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    A. Latar Belakang

    Tumbuhan tropis dunia diperkirakan lebih dari 250.000 spesies dan 1500 spesies

    diantaranya merupakan family Sterculiaceae yang terdapat dalam 70 genus (ressler!

    dkk! 2007". #asil penelusuran pustaka (#akim 200$% &ohman 2005% Amrun dan 'miyah!

    2005% rapti)i 200*" diperoleh berbagai +enis tumbuhan sebagai sumber antioksidan

    alami! satu di antaranya adalah dari suku Sterculiaceae.

    ,alah satu tumbuhan family Sterculiaceae yang tersebar di seluruh kepulauan

    -ndonesia dan sangat potensial untuk diteliti adalah Kleinhovia hospital Linn sebagai

    tumbuhan yang berkhasiat (-mran!dkk! 2007". ,eara tradisional! daun tumbuhan K.

    hospita telah dimanfaatkan sebagai obat oleh masyarakat luas! khususnya di ,ula)esi

    Tenggara dan ,elatan! diperaya berkhasiat sebagai obat yang mampu mengobati

    penyakit li/er (&afliar!200*".

    Tumbuhan paliasa diyakini dapat menghasilkan senya)asenya)a metabolit

    sekunder yang memiliki bioakti/itas menarik dan efek terapetik yang ampuh. ,eara

    tradisional daun tumbuhan paliasa sudah dimanfaatkan sebagai obat tradisional seara

    luas oleh masyarakat khususnya di ,ula)esi ,elatan dan diperaya berkhasiat sebagai

    obat yang mampu mengobati penyakit li/er! hipertensi! dan diabetes (ini dan arminto!

    2012". i daerah 3alimantan ,elatan! seara empirik daun paliasa dimanfaatkan oleh

    masyarakat setempat untuk menegah pertumbuhan uban (pemutihan )arna" pada rambut

    kepala dengan ara keramas. Akan tetapi! untuk pemanfaatan daun tersebut belum ada

    ka+ian yang membuktikannya seara ilmiah.

    Berbagai penelitian telah dilakukan bah)a kandungan kimia yang terdapat dalam

    daun paliasa salah satunya adalah antioksidan. ,aefudin dkk. (2014" telah melakukan

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    penelitian bah)a pada tumbuhan! K. hospitabaik kulit batang maupun daunnya banyak

    mengandung senya)a fla/onoid. la/onoid merupakan antioksidan yang kuat dan dapat

    meredam radikal bebas! termasuk 62! #262! 6#! dan singlet oksigen (62" (,akihama !

    2002". ,elain itu! 3ementrian &iset dan tekhnologi (2012" men+elaskan bah)a paliasa

    diketahui mengandung senya)a aktif leutherol dan 3aempferol 4glukosida yang

    berfungsi sebagai at antioksidan.

    Antioksidan adalah senya)a yang berguna dalam membantu mengatasi kerusakan

    oksidatif akibat radikal bebas atau senya)a oksigen reaktif. Antioksidan dapat beker+a

    dengan ara mengatasi efekefek kerusakan pada kulit manusia yang diakibatkan oleh

    radikal bebas yang merupakan faktor utama pada proses penuaan (aging" dan kerusakan

    +aringan kulit. enuaan dini adalah proses penuaan kulit yang dapat ter+adi akibat dari

    paparan sinar matahari yang berlebihan. ,ehingga! untuk memperlambat proses penuaan

    kulit tersebut! kerusakan kulit perlu diegah atau diperbaiki dengan menggunakan produk

    kosmetik yang mengandung kolagen! /itamin! dan sebagainya. ,alah satu bentuk sediaan

    kosmetik yang sering digunakan yaitu sediaan krim (Amiruddin! 2004 % ir+en 68!

    2005".

    3rim adalah bentuk sediaan setengah padat berupa emulsi kental mengandung

    tidak kurang dari *09 air! dimaksudkan untuk pemakaian luar. Tipe krim ini ada yang

    bertipe air dalam minyak (A:8" dan minyak dalam air (8:A" (Anief! 1;;;".

    Berdasarkan uraian diatas! telah dikatakan bah)a daun paliasa banyak

    mengandung senya)a fla/onoid. 6leh karena itu daun paliasa berpotensi untuk

    dikembangkan men+adi sediaan krim antioksidan. ormulasi sediaan krim antioksidan

    dari ekstrak etanol daun paliasa setelah diformulasikan kemudian diu+i akti/itas

    antioksidannya dengan menggunakan metode #! serta pengu+ian stabilitas fisik

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    sediaan yang meliputi pengamatan organoleptik krim! u+i p#! u+i /iskositas! dan

    homogenitas serta u+i stabilitas dengan metode sentrifugasi.B. &umusan 8asalah

    Berdasarkan latar belakang diatas! permasalahan yang dapat dika+i dalam penelitian

    ini adalah . Tu+uan enelitian

    Tu+uan dari penelitian ini adalah %

    1. 8endapatkan formulasi sediaan krim dari ekstrak daun paliasa2. 8engetahui stabilitas fisik formula sediaan krim ekstrak daun paliasa

    4. 8engetahui akti/itas antioksidan formulasi sediaan krim ekstrak daun paliasa

    . 8anfaat enelitian

    8anfaat yang ingin diapai dari penelitian ini adalah

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    -ndonesia merupakan @egara yang memiliki keanekaragaman hayati tumbuhan

    tropis yang sangat potensial.

    ,ebagaimana diketahui! sekitar 1.2*0 +enis tumbuhan obat berasal dari hutan tropika -ndonesia

    (uhud .! 1;;?". ari +umlah tersebut! beberapa di antaranya adalah tumbuhan endemik (alu+o!

    200$". #asil penelusuran pustaka (#akim 200$% &ohman 2005% Amrun dan 'miyah! 2005%

    rapti)i 200*" diperoleh berbagai +enis tumbuhan sebagai sumber antioksidan alami! satu di

    antaranya adalah dari suku ,teruliaeae.

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    Daun Ndokulo (Kleinhovia hospita L)

    aatkan oleh masyarakat luas sebagai bahan obat tradisional, khususnya penyakit liver, termap, asam prusid dan triterpenoid ('adan *, "##+)% aliasa diketahui mengandung senya

    &ntioksidan

    1ormulasi sediaan Krim antioksidan ekstrak etanol daun paliasa (Kleinhovia hospita Linn)

    k lengket dan mudah dicuci dengan air% dibandingkan dengan sediaan salep, gel maupun pa

    sediaan Krim antioksidan ekstrak etanol daun paliasa (

    valuasi kestabilan krim meliputi5

    organoleptis viskositas, p6, dan homogenitas72i aktivitas antioksidan

    Kerangka Konsep

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    tumbuh di kecamatan asera, kabupaten konawe utara

    Daun anaman paliasa

    kstraksi

    kstrak etanol daun paliasa

    1ormulasi krim

    $ 8

    72i stabilitas 72i aktivitas antioksidan

    rganoleptis

    9iskositas

    !nversi fase

    etes dispersi

    p6

    9olume kriming

    " 8 - 8

    3eterangan etyl alohol! used in pharmaeutial

    preparations! is a miDture of solid aliphati alohols omprising mainly 1

    heDadeanol (>1*#4?6". The ',42G@27 speifies not less than ;0.09 of

    etyl alohol! the remainder onsisting hiefly of related alohols. >ommerially!

    many grades of etyl alohol are a/ailable as miDtures of etyl alohol (*0G709"

    and stearyl alohol (20G409"! the remainder being related alohols.Functional ategor!

    >oating agent% emulsifying agent% stiffening agent.

    Applications in "harmaceutical Formulation or #echnolog!

    >etyl alohol is )idely used in osmetis and pharmaeutial formulations suh

    as suppositories! modifiedrelease solid dosage forms! emulsions! lotions! reams!

    and ointments. -n suppositories etyl alohol is used to raise the melting point of

    the base! and in modifiedrelease dosage forms it may be used to form a

    permeable barrier oating. -n lotions! reams! and ointments etyl alohol is used

    beause of its emollient! )aterabsorpti/e! and emulsifying properties. -t enhanes

    stability! impro/es teDture! and inreases onsisteny. The emollient properties are

    due to absorption and retention of etyl alohol in the epidermis! )here it

    lubriates and softens the skin )hile imparting a harateristi H/el/etyI teDture.

    >etyl alohol is also used for its )ater absorption properties in )aterinoil

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    emulsions. or eDample! a miDture of petrolatum and etyl alohol (1; < 1" )ill

    absorb ?0G509 of its )eight of )ater. >etyl alohol ats as a )eak emulsifier of

    the )aterinoil type! thus allo)ing a redution of the Juantity of other

    emulsifying agents used in a formulation. >etyl alohol has also been reported to

    inrease the onsisteny of )aterinoil emulsions.

    -n oilin)ater emulsions! etyl alohol is reported to impro/e stability by

    ombining )ith the )atersoluble emulsifying agent. The ombined miDed

    emulsifier produes a lose paked! monomoleular barrier at the oilG)ater

    interfae )hih forms a mehanial barrier against droplet oalesene.-n semisolid emulsions! eDess etyl alohol ombines )ith the aJueous

    emulsifier solution to form a /isoelasti ontinuous phase that imparts semisolid

    properties to the emulsion and also pre/ents droplet oalesene. Therefore! etyl

    alohol is sometimes referred to as a Honsisteny impro/erI or a Hbodying agentI!

    although it may be neessary to miD etyl alohol )ith a hydrophili emulsifier toimpart this property.

    -t should be noted that pure or pharmaopeial grades of etyl alohol may

    not form stable semisolid emulsions and may not sho) the same physial

    properties as grades of etyl alohol that ontain signifiant amounts of other

    similar alohols.

    Table -< 'ses of etyl alohol.

    'se >onentration (9"

    mollient 2G5

    mulsifying agent 2G5

    ,tiffening agent 2G10

    ater absorption 5

    $escription

    >etyl alohol ours as )aDy! )hite flakes! granules! ubes! or astings. -t has a

    faint harateristi odor and bland taste.

    Stabilit! and Storage onditions

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    >etyl alohol is stable in the presene of aids! alkalis! light! and air% it does not

    beome ranid. -t should be stored in a )elllosed ontainer in a ool! dry plae.

    ncompatibilities

    -nompatible )ith strong oDidiing agents. >etyl alohol is responsible for

    lo)ering the melting point of ibuprofen! )hih results in stiking tendenies

    during the proess of film oatingibuprofen rystals.

    Method o& Manu&acture

    >etyl alohol may be manufatured by a number of methods suh as esterifiation

    and hydrogenolysis of fatty aids or by atalyti hydrogenation of the

    triglyerides obtained from oonut oil or tallo). >etyl alohol may be purified

    by rystalliation and distillation.

    Sa&et!

    >etyl alohol is mainly used in topial formulations! although it has also been

    used in oral and retal preparations. >etyl alohol has been assoiated )ith

    allergi delayedtype hypersensiti/ity reations in patients )ith stasis dermatitis.

    (2" >rosssensitiation )ith etostearyl alohol! lanolin! and stearyl alohol has

    also been reported.(4!?" -t has been suggested that hypersensiti/ity may be aused

    by impurities in ommerial grades of etyl alohol sine highly refined etyl

    alohol (;;.59" has not been assoiated )ith hypersensiti/ity reations.(5"

    '. gliserin 1( % b/)

    S!non!ms

    >roderol% ?22% glierol% glyerine% glyerolum% lyon 100% 3emstrene%

    6ptim% rierine% 1!2!4propanetriol% trihydroDypropane glyerol.

    hemical *ame and AS +egistr! *umber

    ropane1!2!4triol K5*$15 ? mpirial ormula and 8oleular eight

    >4#$64 ;2.0;

    Structural Formula

    Functional ategor!

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    Antimirobial preser/ati/e% osol/ent% emollient% humetant% plastiier% sol/ent%

    s)eetening agent% toniity agent.

    Applications in "harmaceutical Formulation or #echnolog!

    lyerin is used in a )ide /ariety of pharmaeutial formulations

    inluding oral! oti! ophthalmi! topial! and parenteral preparations% see Table -.-n topial pharmaeutial formulations and osmetis! glyerin is used

    primarily for its humetant and emollient properties. lyerin is used as a sol/ent

    or osol/ent in reams and emulsions.(1G4" lyerin is additionally used in

    aJueous and nonaJueous gels and also as an additi/e in path appliations.(?G*"

    -n parenteral formulations! glyerin is used mainly as a sol/ent and osol/ent.(7G

    10"

    -n oral solutions! glyerin is used as a sol/ent!(10" s)eetening agent!

    antimirobial preser/ati/e! and /isosityinreasing agent. -t is also used as aplastiier and in film oatings.(11G1?"

    lyerin is used as a plastiier of gelatin in the prodution of softgelatin

    apsules and gelatin suppositories.

    lyerin is employed as a therapeuti agent in a /ariety of linial

    appliations!(15" and is also used as a food additi/e.

    $escription

    lyerin is a lear!

    olorless! odorless! /isous! hygrosopi liJuid% it has a s)eet taste!

    approDimately 0.* times as s)eet as surose.

    Stabilit! and Storage onditions

    lyerin is hygrosopi. ure glyerin is not prone to oDidation by the

    atmosphere under ordinary storage onditions! but it deomposes on heating )ith

    the e/olution of toDi arolein. 8iDtures ofglyerin )ith )ater! ethanol (;59"!

    and propylene glyol arehemially stable.

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    ncompatibilities

    lyerin may eDplode if miDed )ith strong oDidiing agents suh as

    hromium trioDide! potassium hlorate! or potassium permanganate. -n dilute

    solution! the reation proeeds at a slo)er rate )ith se/eral oDidation produts

    being formed. Blak disoloration of glyerin ours in the presene of light! or

    on ontat )ith in oDide or basi bismuth nitrate.

    An iron ontaminant in glyerin is responsible for the darkening in olor

    of miDtures ontaining phenols! saliylates! and tannin.

    lyerin forms a bori aid ompleD! glyerobori aid! that is a stronger

    aid than bori aid.

    ,. #EA % b/) -',4

    S!non!ms

    TA% Tealan% triethylolamine% trihydroDytriethylamine% tris (hydroDyethyl"amine%

    trolaminum.

    hemical *ames and AS +egistr! *umber

    2!20!200@itrilotriethanol K10271*

    Empirical Formula and Molecular Weight

    >*#15@64 1?;.1;

    Structural Formula

    Functional ategor!

    Alkaliing agent% emulsifying agent.

    Applications in "harmaceutical Formulation or #echnolog!

    Triethanolamine is )idely used in topial pharmaeutial formulations!

    primarily in the formation of emulsions.

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    hen miDed in eJuimolar proportions )ith a fatty aid! suh as steari

    aid or olei aid! triethanolamine forms an anioni soap )ith a p# of about $!

    )hih may be used as an emulsifying agent to produe finegrained! stable oilin

    )ater emulsions. >onentrations that are typially used for emulsifiation are 2G

    ?9 /:/ of triethanolamine and 2G5 times that of fatty aids. -n the ase of mineral

    oils! 59 /:/ of triethanolamine )ill be needed! )ith an appropriate inrease in the

    amount of fatty aid used. reparations that ontain triethanolamine soaps tend to

    darken on storage. #o)e/er! disoloration may be redued by a/oiding eDposure

    to light and ontat )ith metals and metal ions.Triethanolamine is also used in salt formation for in+etable solutions and

    in topial analgesi preparations. -t is also used in sun sreen preparations.(1"Triethanolamine is used as an intermediate in the manufaturing of

    surfatants! teDtile speialties! )aDes! polishes! herbiides! petroleum

    demulsifiers! toilet goods! ement additi/es! and utting oils. Triethanolamine is

    also laimed to be used for the prodution of lubriants for the rubber glo/es and

    teDtile industries. 6ther general uses are as buffers! sol/ents! and polymer

    plastiiers! and as a humetant.

    $escription

    Triethanolamine is a lear! olorless to pale yello)olored /isous liJuid

    ha/ing a slight ammoniaal odor. -t is a miDture of bases! mainly 2!20!200

    nitrilotriethanol! although it also ontains 2!20 iminobisethanol (diethanolamine"

    and smaller amounts of 2 aminoethanol (monoethanolamine".

    Stabilit! and Storage onditions

    Triethanolamine may turn bro)n on eDposure to air and light.

    The $59 grade of triethanolamine tends to stratify belo) 15$>%

    homegeneity an be restored by )arming and miDing before use.

    Triethanolamine should be stored in an airtight ontainer

    proteted from light! in a ool! dry plae.

    ncompatibilities

    Triethanolamine is a tertiary amine that ontains hydroDy groups% it is

    apable of undergoing reations typial of tertiary amines and alohols.

    Triethanolamine )ill reat )ith mineral aids to formrystalline salts and esters.

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    ith the higher fatty aids! triethanolamineforms salts that are soluble in )ater

    and ha/e harateristisof soaps. Triethanolamine )ill also reat )ith opper to

    formompleD salts. isoloration and preipitation an take plae in the presene

    of hea/y metal salts.

    Triethanolamine an reat )ith reagents suh as thionyl hlorideto replae

    the hydroDy groups )ith halogens. The produts of these reations are /ery toDi!

    resembling other nitrogen mustards.

    4. asam stearat % b/b -01'1

    S!non!ms

    Aidum stearium% etylaeti aid% >rodaid% >ristal % >ristal ,% er/aid%

    570% denor% mersol% Dtra A,% Dtra % Dtra ,% Dtra ,T% 1

    heptadeanearboDyli aid% #ystrene% -ndustrene% 3ortaid 1$;5% earl ,teri%

    risterene% stereophani aid% Tegosteari.

    hemical *ame and AS +egistr! *umber

    6tadeanoi aid K5711?

    Empirical Formula and Molecular Weight

    >1$#4*62 2$?.?7 (for pure material" The ',42G@27 desribes steari aid as

    a miDture of steari aid (>1$#4*62" and palmiti aid (>1*#4262". -n the

    ',42G @27! the ontent of steari aid is not less than ?0.09 and the sum of

    the t)o aids is not less than ;0.09. The ',42G@27 also ontains a

    monograph for purified steari aid% see ,etion 17. The hur *.5 ontains a

    single monograph for steari aid but defines steari aid 50! steari aid 70! and

    steari aid ;5 as ontaining speifi amounts of steari aid (>1$#4*62"% see

    ,etion ;.

    Structural Formula

    Functional ategor!

    mulsifying agent% solubiliing agent% tablet and apsule lubriant.

    Applications in "harmaceutical Formulation or #echnolog!

    ,teari aid is )idely used in oral and topial pharmaeutial

    formulations. -t is mainly used in oral formulations as a tablet and apsule

    lubriant%(1G4" see Table -! although it may also be used as a binder(?" or in

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    ombination )ith shella as a tablet oating. -t has also been suggested that steari

    aid may be used in enteri tablet oatings and as a sustainedrelease drug arrier.

    (5"

    -n topial formulations! steari aid is used as an emulsifying and

    solubiliing agent. hen partially neutralied )ith alkalis or triethanolamine!

    steari aid is used in the preparation of reams.(*!7" The partially neutralied

    steari aid forms a reamy base )hen miDed )ith 5G15 times its o)n )eight of

    aJueous liJuid! the appearane and plastiity of the ream being determined by

    the proportion of alkali used.,teari aid is used as the hardening agent in glyerin suppositories.

    ,teari aid is also )idely used in osmetis and food produts.

    $escription

    ,teari aid is a hard! )hite or faintly yello)olored! some)hat glossy!

    rystalline solid or a )hite or yello)ish )hite po)der. -t hasa slight odor ()ith an

    odor threshold of 20 ppm" and tastesuggesting tallo).

    Stabilit! and Storage onditions

    ,teari aid is a stable material% an antioDidant may also be added to it.

    The bulk material should be stored in a )elllosedontainer in a ool! dry plae.

    ncompatibilities

    ,teari aid is inompatible )ith most metal hydroDides and may be

    inompatible )ith bases! reduing agents! and oDidiing agents.

    6intment bases made )ith steari aid may sho) e/idene of drying out

    or lumpiness due to suh a reation )hen ompounded )ith in or alium salts.

    A number of differential sanning alorimetry studies ha/e in/estigated

    the ompatibility of steari aid )ith drugs. Although suh laboratory studies ha/e

    suggested inompatibilities! e.g. )ith naproDen!(;" they may not neessarily be

    appliable to formulated produts.

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    ,teari aid has been reported to ause pitting in the film oating of tablets

    applied using an aJueous filmoating tehniJue% the pitting )as found to be a

    funtion of the melting point of the steari aid.(10"

    (. metil paraben % b/b -2'

    S!non!ms

    Aseptoform 8% >o,ept 8% 21$% ?hydroDybenoi aid methyl ester% metagin%

    8ethyl >hemosept% methylis parahydroDybenoas% methyl phydroDybenoate%

    8ethyl arasept% @ipagin 8% ,olbrol 8% Tegosept 8% 'niphen 24.

    hemical *ame and AS +egistr! *umber

    8ethyl?hydroDybenoate K;;7*4

    Empirical Formula and Molecular Weight

    >$#$64 152.15

    Structural Formula

    Functional ategor!

    Antimirobial preser/ati/e.

    Applications in "harmaceutical Formulation or #echnolog!

    8ethyl paraben is )idely used as an antimirobial preser/ati/e in

    osmetis! food produts! and pharmaeutial formulations% see Table -. -t may be

    used either alone or in ombination )ith other parabens or )ith other

    antimirobial agents. -n osmetis! methylparaben is the most freJuently used

    antimirobial preser/ati/e.(1"

    The parabens are effeti/e o/er a )ide p# range and ha/e a broad

    spetrum of antimirobial ati/ity! although they are most effeti/e against yeasts

    and molds. Antimirobial ati/ity inreases as the hain length of the alkyl moiety

    is inreased! but aJueous solubility dereases% therefore a miDture of parabens is

    freJuently used to pro/ide effeti/e preser/ation. reser/ati/e effiay is also

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    impro/ed by the addition of propylene glyol (2G59"! or by using parabens in

    ombination )ith other antimirobial agents suh as imidurea% see ,etion 10.6)ing to the poor solubility of the parabens! paraben salts (partiularly

    the sodium salt" are more freJuently used in formulations. #o)e/er! this raises

    the p# of poorly buffered formulations.8ethylparaben (0.1$9" together )ith propylparaben (0.029" has been

    used for the preser/ation of /arious parenteral pharmaeutial formulations% see

    ,etion 1?.

    $escription

    8ethylparaben ours as olorless rystals or a )hite rystalline po)der.

    -t is odorless or almost odorless and has a slight burning taste.

    Stabilit! and Storage onditions

    AJueous solutions of methylparaben at p# 4G* may be sterilied byautola/ing at 120$> for 20 minutes! )ithout deomposition.($" AJueous

    solutions at p# 4G* are stable (less than 109deomposition" for up to about ?

    years at room temperature! )hileaJueous solutions at p# $ or abo/e are sub+et

    to rapid hydrolysis (109 or more after about *0 days storage at room

    temperature".

    8ethylparaben should be stored in a )elllosed ontainer in a ool! dry

    plae.

    ncompatibilities

    The antimirobial ati/ity of methylparaben and other parabens is

    onsiderably redued in the presene of nonioni surfatants! suh as polysorbate

    $0! as a result of mielliation.(10!11" #o)e/er!propylene glyol (109" has been

    sho)n to potentiate theantimirobial ati/ity of the parabens in the presene of

    nonioni surfatants and pre/ents the interation bet)een methylparaben and

    polysorbate $0.(12"

    -nompatibilities )ith other substanes! suh as bentonite!(14"magnesium

    trisiliate!(1?" tal! tragaanth!(15" sodium alginate!(1*" essential oils!(17"

    sorbitol!(1$" and atropine!(1;" ha/e been reported. -t also reats )ith /arious

    sugars and related sugar alohols.(20"

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    Absorption of methylparaben by plastis has also been reported% the

    amount absorbed is dependent upon the type of plasti and the /ehile. -t has been

    laimed that lo)density and highdensitypolyethylene bottles do not absorb

    methylparaben.(21"

    8ethylparaben is disolored in the presene of iron and is sub+et to

    hydrolysis by )eak alkalis and strong aids.

    0. propil paraben % b/b -22'

    S!non!ms

    Aseptoform % >o,ept % 21*% ?hydroDybenoi aid propyl ester% @ipagin %

    @ipasol 8% propagin% ropyl Aseptoform% propyl buteD% ropyl >hemosept%

    propylis parahydroDybenoas% propyl phydroDybenoate% ropyl arasept% ,olbrol

    % Tegosept % 'niphen 24.

    hemical *ame and AS +egistr! *umber

    ropyl ?hydroDybenoate K;?144

    Empirical Formula and Molecular Weight

    >10#1264 1$0.20

    Structural Formula

    Applications in "harmaceutical Formulation or #echnolog!

    ropylparaben is )idely used as an antimirobial preser/ati/e in

    osmetis! food produts! and pharmaeutial formulations% see Table -.-t may be used alone! in ombination )ith other paraben esters! or )ith

    other antimirobial agents. -t is one of the most freJuently used preser/ati/es in

    osmetis.(1"

    The parabens are effeti/e o/er a )ide p# range and ha/e a broad

    spetrum of antimirobial ati/ity! although they are most effeti/e against yeastsand molds% see ,etion 10.

    6)ing to the poor solubility of the parabens! the paraben salts! partiularly

    the sodium salt! are freJuently used in formulations. This may ause the p# of

    poorly buffered formulations to beome more alkaline.ropylparaben (0.029 ):/" together )ith methylparaben (0.1$9 ):/" has

    been used for the preser/ation of /arious parenteral pharmaeutial formulations%

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    ,ee 8ethylparaben for further information.$escription

    ropylparaben ours as a )hite! rystalline! odorless! and tasteless

    po)der.

    Stabilit! and Storage onditions

    AJueous propylparaben solutions at p# 4G* an be sterilied by

    autola/ing! )ithout deomposition.(?" At p# 4G*! aJueous solutions are stable

    (less than 109 deomposition" for up to about? years at room temperature! )hile

    solutions at p# $ or abo/e are sub+et to rapid hydrolysis (109 or more after

    about *0 days atroom temperature".(5"

    ncompatibilities

    The antimirobial ati/ity of propylparaben is redued onsiderably in the

    presene of nonioni surfatants as a result of mielliation.(*" Absorption ofpropylparaben by plastis has been reported! )ith the amount absorbed dependent

    upon the type of plasti and the /ehile.(7" 8agnesium aluminum siliate!

    magnesium trisiliate! yello) iron oDide! and ultramarine blue ha/e also been

    reported to absorb propylparaben! thereby reduing preser/ati/e effiay.($!;"

    ropylparaben is disolored in the presene of iron and is sub+et to

    hydrolysis by )eak alkalis and strong aids. ,ee also 8ethylparaben.

    3. pengaroma -' tetes

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    '. E)aluasi Krim -' ,' ,,

    a. "engamatan rganoleptis

    iamati perubahan )arna! bau (ketengikan"! dan ter+adinya pemisahan fase.

    b. "engamatan 5omogenitas

    8engamati ukuran partikelpartikel pada kaa ob+ek! untuk mengetahui terbentuk partikel

    partikel kasar.

    c. "emeriksaan p5

    engukuran p# dilakukan dengan menggunakan p# meter yang telah dikalibrasi dengan

    menggunakan larutan dapar standar p# ? dan 7. engukuran pada sediaan krim dilakukan

    pada suhu kamar.

    d. "engamatan diameter globul rata6rata

    engukuran globul ratarata dilakukan dengan menggunakan mikroskop optik! krim

    diletakkan di atas kaa ob+ek dan ditutup dengan gelas penutup kemudian dengan

    menggunakan haemasitometer dan mikroskop pada perbesaran tertentu. 3emudian foto

    gambar yang diamati dengan menggunakan kamera digital dan ukur diameter partikelnya

    dan distribusi partikelnya.

    Metode Cycling test

    ,ampel krim disimpan pada suhu ?o> selama 2? +am lalu pindahkan ke dalam o/en yang

    bersuhu ?0M2o> selama 2? +am (satu siklus"! kemudian u+i dilakukan sebanyak * siklus

    kemudian diamati ter+adi adanya pemisahan fase.

    78i Mekanik -Sentri&ugasi

    ,ampel krim dimasukkan ke dalam alat sentrifugasi kemudian dimasukkan ke dalam alat

    sentrifugator pada keepatan 4750 rpm selama 5 +am atau 500010.000 rpm selama 40 menit.

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    erlakuan tersebut sama dengan perlakuan adanya gaya gra/itasi selama setahun. 3emudian

    diamati apakah ter+adi pemisahan atau tidak.