Abstrak
Latar Belakang: C. albicans rongga mulut adalah flora normal yang dapat berubah
menjadi patogen sehingga menyebabkan kandidiasis oral. Ekstrak etanol temulawak
dengan kandungan utama xanthorrhizol dilaporkan dapat menginhibisi dan
mengeradikasi biofilm C. albicans pada konsentrasi 15%, serta menurunkan aktifitas
enzim fosfolipase dan proteinase C. albicans. Selanjutnya, ekstrak etanol temulawak
diformulasikan dan dikembangkan menjadi bentuk sediaan obat tetes mikroemulsi.
Dalam pengembangan bentuk sediaan obat, maka diperlukan penetapan formulasi dan
uji stabilitas biologis, fisik, dan kimia. Tujuan: Menetapkan formulasi dan
mengevaluasi stabilitas fisik dan kimia obat tetes mikroemulsi ekstrak etanol
temulawak Metode: Ekstrak etanol temulawak 15% diformulasikan menjadi sediaan
obat tetes mikroemulsi. Kemudian stabilitas fisik dan kimia dievaluasi 2-4 minggu
pada 3 suhu penyimpanan yang berbeda yaitu 4±2oC; 28±2oC; dan 40±2oC. Selanjutnya
stabilitas fisik berupa organoleptis, homogenitas, pH, viskositas, dan tipe aliran
dievaluasi. Pada stabilitas kimia dievaluasi perubahan kadar xanthorrhizol setelah 2
dan 4 minggu, menggunakan metode GC-MS. Hasil: Formulasi obat tetes mikroemulsi
mengandung ekstrak etanol temulawak 15% memiliki organoleptik; larutan kuning
kecoklatan, rasa pahit, dan berbau khas jamu, homogenitas; terjadi pemisahan antara
komponen minyak dan air, pH berkisar 6,3-6,9, dan tipe alir pseudoplastis pada 2-4
minggu dengan 3 suhu penyimpanan. Viskositas menurun seiring dengan peningkatan
suhu penyimpanan. Kadar xanthorrhizol menurun setelah 2-4 minggu pada ketiga suhu
penyimpanan. Kesimpulan: Adanya pemisahan komponen minyak dan air serta
penurunan kadar zat aktif dalam kurun 2-4 minggu mendasari kesimpulan bahwa
formulasi obat tetes ekstrak etanol temulawak 15% tidak stabil secara fisik dan kimia
setelah disimpan selama 2 dan 4 minggu sehingga masih diperlukan reformulasi.
......Introduction: C. albicans is a normal flora in oral cavity that can be pathogenic that
causing oral candidiasis. Curcuma xanthorrhiza ethanoic extract has a main
component, xanthorrhizol that was reported to be able to inhibit and eradicate C.
albicans biofilms at a 15% concentration and reduce the activity of phospholipase and
proteinase enzymes of C. albicans. Furthermore, curcuma xanthorrhiza ethanoic extract
is formulated and developed into microemulsion oromucosal drops. In the development
of the drug, it is necessary to determine the formulation and test the stability in
biological, physical, and chemical. Objective: Determining the formulation and
evaluating the physical and chemical stability of microemulsion oromucosal drops
containing 15% curcuma xanthorrhiza ethanoic extract. Methods: Curcuma
xanthorrhiza ethanoic extract is formulated into microemulsion oromucosal drops
containing 15% curcuma xanthorrhiza ethanoic extract. Then, the physical and
chemical stability are evaluated for 2-4 weeks in 3 different temperature, that is 4 ±
2oC; 28 ± 2oC; and 40 ± 2oC. Furthermore, the physical stability in the form of
organoleptic, homogeneity, pH, viscosity, and flowing type are evaluated. Chemical
stability is evaluated the xanthorrhizol level using the GC-MS method. Results:
Microemulsio oromucosal drops containing 15% curcuma xanthorrhiza ethanoic
extract have organoleptic; brownish-yellow solution, bitter taste, and smells like herb,
homogeneity; there is a separation between the oil and water phase, pH ranges from
6,3-6,9, and flowing type are pseudoplastic. The viscosity value decreases with the
increasing of storage temperature. Xanthorrhizol level are decreasing after 2-4 weeks
of storage in the 3 different temperature. Conclusion: The separation between the oil
and water phase and degradation of xanthorrhizol level after stored 2-4 weeks are the
underlying conclusion that formulation of oromucosal drops containing curcuma
xanthorrhiza ethanoic extract are not stabile in physical and chemical after stored for 2
and 4 weeks so that the drugs need to be reformulated.
