DAFTAR ISI

KATA PENGANTAR……………………………………………….………….. v

DAFTAR ISI ......................................................................................................... vii

DAFTAR GAMBAR ............................................................................................. ix

DAFTAR TABEL ................................................................................................... x

DAFTAR LAMPIRAN .......................................................................................... xi

INTISARI .............................................................................................................. xii

ABSTRACT ........................................................................................................... xiii

BAB I. PENDAHULUAN ..................................................................................... 1

A. Latar Belakang Masalah .............................................................................. 1

B. Perumusan Masalah .................................................................................... 3

C. Tujuan Penelitian ........................................................................................ 3

D. Manfaat Penelitian ...................................................................................... 3

BAB II. STUDI PUSTAKA ................................................................................... 4

A. Tinjauan Pustaka ......................................................................................... 4

1. Cara Pembuatan Obat yang Baik……………………………………….…...4

2. Disolusi Obat Secara In Vitro ............................................................... 5

3. Disintegrasi Tablet ............................................................................. 11

4. Hubungan Antara In Vivo dan In Vitro ............................................... 12

5. Sistem Klasifikasi Biofarmasetika ...................................................... 12

6. Uji Disolusi Terbanding ..................................................................... 13

7. Monografi Bahan ............................................................................... 13

8. Spektrofotometri UV-Vis....................................................................15 B. Keterangan Empiris ................................................................................... 17

BAB III. METODE PENELITIAN ....................................................................... 18

A. Bahan dan Alat .......................................................................................... 18

B. Cara Penelitian .......................................................................................... 18

C. Analisis Hasil ............................................................................................ 21

BAB IV. HASIL DAN PEMBAHASAN ............................................................. 22

A. Uji Disintegrasi ......................................................................................... 21

B. Uji Disolusi ............................................................................................... 25

BAB V. KESIMPULAN DAN SARAN ............................................................... 37

A. Kesimpulan ............................................................................................... 37

B. Saran .......................................................................................................... 37

DAFTAR PUSTAKA .......................................................................................... 38

LAMPIRAN……………………………………………………………...…….

DAFTAR GAMBAR

 

Gambar 1 Ilustrasi skema proses disolusi sediaan padat ............................................ 6

Gambar 2 Kurva hubungan % obat terlarut terhadap waktu ...................................... 11

Gambar 3 Struktur eritromisin…………………………………...………..………14

Gambar 4 Skema spektrofotometer UV-Vis radiasi berkas ganda ............................. 16

Gmabar 5 Skema jalannya penelitian…………………………………….……….18

Gambar 6 Grafik eritromisin pada λ maksimum 231,5 nm ........................................ 26

Gambar 7 Grafik eritromisin pada λ maksimum 380,5 nm ........................................ 27

Gambar 8 Grafik kurva baku eritromisin tablet tidak bersalut ................................... 28

Gambar 9 Grafik kurva baku eritromisin tablet salut ................................................. 29

Gambar 10 Profil laju disolusi 6 macam produk tablet eritromisin 500 mg ................ 32

Gambar 11 Gambar histogram DE60 (%) ..................................................................... 34

DAFTAR TABEL

 

Tabel I Data hasil uji waktu hancur tablet ............................................................ 22

Tabel II Signifikan produk paten terhadap waktu hancur hasil uji t. ...................... 23

Tabel III Signifikan produk generik terhadap waktu hancur hasil uji t .................... 24

Tabel IV Hasil kurva baku eritromisin 231,5 nm ..................................................... 28

Tabel V Hasil kurva baku eritromisin 380,5 nm .................................................... 29

Tabel VI Laju disolusi produk paten dan produk generik ........................................ 31

Tabel VII % terdisolusi produk paten dan produk generik tablet eritromisin

waktu 60 menit .......................................................................................... 33

Tabel VIII Nilai DE60 produk paten dan produk generi tablet eritromisin…….....34

Tabel IX Hasil uji t DE60……………………………………………………….. 35

DAFTAR LAMPIRAN

Lampiran 1 Data uji waktu hancur………………………………………..…40

Lampiran 2 Contoh perhitungan kadar eritromisin terdisolusi……………..40

Lampiran 3 Nomor registrasi dan waktu kadaluarsa tablet eritromisin…….42

Lampiran 4 Contoh perhitungan Area Under Curve (AUC) dan Dissolution

Efficiency (DE)……………………………………………….…..42

Lampiran 5 Contoh hasil análisis statistika One Way ANOVA dan Tukey

HSD terhadap DE60……………………….……………..……..45