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- 저자 : Yusrida Darwis (검색결과 2 건)
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Yusrida Darwis,Ravi Sheshala,Nurzalina Khan,Mallikarjun Chitneni 대한약학회 2011 Archives of Pharmacal Research Vol.34 No.11
The aim of this study was to formulate cost effective taste-masked orally disintegrating tablets of ondansetron, a bitter drug using different superdisintegrants by a wet granulation technique. Microcrystalline cellulose (Avicel) as a diluent and disintegrant in addition to aspartame as a sweetener were used in all formulations. The prepared tablets were evaluated for weight variation, thickness, hardness, friability, drug content, water content, in vitro disintegration time and in vitro drug release. The tablets’ hardness was maintained in the range of 2-3 kg and friability was <1% for all batches. All tablet formulations disintegrated rapidly in vitro within 5.83 to 33.0 sec. The optimized formulation containing 15% Polyplasdone XL-10 released more than 90% of drug within 5 min and the release was comparable to that of a commercial product. In human volunteers, optimized formulation was found to have a pleasant taste and mouth feel and they disintegrated in the oral cavity within 12 sec. The stability results were also satisfactory. A pharmacokinetic study with the optimized formulation was performed in comparison with a reference (Zofer MD 8^®) and they were found to be bioequivalent. In conclusion, a cost effective ondansetron orally disintegrating tablet was successfully prepared with acceptable hardness, desirable taste and rapid disintegration in the oral cavity.
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Mun Fei Yam,Elsnoussi Ali Hussin Mohamed,Lee Fung Ang,Li Pei,Yusrida Darwis,Roziahanim Mahmud,Mohd. Zaini Asmawi,Rusliza Basir,Mariam Ahmad,유혜현,김동현,정혜진 사단법인약침학회 2012 Journal of Acupuncture & Meridian Studies Vol.5 No.4
Orthosiphon stamineus extracts contain three flavonoids (3’-hydroxy-5, 6, 7, 4’-tetramethoxyflavone, sinensetin, and eupatorin) as bioactive substances. Previous reported high performance liquid chromatography- ultraviolet (HPLC-UV) methods for the determination of these flavonoids have several disadvantages, including unsatisfactory separation times and not being well validated according to International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) standard guidelines. A rapid, specific reversed-phase HPLC method with isocratic elution of acetonitrile: isopropyl alcohol: 20 mM phosphate buffer (NaH2-PO4) (30:15:55, v/v) (pH 3.5) at a flow-rate of 1 ml/minute, a column temperature of 25_C, and ultraviolet (UV) detection at 340 nm was developed. The method was validated and applied for quantification of different types of O stamineus extracts and fractions. The method allowed simultaneous determination of 3’-hydroxy-5,6,7,4’- tetramethoxyflavone, sinensetin, and eupatorin in the concentration range of 0.03052 e250 mg/ml. The limits of detection and quantification, respectively, were 0.0076 and 0.061 mg/ml for 3’-hydroxy-5,6,7,4’-tetramethoxyflavone, 0.0153 and 0.122 mg/ml for sinensetin and 0.0305 and 0.122 mg/ml for eupatorin. The percent relative standard deviation (% RSD) values for intraday were 0.048e0.368, 0.025e0.135, and 0.05e0.476 for 3’-hydroxy-5,6,7,4’-tetramethoxyflavone, sinensetin, and eupatorin, respectively, and those for intraday precision were 0.333e1.688, 0.722e1.055, and 0.548e1.819, respectively. The accuracy for intraday were 91.25%e103.38%, 94.32%e109.56%, and 92.85%e109.70% for 30-hydroxy-5,6,7,40-tetramethoxyflavone, sinensetin, and eupatorin, respectively, and those for interday accuracy were 97.49%e103.92%, 103.58% e104.57%, and 103.9%e105.33%, respectively. The method was found to be simple, accurate and precise and is recommended for routine quality control analysis of O stamineus extract containing the three flavonoids as the principle components in the extract.
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