摘要
目的 建立一种方法测定海藻酸钙凝胶小球中醋酸地塞米松的含量 ,考察小球在不同介质中的溶出性能。 方法 以磷酸缓冲液——无水乙醇 (2∶ 1V/V)为溶剂 ,采用系数倍率法测定制剂含量 ,测定和比较小球在纯化水、盐酸缓冲液 (p H=1.3 )和磷酸缓冲液 (p H=6.8)中的累积溶出率。结果 在 4.78μg· ml- 1 ～ 2 5 .5 6μg· ml- 1 的浓度范围内 ,方法线性关系良好 ,平均回收率为 10 0 .2 5 % ,RSD为 0 .3 8% (n=6) ;该制剂在纯化水和盐酸缓冲液中溶出量极少 ,而在磷酸缓冲液中溶出行为符合 Higuchi方程。 结论 测定方法可靠、简便、重现性好 ;
OBJECTIVE A method was developed for the determination of Dxamethasone Acetate in calcium alginate gel beads and observed the release properties of gel beads in different media.METHODS It was determined by using phosphate buffer dehydrated alcohol(2∶1V/V)as the solvent with K Ratio Spectrophotometry.The cumulative release rates of calcium alginate gel beads were determined and inverstigated in water,hydrochloride buffer(pH=1 3)and phosphate buffer(pH=6 8)RESULTS A good linearity could be found in the range of 4 78μg·ml -1 ～25 56μg·ml -1 .The average recovery rate was 100 25%and RSD was not more than 0 38%(n=6).There was little drug released from the gel beads in water and hydrochloride buffer,but in phosphate buffer the releasing behavior followed the Higuchi kinetics.CONCLUSION The method was simple,reproducible for the determination of DxAmethasone acetate in calcium alginate gel beads.The gel beads can be used as the carrier of acid labile drug.
出处
《海峡药学》
2002年第3期29-31,共3页
Strait Pharmaceutical Journal
