Latar Belakang: C. albicans rongga mulut adalah flora normal yang dapat berubahmenjadi patogen sehingga menyebabkan kandidiasis oral. Ekstrak etanol temulawakdengan kandungan utama xanthorrhizol dilaporkan dapat menginhibisi danmengeradikasi biofilm C. albicans pada konsentrasi 15%, serta menurunkan aktifitasenzim fosfolipase dan proteinase C. albicans. Selanjutnya, ekstrak etanol temulawakdiformulasikan dan dikembangkan menjadi bentuk sediaan obat tetes mikroemulsi.Dalam pengembangan bentuk sediaan obat, maka diperlukan penetapan formulasi danuji stabilitas biologis, fisik, dan kimia. Tujuan: Menetapkan formulasi danmengevaluasi stabilitas fisik dan kimia obat tetes mikroemulsi ekstrak etanoltemulawak Metode: Ekstrak etanol temulawak 15% diformulasikan menjadi sediaanobat tetes mikroemulsi. Kemudian stabilitas fisik dan kimia dievaluasi 2-4 minggupada 3 suhu penyimpanan yang berbeda yaitu 4±2oC; 28±2oC; dan 40±2oC. Selanjutnyastabilitas fisik berupa organoleptis, homogenitas, pH, viskositas, dan tipe alirandievaluasi. Pada stabilitas kimia dievaluasi perubahan kadar xanthorrhizol setelah 2dan 4 minggu, menggunakan metode GC-MS. Hasil: Formulasi obat tetes mikroemulsimengandung ekstrak etanol temulawak 15% memiliki organoleptik; larutan kuningkecoklatan, rasa pahit, dan berbau khas jamu, homogenitas; terjadi pemisahan antarakomponen minyak dan air, pH berkisar 6,3-6,9, dan tipe alir pseudoplastis pada 2-4minggu dengan 3 suhu penyimpanan. Viskositas menurun seiring dengan peningkatansuhu penyimpanan. Kadar xanthorrhizol menurun setelah 2-4 minggu pada ketiga suhupenyimpanan. Kesimpulan: Adanya pemisahan komponen minyak dan air sertapenurunan kadar zat aktif dalam kurun 2-4 minggu mendasari kesimpulan bahwaformulasi obat tetes ekstrak etanol temulawak 15% tidak stabil secara fisik dan kimiasetelah disimpan selama 2 dan 4 minggu sehingga masih diperlukan reformulasi.
Introduction: C. albicans is a normal flora in oral cavity that can be pathogenic thatcausing oral candidiasis. Curcuma xanthorrhiza ethanoic extract has a maincomponent, xanthorrhizol that was reported to be able to inhibit and eradicate C.albicans biofilms at a 15% concentration and reduce the activity of phospholipase andproteinase enzymes of C. albicans. Furthermore, curcuma xanthorrhiza ethanoic extractis formulated and developed into microemulsion oromucosal drops. In the developmentof the drug, it is necessary to determine the formulation and test the stability inbiological, physical, and chemical. Objective: Determining the formulation andevaluating the physical and chemical stability of microemulsion oromucosal dropscontaining 15% curcuma xanthorrhiza ethanoic extract. Methods: Curcumaxanthorrhiza ethanoic extract is formulated into microemulsion oromucosal dropscontaining 15% curcuma xanthorrhiza ethanoic extract. Then, the physical andchemical 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 oforganoleptic, homogeneity, pH, viscosity, and flowing type are evaluated. Chemicalstability is evaluated the xanthorrhizol level using the GC-MS method. Results:Microemulsio oromucosal drops containing 15% curcuma xanthorrhiza ethanoicextract have organoleptic; brownish-yellow solution, bitter taste, and smells like herb,homogeneity; there is a separation between the oil and water phase, pH ranges from6,3-6,9, and flowing type are pseudoplastic. The viscosity value decreases with theincreasing of storage temperature. Xanthorrhizol level are decreasing after 2-4 weeksof storage in the 3 different temperature. Conclusion: The separation between the oiland water phase and degradation of xanthorrhizol level after stored 2-4 weeks are theunderlying conclusion that formulation of oromucosal drops containing curcumaxanthorrhiza ethanoic extract are not stabile in physical and chemical after stored for 2and 4 weeks so that the drugs need to be reformulated. |
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