tehnologie farmaceutic

7/24/2019 tehnologie farmaceutic

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TEHNOLOGIE FARMACEUTIC, FARMACIE AN IV, SEM. II, LP. 6, 23-27. 03. 2015

PREPARATE SEMISOLIDE PENTRU APLICAII CUTANATE(PRAEPARATIONES MOLLES AD USUM DERMICUM) FR X, SUPLIMENT 2004

UNGUENTE (UNGUENTA) - FR X

Pre!r!"e#e $e%&$'#&(e e)"r* !#&+!re +*"!)!" $*)" (e$"&)!"e *)e& e#&err& #'+!#e $!*

"r!)$(er%&+e ! $*$"!)e#'r !+"&/e $!* e)"r* !+&*)e! #'r r'"e+"'!re $!* e%'#&e)". E#e !* !$e+"

'%'e). FR , S*#. 2004

U)*e)"e#e $*)" re!r!"e !r%!+e*"&+e $e%&$'#&(e (e$"&)!"e !#&+r&& e &e#e $!* e

%*+'!$e, &) $+' "er!e*"&+ $!* (e r'"e+&e $*)" +')$"&"*"e (&) e+&&e)& !8e (e *)*e)"4 &) +!re

$e (&$er$e!8 $*$"!)e %e(&+!%e)"'!$e.

9) *)+&e (e r!(*# (e (&$er$&e !# $*$"!)e#'r !+"&/e, *)*e)"e#e '" &: *)*e)"e-$'#*&&,

*)*e)"e-e%*#$&&, *)*e)"e-$*$e)$&& $!* *)*e)"e +* %!& %*#"e !8e %&"e $!* '#&!8&+e4 ;

Unguenta, FR .

FR , $*#. 200


2/53

e$"e 25 - FR 4 &&, e$"e !)*%&"e

+')+e)"r!>&& '" & e#*r& ?&(r'e $!* #&'e 'r!)'e#*r& $!* '#e'e#*r&4. A* *)+" (e


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*)*e)"L@H +re%e,U)*e)"e-$*$e)$&& !$"e4,U)*e)"e-'#&!8&+e %&"e4

Pr'+e(e*# (e !r&+!>&e

U)*e)"e $"ere

U)*e)"e#e '"!#%&+e,U)*e)"e#e +* !)"&&'"&+e,U)*e)"e#e !(%&)&$"r!"e e r)&(e$+?&$e, &e#e! #e8!", &e#e!$*!r'r

U)*e)"e e)"r* +!re $e

re/e(e ' !)*%&"

S"r!"*# $*er&+&!# !# &e#&&

U)*e)"e e)('(er%&+e, +*!+>&*)e %!& &e

A*) (e #! #'+*# (e !(%&)&$"r!re


4/53

CARACTERELE I CONTROLUL CALITII UNGUNETELOR

9) FR $*)" &&, ('8!re! $*$"!)>e#'r

%e(&+!%e)"'!$e.

Ex!"#$% &'&"'"%' !&'*&+&"

U)*e)"e#e "re*&e $ !& *) !$e+" '%'e) =& $ re8&)"e +*#'!re! =& %&r'$*#

+!r!+"er&$"&+e +'%')e)"e#'r.

Caractere vizuale

aspect: *)*e)"e#e "re*&e $ !& *) !$e+" '%'e) =& $ re8&)"e +*#'!re! =& %&r'$*#

+!r!+"er&$"&+ +'%')e)"e#'r !$e+"*# '!"e & (e$+r&$ +!:

$"r#*+&"'r, #*+&'$-%"$'$ $!"&)!"4 $!* %!"

"r!)$!re)", "r!)$#*+&(, '!#e$+e)" $!* '!+.

consistena: $e (e$+r&e r&):

' r&&(&"!"e, $"!re +'%!+" $!* !)"

' e#&&+!re er% $!* +!re "re%*r

omogenitate: *)*e)"*#


5/53

+3-*# *)*e)"e#'r "re*&e $ &e +*r&)$ &'%e"r&+. 9) +!8*# ?&(r'e#*r'r, H-*# '!"e & (e"er%&)!" (&re+" e

r'(*$ $!* r&) (*!re +* !.

D""'!#'" **"#"

C')$&$"e)>! e$"e (e&)&" +! r'r&e"!"e! *)*e)"*#*& (e ! $e '*)e #! (e'r%rer'/'+!"e (e 'r>e#e e"er&'!re e! re#e/ +!r!+"ere#e re'#'&+e !#e *)*e)"*#*& +!: r&&(&"!"e!

(*r&"!"e!, #!$"&+&"!"e!, &'!(e8&/&"!"e!, er%e!&"!"e!.

9) *)+>&e (e +')$&$"e)>, *)*e)"e#e $e +#!$&&+


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F 1 - 1,5 !8e (e *)*e)" &)(&ere)"e e)"r* &e#e,

F 1,6 - 1,D !8e (e *)*e)" +* !+!)"'8 /&8&, (!r %'(er!",

F 2 - !8e (e *)*e)" +* !+!)"'8 r')*)>!", F !8e (e *)*e)" +* !+!)"'8 '!r"e r')*)>!", &r&"!)"e e)"r* &e#e.

M!'r&"!"e! e+&&e)>'r !* !+"'r& (e !+!)"'8 %e(&&, B) #! 2, %!& *>&)

+'re$*)8"'!re $*)": /!$e#&)!, !r!&)!, *#e&*# (e r&+&).

C#*"'7'" 9) re+&&e)"e &)e


7/53

AJE E UNGUENT - PREPARARE

!8e#e (e *)*e)" $*)" !#+"*&"e (e '&+e& (&) !%e$"e+*r& (e e+&&e)&, %!& r!r (&) *)*#

$&)*r. &) *)+" (e /e(ere +!)"&"!"&/ !+e$"e! rere8&)" +e! %!& %!re !r"e (&)"r-*) *)*e)" $&

&%r&%! re!r!"*#*& +')$&$"e)"! ('r&"!. !+! $*)" '#'$&"e +! !"!re !* !+>&*)e r'"e+"'!re #!

!$'+&ere! +* $*$"!)e !+"&/e /'r !/e! r'# "er!e*"&+.

O&)ere! !8e#'r (e *)*e)" r&) r'+e(e*# (e "'&re e$"e )e+e$!r !"*)+& +B)( !+e$"e! !*

*)+"e (e "'&re (&er&"e, $!* e$"e *K*r!" (&8'#/!re! *)'r r&)+&&& !+"&/e.

Pr&)


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T'!"e !+e$"e !8e #! !#&+!re e &e#e #!$ ' *r%! r!$! +!re )* $e '!"e & e%*#$&/e '" &)+'r'r! !! +! !8! &)"er)! $& $e )*%e$+ !8e (e !$'r>&e.

E: U)*e)"*# $&%#* F.R. 4,

U)*e)"*# +* !#+''#& (e #!)! F.R. I4

O $+?e%!"&8!re ! !8e#'r (e *)*e)" r!$e $-!r *"e! re8e)"!


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!$'#*" #! &erere, e)8e) $& +#'r''r%, *$'r $'#*! &) !+e"!" (e e", !+e"')!, e"er $& e"er (e

e"r'#, r!+"&+ &)$'#*! &) !! e$"e %&$+&! &) $"!re "'&"! +* *#e&*r& /ee"!#e $& !r!&)!

#&+?&(!. Are *)+"*# (e &+*r!re 36-2C.

V!$e#&)! !#! e$"e *) !%e$"e+ $e%&$'#&( (e ?&(r'+!r*r& $!"*r!"e, '"&)*"e (&) e"r'#,

*r&&+!"e $& (e+'#'r!"e. E$"e %!$! !#!, +* !$e+" '%'e), !)"!, ')+"*'!$!, '!+! &) $"r!" r'$ $&

"r!$#*+&(! &) $"r!" $*"&re, !r! %&r'$ $& !r! *$". I) $"!re "'&"! e !&! (e !! "re*&e $! $e

re8&)"e +! *) #&+?&( "r!)$!re)", !r! $e(&%e)", !r! &%*r&"!"& %e+!)&+e, !r! %&r'$ $& +* ' $#!!

#*'re$+e)"! /er(e-!#!$"r*&e. E$"e *$'r $'#*! &) !+e"')!, e)8e), +#'r''r%, r!+"&+ &)$'#*! &)

!!, !#+''#, #&+er'#.E$"e %&$+&! +* *#e&*r& r!$e $& !r!&)! #&+?&(!. Are *)+"*# (e &+*r!re 3-

55C.

!+! $e !(!*! +'#e$"er'# $!* !#+''# +e"&+ $e %!re$"e +!!+&"!"e! (e &)+'r'r!re ! !e&

!+e$"e! $e /'r $+!(e (&) +!)"&"!"e! (e /!$e#&)! !#! (&) 'r%*#! $& )* (&) #!)'#&)! (e'!re+e

#!)'#&)! (e"er%&)! +')$&$"e)"! re!r!"*#*&.

8A9E DE UNGUENT EMULSIE A:U

A+e$"e !8e (e *)*e)" +')"&) e+&&e)& #&'& +! !8! e"er)! $& !! $!* ' $'#*"&e


10/53

OSERVATII

e +!"e 'r& $e re$+r&e #!)'#&)! $e /! '#'$& #!)'#&)! ?&(r!"!"! +* +')(&"&! +! $*$"!)"e#e

!+"&/e !$'+&!"e $! &e $"!e &) %e(&* !'$. !+! *r%!r&% &)+'r'r!re! *)'r +!)"&"!"& %!r& (e !!

$!* $'#*"&e !'!$! $e /! '#'$& #!)'#&)! !)?&(r!. L!)'#&)! ?&(r!"!"! '!"e +')&)e !)"&'&(!)"&, (!r &)

!+e$" +!8, !+e$"&! "re*&e %e)"&')!"& e e"&+?e"! re+&&e)"*#*&.

Se +')$er/! &) re+&&e)"e &)e &)+?&$e, er&" (e #*%&)!, #! +e# %*#" 25C.

INTREUINTARI

N* $e '#'$e="e +! !"!re /! &)"r! &) +'%'8&"&! *)'r !8e (e *)*e)" !#!"*r& (e !#"&e+&&e)"& #&'&.

8A9E DE UNGUENTE EMULSIE U:A

U)*e)"e#e e%*#$&e U@A !* ('* !8e:

- ' !8 e"er) rere8e)"!" (e ! $!* (e ' $'#*&e !'!$,

- ' !8 &)"er) +!re e$"e !#+"*&" (&) e+&&e)& #&'&.

9) $&$"e% $*)" re8e)& +'%')e)& +* r'r&e"& e%*#$&/e (e "& U@A, )e+e$!r& e)"r*

$"!&8!re! $&$"e%*#*&.

E%*#!"'r&& '#'$&& $*)":


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UNGUENTUM EMULSIFICANS (FR X)

U)*e)" e%*#!"'r

A#+'?'#*% +e"#$"e!r#&+*% e%*#$&&+!)$ 30

P!r!&)*% #&*&(*% 35

V!$e#&)*% !#*% 35

PREPARARE

A%e$"e+*# (e $*$"!)e $e "'eK"e e !&! (e ! K& !'& $e "r&"*re!8 B) #! r+&re e)"r*

'%'e)&8!re.

OSERVAII

A#+''#*# +e"$"e!r&+ e%*#!"'r $!* +e!r! L!)e""e $e '&)e (&):

Ce"$"e!r$*#!" (e $'(&* 10

A#+''# +e"$"e!r&+ D0

A 5

A#+''#*# +e"$"e!r&+ $e


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C+&""%'"

A."67"

C'&"'"&%"

G'. ."

+"#"''";# +"%"

S/%"

T%"'#&$#

A&$#""'+"$&

Ex"!+%"


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(e'$e&" &)+'%!"&&">'r e)er!"e %!& !#e$ (e +!r!+"er*# &')'e) !# +'%')e)"e#'r.*+"&"!"e! ?&(r'e#*r'r $!* ! ! e#*r'r +* PEG $e '!"e &! !+e$"'r!. Ge#*re *>&)/B$+'!$e $e *"&8e!8 +! & e)"r* +!"e"ere, %)*=& (e e!%&)!re $!*+?&r*r&+!#e. Ge#*re '" & *"&8!"e, (e !$e%e)e!, +! !8e (e *)*e)"


14/53

!e&. 9) !+e$" $+' $e *"&8e!8 +! *%e+"!)>&: #&+er&)!, r'e)#&+'#*#, $'r&"'#*#, +!re !*" #!re>&)ere! !e&.

Conservanii "re*&e $ &e +'%!"&& +* !e)>&& 'r%!"'r& (e e#. N&!&) =& )&!$'#, &e

$&)*r&, &e &ere+'%!)(!"e $*)" (e 0,1-0,2 e)"r* )&!&) =& 0,02-0,05 e)"r* )&!$'#. A#>& +')$er/!)>&*"&8!>& e)"r* e#*r& $*)": +#'r'+re8'#*#, !+&(*# e)8'&+, +#'r*r! (e e)8!#+')&*, !+e"!"*# (e+#'r?e&(&).

UNGUENTUM MACROGOLI (FR X)U#1$"#$% &$ +%"%"#1%&%

M!+r''# 00 50M!+r''# 000 50

PREPARAREA%e$"e+*# $e "'e$"e e !&! (e !! #! !r'. 60'C $& !'& $e "r&"*re!8! !)! #! r!+&e e)"r*

'%'e)&8!re.

ESCRIEREU)*e)" '%'e), (e +*#'!re !#!, +* !$e+" $&(e'$, !r'!e !r! %&r'$.OSERVATIIM!+r''#&&, +!r'! $!* '#&e"e)#&+'#&& $*)" '#&%er& (e +')(e)$!re !& '&(*#* (e e"e)

+* !!. S*)" '!r"e *$'r $'#*& &) !!, !+e"')!, !#+''# $& +#'r''r% r!+"&+ &)$'#*& &) e"er,!r!&)! #&+?&(! $& *#e&*r& r!$e. S"!re! (e !re!re (e&)(e (! %!$! %'#e+*#!r!: %!+r''#&& 200 $&00 $*)" #&+?&(e /!$+'!$e, !r'!e &)+'#'re, #&%e8& +* %&r'$ $#! +!r!+"er&$"&+, +* *$" &)"!& (*#+e,


15/53

UNGUENTUM GL>CEROLI (FRX)U#1$"# &$ 1%&"'%

A%#*% 7,00Me"?#&$!r!?(r'e)8'!$ 0,1Pr'#&$!r!?(r'e)8'!$ 0,02G#+er'#*% D3,00A*! (&$"#!"! 7,00

S&)')&%: #&+er'#!" (e !%&('), *)*e)" (e #&+er&)!.

PREPARAREI)"r-' +!$*#! (e 'r"e#!) &) re!#! +!)"!r&"! $& &)+!#8&"! $e !(!*! !%&(')*#, )&!e$"r&& $&

!! &)+!#8&"! #! !r'. 700C. Se #!$! #! &%&!" !r'&%!"&/ 10 %&)., $e !(!*! #&+er&)! &)+!#8&"! e!&! (e !! #! !r'. D00C $& $e &)+!#8e$"e e $&"! !)! #! e#&&+!re. Se +'%#e"e!8! +* !! &)+!#8&"!#! %!$! re/!8*"!.

ESCRIEREU)*e)" '%'e), &)+'#'r, "r!)$#*+&( +* %&r'$ +!r!+"er&$"&, ?&r'$+'&+.

OSERVATIIA%&(')*# e$"e ' *#ere &)!, !#!, !r! %&r'$ $& !r! *$". E$"e r!+"&+ &)$'#* &) !#+''# $&!! #! ' "e%er!"*r! &)"re -150C. Are ('*! +'%')e)"e: !%!8! +* $"r*+"*r! &'r%!, $'#*! &)!! $& !%'e+"&)! +* $"r*+"*r! r!%&&+!"! +!re 'r%e!8 ' re>e! "r&(&%e)$&')!#! re$')$!! (e$"r*+"*r! (e e#.

E&$"! %!& %*#"e $'r"*r& (e !%&(') &) *)+>&e (e r'/e)&e)"!: (e r!* , (e 'r*%, (e 're8,(e +!r"'&. Pe)"r* '>&)ere! #&+er'#!"*#*& $e reer! '#'$&re! !%&(')*#*& (e rB* +!re !re '$"!&"!"e %!& %!re $& e#&&+! #! ' "e%er!"*r! %!& $+!8*"!. A%&(')*# (e 'r*% $& (e 're8


16/53

!(!*!$'#*"&!N!OH 10Q (*!"! +* 10 !!, $e '%'e)&8e!8! $& $e +'%#e"e!8! +* !! #! %!$!re/!8*"!.

ESCRIERE

U)*e)" '%'e), &)+'#'r, "r!)$#*+&( +* %&r'$ $#! +!r!+"er&$"&+.OSERVATIIC!r''#&& $*)" '#&%er& (e ?&(r'&/&), $'#*& &) $'#*"&& (e ?&(r'&8& !#+!#&)& $& !r"&!#&

$'#*& &) !!. A* "e)(&)"! (e ! $e !#'%er! &) !! $& (e !+ee! $e re$!r! (e!$*r! !e& $* !&"!re.Se '" #!$! #! &%&!" !)! #! 2?. #! !(!*!re!N!OH !re #' (&8'#/!re! $& e#&&+!re! &) !+e#!$&"&%. Ge#* (e +!r''# e$"e $"! #! *) H +*r&)$ &)"re 5,5 ; 10 *) e+e$ (e N!OH (*+e #!$+!(ere! +')$&$"e)"e&, !+e!$"! )* e$"e &)#*e)"!"! (e "e%er!"*r!. Pe)"r* )e*"r!#&8!re $e '!"e '#'$&$& "r&e"!)'#!%&)!. E$"e *) e# !)&')!+"&/ $& )* $e '!"e !$'+&! +* $*$"!)"e+!"&')!+"&/e.C')+e)"r!"&! &) +!r''# '!"e /!r&! &)"re 0,5-5Q &) *)+>&e (e +')$&$"e)"! ('r&"!.

T!e# 2Ne*"r!#&8!re! +!r''#*#*& & $'#/e)>&

S%7"#

A1"# #"$'%6# (1:1 C'/+%)

NO30, - 0,4

TEA?,? - ?,

T'"%!#0,B - ?,0

A!


17/53

INTREUINTARI!8! (e *)*e)" #! '"&)ere! *)*e)"e#'r %e(&+!%e)"'!$e.

CONSERVAREI) re+&&e)"e &)e &)+?&$e, #! +e# %*#" 250C.

PROPRITILE AJELOR E UNGUENT HIROSOLUILE

G"% ." !&'1%(FR X)

G%&"'% ."!.# (FR X)

G"% ." &'/+% ?

C!+6"

D$'"

C+&" "%'"

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&)B)( $e!%! (e !+e$"e r'r&e"& !#e $*$"!)e#'r, (&$er$!re! #'r


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I'( 0. ; 1 6 - S'#*

I?"&'# M&$+& M&$+& M&$+& M&$+&

Me)"'# 1 ; 20 17 ; 1 15 ; 1 M&$+&

Re$'r+&)'# - - ; 6.7 S'#*

+'#'r!"&&4

S*#!%&(e - - 0.7 ; 0.D S'#*+'#'r!"&&4

UNGUENTUM CAMP3ORAE ?0 U)*e)" +!%'r!" 10

C!%?'r!e 10U)*e)"*% $&%#e D0

OSERVATIIC!%'r*# e$"e ' $*$"!)"! re* $'#*! &) !!, (!r *$'r $'#*! &) *#e&*r& $& r!$&%&.

&8'#/!re! +!%'r*#*& &) e+&&e)" $e !+e +* r&! e)"r* ! e/&"! &er(ere (e $*$"!)"! r&)0


20/53

C')$&$"e)"!

C!r!+"ere "!+"e

C!!+&"!"e (ee"!#!re

Gr!( (e e)e"r!re&) &e#e

C')(&&')!re K&+')$er/!re

I)(&+!&&"er!e*"&+e

UNGUENT CU XILOCAINA 2

'+!&)! +#'r?&(r&+! 2H&(r'e# (e +!r''# D0 .$.!( 100

OSERVATII'+!&)! +#'r?&(r&+! e$"e ' $*$"!)"! *$'r $'#*! &) !! $& $'#*"&! '"&)*"! $e '!"e


21/53

C')$&$"e)"!

C!r!+"ere "!+"e

C!!+&"!"e (ee"!#!re

Gr!( (e e)e"r!re&) &e#e

C')(&&')!re K&+')$er/!re

I)(&+!&&"er!e*"&+e

UNGUENTE SUSPENSII

!+! $*$"!)"! $'#&(! e$"e &)$'#*! &) e+&&e)", +!" $& &) !#"& $'#/e)"& e: (er%!"'#, $*#,&$%*" $*)&"r&+, '&( (e 8&)+, e"+.4 $e re+*re #! $*$e)(!re &) !8! (e *)*e)". I) !+e$" +!8$*$"!)"! $e !(*+e &) $"!re (e *#ere '!r"e &)! K& +?&!r e"r!&) $&"! VIII, re$e+"&/ I4.C')'r% FR D0Q !r"&+*#e $*$e)(!"e "re*&e $! re8&)"e *) (&!%e"r* (e +e# %*#" 50 %, &!re)"r* 10Q (&) !r"&+*#e $e !(%&"e *) (&!%"r* (e +e# %*#" 100 %.

!+! r'+e)"*# (e $*$"!)"! $*$e)(!"! e$"e $* 5Q, !+e$"! (*! *#/er&8!re re!#!!, $e


22/53

e&)&&!re!r!"*#*&

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!8! (e *)*e)"

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A$e+"

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23/53

e&)&&!re!r!"*#*&

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!8! (e *)*e)"

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re+& !& %'!r*#*& $& !% '"&)e *) re!r!" )e+'re$*)8!"'r +* r*)&. A+&(*# $!#&+&+ re!+"&')e!8!+* %e"!#e#e re#e $& )* /'% '#'$& #! re!r!re *$"e)$e %e"!#&+e $& )&+& $&"! +* &r %e"!#&+. C')'r%FR I, &) "&% !+e$" *)*e)" $e '" 'r%! r*)&, +!8 &) +!re )* $e %!& '#'$e$"e.

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