不同来源十二烷基硫酸钠对非布司他片体外溶出的影响

Effects of Sodium Dodecyl Sulfate from Different Sources on in Vitro Dissolution of Febuxostat Tablets

关键词:  十二烷基硫酸钠  增溶作用  非布司他片  溶出度  相似因子  耐用性  聚类分析

Key words:  sodium dodecyl sulfate  solubilization  febuxostat tablets  dissolution  similarity factor  robustness  hierarchical clustering analysis

摘要:

目的 考察不同来源十二烷基硫酸钠（sodium dodecyl sulfate，SDS）对非布司他片溶出行为的影响，为其质量控制提供思路。方法 采用桨法，以不同浓度的SDS溶液900 mL为溶出介质，转速为50 r·min^-1，取续滤液用紫外分光光度法测定，在315 nm的波长处测定溶出曲线。结果 不同来源SDS对非布司他片的溶出行为有着不同的影响，借鉴相似因子法来评价其相互间溶出行为的相似性，可将其溶出行为分为2类。结论 采用SDS作为溶出介质，需要明确其组分，才能保证溶出方法的耐用性，从而起到控制药品质量的作用。

Abstract:

OBJECTIVE To investigate the effects of sodium dodecyl sulfate(SDS) from different sources on in vitro dissolution of febuxostat tablets and provide ideas for its quality control. METHODS Perform the dissolution test with paddles, using 900 mL of SDS solution with different concentration as the dissolution media, the rotational speed was 50 r·min^-1. Continuous filtrate was determined by UV spectrophotometry and dissolution curve was determined at 315 nm. RESULTS Different sources SDS had different effects on the dissolution behavior of febuxostat tablets. Using the similarity factor method to evaluate the similarity of dissolution behavior between them, the dissolution behavior could be divided into two categories. CONCLUSION By using SDS as dissolution medium, it is necessary to define its components in order to ensure the durability of dissolution method, so as to control the quality of drugs.