Kelompok 2A

Nama :
1. Muhammad bagus sumarsono 201610410311035
2. A
3. B
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Agenda Style

1 TINJAUAN FARMAKOLOGI BAHAN OBAT

2 TINJAUAN SIFAT FISIKOKIMIA BAHAN OBAT

3 BENTUK SEDIAAN, DOSIS DAN CARA PEMBERIAN

4 FORMULASI DAN PELAKSANAAN

Tetes mata
Dengan bahan obat chloramphenicol
 TINJAUAN FARMAKOLOGI BAHAN OBAT

KLORAMFENIKOL….?

Kloramfenikol adalah salah satu antibiotik yang secara kimiawi diketahui paling stabil
dalam segala pemakaian. Dia memiliki stabilitas yang sangat baik pada suhu kamar dan
kisaran pH 2 sampai 7, stabilitas maksimumnya dicapaipada pH 6. Pada suhu 25℃ dan
pH 6, memiliki waktu paruh hampir 3 tahun. Yang menjadi penyebab utama terjadinya
degradasi kloramfenikol dalam media air adalah pemecahan hidrolitik pada pemecahan
amida. Laju reaksinya berlangsung dibawah orde pertama dan tidak tergantung pada
kekuatan ionik media (Connors, 1986).
 Our Services

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INDIKASI PERINGATAN
Kloramfenikol merupakan antibiotik Hindari pemberian berulang dan
spektrum luasKloramfenikol juga jangka panjang. Turunkan dosis
digunakan pada fibrosis sistik untuk pada gangguan fungsi hati dan
mengatasi infeksi pernafasan ginjal. Pada neonatus dapat
karena Burkholderia cepacia yang menimbulkan grey baby
resisten terhadap antibiotik lain
syndrome.

3 4
KONTRAINDIKASI EFEKSAMPING
wanita hamil, menyusui dan pasien kelainan darah yang reversibel
porfiria. dan ireversibel seperti anemia
aplastik (dapat berlanjut menjadi
leukemia), neuritis perifer, neuritis
DOSIS optik, eritema multiforme, mual,

5
oral, injeksi intravena atau infus: 50 mg/kg muntah, diare, stomatitis, glositis,
bb/hari dibagi dalam 4 dosis. ANAK: hemoglobinuria nokturnal.
epiglotitis hemofilus, meningitis purulenta, 50-
100 mg/kg bb/hari dalam dosis terbagi. BAYI
di bawah 2 minggu, 25 mg/kg bb/hari (dibagi
dalam 4 dosis). 2 minggu-1 tahun, 50 mg/kg
bb/hari (dibagi 4 dosis).
 Your Picture Here
( Farmakope indonesia ed V. Hal 673)
Tinjauan sifat fisika kimia
Rumus molekul
C11H12Cl2N2O5
Bobot molekul
323,13g/mol
Kelarutan
Sukar larut dalam air; mudah larut dalam
etanol, dalam propilen glikol, dalam aseton
dan dalam etil asetat.
( Farmakope indonesia ed V. Hal 673)
Stabilitas
Stabilitas baik pada suhu kamar dan kisaran
pH 2-7, suhu 25oC dan pH mempunyai waktu
paruh hampir 3 tahun. Sangat tidak stabil
dalam suasana basa.
Inkompaktibilatas
inkompatibilitas dengan adanya kandungan
seperti aminofilin, ampisilin, asam
askorbat, kalsium klorida, chlorpromasin
HCl, garam eritromisin, gentamisin sulfat,
natrium hidrokortison suksinat, natrium
nitrofurantoin (Lund,1994).
Bentuk sediaan,dosis,cara pemberian
Tetes mata chloramphenicol
Permasalahan formulasi
• Tetes mata :
0.5 % (larutan) dan 1 % (salep);
tiap 10 ml mengandung 50 mg
kloramfenikol.
• pH : Antara 4,5 dan 7,5 (FI ed
IV)
• pH sediaan : Antara 7,0 dan 7,5;
kecuali obat tetes mata tanpa
larutan dapar atau digunakan
untuk hewan antara 3,0 dan 6,0.
(FI ed IV)
• Suhu lebur : 149° C - 153° C
• Kestabilan : Terurai oleh cahaya
Name Here
(FI ed III)
Programmer
Cara mengatasi
1. Dilarutkan dalam pelarut netral
atau agak asam jadi dilarutkan
1. Zat aktif tidak larut dalam natrii tetraboras dan
dikombinasikan dengan asam
dalam air ? borak karena merupakan larutan
2. Air mudah asam yang tidak terlalu kuat.
Asam borak ditambahkan untuk
ditumbuhi jamur ? meningkatkan efektifitas natrii
3. Sediaa harus tetraboras.
2. Digunakan bahan pengawet
Isohidris ? Phenylhydrargyri Nitras.
3. Digunakan dapar pH 7 Natrii
tetraboras. Selain itu Natrii
tetraboras juga berfungsi
sebagai buffering agent
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Formulasi
Tetes mata chloramphenicol

Berdasarkan Formularium Nasional hal 65 :

Chloramphenicoli guttae opthalmicae
Tetes Mata Kloramfenikol
Komposisi. Tiap 10 ml mengandung
Chloramphenicolum 50 mg
Acidum Boricum 150 mg
Natrii Tetraboras 30 mg
Phenylhydrargyri Nitras 200 µg
Aqua destilata hingga 10 ml
Formulasi yang direncanakan
Tetes mata chloramphenicol

No. Bahan Fungsi Jumlah

1. Chloramphenicolum Bahan Aktif 50 mg

2. Acidum Boricum Pengawet 150 mg

3. Natrii Tetraboras Penstabil 30 mg
4. Aqua destilata Pelarut Ad 10 ml
Formulasi yang direncanakan
Tetes mata chloramphenicol
Nama Bahan Fungsi Kelarutan pH Stabil Cara Sterilisasi
Chloramphenicolum Bahan Aktif Sukar larut dalam air; Antara 4,5 dan  
    mudah larut dalam 7,5 (FI ed IV)
  etanol, dalam  
propilenglikol, dalam
aseton dan dalam etil
asetat.
Acidum Boricum Pengawet Larut dalam 20 bagian 3.5–4.1  
air, dalam 3 bagian air (5% b/v
mendidih, dalam 16 larutan
bagian etanol (95 %) cairan)
dan dalam 5 bagian
gliserol

 
Natrii Tetraboras penstabil Larut dalam 20 bagian 9.0–9.6  
air, dalam 0,6 bagian (4% w/v
air endidih dan dalam aqueous
lebih kurang 1 bagian solution)
gliserol; praktis tidak
larut dalam etanol (95
%)
Aqua destilata pelarut Larut dalam berbagai pelarut    
polar
Formulasi yang direncanakan
Tetes mata chloramphenicol

PERHITUNGAN VOLUME DAN BERAT

 
ΔTf = Liso x berat x 1000
BM x V
Kloramfenikol 0,5%
ΔTf = 1,86x 50/1000 x 1000
323,13 x 10
= 0,02878= 0,03
Acidum Boricum 1,5%
ΔTf asam borat 1% = 0,28
ΔTf asam borat 1,5% = x 0,28 = 0,42
Natrii Boras 0,3%
ΔTf natrii borat 1% = 0,24
ΔTf natrii borat 0,3% = x 0,24 = 0,07
B = 0,52 – (0,03 + 0,42 + 0,07)
= 0 (isotonis)
PENIMBANGAN BAHAN
Volume yang dibuat = (n x v) + 6
= (2 x 10,5 ml) + 6
= 27 ml ≈ 35 ml
Volume yang dibuat untuk total sediaan tetes mata adalah 20 ml, untuk antisipasi maka volumenya dilebihkan menjadi 35 ml.
Jadi bahan yang ditimbang :
Kloramfenikol = 0,5% x 35 ml = 0,175 gram
Acidum Boricum = 0,15% x 35 ml = 0,0525 gram
Natrii tetraboras = 0,3% x 35 ml = 0,105 gram
API ad 30 ml
Alat dan wadah dan cara sterilisasi
Tetes mata chloramphenicol

Nama alat Jumlah Cara sterilisasi Waktu

Spatel logam 1 Oven 170⁰ C 30 menit
Pinset logam 1 Oven 170⁰ C 30 menit
Batang pengaduk 1 Oven 170⁰ C 30 menit
Kaca arloji 2 Oven 170⁰ C 30 menit
Cawan penguap 2 Oven 170⁰ C 30 menit
Gelas ukur 2 Autoklaf (115 - 116 ⁰ C) 30 menit
Pipet tetes tanpa karet 1 Autoklaf (115 - 116 ⁰ C) 30 menit
Karet pipet 1 Rebus 30 menit
Corong gelas dan kertas saring lipat 1 Autoklaf (115 - 116 ⁰ C) 30 menit
terpasang
Kapas   Autoklaf (115 - 116 ⁰ C) 30 menit
Erlenmeyer 2 Oven 170⁰ C 30 menit
Beacker glass 3 Oven 170⁰ C 30 menit
Wadah tetes mata tanpa tutup 2 Direndam dengan alkohol  
Tutup wadah tetes mata 2 Direndam dengan alkohol  
Prosedur kerja
Tetes mata chloramphenicol

1. Disiapkan alat dan bahan yang akan digunakan

2. Disiapkan Aqua Pro Injeksi bebas O2
3. Ditimbang masing-masing bahan yang akan digunakan pada neraca timbangan dengan kaca arloji yang
sebelumnya telah disterilkan secara aseptis.
4. Dikalibrasi beaker glass dan botol tetes mata yang akan digunakan (10,5 ml)
5. Dilarutkan masing-masing bahan dalam API.
6. Larutkan asam borat dan natrii borat pada masing-masing beaker. Kemudian dicampur untuk digunakan
dalam melarutkan kloramfenikol sedikit demi sedikit dimasukan ke larutan tersebut. Kemudian dimasukan
sisa API. Lakukan pengecekan pH (pH yang diinginkan yaitu 7).
7. Melapisi corong dengan kertas saring dan dibasahi dengan API kemudian pindahkan corong ke beaker
glass yang sudah dikalibrasi. Kemudian disaring larutan ke dalam erlenmeyer.
8. Sisa 2/5 bagian API digunakan untuk membilas kemudian disaring lagi ke dalam beaker glass yang berisi
filtrat.
9. Ditambahkan API sampai batas kalibrasi
10.Diambil sebanyak 10,5 ml untuk tiap wadah dan mengisikan larutan ke dalam wadah, ditutup dengan
penutupnya.
11.Lakukan sterilisasi akhir.
12.Diberi etiket dan dilakukan evaluasi.
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