文章摘要
张翔.降脂灵分散片溶出度检查方法的改进与探讨[J].中国药品标准,2016,17(4):279-281
降脂灵分散片溶出度检查方法的改进与探讨
Discussion and Improvement on Dissolution Test of Jiangzhiling Dispersible Tablets
投稿时间:2015-12-18  修订日期:2016-06-23
DOI:
中文关键词: 降脂灵分散片  溶出度  滤膜吸附  高速离心
英文关键词: Jiangzhiling Dispersible Tablets  dissolution  membrane adsorption  high speed centrifugation
基金项目:
作者单位E-mail
张翔* 南京市食品药品监督检验院 shrek1@163.com 
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中文摘要:
      目的:溶出度是考查固体制剂体外生物利用度的重要参考指标,按现行降脂灵分散片标准检验,存在“溶得出却测不出”的现象,针对此进行方法改进。 方法:对溶出度供试液不同过滤法进行比较,并对活性成分的加热条件及提取溶剂进行考察。 结果:采用离心后上清液,可较好地降低物料及滤膜的吸附干扰;二苯乙烯苷在80℃水浴溶解20 min,易充分释放。 结论:采用改进后的过滤方法及溶解条件,可更加真实地反映药品的质量状况。
英文摘要:
      Objective:Dissolution is an important reference in evaluating vitro bioavailability of solid preparations. With the current standard , low dissolution results would be obtained which could not reflect the actual quality of the drug, so the dissolution test method must be improved. Methods:Different filtration and heating methods of the test solution were studied as well as the extraction solvent. Results:After centrifuging, the attachment interference of filter and material could be greatly reduced; stibeneglycoside dissolved at 80℃for 20min was easy to release. Conclusion: The improved filtering method and dissolution conditions can be used to reflect the quality of the drug.
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