FORMULASI MATRIKS PATCH TRANSDERMAL EKSTRAK ETANOL 70 % BUNGA ROSELA (Hibiscus sabdariffa L.) DENGAN KOMBINASI POLIMER POLIVINIL ALKOHOL : HIDROKSI PROPIL METIL SELULOSA : KARBOKSI METIL SELULOSA NATRIUM

NURISTA DIDA A, Prof.Dr.Akhmad Kharis Nugroho,M.Si., Apt. ; Dr. Erna Prawita Setyowati,M.Si., Apt.

2016 | Tesis | S2 Ilmu Farmasi

Patch transdermal merupakan bentuk sediaan yang dapat menghantarkan obat melalui kulit dan menghasilkan efek sistemik. Penelitian mengenai herbal patch telah banyak dilakukan untuk mengatasi berbagai macam penyakit. Pada penelitian ini akan dilakukan optimasi formula matriks patch transdermal ekstrak etanol 70% bunga Rosela dan uji transpor in vitro formula optimum serta melihat pengaruhnya terhadap kematian sel 3T3L-1. Formulasi sediaan dibuat dalam bentuk matriks patch transdermal dengan polimer PVA:HPMC:CMC Na. Skrining dosis ekstrak etanol 70% bunga Rosela dalam matriks patch transdermal dilakukan dengan cara menghitung IC50 dari ekstrak. Optimasi polimer menggunakan software Design Expert versi 7.1.5 metode Simplex Lattice Design. Evaluasi formula meliputi ketebalan (mm), variasi bobot (%), susut pengeringan (%), drug content (%), dan sifat fisik patch. Formula optimal dilakukan uji transpor in vitro dengan menggunakan membran kulit tikus dan membran millipore. Sampel hasil uji transpor in vitro dilakukan pengujian pada sel 3T3L-1 untuk melihat persen kematian sel. Analisis statistika persen kematian sel 3T3L-1 dilakukan dengan ANOVA satu jalan pada taraf kepercayaan 95%. Hasil penelitian menunjukkan ekstrak etanol 70% bunga Rosela memberikan pengaruh pada pengurangan jumlah sel 3T3L-1 dengan nilai IC50 11,16 mg/mL. Analisis statistika persen kematian menunjukkan adanya perbedaan yang signifikan antar tiap dosis. Formula optimum matriks patch transdermal diperoleh perbandingan PVA:HPMC:CMC Na yaitu 4,833 %: 1 %: 0,662 % b/v dengan nilai desirability 0,792. Evaluasi matriks patch transdermal dari formula optimum diperoleh nilai ketebalan 0,3033+0,01 mm, variasi bobot 0,0856+0,002%, susut pengeringan 8,67+0,71 %, drug content 45,06+3,364 %, dan sifat fisik patch 15,6+3,114. Hasil uji transpor formula optimum secara in vitro melewati membran kulit tikus maupun millipore tidak terdeteksi sehingga perlu dilakukan pengembangan formulasi lebih lanjut untuk mengoptimalkan hasil uji transpor in vitro.

Transdermal drug delivery system can deliver drugs through the skin therefore produce systemic effects . Research on herbal patches had been done to treat various diseases. The purposes of this study were (1) to optimize combination of PVA : HPMC : CMC Na as matrix in transdermal patch formula loaded with 70% ethanolic extract of Hibiscus sabdariffa L.;(2) to observe the optimal formula’s transport behavior in vitro, and to observe its cytotoxic effect to wards 3T3L-1 cells. Formulation transdermal matrix patch with a combination of PVA:HPMC: CMC Na polymers. Screening dose of 70% ethanol extract of Hibiscus sabdariffa L. in the matrix transdermal patch to calculate the IC50 of the extract. Concentration of PVA : HPMC : CMC Na were optimized using Simplex Lattice Design Method on Design Expert 7.1.5 software. All formulas were evaluated for its thickness (mm), weight variation (%), moisture content (%), drug content, and physical properties as optimization parameters. The optimal formula was then observed for its transport behavior in both skin membrane and millipore membrane in vitro. Also its cytotoxic effect toward 3T3L-1 cells using MTT assay. 3T3L-1 cell death percentage was analiyzed using one way Anova at 95% confidance level. The results showed 70% ethanol extract of Hibiscus sabdariffa L. was reducing the number of 3T3L-1 cells with IC50 values of 11,16 mg/mL. Statistical analysis percentage 3T3L-1 cell death showed a significant difference in variation dose. The most optimal formula transdermal matrix patch with a combination of PVA: HPMC: CMC Na polymers was 4,833%: 1%: 0,662% w/v with desirability value 0,792. Evaluation transdermal matrix patch of the optimum formula obtained value thickness 0,3033+0,01 mm, weight variation 0,0856+0,002%, moisture content 8,67+0,71 %, drug content 45,06+3,364 %, and physical properties 15,6+3,114. The result of the optimum formula transport across a membrane in vitro mouse skin or Millipore undetectable so it need further development formula to optimize the in vitro transport .

Kata Kunci : Ekstrak etanol 70% bunga Rosela, matriks, optimasi, sel 3T3L-1