BAB 1 PENDAHULUAN 1.1 LatarBelakang Seiringdengansemakinberkembangnyasainsdanteknologi,perke mbangan
di
duniafarmasi
pun
takketinggalan.Semakinharisemakinbanyakjenisdan takketinggalan.Semakinhari semakinbanyakjenisdanragampenyakit ragampenyakit yang
muncul.Perkembanganpengobatan
pun
terus
dikembangkan.Berbagaimacambentuksediaanobat, dikembangkan.Berbagai macambentuksediaanobat, baikitu liquid, solid dan semisolid telahdikembangkanolehahlifarmasidanindustri. telahdikembangkanolehahlifarmasidanindustri. Ahlifarmasimengembangkanobatuntukpemenuhan Ahlifarmasimengembangkanobatuntukpemenuhankebutuhanmas kebutuhanmas yarakat, yang bertujuanuntukmemberikanefekterapiobat, dosis yang sesuaiuntuk dikonsumsiolehmasyarakat.Selainitu, sediaan semisolid digunakanuntukpemakaianluarsepertikrim,
salep,
gel,
pasta
dansuppositoria yang digunakanmelaluirektum.Kelebihandarisediaan semisolid
iniyaitupraktis,
mudahdibawa,
mudahdipakai,
mudahpadapengabsorbsiannya.Jugauntukmemberikanperlindunganpe ngobatanterhadapkulit. Berbagaimacambentuksediaan semisolid memilikikekurangan, salahsatudiantaranyayaitumudah
di
tumbuhimikroba.Untukmeminimalisirkekurangantersebut, paraahlifarmasisharusbiasmemformulasikandanme paraahlifarmasisharusbias memformulasikandanmemproduksisediaans mproduksisediaans ecaratepat.Dengandemikian, langkah
yang
farmasisharusmengetahuilangkah-
tepatuntukmeminimalisirkejadian
yang
tidakdiinginkan.Dengancaramelakukan, menentukanformulasidenganbenardanmemperhatikankonsentrasisert akarakteristikbahan
yang
digunakandandikombinasikandenganbaikdanbenar.pada digunakandandikombinasikandenganbaikdanbenar. pada
percobaan
kali ini dilakukan pembuatan krim pemutih yang dimana hampir semua masyrakat di indonesia menggunakannya untuk memperantik diri serta
mengubah
fisiologis fisiologis
dari
tubuh.
Krim Krim
pemutih
pemutih
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merupakan campuran bahan kimia dan lainnya dengan khasiat bisa memucatkan noda hitam (coklat) pada kulit. Tujuan penggunaanya dalam jangka waktu yang lama lama agar dapat menghilangkan menghilangkan atau mengurangi hiperpigmentasi pada kulit, tetapi penggunaan yang harus terus menerus justru akan menimbulkan pigmentasi dengan efek permanen Sediaankrimsebelumdigunakanharusdilaku Sediaankrimsebelumdigunakanharusdilakukanpengujianuntukme kanpengujianuntukme nentukanstabilitasdankualitaskrimsehinggamenjaminhasilakhir
yang
berkhasiatdanmenghasilkanefekterapipadasetiappenggunaan. 1.2 MaksudPercobaan Adapunmaksuddaripercobaaniniadalahmengetahui Adapunmaksuddaripercoba aniniadalahmengetahuicarapembuat carapembuat ansediaankrimdenganbaik. 1.3 TujuanPercobaan Adapuntujuandaripelaksanaanpraktikuminiadalahu Adapuntujuandaripelak sanaanpraktikuminiadalahuntukmengetah ntukmengetah uidanmemahamiformulasikrimpencerahkulitsertamenentukankonsentr asi optimum bahandalamformulasi. bahandalamformulasi.
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BAB II TINJAUAN PUSTAKA 2.1 Tinjauan Tentang Kulit Kulit merupakan suatu lapisan yang menutupi permukaan tubuh dan memiliki fungsi utama sebagai pelindung dari berbagai macam gangguan dan rangsangan luar.Luas kulit manusia rata-rata ± 2 meter persegi dengan berat 10 kg jika dengan lemaknya atau 4 kg tanpa lemak (Tranggono dan Latifah, 2007). Tebalnya kulit bervariasi mulai 0,5 mm sampai 6 mm tergantung dari letak, umur dan jenis kelamin. Kulit tipis terletak pada kelopak mata, penis, labium minus dan kulit bagian medial lengan atas, sedangkan kulit tebal terdapat pada telapak
tangan,
telapak
kaki,
punggung,
bahu
dan
bokong
(Perdanakusuma, 2007). 2.1.1 Anatomi Kulit Kulit secara embriologis terbagi atas dua lapisan utama yaitu epidermis (kulit ari) sebagai lapisan epitel paling luar berasal dari ektoderm dan dermis (korium, kutis, kulit jangat) sebagai lapisan dalam yang berasal dari mesoderm (Tranggono dan Latifah, 2007; Perdanakusuma, 2007). Epidermis Epidermis merupakan bagian kulit paling luar yang tipis, avaskuler, dan terdiri dari sel epitel berlapis pipih bertanduk, keratinosit, mengandung sel melanosit, langerhans dan merkel (Perdanakusuma, 2007). Epidermis terdiri dari lima lapisan yaitu: 1) Stratum korneum (lapisan tanduk) Stratum korneum terdiri atas beberapa lapis sel yang pipih dengan ketebalannya 20-30 lapisan dan ¾ dari ketebalan epidermis, sel mati, tidak memiliki inti, tidak mengalami proses metabolisme, tidak berwarna, dan sangat sedikit mengandung air. Lapisan ini sebagian besar terdiri atas
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keratin yaitu protein yang tidak larut dalam air, dan sangat resisten terhadap bahan-bahan kimia, hal ini berkaitan dengan fungsi kulit untuk memproteksi tubuh dari pengaruh luar. Secara alami, sel-sel yang sudah mati dipermukaan kulit akan melepaskan diri untuk beregenerasi (Tranggono dan Latifah, 2007). 2) Stratum lusidum (lapisan jernih) Stratum lusidum terletak tepat di bawah stratum korneum, merupakan lapisan tipis, jernih, mengandung eleidin, sangat tampak jelas pada telapak tangan dan telapak kaki.Antara stratum lucidum dan stratum granulosum terdapat lapisan keratin tipis yang disebut rein’s barrier yang tidak bisa ditembus (impermeable) (Tranggono dan Latifah, 2007). 3) Stratum granulosum (lapisan berbutir-butir) Stratum granulosum tersusun oleh sel-sel keratinosit yang berbentuk poligonal pipih dengan inti ditengah dan sitoplasma terisi oleh granula basofilik kasar yang dinamakan granula keratohialin yang mengandung protein kaya akan histidin. Pada lapisan granulosum terdapat sel Langerhans, tidak memiliki mukosa dan tampak jelas pada telapak tangan dan kaki (Perdanakusuma, 2007). 4) Stratum spinosum (lapisan malphigi) Stratum spinosum memiliki sel yang berbentuk kubus dan seperti berduri, berinti besar dan oval.Setiap sel berisi filamen-filamen kecil yang terdiri atas serabut protein yang dinamakan tonofibril yang berfungsi untuk mempertahankan kohesi sel dan melindungi terhadap efek abrasi.Diantara selsel stratum spinosum terdapat sel Langerhans yang berperan dalam sistem imun tubuh (Tranggono dan Latifah, 2007; Perdanakusuma, 2007; Wasitaatmadja, 1997).
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5) Stratum germinativum atau membran basal (lapisan basal) Stratum
germinativum
merupakan
lapisan
terbawah
epidermis.Di dalam stratum germinativum terdapat sel-sel melanosit, yaitu sel-sel yang tidak mengalami keratinisasi dan fungsinya hanya membentuk pigmen melanin dan melalui dendrit diberikan ke sel-sel keratinosit.Satu sel melanin untuk sekitar 36 sel keratinosit disebut unit melanin epidermal (Tranggono dan Latifah, 2007). Adapun fungsi epidermis adalah sebagai proteksi kulit untuk melawan stimuli dari luar seperti dehidrasi, sinar ultraviolet dan faktor fisik lainnya seperti faktor kimia, organisasi sel, tempat untuk mesintesis vitamin D dan sitokin, pembelahan dan mobilisasi sel, pigmentasi kulit (melanosit) dan pengenalan alergen (sel Langerhans) (Perdanakusuma, 2007; Mitsui, 1997) . 2.1.2 Fungsi Kulit a. Fungsi perlindungan Kulit melindungi tubuh dari berbagai gangguan eksternal, baik fisik kimiawi maupun biologis meliputi tekanan, gesekan, tarikan, zat-zat kimia iritan, gangguan panas atau dingin, gangguan sinar ultraviolet, gangguan kuman, jamur, bakteri, atau virus. Serabut elastis pada dermis dan jaringan lemak subkutan berfungsi untuk mencegah gangguan fisik dan mekanik pada tubuh bagian dalam. Lapisan tanduk dan mantel lemak kulit menjaga kadar air dengan mencegah masuknya air dari luar tubuh dan penguapan air, serta sebagai barrier terhadap racun dari luar. Mantel asam kulit dapat mencegah pertumbuhan bakteri dikulit.Sel melanin dapat menyerap sebagian sinar ultraviolet (Mitsui, 1997; Wasitaatmadja, 1997).
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b. Fungsi absorbsi Absorbsi melalui kulit terdiri dari dua jalur, yaitu melalui epidermis dan melalui kelenjar sebacea. Bahan-bahan yang mudah larut dalam lemak akan lebih mudah diabsorbsi dibandingkan dengan air ataupun bahan yang dapat larut dalam
air
(Mitsui,
1997).
Kemampuan
absorbsi
kulit
dipengaruhi oleh tebal tipisnya kulit, hidrasi, kelembaban udara, metabolisme, dan jenis pembawa zat yang menempel di kulit (Wasitaatmadja, 1997). c. Fungsi pembentukan pembentukan pigmen (melanogenesis) Sel pembentuk pigmen melanin kulit yaitu melanosit terletak di stratum germinativum atau lapisan basal.Sel melanosit berasal dari rigi saraf, jumlahnya 1:10 dari sel basal. Sinar matahari mempengaruhi produksi melanin, semakin lama kulitterpapar sinar matahari maka produksi melanin akan meningkat (Wasitaatmadja, 1997). d. Fungsi keratinisasi Keratinisasi dimulai dari sel basal kuboid bermitosis ke atas sehingga bentuknya menjadi lebih poligonal yaitu sel spinosum,
terangkat
keatas
menjadi
lebih
pipih,
dan
bergranula menjadi sel granulosum, kemudian sel tersebut terangkat ke atas menjadi lebih pipih dan granula serta intinya hilang dan akhirnya sampai dipermukaan kulit menjadi sel tanduk yang mati, protoplasmanya mengering menjadi keras, pipih, tak berinti. Proses ini berlangsung terus - menerus pada lapisanepidermis disebut Cel Turn Over Time dan berguna untuk rehabilitasi kulit agar dapat melaksanakan fungsinya dengan
baik
(Tranggono
Wasitaatmadja,1997).
dan
Latifah,
2007;
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2.2 Tinjauan Tentang Proses Pigmentasi Kulit Melanin merupakan pigmen penentu warna kulit yang paling penting di lapisan epidermal kulit.Melanin ditransfer di dekat keratinosit melalui dendrit dari melanosit.Dalam kulit manusia, melanosit terdiri atas antara 1 hingga 7 atau 8 sel basal dalam lapisan basal epidermal, akar rambut dan selubung akar terluar.Densitas tidak mempengaruhi variasi antara ras yang berbeda.Oleh karena itu, variasi
warna
kulit
ras
disebabkan
oleh
perbedaan
produksi
melanosom dalam tiap melanosit, jumlah melanosom yang ditransfer ke keratinosit, dan derajat kematangan dan dispersi melanosom dalam keratinosit (Mitsui, 1997).Satu sel melanosit dikelilingi oleh sekitar 36 sel keratinosit, dan kesatuan ini dinamakan unit melanin epidermal (Tranggono dan Latifah, 2007). Melanin dibentuk dengan beberapa tahapan reaksi yang dikatalisis oleh enzim dalam melanosom. Pembentukan melanin diawali dengan enzim enzim tirosinase tirosinase
mengkatalisis hidroksilasi tirosin
menjadi dihidroksi fenilalanin atau DOPA. DOPA merupakan kofaktor dalam proses oksidasi berikutnya dan sebagai substrat enzim tirosinase. DOPA akan teroksidasi menjadi dopakuinon dikatalisis oleh enzim tirosinase. Dopakuinon yang terbentuk memiliki kereaktifan yang tinggi sehingga akan bereaksi secara spontan membentuk dopakrom melalui auto-oksidasi hingga terbentuk melanin (Chang, 2009). Melanin yang terbentuk ada dua tipe yaitu eumelanin dan feomelanin.Eumelanin (pigmen warna coklat) terbentuk melalui serangkaian reaksi oksidasi dari dihidroksiindol (DHI) dan asam
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2.3 Tinjauan Tentang Hambatan Enzim Tirosinase Hambatan enzim tirosinase atau hambatan melanogenesis, yakni senyawa yang dapat mengganggu pembentukan melanin, baik secara langsung menghambat atau hanya berinteraksi dengan enzim (Chang, 2009).Chang (2012) menyebutkan bahwa penghambatan aktivitas enzim tirosinase merupakan mekanisme depigmentasi yang paling sering digunakan, karena penghambatan bersifat spesifik dengan target melanogenesis di sel melanosit tanpa menimbulkan efek samping. Menurut Chang (2009), agen hambatan enzim tirosinase dapat dikelompokkan menjadi lima golongan yaitu senyawa polifenol, turunan benzaldehid dan benzoat, steroid dan lipid rantai panjang, hambatan alami atau sintetik, agen inaktivator ireversibel berdasarkan struktur kimia atau mekanisme penghambatan. Polifenol merupakan senyawa yang termasuk kelompok terbesar sebagai hambatan tirosinase.Flavonoid termasuk senyawa polifenol yang paling banyak tersebar di daun, biji, kayu, dan bunga pada tanaman.Flavonoid dapat dibagi ke dalam tujuh kelompok yaitu f lavon, flavonol, flavanon, flavanol, isoflavon, kalkon dan katekin. Senyawa isoflavon merupakan golongan flavonoid yang dapat menghambat aktivitas enzim tirosinase dengan mengkhelat logam tembaga (Cu) yang merupakan active site enzim tirosinase akibat adanya gugus hidroksil pada pada cincin A dan B pada isoflavon (gu gus OH pada C6 - C8 dan C4’) (Chang, 2009). Posisi gugus hidroksil dan jumlah gugus hidroksil memiliki peranan penting dalam menghambat aktivitas enzim tirosinase.Semakin banyak jumlah gugus OH pada cincin benzen,
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dahulu diramu dari bahan-bahan alami yang terdapat disekitarnya. Sekarang kosmetik dibuat manusia tidak hanya dari bahan alami tetapi juga bahan sintetik untuk maksud meningkatkan kecantikan (Wasitaatmadja, 1997). Klasifikasi kosmetik menurut Shai, Maibach dan Baram (2009) yaitu : 1. Memperbaiki penampilan. Tujuannya memeperbaiki penampilan dengan menekankan pada bagian muka atau tubuh yang terlihat lebih baik supaya penglihatan orang tersebut terfokus pada bagian tersebut. 2. Perawatan kulit. Digunakan untuk mencapai dan memepertahankan kehalusan dan kelenturan kulit. 3. Pelindung kulit. Tujuannya adalah melindungi kulit dari sinar matahari, angin, dingin, dan lain-lain. Kosmetik medik adalah kosmetik yang dikombinasikan dikombinasikan dengan bahan-bahan yang secara farmakologi aktif atau bahan obat untuk memperbaiki atau menyembuhkan kelainan pada kulit (Tranggono dan Latifah. 2007). Kosmetisikal adalah Produk mempengaruhi fisiologi kulit namun masih boleh dibeli secara bebas –terbatas –terbatas tanpa harus memakai resep dokter. Contohnya adalah produk yang mengandung glabridin, arbutin, asam kojik, kedelai (soy (soy ), ), asam glikolat dan hidrokuinon dibawah 2% (Suhartini, dkk, 2013). Kosmetomedik adalah Produk yang mempengaruhi fisiologi kulit dan hanya boleh dibeli dengan resep dokter, contohnya adalah hidrokuinon diatas 2% dan asam retinoat (Suhartini, dkk, 2013).
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pada kulit, alergi, iritasi kulit serta pemakaian dengan dosis tinggi dapat
menyebabkan
kerusakan
permanen
otak,
serta
dapat
menyebabkan kanker (Parengkuan, 2013). Definisi krim pemutih kulit adalah sediaan kosmetik yang berbentuk krim merupakan campuran bahan kimia dan atau bahan lainnya yang digunakan untuk memucatkan noda hitam/coklat pada kulit (SNI, 1998). Standar krim pemutih kulit berdasarkan SNI (Standar Nasional Indonesia) Nomor 16-4954-1998 tentang krim pemutih kulit. Dimana pembuatan
standar
ini
berdasarkan
PerMenKes
No.96/MenKes/Per/V/1997 tentang wadah pembungkus, penandaan dan periklanan, SNI 19-0429-1989 petunjuk pengambilan contoh cairan dan semi padat, PerMenKes No.376/MenKes/Per/VIII/1990 tentang bahan, zat warna, zat pengawet dan sediaan tabir surya pada kosmetik, Ditjen POM No: HK.00.06.4.02894 tentang persyaratan cemaran mikroba pada kosmetik, SNI 16-0212-1995/Revisi 1987 Farmakope Indonesia Edisi IV, dan SNI 16-0218-1997 Kodeks Kosmetik Indonesia, Edisi II Volume I dan II (SNI, 1998).
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instrument, metode klasik yang paling utama adalah analisis warna atau reaksi warna, metode ini dipakai untuk senyawa anorganik (kation dan anion), atau juga untuk senyawa organik seperti sering digunakan untuk skrining fitokimia dalam penentuan metabolit sekuder tumbuhan. Metode lain dalam tujuan ini adalah uji warna nyala, kedua metode tersebut diawali dengan analisis organoleptis atau uji pendahuluan (Arif, 2009). Metode identifikasi terbagi menjadi reaksi fisika, reaksi kimia danreaksi fisika-kimia. Reaksi kimia terdiri dari pembentukan gas atau bau,pembentukan warna dan pembentukan endapan. Reaksi warna ataupembentukan warna pada reaksi kimia mempunyai beberapa keuntungandan kerugian. Kerugian dari penggunaan reaksi warna, yaitu warnanya dapatditutupi oleh ketidakmurnian atau adanya senyawa lain. Sedangkankeuntungan dari reaksi ini antara lain sederhana sehingga mudah dilakukan,mudah diinterprestasikan, warna terbentuk dengan cepat dan mudah diamati,sensitifitasnya cukup tinggi, murah dan tidak memerlukan alat yang mahaldan keahlian yang tinggi (Chang, 2005). 2.6 Tinjauan Arbutin Salah satu pencerah kulit yang tergolong inhibitor tirosinase adalah
arbutin.
Arbutin
atau
2-Hydroxymethyl
–
6-(4-
hydroxyphenoxy)oxane – 3,4,5 triol telah lama digunakansebagai bahan pemutih dalam produk kosmetik. Sebagai pencerah, arbutin biasanya dikombinasikan dengan berbagai bahan lain dan dapat ditemui
dalam
berbagai
formula
yaitu
krim
ataupun
serum.
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Arbutin didapatkan dari hasil ek strak tanaman bearberry.Arbutin terbukti mampu menghambat terbentuknya enzim tironase, sehingga produksi melanin jadi terhambat.Arbutin banyak digunakan dalam berbagai produk perawatan kulit dan wajah yang bertujuan untuk membuat kulit tampak lebih cerah.Menurut hasil penelitian, arbutin juga terdapat pada kulit buah pir dan gandum. (Mulyawan,2013).. (Mulyawan,2013).. 2.2 Uraian Bahan 1. Arbutin Nama resmi
: ARBUTINUM
Nama lain
: Arbutin
Kelas fungsional
: Zat Aktif
Konsentrasi
: 1%-5%
Rm / Bm
: C12H16O7
Indikasi
: Memutihkan dan menyamarkan flekflek hitam pada kulit
Mekanisme kerja
: Arbutin bekerja melalui mekanisme penghambatan biosintesis melanin
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Konsentrasi Pemerian
: 10-30% :Massa lemak, lengket, bening, putih, sifat ini tetap setelah zat dileburkan dan
dibiarkan
menjadi
dingin
tanpa
diaduk berfluoresensi lemah. Juga jika dicairkan, tidak berbau, hampir tidak berasa. Kelarutan
: Praktis tidak larut dalam air dan
etanol95P,larut dalam kloroform P, dalam eter P, dalam eterminyak tanah P Stabilitas
: Bahan yang secara inheren stabil karena tidak reaktif sebagian besar ini adalah stabilitas terjadi karena adanya
sejumlah
kecil
kotoran.
Dipaparan cahaya, kotoran ini dapat teroksidasimenghitamkan petoolatuni dan menghasilkan bau yang tidak
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Kelarutan
: Tidak larut dalam air, agak sukar larut dalam
etanol
dingin.Larut
sempurna dalam kloroform dan eter juga minyak lemak Stabilitas
: Stabil
jika
disimpan
pada
wadah
tertutup dan terlindung dari cahaya. Inkompatibilitas
: Inkompatibel dengan zatpengkosidasi
Penyimpanan
: Dalam wadah tertutup baik
4. Metil paraben (Rowe R C,2009) Nama resmi
: METHYLUS PARABENUM
Nama lain
: Nipagin, metil paraben
Kelas fungsional
: Pengawet
Konsentrasi
: 0,02-0,3%
Rm / Bm
: C8H8O3/152,15
Pemerian
: Serbuk
hablur,
berwarna
putih,
hampir berbau, tidak ada rasa Kelarutan
: Larut
dalam 600 bagian air,
20
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tidak ada rasa Kelarutan
: Sukar larut dalam air, larut dalam 3,5
bagian etanol (95%) P, 3 bagian aseton P, dalam 40 bagian minyak. Stabilitas
: Propil paraben encer, pH 3-6 dapat
disterilkandengan autoklaf tanpa dekomposisi. pH 3-6 larutan yang stabil (kurang dari 10% ) dekomposisi). Pada pH 8 atau diatas terhidrolisis Penyimpanan
: Dalam wadah tertutup baik
6. Gliserin (Rowe R C,2009) C,2009) Nama resmi
: GLYCERINUM
Nama lain
: Gliserin
Kelas fungsional
: Zat Tambahan
Konsentrasi
:-
Rm / Bm
: C3H8O3 / 92,09
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muda atau kuning pucat, agak tembus cahaya, bau lemah dan khas. Kelarutan
: Praktis tidak larut dalam air, agak sukar larut dalam etanol (95%) P,
mudah larut dalam kloroform P dan dalam eter P Penyimpanan
: Dalam wadah tertutup baik,
terlindung dari cahaya ditempat sejuk. 8. Span 80 (Rowe R C,2009) Nama resmi
: SORBITON MONOLEATE
Nama lain
: Span 80
Kelas fungsional
: Emulgator fase minyak
Konsentrasi
: 15 %
Rm / Bm
: C24H44O6 / 429
Pemerian
: Larutan berminyak, tidak berbau,
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Konsentrasi
: 1-15%
Rm / Bm
: CO4H124O26 / 1,310
Pemerian
:Polisorbat memiliki bau yang khas, dan hangat, rasa agak pahit, cairan minyak, berwarna kuning.
Kelarutan
: Larut dalam etanol dan air, tidaklarut dalam minyak mineral danminyak sayur
Stabilitas
:
Stabil
terhadap
elektolit
dan
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BHA
0,05%
Propilenglikol
10%
Aquadest
10%
III.1.2 Formula yang disetujui Tiap 10 ml mengandung Arbutin
2%
Vaselin Alba
25%
Cera Alba
5%
Metil paraben
0,18%
Commented [U1]: Tidk usah
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06-AL
Adeps Lanae
Agen emulsi 2,2g
07-SP
Span 80
Emulgator
0,33 g
08-TW
Tween 80
emulgator
0,165 g
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Gliserin
=
10 10 = 1
,
BHA
=
Adeps lanae
=
Aquadest
= 10- (0,2 + 2,5 + 0,5 + 0,3+ 0,184+ 0,018+ 0,02+
10 = 0,00 0,005 5
10 10 = 2
1+0,005+ 2) = 10- 6,723 III.2 Alat dan bahan III.2.1 Alat
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1. Pemeriksaan pH Krim
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lain. Senyawa arbutin memiliki sifat hidrofilik sehingga baik diformulasikan
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paraben dan propil paraben dimana pengawet ini merupakan antibakteri
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