Soybean Oil S
1
Nonproprietary Names
BP: Refned Soya Oil JP: Soybean Oil PhEur: Soya-Bean Oil, Refned USP: Soybean Oil
Synonyms
!"eite de so#a$ %al"hem &'O-11($ )ipe* 1+$ )ipe* ++$ Shoun %.$ soiae oleum ra/natum$ so#a bean oil$ soyabean oil$ soya bean oil0
%hemi"al Name and %!S Reistry Number
Soybean oil 23++1--4
(
Empiri"al Empiri"a l 5ormula and 6ole"ular 6ole"ula r 7eiht
! typi"al analysis o8 o8 refned soybean oil indi"ates the "omposition "omposition o8 the a"ids, present as ly"erides, to be: linolei" a"id 9+9;$ linoleni" a"id 91+;$ olei" a"id 1<;$ palmiti" a"id =1;$ and and steari" a"id <;0 Other a"ids a"ids are are present present in tra"e >uantities0?1@
9
Stru"tural 5ormula 5ormula
See Se"tions ( and 30
<
5un"tional %ateory
Oleainous Aehi"le$ solAent0
!ppli"ations in Pharma"euti"al 5ormulation 5ormulation or
.e"hnoloy .e"hnoloy &n pharma"euti"al pharma"euti"al preparations, soybean oil emulsions emulsions are are primarprimar- ily used as a 8at sour"e in total parenteral nutrition ?.PN@ ?.PN@ reimens0?@ !lthouh other other oils, su"h as peanut oil, haAe been used 8or this purpose, soybean oil is no pre8erred pre8erred be"ause it is asso"iated ith 8eer adAerse rea"tions0 Emulsions "ontainin soybean oil haAe also been used as Aehi"les 8or the oral and intraAenous administration o8 drus$?,(@ dru substan"es that haAe been in"orporated into su"h emulsions in"lude amphoteri"in,?9@ diaCepam, retinoids, ?3@ Aitamins,?=@ poorly ater-soluble ster- oids,?1+,11@ Duoro"arbons,?1,1@ ibupro8en,?1(@ ibupro8en,?1(@ and insulin0?19@ &n addition, soybean oil has been used in the 8ormulation o8 many dru deliAery systems su"h as liposomes,?1<@ mi"rospheres, mi"rospheres, ?1@ dry emulsions,?13@ sel8-emulsi8yin sel8-emulsi8yin systems,?1=,+@ mi"roemulsions,?1, mi"roemulsions,?1,@ @
nanoemulsions?,(@ and nano"apsules,?@ and multiple emulsions0?<@
solid-in-oil suspen- sions,?9@
Soybean oil may also be used in "osmeti"s and is "onsumed as an edible oil0 !s soybean oil has emollient emollient properties, it is used as a bath additiAe additiAe in the treatment o8 dry sin "onditions0
3
Fes"ription
.he USP des"ribes soybean oil as the refned f*ed oil obtained 8rom the seeds o8 the soya plant Gly"ine ma* 6err0 ?5aba"eae@$ i8 an anto*idant is added, the name and >uantity must be spe"ifed on the label0 .he PhEur <0 defnes refned soybean oil as the 8atty oil obtained 8rom the seeds o8 Gly"ine so#a Sieb0 and Hu""0 and Gly"ine ma* ?)0@ 6err0 ?G0 hispida ?6oen"h@ 6a*im0@ by e*tra"tion and subse>uent refnin$ it may "ontain a suitable antio*idant0 .he PhEur <0 also in"ludes a monoraph 8or hydroenated soybean oil0 See 'eetable Oil, hydroenated, type 10 Soybean oil is a "lear, pale-yello "olored, odorless or almost odorless li>uid, ith a bland taste that solidifes beteen
1+ and
1<3%0
=
Pharma"opeial Spe"if"ations
See .able &0
.able &: Pharma"opeial spe"if"ations 8or soybean oil0
.est
JP I'
PhEur <0
USP
+0=
Soybean Oil
<3
11 Stability and Storae %onditions Soybean oil is a stable material i8 prote"ted 8rom atmospheri" o*yen0 .he 8ormation o8 undesirable DaAors in soybean oil is a""elerated by the presen"e o8 +0+1 ppm "opper and +01 ppm iron, hi"h a"t as "atalysts 8or o*idation$ this "an be minimiCed by the addition o8 "helatin aents0
Proloned storae o8 soybean oil emulsions, parti"ularly at eleAated temperatures, "an result in the 8ormation o8 8ree 8atty a"ids, ith a "onse>uent redu"tion in the p o8 the emulsion$ deradation is minimiCed at p <0 oeAer, soybean oil emulsions are stable at room temperature i8 stored under nitroen in a liht-resistant lass "ontainer0 Plasti" "ontainers are permeable to o*yen and should not be used 8or lon-term storae sin"e o*idatiAe derada- tion "an o""ur0 .he stability o8 soybean oil emulsions is "onsiderably inDuen"ed by other additiAes in a 8ormulation0?@ Soybean oil should be stored in a ell-flled, airtiht, liht- resistant "ontainer at a temperature not e*"eedin 93%0
1
&n"ompatibilities
Soybean oil emulsions haAe been reported to be in"ompatible at 93% ith a number o8 materials in"ludin "al"ium "hloride, "al"ium lu"onate, manesium "hloride, phenytoin sodium, and tetra"y"line hydro"hloride0?(@ )oer "on"entrations o8 these materials, or loer storae temperatures, may result in improAed "ompatibility0 .he sour"e o8 the material may also aKe"t "ompat- ibility$ 8or e*ample, hile one in#e"tion 8rom a parti"ular manu8a"turer miht be in"ompatible ith a 8at emulsion, an in#e"tion ith the same amount o8 a"tiAe dru substan"e 8rom another manu8a"turer miht be "ompatible0 !mphoteri"in B has been reported to be in"ompatible ith ?9@
Re8ra"tiAe inde*
L
eaAy metals a"ids
L L
5atty a"id "omposition
10(9 L L
L
10(<910(9 (+0++1; 5ree 8atty M
M
M
Unsaponifable matter
(10+;
(109;
(10+;
soybean oil "ontainin 8at emulsions under "ertain "onditions0 Soybean oil emulsions are also in"ompatible ith many other dru substan"es, &' in8usion solutions, and ions ?aboAe "ertain "on"entrations@0 7hen plasti" syrines are used to store soybean oil emulsion, sili"one oil may be e*tra"ted into the emulsion$ sellin o8 the syrine pump also o""urs, resultin in the ne"essity 8or in"reased ?<@
%ottonseed oil
L
L
M
8or"es to maintain the motion o8 the pluner0
Pero*ide
L
(1+0+ or
M
(90+?a@ !laline impurities L L (+0; (+01;?a@ L
M L 7ater
L Brassi"asterol L
?a@ &n soybean oil intended 8or parenteral use0
1+ .ypi"al Properties !utoinition temperature ((93% Fensity 33% 5reeCin point
1+ to
ydro*yl Aalue
(3
1<3%
+0=1<+0= "m at 93% 5lash point
&nter8a"ial tension Re8ra"tiAe inde* Solubility
9+ mNm ?9+ dynes"m@ at +3%0 n9 10(110(9
Pra"ti"ally insoluble in ethanol ?=9;@ and ater$
mis"ible ith "arbon disulfde, "hloro8orm, ether, and liht petroleum0 Sur8a"e tension
9 mNm ?9 dynes"m@ at +3%0
'is"osity ?dynami"@ 10= mPa s ?10= "P@ at +3%$ ==0 mPa s ?==0 "P@ at 1+3%$ 9+0+= mPa s ?9+0+= "P@ at 93%$ 303< mPa s ?303< "P@ at (+3%0
1 6ethod o8 6anu8a"ture Obtained by solAent e*tra"tion usin petroleum hydro"arbons, or
S
to a lesser e*tent by e*pression usin "ontinuous s"re-press operations, o8 the seeds o8 either Gly"ine ma* ?)euminosae@ or Gly"ine so#a ?)euminosae@0 .he oil is refned, deodoriCed, and "larifed by fltration at about +3%0 !ny phospholipids or sterols present are remoAed by refnin ith alali0
1( Sa8ety Soybean oil is idely used intramus"ularly as a dru Aehi"le or as a "omponent o8 emulsions used in parenteral nutrition reimens$ it is also "onsumed as an edible oil0 Generally, soybean oil is rearded as an essentially nonto*i" and nonirritant material0 oeAer, serious adAerse rea"tions to soybean oil emulsions administered parent- erally haAe been reported0 .hese in"lude "ases o8 hypersensitiAity,?@ %NS rea"tions,?3@ and 8at embolism0?=@ &nter8eren"e ith the anti"oaulant eKe"t o8 ar8arin has also been reported0?(+@
!naphyla"ti" rea"tions haAe also been reported 8olloin the "onsumption o8 8oods deriAed 8rom, or "ontainin, soybeans0 Re"ently there has been "on"ern at the "on"entration o8 phytoestro- ens in some soy-deriAed produ"ts0 !dministration o8 soy protein to humans has resulted in sinif"antly de"reased serum lipid "on"entrations0?(1@ &n 1===, the U 6edi"al FeAi"es !en"y announ"ed the Aoluntary ithdraal o8 a breast implant that "ontained soybean oil0 .he de"ision as taen be"ause not enouh as non at that
<3 (
Soybean Oil
time about the lon-term sa8ety and the rate o8 breadon o8 the soybean oil in the fllin and its possible eKe"ts on the body0?(@ )F9+ ?mouse, &'@: 01 ?(@ )F9+ ?rat, &'@: 1<09
19 andlin Pre"autions ObserAe normal pre"autions appropriate to the "ir"umstan"es and >uantity o8 material handled0 Spillaes o8 soybean oil are slippery and should be "oAered ith an inert absorbent material prior to disposal0
1< Reulatory Status &n"luded in the 5F! &na"tiAe &nredients Fatabase ?&' in#e"tions, oral "apsules, and topi"al preparations@0 &n"luded in nonparenteral ?"heable tablets$ oral "apsules$ oral loCenes$ topi"al bath additiAes@ and parenteral ?emulsions 8or &' in#e"tion or in8usion@ medi"ines li"ensed in the U0 &n"luded in the %anadian )ist o8 !""eptable Non-medi"inal &nredients0
1 Related Substan"es %anola oil$ "orn oil$ "ottonseed oil$ peanut oil$ sesame oil$ sunDoer oil0
13 %omments .he stability o8 soybean oil emulsions may be readily disturbed by the addition o8 other materials, and 8ormulations "ontainin soybean oil should there8ore be eAaluated "are8ully 8or their "ompatibility and stability0 ! spe"if"ation 8or soybean oil is "ontained in the 5ood %hemi"als %ode* ?5%%@0?((@
1=
Spe"if" Re8eren"es
1 British Standards &nstitute0 Spe"if"ation 8or %rude 'eetable 5ats, BS +0 )ondon: 6SO, 1==+0 6"NiK B)0 %lini"al use o8 1+; soybean oil emulsion0 !m J osp Pharm 1=$ (: 1+3+1+3<0 Jeppsson R0 EKe"ts o8 barbituri" a"ids usin an emulsion 8orm intraAenously0 !"ta Pharm Sue" 1=$ =: 31=+0 ( 6edina J et al0 Use o8 ultrasound to prepare lipid emulsions o8 loraCepam 8or intraAenous in#e"tion0 &nt J Pharm ++1$ 1
Pas"ual B et al0 !dministration o8 lipid-emulsion Aersus "onAentional amphoteri"in B in patients ith neutropenia0 !nn Pharma"other 1==9$ =: 11=1+10 3 NaneAis R et al0 Studies on the intraAenous pharma"oineti"s o8 three retinoids in the rat0 &nt J Pharm 1==($ 1+1: (=9<0 = Fahl GB et al0 Stability o8 Aitamins in soybean oil 8at emulsion under "onditions simulatin intraAenous 8eedin o8 neonates and "hildren0 J Parenter Enteral Nutr 1==($ 13?@: (=0 1+ 6al"olmson %, )aren"e 6J0 ! "omparison o8 the in"orporation o8 model steroids into non-ioni" mi"ellar and mi"roemulsion systems0 J Pharm Pharma"ol 1==$ (9: 1(11(0 11 Steroid anaestheti" aents 2editorial40 )an"et 1==$ (+: 33(0 1 Johnson O) et al0 .hermal stability o8 Duoro"arbon emulsions that transport o*yen0 &nt J Pharm 1==+$ 9=: 11190 1 Johnson O) et al0 )on-term stability studies o8 Duoro"arbon o*yen transport emulsions0 &nt J Pharm 1==+$ <: <90 1( Rathi )G et al0 &ntraAenous ibupro8en lipid emulsions 8ormulation and in Aitro eAaluation0 Eur J Parenter Pharm S"i ++$ 1?1@: 110 19 6orishita 6 et al0 &mproAin insulin enteral absorption usin ater-in- oil emulsion0 &nt J Pharm 1==3$ 1?1@: 13=1=30
1< Stri"er , 6uQ ller 0 2.he storae stability o8 dispersions o8 soybean- le"ithin liposomes04 Pharm &nd 1=3($ (<: 1191132in German40 1 Salmero n 6F et al0 En"apsulation study o8 <-methylprednisolone in li>uid mi"rospheres0 Fru FeA &nd Pharm 1==$ ?@: 11<0 13 Pedersen GP et al0 Solid state "hara"terisation o8 a dry emulsion: a potential dru deliAery system0 &nt J Pharm 1==3$ 11?@: 9+0 1= rishna G, Sheth BB0 ! noAel sel8 emulsi8yin parenteral dru deliAery system0 PF! J Pharm S"i .e"hnol 1===$ 9?(@: 1<31<0 + .aha E& et al0 Response sur8a"e methodoloy 8or the deAelopment o8 sel8nanoemulsifed dru deliAery system ?SNEFFS@ o8 all-trans-retinol a"etate0 Pharm FeA .e"hnol ++9$ 1+?@: <+0
1 arasulu et al0 %ontrolled release o8 methotre*ate 8rom 7O mi"roemulsion and its in Aitro antitumour a"tiAity0 Fru FeliA ++$ 1(?(@: 90 an SR et al0 Phospholipid-based mi"roemulsion 8ormulation o8 all- transretinoi" a"id 8or parenteral administration0 &nt J Pharm ++($
7arisnoi"haroen 7 et al0 Non-ioni" oil-in-ater mi"roemulsions: the eKe"ts o8 oil type on phase behaAiour0 &nt J Pharm +++$ 1=3?1@: 0 ( .rissel )!0 andboo on &n#e"table Frus, =th edn0 Bethesda, 6F: !meri"an So"iety o8 ospital Pharma"ists, 1==<$ (9((0 9 .rissel )!0 !mphoteri"in B does not mi* ith 8at emulsion 2letter40 !m J ealth Syst Pharm 1==9$ 9: 1(<1(<(0 < %apes F5 et al0 .he eKe"t on syrine per8orman"e o8 Duid storae and repeated use: impli"ations 8or syrine pumps0 PF! J Pharm S"i .e"hnol 1==<$ 9+?Jan5eb@: (+9+0 iyama F. et al0 ypersensitiAity 8olloin lipid emulsion in8usion in an adult patient0 J Parenter Enteral Nutr 1=3=$ 1: 13+0 3 Jelline E0 Faners o8 intraAenous 8at in8usions 2letter40 )an"et 1=<$ ii: =<0 = Estebe JP, 6alledant 0 5at embolism a8ter lipid emulsion in8usion 2letter40 )an"et 1==1$ : <0 (+ )utomsi F6 et al0 7ar8arin resistan"e asso"iated ith intraAenous lipid administration0 J Parent Enteral Nutr 1=3$ 11?@: 1<130 (1 !nderson J7 et al0 6eta-analysis o8 the eKe"ts o8 soy protein intae on serum lipids0 N Enl J 6ed 1==9$ ?9@: <30 ( Bradbury J0 Breast implants "ontainin soy-bean oil ithdran in U 2nes40 )an"et 1===$ 9: =+0 ( Seet F', ed0 Reistry o8 .o*i" EKe"ts o8 %hemi"al Substan"es0 %in"innati: US Fepartment o8 ealth, 1=3$ ((9(0 (( 5ood %hemi"als %ode*,
|
Bethesda, 6F: United States
Pharma"opeia, ++3$ =10
+ General Re8eren"es Benita S, )eAy 60 Submi"ron emulsions as "olloidal dru "arriers 8or intraAenous administration: "omprehensiAe physi"o"hemi"al "hara"ter- iCation0 J Pharm S"i 1==$ 3: 1+<=1+=0
FelaAeau P, otellier 50 2Oils o8 pharma"euti"al, dieteti", and "osmeti" interest, part &: maiCe, soybean, sunDoer04 !nn Pharm 5r 1=1$ =: ==(12in 5ren"h40
Star"h
<3 9
6irtallo J6, Oh .0 ! ey to the literature o8 total parenteral nutrition: update 1=30 Fru &ntell %lin Pharm 1=3$ 1: 9=(<+<0 Smolinse S%0 andboo o8 5ood, Fru, and %osmeti" E*"ipients0 Bo"a Raton: 5): %R% Press, 1==$ 3390 7ol8 7J0 ir-Othmer En"y"lopedia o8 %hemi"al .e"hnoloy0, Aol0 1: , rd edn0 Ne or: 7iley-&nters"ien"e, 1=31$ (1((0
1 !uthor %G %able0
Fate o8 ReAision + 5ebruary ++=0
TerjemahanMatikan terjemahan instan
Minyak kedelai S 1 Nama Nonproprietary BP: Refined Soya Oil JP: Minyak Kedelai PhEr: Soya!Bean Oil" dimrnikan #SP: Minyak Kedelai $ Sinonim %&eite de soja' (al&hem )*O!11+' ,ipe- 1./' ,ipe- $..' S ho0n (T' soiae olem raffinatm' soja minyak ka&an0' minyak kedelai' minyak ka&an0 kedelai 2 Nama Kimia dan Nomor (%S minyak kedelai 34..1!$$!/5 + 6ormla empiris dan Berat Molekl Se7ah analisis khas minyak kedelai olahan mennjkkan komposisi asam" hadir se7a0ai 0liserida" menjadi: asam linoleat 8.!8/9' asam linolenat 8!1.9' asam oleat 1/!$9' asam palmitat ;!129' dan asam stearat 2!9 asam lain yan0 hadir dalam jmlah jejak <1=
8 6ormla Strktral ,ihat Ba0ian + dan 4 6n0sional Kate0ori kendaraan olea0inos' pelart / %plikasi di 6armasi 6ormlasi ata Teknolo0i >alam sediaan farmasi" emlsi minyak kedelai yan0 primar! ily di0nakan se7a0ai sm7er lemak total ntrisi parenteral
dan inslin <18= Selain it" minyak kedelai telah di0nakan dalam permsan 7anyak sistem pen0iriman o7at seperti liposom" <1= mikrosfer" <1/= emlsi kerin0" <14= sistem self!pen0emlsi" <1;"$.= mikroemlsi" <$1"$$=
nanoemlsions <$2"$+= dan nano&apsles" <$2= yan0 solid dalam minyak dimensi!disspensi" <$8= dan 7e7erapa emlsi <$= Minyak kedelai j0a dapat di0nakan dalam kosmetik dan dikonsmsi se7a0ai minyak na7ati Minyak kedelai memiliki sifat emolien" di0nakan se7a0ai aditif mandi dalam pen0o7atan kondisi klit kerin0
4 Keteran0an #SP 2$ men00am7arkan minyak kedelai se7a0ai minyak tetap hals diperoleh dari 7iji tanaman kedelai Aly&ine ma- Merr <6a7a&eae=' jika anto-idant ditam7ahkan" nama dan kantitas hars ditentkan pada la7el The PhEr $ mendefinisikan minyak kedelai olahan seperti minyak lemak yan0 diperoleh dari 7iji Aly&ine soja Sie7 dan && dan Aly&ine ma- <,= Merr
en0an ekstraksi dan pemrnian selanjtnya' mn0kin men0andn0 antioksidan yan0 sesai The PhEr $ j0a men&akp mono0rafi ntk minyak kedelai terhidro0enasi ,ihat Minyak Sayr" terhidro0enasi" tipe 1 minyak kedelai adalah jelas" 7erCarna p&at!knin0" tidak 7er7a ata hampir &air tidak 7er7a" den0an rasa ham7ar yan0 mem7ek antara 1. dan 14(
; Pharma&opeial Spesifikasi ,ihat Ta7el ) Ta7el ): spesifikasi Pharma&opeial ntk minyak kedelai #ji JP D* PhEr $ #SP 2$
$$ .;$$ Minyak Kedelai 4 2 11 Sta7ilitas dan Penyimpanan Kondisi minyak kedelai adalah 7ahan yan0 sta7il jika terlindn0 dari oksi0en atmosfer Pem7entkan rasa yan0 tidak diin0inkan dalam minyak kedelai diper&epat oleh kehadiran .".1 ppm tem7a0a dan ."1 ppm 7esi" yan0 7ertindak se7a0ai katalis ntk oksidasi' ini dapat diminimalkan den0an penam7ahan a0en &helatin0 penyimpanan lama emlsi minyak kedelai" tertama pada sh tin00i" dapat men0aki7atkan pem7entkan asam lemak 7e7as" den0an penrnan konseken dalam p emlsi' de0radasi
diminimalkan pada p !/ Namn" emlsi minyak kedelai sta7il pada sh kamar jika disimpan di 7aCah nitro0en dalam Cadah ka&a lamp!tahan Cadah plastik yan0 permea7el terhadap oksi0en dan tidak 7oleh di0nakan ntk penyimpanan jan0ka panjan0 sejak oksidatif de0radasi dapat terjadi Sta7ilitas emlsi minyak kedelai san0at dipen0arhi oleh aditif lainnya dalam formlasi <$/!22= minyak kedelai hars disimpan dalam" kedap dara" Cadah tahan &ahaya!7aik diisi pada sh yan0 tidak mele7ihi $84( 1$ )nkompati7ilitas emlsi minyak kedelai telah dilaporkan tidak sesai den0 an $84( den0an sejmlah 7ahan termask kalsim klorida" kalsim 0lkonat" ma0nesim klorida" fenitoin natrim" dan hidroklorida tetrasiklin <2+= konsentrasi rendah dari 7ahan!7ahan ini" ata sh penyimpanan yan0 le7ih rendah" dapat men0aki7atkan penin0katan kompati7ilitas Sm7er 7ahan j0a dapat mempen0arhi a@as &ompat!' misalnya" sementara sat sntikan dari prodsen tertent mn0kin tidak sesai den0an emlsi lemak" sntikan den0an jmlah yan0 sama dari 7ahan o7at aktif dari prodsen lain mn0kin kompati7el %mfoterisin B telah dilaporkan tidak sesai den0an <28= indeks 7ias ! 1"+/8 1"+8!1"+/8 lo0am 7erat ! ! +."..19 asam lemak 7e7as ! ! F komposisi asam lemak ! F F
al #nsaponifia7le +1".9 +1"89 +1".9 minyak kedelai yan0 men0andn0 emlsi lemak di 7aCah kondisi tertent emlsi minyak kedelai j0a kompati7el den0an 7anyak @at lain o7at" &airan infs )*" dan ion alam minyak kedelai ditjkan ntk pen00naan parenteral
1. Properti Khas Sifat peledak ++84( >ensitas .";1!.";$$ 0 G &m2 pada $84( Titik nyala $4$4( Pem7ekan titik 1. ke 14( hidroksil +!4 te0an0an antar mka 8. mN G m <8. dyne G &m= di $.4( indeks 7ias N$8 H 1"+/1!1"+/8 Kelartan Praktis tidak lart dalam etanol <;89= dan air' lart den0an kar7on dislfida" kloroform" eter" dan minyak 7mi rin0an te0an0an permkaan $8 mN G m <$8 dyne G &m= di $.4( *iskositas
12 Metode )ndstri >iperoleh den0an ekstraksi pelart men00nakan hidrokar7on minyak 7mi" ata S pada tin0kat le7ih rendah den0an ekspresi men00nakan kontiny s&reC!tekan operasi" dari 7enih 7aik Aly&ine ma- <,e0minosae= ata Aly&ine soja <,e0minosae= minyak hals" deodori@ed" dan diklarifikasi den0an penyarin0an sekitar .4( Setiap fosfolipid ata sterol hadir dihaps den0an menyemprnakan den0an alkali 1+ Keselamatan minyak kedelai 7anyak di0nakan intramsklar se7a0ai kendaraan o7at ata se7a0ai komponen dari emlsi yan0 di0nakan dalam rejimen ntrisi parenteral' it j0a dikonsmsi se7a0ai minyak na7ati #mmnya" minyak kedelai dian00ap se7a0ai 7ahan dasarnya tidak 7era&n dan nonirritant Namn" efek sampin0 yan0 seris ntk e mlsi minyak kedelai di7erikan oran0ta erally telah dilaporkan )ni termask kass hypersensiti?! ity" <2/= reaksi (NS" <24= dan lemak em7oli <2;= )nterferensi den0an efek antikoa0lan dari Carfarin j0a telah dilaporkan <+.= reaksi anafilaksis j0a telah dilaporkan setelah konsmsi makanan yan 0 7erasal dari" ata men0andn0" kedelai Bar!7ar ini ada kekhaCatiran pada konsentrasi 0ens phytoestro! di 7e7erapa prodk kedelai yan0 ditrnkan %dministrasi protein kedelai mansia telah men0aki7atkan si0nifikan penrnan konsentrasi lipid serm <+1= Pada tahn 1;;;" )n00ris %lat Kesehatan Badan men0mmkan penarikan skarela dari implan paydara yan0 7erisi minyak kedelai Keptsan it diam7il karena tidak &kp dikenal pada saat it Minyak 4 + Kedelai
Cakt tentan0 keamanan jan0ka panjan0 dan tin0kat kersakan pada minyak kedelai dalam men0isi dan efek yan0 mn0kin pada t7h <+$=
,>8. 8.
18 Tindakan Penan0anan Perhatikan tindakan pen&e0ahan yan0 normal sesai den0an keadaan dan kantitas 7ahan ditan0ani Tmpahan minyak kedelai yan0 li&in dan hars dittp den0an 7ahan penyerap lem7am se7elm di7an0
1 Stats Re0latory Termask dalam 6>% aktif Bahan >ata7ase aftar Kanada Bahan Non!o7at yan0 dapat diterima
1/ at Terkait Minyak &anola' minyak ja0n0' minyak 7iji kapas' minyak ka&an0' minyak Cijen' minyak 7n0a matahari
14 Komentar Sta7ilitas emlsi minyak kedelai dapat mdah ter0an00 oleh penam7ahan 7ahan lain" dan formlasi yan0 men0andn0 minyak kedelai karenanya hars die?alasi se&ara hati!hati ntk kompati7ilitas dan sta7ilitas mereka Se7ah spesifikasi ntk minyak kedelai yan0 terkandn0 dalam makanan terse7t (hemi&als (ode- <6((= <++=
1; Referensi Tertent 1 British Standards )nstitte Spesifikasi ,emak Na7ati mentah" BS /$./ ,ondon: MSO" 1;;. $ M&Niff B, pen00naan klinis dari 1.9 emlsi minyak kedelai %m J osp Pharm 1;//' 2+: 1.4.!1.4 2 Jeppsson R Pen0arh asam 7ar7itrat men00nakan 7entk emlsi intra?ena %&ta Pharm Se& 1;/$' ;: 41!;. + Medina J et al Pen00naan #SA ntk mempersiapkan emlsi lipid dari lora@epam ntk injeksi intra?ena )nt J Pharm $..1' $1 <1!$=: 1!4 8 Iasan KM %mfoterisin B!intralipid O7at Masa >epan 1;;+' 1; <2=: $$8!$$/ *ita E )ntralipid di profilaksis amfoterisin B nefrotoksisitas %nn Pharma&other 1;;+' $4: 114$!1142 / Pas&al B et al %dministrasi lipid!emlsi terhadap amfoterisin B kon?ensional pada pasien den0an netropenia %nn Pharma&other 1;;8' $;: 11;/!1$.1
4 Nanke?is R et al Stdi pada farmakokinetik intra?ena ti0a retinoid pada tiks )nt J Pharm 1;;+' 1.1: $+;!$8 ; >ahl AB et al Sta7ilitas ?itamin dalam ked elai emlsi lemak minyak di 7aCah kondisi simlasi infs neonats dan anak!anak J Parenter Enteral N tr 1;;+' 14 <2=: $$2+!$$2; 1. Mal&olmson (" ,aCren&e MJ Per7andin0an pen00a7n0an model steroid ke dalam non!ionik misel dan mikroemlsi sistem J Pharm Pharma&ol 1;;2' +8: 1+1!1+2 11 a0en anestesi steroid 3editorial5 ,an&et 1;;$' 2+.: 42!4+ 1$ Johnson O, et al sta7ilitas termal emlsi floro&ar7on yan0 men0an0kt oksi0en )nt J Pharm 1;;.' 8;: 121!128 12 Johnson O, et al Stdi sta7ilitas jan0ka panjan0 dari floro&ar7on oksi0en emlsi transportasi )nt J Pharm 1;;.' 2: 8!/$ 1+ Rathi ,A et al )ntra?ena emlsi lipid i7profen ! formlasi dan dalam e?alasi ?itro Er J Parenter Pharm S&i $../' 1$ <1=: 1/!$1 18 Morishita M et al Menin0katkan inslin penyerapan enteral men00nakan emlsi minyak air! in )nt J Pharm 1;;4' 1/$ <1!$=: 14;!1;4 1 Stri&ker " M# ller 3Sta7ilitas penyimpanan dispersi liposom lesitin soy7ean!5 Pharm )nd 1;4+' +: 11/8!1142 3dalam 7ahasa Jerman5 1/ Salmero n M> et al Stdi enkapslasi !methylprednisolone di mikrosfer &air O7at >e? )nd Pharm 1;;/' $2 <$=: 122!12 14 Pedersen AP et al Padat karakterisasi keadaan emlsi kerin0: sistem pen0iriman o7at potensial )nt J Pharm 1;;4' 1/1 <$=: $8/!$/. 1; Krishna A" Sheth BB Se7ah pen0emlsi diri sistem pen0iriman o7at parenteral 7ar P>% J Pharm S&i Te&hnol 1;;;' 82 <+=: 14!1/ $. Taha E) et al metodolo0i respon permkaan ntk pen0em7an0an sistem pen0iriman o7at diri nanoemlsified >S= dari sema!trans!retinol asetat Pharm >e? Te&hnol $..8' 1. <2=: 22!2/. $1 Karasl et al >ikontrol rilis methotre-ate dari I G O mikroemlsi dan in ?itro akti?itas antitmor nya >eli? o7at $../' 1+ <+=: $$8!$22 $$ Can0 SR et al formlasi mikroemlsi 7er7asis fosfolipid dari sema!trans!retinoi& a&id ntk pem7erian parenteral )nt J Pharm $..+' $/ <1!$=: 1/8!142 $2 Santos!Ma0alhaL es NS et al Operator!operator koloid ntk 7 en@atin penisilin A: nanoemlsions dan nano&apsles )nt J Pharm $...' $.4 <1!$=: /1! 4. $+ 6an0 J et al ,ipid emlsi nano!s7mikron se7a0ai kendaraan ntk pen0iriman flr7iprofen topikal >eli? o7at $..+' 11 <$=: ;/!1.8 $8 Piao et al pen0iriman oral natrim diklofenak men00nakan sspensi minyak padat!in 7ar )nt J Pharm $..' 212: 18;!1$ $ Bokir %" ayta A Persiapan dan e?alasi 7e7erapa emlsi air dalam minyak dalam air ris&oll >6 et al pertim7an0an praktis men0enai pen00naan total admi-tres ntrisi %m J
osp Pharm 1;4' +2: +1!+1; $; Iashin0ton ( Sta7ilitas emlsi lemak intra?ena total &ran ntrisi parenteral )nt J Pharm 1;;.' : 1!$1 2. Mannin0 RJ" sta7ilitas Iashin0ton ( Kimia total &ran ntrisi parenteral )nt J Pharm 1;;$' 41: 1!$. 21 Jmaa M" M# ller BI Pen0arh komponen minyak dan kondisi tion homo0enisa! pad a sifat fisikokimia dan sta7ilitas emlsi lemak parenteral )nt J Pharm 1;;4' 12 <1!$=: 41!4; 2$ Jmaa M" M# ller BI Sta7ilisasi emlsi lemak parenteral men00nakan non!ionik %B% kopolimer srfaktan )nt J Pharm 1;;4' 1/+ <1!$=: $;! 2/ 22 Iarisnoi&haroen I et al Non!ionik minyak dalam air mikroemlsi: efek dari jenis minyak pada perilak fase )nt J Pharm $...' 1;4 <1=: /!$/ 2+ Trissel ,% Bk Pandan tentan0 Sntik Narko7a" edn ; Bethesda" M>: %meri&an So&iety of ospital %poteker" 1;;' +28!++/ 28 Trissel ,% %mfoterisin B tidak 7er&r den0an emlsi lemak 3srat5 %m J Kesehatan Syst Pharm 1;;8' 8$: 1+2!1++ 2 (apes >6 et al Efek pada kinerja jarm sntik penyimpanan &airan dan pen00naan 7erlan0: implikasi ntk pompa jarm sntik P>% J Pharm S&i Te&hnol 1;;' 8. T et al ipersensiti?itas 7erikt infs emlsi lemak pada pasien deCasa J Parenter Enteral Ntr 1;4;' 12: 214!2$. 24 Jellinek E Bahaya infs lemak intra?ena 3srat5 ,an&et 1;/' ii: ;/ 2; Este7e JP" Malledant 6at em7oli setelah infs emlsi lemak 3srat5 ,an&et 1;;1' 22/: /2 +. ,tomski >M et al resistensi Carfarin terkait den0an administrasi lipid intra?ena J )ndk Enteral Ntr 1;4/' 11 <2=: 21!214 +1 %nderson JI et al Meta!analisis dari efek aspan protein kedelai pada lipid serm N En0l J Med 1;;8' 222 <8=: $/!$4$ +$ implan paydara Brad7ry J men0andn0 minyak kedelai!ka&an0 ditarik di )n00ris 37erita5 ,an&et 1;;;' 282: ;.2 +2 Manis >*" ed Rte&s (in&innati: #S >epartment of ealth" 1;4/' ++8+ ++ Makanan (hemi&als (ode-" edn Bethesda" M>: %merika Serikat 6armakope" $..4' ;$1 $. Referensi #mm Benita S" ,e?y M emlsi s7mikron se7a0ai pem7aCa o7at koloid ntk pem7erian intra?ena: fisikokimia komprehensif karakter!isasi J Pharm S&i 1;;2' 4$: 1.;!1./; >ela?ea P" otellier 6 3Minyak farmasi" diet" dan 7n0a kosmetik" 7a0ian ): Ja0n0" kedelai" 7n0a matahari5 %nn Pharm 6r 1;/1' $;: 2;;!+1$ 3dalam 7ahasa Pran&is5 Pati 4 8
Mirtallo JM" Oh T Kn&i literatr dari total ntrisi parenteral: memper7ari 1;4/ O7at )ntell (lin Pharm 1;4/' $1: 8;+!. Smolinske S( and7ook of 6ood" O7at" dan Kosmetik eksipien Bo&a Raton: 6,: (R( Press" 1;;$' 242!248 Seri0ala IJ Kirk!Othmer En&y&lopedia of (hemi&al Te&hnolo0y" *ol $1:" 2 edn NeC ork: Iiley!)nters&ien&e" 1;41' +1/!++$ $1 Penlis (A ka7el $$ Tan00al Re?isi $. 6e7rari $..;
