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目的以尼美舒利为难溶弱酸性模型药物,研究提高该类药物释放速率的方法。方法以聚乙二醇6000(PEG6000)为载体,采用熔融法制备尼美舒利固体分散体;测定含不同碱化剂(包括NaOH、KOH、Ca(OH)2、Na2CO3、CaCO3)的尼美舒利固体分散体中药物的释放速率。结果加入碱化剂能显著增加尼美舒利在蒸馏水中的释放度,碱化剂不同,药物的释放度不同;碱化剂的碱性越强,分散体的颜色越深,其吸湿性也相对越大。结论在尼美舒利PEG6000固体分散体中加入碱化剂可显著改善该类药物的体外释放特点,并呈现明显的非pH依赖性。
Objective Nimesulide is a slightly soluble and weakly acidic drug, to study the method of increasing the release rate of these drugs. Methods The solid dispersion of nimesulide was prepared by melt method using polyethylene glycol 6000 (PEG6000) as the carrier. The nimesulide solid dispersion containing different alkalizing agents (including NaOH, KOH, Ca (OH) 2, Na2CO3 and CaCO3) Shure solid dispersion drug release rate. Results The addition of alkalizer significantly increased the release of nimesulide in distilled water. The different alkalinizing agents and drug release were different. The stronger alkalinity of alkalizing agent was, the darker the dispersion was and the hygroscopicity Relatively larger. Conclusion The addition of alkalinizing agents to the solid dispersions of nimesulide PEG6000 can significantly improve the in vitro release characteristics of these drugs and show obvious pH-independent.