FP IX dla chlorowodorku efedryny dawka jednorazowa wynosi 0,05g, a dobowa 0,15g.

   Przykładowe obliczanie recepty:
0,07 - 100,0
x - 30,0
x = 0,021g - zawartość chlorowodorku efedryny w syropie.

0,021g + 0,5g = 0,521g – łączna ilość chlorowodorku efedryny w recepcie.

Średnia masa łyżki wynosi 16,0g.
0,521 - 100,0
x - 16,0
x = 0,083 g dawka jednorazowa, dobowa 3 x 0,083g = 0,249g.
Dawki zostały przekroczone, należy je zmniejszyć.
0,15g : 3 = 0,05g
0,05 – 16,0
x - 100,0
x = 0,312g
0,312g - 0,021g = 0,29g tyle należy odważyć chlorowodorku efedryny.
   W osobnych zlewkach należy rozpuścić fenobarbital sodowy i chlorowodorek efedryny. Do wytarowanej butelki przelać roztwór fenobarbitalu sodowego, dodać syrop Tussipect, a na końcu rozpuszczony chlorowodorek efedryny.
Phenobarbitali natrici 1,0
Sol. Sal Erlenmeyeri 3,0/50,0
Neospasmini 30,0
Aquae ad 100,0

M.f. mixt.
D.S. 2 x dziennie łyżkę
   Mamy tu do czynienia z niezgodnością typu wytrącania słabego kwasu. Przy stężeniu 1% fenobarbitalu sodowego zawsze występuje niezgodność z bromkiem amonu, składnikiem soli Erlenmeyera. Należy ilość bromku amonu zamienić na bromek potasu i bromek sodu w równych częściach.

   Przykładowe obliczenia:
Skład soli Erlenameyera: 2 cz. KBr, 2 cz. NaBr, 1 cz. NH4Br
2 - 5
X - 3
x = 1,2 KBr i NaBr
NH4Br = 0,6

   Skład recepty powinien być następujący:


Phenobarbitali natrici 1,0
Natrii bromidi 1,5
Kalii bromidi 1,5
Neospasmini 30,0
Aquae ad 100,0

Phenobarbitali natrici 0,3
Papaverini hydrochloridi 0,4
Neospasmini 15,0
Aquae ad 100,0

M.f. mixt.
D.S. 3 x dziennie łyżkę deserową
   Występuje tu niezgodność typu wytrącania słabej zasady. W obecności alkalicznego fenobarbitalu wytrąca się trudno rozpuszczalna zasada. Papawerynę należy podać osobno w postaci 10 proszków.
Masa 1 łyżki to 10g, 100 : 10 = 10 dawek
0,4g : 10 = 0,04g - ilość chlorowodorku papaweryny na 1 proszek.

Masa 1 proszka jest mniejsza od 0,1g dlatego należy uzupełnić go laktozą do 0,1g.
0,1g – 0,04g = 0,96g - ilość laktozy na 1 proszek.
0,96g x 10 = 9,6g – ilość laktozy na 10 proszków.


   Fenobarbital sodowy rozpuścić w zlewce w części wody, przelać do wytarowanej butelki, dodać Neospasminę i uzupełnić wodą do 100 g.

   Odważyć chlorowodorek papaweryny w ilości 0,4g oraz 9,6 g laktozy. Zatrzeć pory moździerza częścią laktozy, dodać chlorowodorek papaweryny oraz resztę laktozy. Rozsypać według naważki wzorcowej do opłatków skrobiowych.

   Reakcja podwójnej wymiany zachodzi podczas wytrącania się bromowodorków i jodowodorków alkaloidów. Bromki lub jodki przepisane w mieszankach w ilości 5% lub więcej dają niezgodności z następującymi alkaloidami: fosforanem kodeiny, siarczanem chininy, chlorowodorkiem morfiny, chlorowodorkiem papaweryny (osady powstają również jeżeli stężenie bromków lub jodków wynosi tylko 2%).
Kalii iodidi 2,0
Papaverini hydrochloridi 0,2
Aquae ad 100,0

M.f. sol.
D.S. 3 x dziennie łyżeczkę
   W powyższej recepcie stężenie jodku potasu wynosi 2%, a chlorowodorku papaweryny 0,2%. Nastąpi więc wytrącenie jodowodorku papaweryny. W celu wyeliminowania niezgodności należy sporządzić dwa osobne roztwory lub papawerynę podać osobno w postaci proszków.
Natrii bromidi 5,0
Codeini phosphatis 0,1
Aquae ad 100,0

M.f. sol.
D.S. 3 x dziennie łyżeczkę
   W recepcie występują bromki w ilości 5% oraz alkaloidy kodeiny w ilości 0,1%.  Osad nie wytrąci się. Gdyby stężenie fosforanu kodeiny było 0,5% lub wyższe wtedy nastąpiłoby wytrącenie osadu.
Sol. Rivanoli 1‰
Aquae Calcis  aa 50,0
M.f. sol
S. zew
   Rywanol (mleczan etakrydyny) reaguje z wodorotlenkiem wapnia zawartym w wodzie wapiennej. Powstaje mleczan wapnia oraz wytrąca się etoksydwuaminoakrydyna. Rywanol w roztworach alkalicznych nie jest aktywny. Poprawa recepty polega na rozdzieleniu składników.

   Wzrastająca liczba nowych substancji leczniczych, a także licznych ich kombinacji stwarza nowe możliwości pojawiania się niepoznanych jeszcze niezgodności.

dr n. farm. Katarzyna Świąder
Katedra i Zakład Farmacji Stosowanej
Uniwersytet Medyczny w Lublinie
1. Jachowicz R.: Receptura apteczna. PZWL. Warszawa, 2010.
2. Krówczyński L., Jachowicz R.: Ćwiczenia z receptury. Wyd. UJ. Kraków, 2000.
3. Farmakopea Polska IX , Warszawa 2011.
4. Modrzejewski F.: Niezgodności recepturowe, PZWL Warszawa 1964.

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