| 张晓婷,罗丹冬,李庆国,等.基于响应面法初步探究他达拉非喷雾干燥工艺条件[J].安徽医药,待发表. |
| 基于响应面法初步探究他达拉非喷雾干燥工艺条件 |
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| 投稿时间：2026-09-09 录用日期：2026-11-03 |
| DOI： |
| 中文关键词: 喷雾干燥 固体分散体 工艺参数 Soluplus® |
| 英文关键词: |
| 基金项目:国家中医药传承创新发展示范项目（广州）-羊城老药工项目 |
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| 中文摘要: |
| 目的 通过响应面法初步探究他达拉非-Soluplus喷雾干燥工艺，并分析结果。方法 采用喷雾干燥法，设置不同固含量、进口温度和进料速率制备固体分散体，以产品得率、溶解度为指标，通过响应面法优化工艺参数，结合扫描电镜观察颗粒微观形貌并考察固体分散体稳定性。结果 喷雾干燥试验范围内优化工艺条件为：固含量5%、进口温度68?℃、进料速率1.5 mL/min，经验证其得率为72.5%。固含量增加至25%时，颗粒形貌劣变。X射线粉末衍射结果提示所得5%固含量固体分散体药物主要以无定形态存在，但稳定性较差，处方仍需进一步优化。结论 固含量是影响得率的关键因素，固含量越低得率越高。进口温度需结合固体－溶剂体系选择。进料速率与得率存在抛物线关系。各因素对溶解度未表现出明显的调控效应。研究可为他达拉非固体分散体制备提供参考。 |
| 英文摘要: |
| Abstract: Objective: To preliminarily investigate the spray drying process of tadalafil-Soluplus solid dispersions using response surface methodology and analyze the experimental results. Methods: Solid dispersions were prepared via spray drying at different solid contents,inlet temperatures,and feed rates. Response surface methodology was employed to optimize process parameters with product yield and solubility as evaluation indicators. Particle morphology was characterized by scanning electron microscopy, and the stability of solid dispersions was assessed. Results: The optimized spray drying process conditions within the experimental range were 5% solid content, an inlet temperature of 68 ℃,and a feed rate of 1.5 mL/min, with a verified yield of 72.5%. Increasing solid content to 25% resulted in deteriorated particle morphology. X-ray powder diffraction revealed that the drug in solid dispersions was predominantly amorphous, while the product showed poor stability, requiring further formulation optimization.Conclusion: Solid content is a key factor influencing yield, and lower solid content corresponds to higher yield. The inlet temperature shall be chosen based on the solid–solvent system. The feed rate exhibits a parabolic relationship with yield. All investigated parameters show no significant regulatory effect on drug solubility. The optimized process can provide a reliable reference for the preparation of tadalafil Soluplus solid dispersions. |
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