粒径及粒度分布是原料药的关键质量属性之一。ICH Q6A明确要求,对于影响药物溶出度、溶解度、生物利用度、制剂工艺、稳定性及含量均匀度的原料药,必须制定粒度标准。在固体制剂开发中,难溶性药物的微粉化是提高溶出速率的核心策略——通过减小粒径增大比表面积,可显著提升药物与溶出介质的接触面积,从而改善生物利用度。
原料药粉碎和粒径分析
原料药的粉碎,筛分
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English
粒径及粒度分布是原料药的关键质量属性之一。ICH Q6A明确要求,对于影响药物溶出度、溶解度、生物利用度、制剂工艺、稳定性及含量均匀度的原料药,必须制定粒度标准。在固体制剂开发中,难溶性药物的微粉化是提高溶出速率的核心策略——通过减小粒径增大比表面积,可显著提升药物与溶出介质的接触面积,从而改善生物利用度。


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