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Abstrak :
Berdasarkan penelitian sebelumnya, eksipien sambung silang koproses xanthan gum-amilosa (CL-Ko-A-XG) berpotensi sebagai matriks dalam formulasi tablet lepas lambat. Penelitian ini bertujuan untuk mengetahui jumlah eksipien yang terdegradasi oleh α-amilase dan pengaruh α-amilase terhadap profil disolusi dari tablet lepas lambat yang menggunakan matriks CL-Ko-A-XG. Eksipien disambungsilang dengan dua konsentrasi natrium trimetafosfat, yaitu 6% (CL6-Ko-A-XG) dan 12% (CL12-Ko-A-XG). Tiap eksipien dibuat dengan tiga perbandingan amilosa-xanthan gum, antara lain 1:1, 1:2 dan 2:1. Uji degradasi enzimatik dilakukan dilakukan terhadap serbuk eksipien selama 60 menit. Selain itu, eksipien digunakan sebagai matriks tablet lepas lambat dan diformulasi dengan metode kempa langsung. Kemudian, dilakukan uji disolusi dalam medium dapar fosfat pH 7,4 dengan dan tanpa α-amylase selama 8 jam. Hasil penelitian ini menunjukkan bahwa eksipien CL6-Ko-A-XG dan CL12-Ko-A-XG terdegradasi sebesar 20% berturut-turut selama 10 dan 30 menit. Selain itu, tablet F1-F6 menunjukkan profil pelepasan obat diperlambat yang mengikuti kinetika pelepasan orde nol dan Korsmeyer-Peppas, dan tidak terpengaruh dengan adanya α-amylase. Dari penelitian ini, dapat disimpulkan bahwa eksipien CL-Ko-A-XG lebih tahan terhadap degradasi enzimatik dibandingkan amilosa. Oleh karena itu, eksipien ini berpotensi sebagai matriks tunggal tablet lepas lambat. ...... Based on previous studies, cross-linked of coprocessed xanthan gum-amylose excipient (CL-Co-A-XG) has potential as a matrix in a sustained release tablet formulation. This study aims to determine amount of excipient that is degraded by α-amylase and influence of α-amylase to the dissolution profile of sustained release tablet that used matrix CL-Co-A-XG. Excipient is cross-linked with two concentration of sodium trimetaphospate, which is 6% (CL6-Co-A-XG) and 12% (CL12-Co-A-XG). Each excipient was made with ratio 1:1, 1:2 and 2:1 amylose-xanthan gum. Enzymatic degradation testhas been performed on excipient powder for 60 minutes. Beside that, sustained release tablet with CL-Co-A-XG excipient as matrix was formulated by direct compression method. Then, performed drug dissolution test in phosphate buffer pH 7.4 using and without α-amylase as medium for 8 hours. The results of this study showed that CL6-Co-A-XG and CL12-Co-A-XG were degraded 20% for 10 and 30 minutes. In addition, the release profile of F1-F6 tablets showed the sustained release profile which follow zero-order and Korsmeyer-Peppas kinetic, and not affected by presence of α-amylase. From this study, it can be concluded that the CL-Ko-A-XG excipients is more resistant from enzymatic degradation than amylose. Therefore, this excipient potential as a single matrix sustained release tablets.

Abstrak :
Asam dokosaheksaenoat (DHA) adalah salah satu jenis asam lemak tidak jenuh rantai panjang omega-3. DHA merupakan salah satu pengisi pada suplemen makanan sediaan kapsul cangkang lunak yang beredar. Analisis dengan kromatografi gas secara langsung akan membutuhkan waktu analisis yang lama karena titik didih asam lemak yang sangat tinggi sehingga perlu dilakukan derivatisasi sebelum dianalisis. Penelitian ini bertujuan untuk memperoleh kondisi analisis optimum DHA agar diperoleh metode yang valid untuk digunakan pada penetapkan kadar DHA dalam produk suplemen makanan sediaan kapsul cangkang lunak. Derivatisasi dilakukan dengan metode esterifikasi Lepage menggunakan reagen metanol-toluen 4:1(v/v) dan katalis asetil klorida pada suhu 100ºC selama 60 menit. Analisis dilakukan menggunakan kromatografi gas dengan kolom VB-wax (60 m x 0,32 mm), suhu kolom terprogram 140ºC-180ºC, kenaikan 2ºC/menit, lalu 180ºC-200ºC, kenaikan 5ºC/menit, dan dipertahankan selama 20 menit. Suhu injektor dan suhu detektor masing-masing 230ºC dan 250ºC; laju alir gas helium 0,80 ml/menit, volume penyuntikan 1,0 µl, dan dideteksi dengan detektor ionisasi nyala. Pada kondisi optimum waktu retensi metil dokosaheksaenoat adalah 14,821 menit dengan faktor ikutan 1,797. Metode yang diperoleh valid dengan presisi (KV) antara 0,67-1,43%, dan uji perolehan kembali 98,02-101,76%. Sampel A rata-rata kesesuaian kadar terhadap label adalah 90,32% dan sampel B rata-rata kesesuaian kadar terhadap label adalah 95,58%. ...... Docosahexaenoic acid (DHA) is one of the long chain omega 3 unsaturated fat. DHA is contained in capsule type food supplement that circulates around the market. A direct analysis with cromotography gas requires a very long time, due to the high melting point of the fatty acid,thus derivatization is needed before analysis. The aim of this research is to obtain the perfect condition for DHA analysis in order to achievea valid method to determine the right level of DHA in capsul supplement product. Derivatization is done through esterification Lepage using reagen metanol-toluen 4:1(v/v) and acetyl chloride catalyst at 100ºC for 60 minutes. The analysis is done using chromatography gas with VB-wax column (60 m x 0,32 mm) the column is program to 140ºC-180ºC and an increase of 2ºC/minute then 180ºC-200ºC with an increase of 5ºC/minute and mantained for 20 minutes. The temperature of injector and the detector temperature are both 230ºC and 250ºC; the flow rate of the gas helium 0,80 mL/minute, the injection volume 1,0 µl and detected by flame ionization detector. In the optimum condition the time of the methyl docosahexaenoic retention is 14,1821 minute with tailing factor 1,797. The obtained method is valid with a 0,67-1,43% precision, and recovery test 98,02-101,76%. The average compatibility rate of sample A towards the lable is 90,32%, while the average compatibility rate B towards the lable is 95,58%.

Abstrak :
[Kurkumin merupakan pigmen berwarna jingga kekuningan yang dapat mengalami dekomposisi struktur apabila terkena cahaya. Hal ini menyebabkan senyawa kurkumin menjadi tidak aktif. Salah satu upaya untuk mempertahankan kestabilan kurkumin ini adalah dengan penyalutan lapis tipis. Tujuan dari penelitian ini adalah membuat mikropartikel ekstrak kunyit dengan hidroksipropil metilselulosa (HPMC) menggunakan fluidized bed. Proses penyalutan dilakukan pada ekstrak kunyit 35 mesh (F2) dan 60 mesh (F3) dengan penyalut hidroksipropil metilselulosa (HPMC) 0,5%. Hasil SEM menunjukkan permukaan halus dan glossy pada formula F2 dan F3. Mikropartikel ekstrak kunyit diuji stabilitasnya di bawah pengaruh suhu; sinar matahari; sinar UV 254 nm; dan sinar lampu. Pada formula F2 diperoleh perubahan kadar berturut-turut sebesar 0,09%; 1,62%; 0,09%; dan 0,15%. Pada formula F3 diperoleh perubahan kadar berturut-turut sebesar 4,88%; 9,35%; 3,32%; dan 3,84%. Proses penyalutan ekstrak kunyit dengan hidroksipropil metilselulosa menggunakan fluidized bed belum memberikan hasil yang optimal secara fisik serta penyalutan ekstrak kunyit dengan hidroksipropil metilselulosa dapat meningkatkan kestabilan dari pengaruh suhu dan cahaya. ...... Curcumin is yellow-orange pigment. The structure of curcumin can be decomposed when exposed to light, which causes the compound of curcumin becomes inactive. To maintain the stability, curcumin has performed thin film coating. This research was intended to produce microparticles of turmeric extract coated hydroxypropyl methylcellulose by fluidized bed. The coating process is performed on curcumin extract 35 mesh (F2) and 60 mesh (F3) with 0,5% hydroxypropyl methylcellulose (HPMC) polymer. SEM results showed that formulation F2 and F3 have smooth surface and glossy. Microparticle of curcumin extract has been exposed at certain temperature condition, sunlight, UV 254 nm light, and light. F2 formulation is obtained change of assay consencutively by 0,09%; 1,62%; 0,09%; and 0,15%. F3 formulation is obtained change of assay consencutively by 4,88%; 9,35%; 3,32%; and 3,84%. Coating process of curcumin extract with hydroxyprophyl methylcellulose by fluidized bed, not provide optimal physically results yet. Coating of turmeric extract with hydroxypropyl methylcellulose could increases the stability of curcumin that affected by temperature and light exposure., Curcumin is yellow-orange pigment. The structure of curcumin can be decomposed when exposed to light, which causes the compound of curcumin becomes inactive. To maintain the stability, curcumin has performed thin film coating. This research was intended to produce microparticles of turmeric extract coated hydroxypropyl methylcellulose by fluidized bed. The coating process is performed on curcumin extract 35 mesh (F2) and 60 mesh (F3) with 0,5% hydroxypropyl methylcellulose (HPMC) polymer. SEM results showed that formulation F2 and F3 have smooth surface and glossy. Microparticle of curcumin extract has been exposed at certain temperature condition, sunlight, UV 254 nm light, and light. F2 formulation is obtained change of assay consencutively by 0,09%; 1,62%; 0,09%; and 0,15%. F3 formulation is obtained change of assay consencutively by 4,88%; 9,35%; 3,32%; and 3,84%. Coating process of curcumin extract with hydroxyprophyl methylcellulose by fluidized bed, not provide optimal physically results yet. Coating of turmeric extract with hydroxypropyl methylcellulose could increases the stability of curcumin that affected by temperature and light exposure.]

Abstrak :
[Niasinamida merupakan vitamin yang larut di dalam air dikenal sebagai vitamin B3 dan telah digunakan untuk mengobati beberapa jenis permasalahan pada kulit. Penelitian ini bertujuan untuk membuat formulasi emulgel yang menggunakan silikon untuk membandingkan daya penetrasi secara in vitro antara emulgel dengan silikon dan tanpa penambahan silikon serta uji stabilitas fisik sediaan. Semua formulasi di uji daya penetrasinya secara in vitro dengan sel difusi Franz menggunakan membran abdomen tikus betina galur Sprague dawley. Jumlah kumulatif niasinamida yang terpenetrasi dari emulgel yang tidak mengandung silikon (F1) adalah 2028,8 ± 64,3 µg/cm2 sedangkan emulgel yang mengandung silikon secara berturut turut (F2-dimetikon dan F3-siklometikon) adalah 4662,4 ± 11,4 µg/cm2 dan 2679,45 ± 9,3 µg/cm2. Nilai fluks berturut-turut F1, F2, dan F3 adalah 253,6 ± 8,0 µg/cm2jam, 582,7 ± 1,4 µg/cm2jam, dan 334,93 ± 1,2 µg/cm2jam. Serta nilai % kumulatif terpenetrasi berturut-turut sebesar 8,89 ± 0,28 %, 17,95 ± 0,04 %, dan 11,83 ± 0,04 %. Berdasarkan hasil tersebut, dapat disimpulkan bahwa adanya silikon terbukti dapat meningkatkan penetrasi emulgel niasinamida dan ketiga formulasi menunjukan kestabilitan fisik yang baik. ...... Niacinamide is a water-soluble vitamin, also known as vitamin B3 and has been used to treat several types of dermatological pathologies. The purpose of this research are to make emulgel formulations using silicones to compare the penetration ability as in vitro test between emulgel with or without silicon, and the physical stability test. Penetration ability of all formulations were examined by Franz diffusion cell as in vitro test using Sprague Dawley rat abdomen skin for diffusion membrane. Total cumulative penetration of niacinamide from emulgel without silicone formulation (F1) is 2028,8 ± 64,3 µg/cm2 and emulgel with silicone formulation (F2-dimethicone and F3-cyclomethicone) are 4662,4 ± 11,4 µg/cm2 and 2679,45 ± 9,3 µg/cm2. Fluks of niacinamide respectively (F1, F2, and F3) are 253,6 ± 8,0 µg/cm2hour, 582,7 ± 1,4 µg/cm2hour, and 334,93 ± 1,2 µg/cm2hour. The presentage of penetrated niacinamide are 8,89 ± 0,28 %, 17,95 ± 0,04 %, and 11,83 ± 0,04 %, respectively. Based on those result, it can be concluded that silicone compound can increase the penetration ability of niacinamide emulgels and all formulations showed good physical ;Niacinamide is a water-soluble vitamin, also known as vitamin B3 and has been used to treat several types of dermatological pathologies. The purpose of this research are to make emulgel formulations using silicones to compare the penetration ability as in vitro test between emulgel with or without silicon, and the physical stability test. Penetration ability of all formulations were examined by Franz diffusion cell as in vitro test using Sprague Dawley rat abdomen skin for diffusion membrane. Total cumulative penetration of niacinamide from emulgel without silicone formulation (F1) is 2028,8 ± 64,3 µg/cm2 and emulgel with silicone formulation (F2-dimethicone and F3-cyclomethicone) are 4662,4 ± 11,4 µg/cm2 and 2679,45 ± 9,3 µg/cm2. Fluks of niacinamide respectively (F1, F2, and F3) are 253,6 ± 8,0 µg/cm2hour, 582,7 ± 1,4 µg/cm2hour, and 334,93 ± 1,2 µg/cm2hour. The presentage of penetrated niacinamide are 8,89 ± 0,28 %, 17,95 ± 0,04 %, and 11,83 ± 0,04 %, respectively. Based on those result, it can be concluded that silicone compound can increase the penetration ability of niacinamide emulgels and all formulations showed good physical., Niacinamide is a water-soluble vitamin, also known as vitamin B3 and has been used to treat several types of dermatological pathologies. The purpose of this research are to make emulgel formulations using silicones to compare the penetration ability as in vitro test between emulgel with or without silicon, and the physical stability test. Penetration ability of all formulations were examined by Franz diffusion cell as in vitro test using Sprague Dawley rat abdomen skin for diffusion membrane. Total cumulative penetration of niacinamide from emulgel without silicone formulation (F1) is 2028,8 ± 64,3 µg/cm2 and emulgel with silicone formulation (F2-dimethicone and F3-cyclomethicone) are 4662,4 ± 11,4 µg/cm2 and 2679,45 ± 9,3 µg/cm2. Fluks of niacinamide respectively (F1, F2, and F3) are 253,6 ± 8,0 µg/cm2hour, 582,7 ± 1,4 µg/cm2hour, and 334,93 ± 1,2 µg/cm2hour. The presentage of penetrated niacinamide are 8,89 ± 0,28 %, 17,95 ± 0,04 %, and 11,83 ± 0,04 %, respectively. Based on those result, it can be concluded that silicone compound can increase the penetration ability of niacinamide emulgels and all formulations showed good physical ]

Abstrak :
Pegagan (Centella asiatica L. Urban) mengandung asiatikosid yang dapat dimanfaatkan dalam penggunaan kosmetik anti-aging yang terbukti dapat meningkatkan sintesis kolagen. Asiatikosid memiliki berat molekul yang besar dan bersifat hidrofilik sehingga menyebabkan sulit berpenetrasi melalui kulit. Transfersom merupakan salah satu sistem pembawa yang cocok untuk meningkatkan penetrasi zat aktif. Penelitian ini bertujuan memformulasikan dan mengkarakterisasi transfersom ekstrak daun pegagan. Selanjutnya transfersom dengan formula terbaik diformulasikan ke dalam bentuk sediaan gel serta dibuat gel kontrol tanpa transfersom. Kedua sediaan tersebut dievaluasi dan diuji penetrasi secara in vitro menggunakan sel difusi Franz pada tikus betina galur Sprague Dawley. Pada penelitian ini telah dilakukan optimasi formula transfersom, yaitu F1, F2 dan F3 dengan konsentrasi asiatikosid berturut-turut adalah 0,3%; 0,5%; dan 0,7% Hasil menunjukan bahwa F1 adalah formula terbaik dengan morfologi yang sferis, efisiensi penjerapan 85,80 ± 0,22 %, Dmean volume 124,62 ± 0,86 nm, nilai indeks polidispersitas 0,125 ± 0,008, zeta potensial -36,3 ± 0,30 mV dan indeks deformabilitas 1,12 sehingga digunakan pada formulasi gel. Jumlah kumulatif asiatikosid yang terpenetrasi dari sediaan gel, yaitu 1050,85 ± 19,82 μg/cm2 untuk gel transfersom dan 540,21 ± 12,28 μg/cm2 untuk gel kontrol. Presentase jumlah asiatikosid terpenetrasi dari sediaan gel transfersom dan sediaan gel kontrol secara berturut-turut adalah 51,80 ± 0,97 % dan 26,63 ± 0,60%. Fluks dari sediaan gel transfersom dan gel kontrol berturut-turut 47,92 ± 1,74 μg/cm2/jam dan 26,57 ± 0,77 μg/cm2/jam. Berdasarkan hasil tersebut dapat disimpulkan bahwa sediaan gel transfersom memiliki daya penetrasi yang lebih baik dibandingkan dengan gel kontrol. ...... Asiaticoside from Gotu kola leaves extract (Centella asiatica L. Urban) could be used as an active substance for anti-aging cosmetics. It has proven to increase collagen synthesis. Asiaticoside is hydrophillic and has a high molecular weight, therefore it would be difficult to penetrate to the skin. Transfersome is a suitable carrier system that can enhance the penetration of active substances. This study aims to formulate and characterize transfersome Gotu kola leaves extract and formulated it into a gel, a control gel also prepared without transfersome. Both gels were evaluated and penetration tested using Franz diffusion cells with the skin of female Sprague Dawley rats. Transfersome was formulated with different concentration of active substance; equals of asiaticoside 0,3% (F1), 0,5% (F2), and 0,7% (F3). The F1 transfersome were incorporated into gel dosage form, since the F1 transfersome had spherical morphology, the highest entrapment efficiency 85.80 ± 0.22%, Dmean volume 124.62 ± 0.86 nm, polydispersity index 0.125 ± 0.008, zeta potensial -36,3 ± 0,30 mV and deformability index 1.12. The cumulative amount of asiaticoside that was penetrated is 1050.85 ± 19.82 μg/cm2 for transfersome gel and 540.21 ± 12.28 μg/cm2 for control gel. Cumulative percentage of penetrated asiaticoside for transfersome gel and control gel were 51.80 ± 0.97% and 26.63 ± 0.60%, respectively. The flux of transfersome gel containing asiaticoside and control gel are respectively 47.92 ± 1,74 μg/cm2/hours and 26.57 ± 0.77 μg/cm2/hours. Based on these results it can be concluded that asiaticoside contained in transfersome gel has a better penetration compared to the control gel.

Abstrak :
Kontrasepsi oral menempati peringkat kedua metode kontrasepsi yang paling banyak digunakan di Indonesia, namun tingkat putus obat akibat reaksi obat yang tidak dikehendaki (ROTD) cukup tinggi (13,2%). Hanya sebagian kecil akseptor (23,9%) yang diberikan informasi tentang hal yang dapat dilakukan jika mengalami ROTD seperti pilihan kontrasepsi oral dengan progestin generasi terbaru yang memiliki efek samping lebih rendah. Tujuan penelitian ini adalah membandingkan ROTD dari pil kontrasepsi kombinasi yang berisi levonorgestrel (generasi kedua) dengan desogestrel (generasi ketiga). Metode penelitian ini adalah potong lintang komparatif dengan sampel yang diperoleh secara acak dari enam kelurahan di kecamatan Sukmajaya Depok pada rentang waktu Agustus ? November 2015. Pengambilan data dilakukan menggunakan metode wawancara. Sampel penelitian adalah 60 akseptor kelompok levonorgestrel dan 40 akseptor kelompok desogestrel. Keluhan ROTD meliputi perdarahan di luar menstruasi (16,7%;5%), sakit kepala (16,7% ; 5%), mual/muntah (25% ; 0), nyeri payudara (13,3% ; 0), gangguan terkait hubungan seksual (23,3% ; 7,5%), penambahan berat badan (35% ; 22,5%), jerawat (3,3% ; 7,5%) dan chloasma (28,3% ; 5%). Proporsi kejadian tersebut secara signifikan lebih tinggi pada kelompok levonorgestrel pada gangguan hubungan seksual (OR 3,75, 95% CI : 1,003 ? 14,050, p = 0,039) dan chloasma (OR 7,51, 95% CI : 1,629 ? 34,647, p = 0,004). ...... Oral contraceptive was second contraception method most widely used in Indonesia, but had high percentage rate (13,2%) of withdrawal due to adverse drug reactions (ADR). Only small portion users (23,9%) who had been provided information about other oral contraceptive with the newer progestin generation as alternative option to minimize ADR. This study was conducted to compare prevalence of ADR between combined oral contraceptives contain levonorgestrel (second generation) and desogestrel (third generation) which expected to have less side effects. Study was done as cross sectional comparative design with random sampling from users in six villages in Sukmajaya district, Depok City. Data were collected by interview. Samples consists of 60 users of levonorgestrel and 40 users of desogestrel. ADR complaints include intermenstrual bleeding (16.7%; 5%), headache (16.7%; 5%), nausea/vomiting (25%; 0), breast tenderness (13.3%; 0), impaired sexual intercourse (23.3%; 7.5%), weight gain (35%; 22.5%), acne (3.3%; 7.5%) and chloasma (28.3%; 5%). The proportion of these events was significantly higher in the group of levonorgestrel for impaired sexual intercourse (OR 3.75, 95% CI: 1.003 to 14.050, p = 0.039) and chloasma (OR 7.51, 95% CI: 1.629 to 34.647, p = 0.004).