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Polysorbate 80이 sulfanilamide sulface-tamide 과립의 용출에 미치는 영향

Polysorbate 80이 sulfanilamide sulface-tamide 과립의 용출에 미치는 영향
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Effect of Polysorbate 80 on the Dissolution of Sulfanilamide and Sulfacetamide Granules
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대학원 약학과
이화여자대학교 대학원
Polysorbate 80이 hydrophilic drug인 sulfanilamide 및 sulfacetamide과립의 용출에 미치는 영향을 알아보고자, starch, microcrystalline cellulose, polyvinylpyrrolidone 및 polysorbate 80등의 농도를 달리하여 습식과립법으로 과립을 조제한 후 약물의 용출특성을 비교 검토하였다. 그 결과는 다음과 같다. 1. Sulfanilamide 및 sulfacetamide과립의 T 75%는 4.60분 및 2.50분으로 sulfacetamide가 sulfanilamide보다 용출속도가 빠르다. 2. 0.1% Polysorbate 80이 연합된 sulfanilamide과립에서는 control에 비해 용출이 지연되었으나, sulfacetamide의 경우에는 0.1% polysorbate 80의 첨가로 control보다 용출이 증대되었다. 3. Starch를 연합한 과립에서는 sulfanilamide 및 sulfacetamide의 용출이 control에 비해 증대되었다. 또 starch에 polysorbate 80의 첨가시 sulfanilamide에서는 starch만 첨가된 과립에서보다 용출이 지연되었고, sulfacetamide에서는 용출에 polysorbate 80의 영향을 받지 않았다. 4. Microcrystalline cellulose를 연합한 과립에서는 sulfanilamide 및 sulfacetamide의 용출이 control에 비해 지연되었다. 또한 microcrystalline cellulose에 polysorbate 80을 첨가한 경우에는 더욱 용출이 지연되었으나, 10% microcrystalline cellulose에 0.1% polysorbate 80이 첨가된 과립에서는 10% microcrystalline cellulose만이 첨가된 과립보다 용출이 증대되었다. 5. Polyvinylpyrrolidone을 연합한 과립의 경우, sulfanilamide 및 sulfacetamide의 용출은 control에 비해 증대하였다. Polyvinylpyrrolidone에 polysorbate 80을 첨가하면, sulfanilamide에서는 polyvinylpyrrolidone만의 과립보다 용출이 지연되었으나 sulfacetamide에서는 용출이 증대되었다.;This study was carried out to investigate the effect of surfactant on the dissolution of relatively hydrophilic drug, sulfanilamide (SF) and sulfacetamide (SFA) granules. The granules were prepared by moist granulation. The additive incorporated in the granules is starch or MCC as excipient, PVP as binder, and polysorbate 80 (P-80). The dissolution characteristics of SF and SFA granules in distilled water were as follows: T_(75%) of SF granule was 4.60 min. and that of SFA granule was 2.50 min. Incorporation of 0.1% P-80 in SF granule retarded the dissolution of SF as compared with control, but addition of 0.1% P-80 to SFA granule improved the dissolution of SFA in comparison with control. In SF and SFA granules formulated with either starch or PVP, the release of the drug was increased as compared with control. In SF granule, the dissolution of the drug was further reduced by the inclusion of P-80 in the granule containing starch or PVP. Incorporation of P-80 in SFA granule with starch or PVP affected little on the dissolution of the drug. Addition of a nonswelling excipient, MCC decreased the dissolution rate of SF and SFA granules as compared with each control. The presence of P-80 in these granules made the dissolution rate slower in comparison with the granules containing only MCC.
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