对柳氮磺吡啶肠溶片释放行为及其限度标准的探讨

目的：考察《中国药典》2010年版柳氮磺吡啶肠溶片中薄膜衣片和糖衣片处方工艺对释放度的影响，探讨其释放度限度标准的科学性与合理性。方法：采用转篮法（转速为100 r·min^-1），考察国内7家生产企业样品在pH 6.0，pH 6.8，pH 7.5磷酸盐缓冲液中的体外释放行为。结果：在pH 7.5磷酸盐缓冲液中，不同企业的肠溶薄膜衣片释放曲线一致；薄膜衣片和糖衣片的释放曲线存在差异；在pH 6.0和pH 6.8磷酸盐缓冲液中，国内原研企业的薄膜衣片释放行为最符合该品种的药剂学特性。结论：通过对比国内外药典关于该品种的释放度限度规定及国内样品在3种释放介质中的释放行为研究，认为《中国药典》2010年版柳氮磺吡啶肠溶片释放度限度标准有待完善，肠溶糖衣片的处方工艺有待优化。

Discussion on the Dissolution Behavior and Standards of Sulfasalazine Enteric-coated Tablets

Objective：To study the impacts of the formulation and related technology on the degree of dissolution of the enteric-coated tablets and sugar-coated tablets in Chinese pharmacopeia 2010 edition and reevaluate the scientific rationale of the current its methods and related standards on dissolution of the Sulfasalazine Enteric-coated Tablets.Methods： The rotating basket method was used with 100 r· min^-1 to check the release behavior of the samples in vitro of seven domestic pharmaceutical enterprises in phosphate buffers at pH 6.0, pH 6.8 and pH 7.5.Results：In the phosphate buffer at pH 7.5, the enteric-coated tablets release curves were consistent in different enterprises, while the release curves of enteric-coated tablets and sugar-coated tablets were different.In the phosphate buffer solutions at pH 6.0 and pH 6.8 the release behavior of the enteric-coated tablets of the original domestic drug developing enterprise ba-sically conformed to the characteristics of the drug.Conclusion： By comparing the dissolution standards of Chinese and international pharmacopoeias and studying the dissolution of domestic samples in three kinds of release media, we conclude that the release limit standard in Chinese Pharmacopeia 2010 edition needs to be improved and the formulation and related processes of sugar-coated tablets need to be optimized.