Super Refined™ 超级精制药用辅料

Super Refined™ 超级精制药用辅料，采用Croda禾大独有的 Super Refined™ 纯化工艺，降低过氧化物、醛类及催化剂残留物等氧化杂质。这一先进的纯化工艺可显著减少辅料与药物活性成分（API）之间的潜在相互作用，从而提升制剂配方的稳定性与药物疗效，减少对细胞的刺激及潜在致敏风险。

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Super Refined™ 超级精制药用辅料的核心优势？

Super Refined™ 是我们纯度最高的辅料产品系列，得益于专有的 Super Refined™ 精制技术，具备以下优势：

卓越的批次间一致性
为众多产品提供超越药典标准的全面CoA检测报告
氮气保护，降低氧化风险
改善原料药API稳定性，延长效期
降低细胞刺激和过敏反应风险，提升患者用药安全性和耐受性
符合多国药典 (USP/NF, Ph. Eur., JP/JPE, ChP)

Super Refined™ 辅料在药物配方中的作用

选择合适的药用辅料至关重要。辅料与药物成分及整体配方的兼容性，往往决定了一款药物是以失败告终，还是获得商业成功。 Croda禾大的 Super Refined™ 系列药用辅料，采用独有的纯化工艺生产，可确保众多不同结构类型的辅料纯度与性能，始终如一，从而为药物制剂研发人员提供可靠支持：

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我们始终以协助客户实现市场成功为荣。凭借深厚的技术积累，我们的专家团队可运用专有纯化技术，为您的药物配方量身定制 Super Refined™ 药用辅料解决方案。点击此处，与我们的技术专家取得联系。

在制剂配方中使用Super Refined™ 超级精制辅料的优势

Super Refined™ 药用辅料采用我们专有的纯化技术生产，为药物开发人员带来多项关键优势：

配方稳定性：Super Refined™ 超级精制技术显著降低 API 降解风险
批次间一致性：确保稳定一致的批间重复性与工艺重现性，为从研发到商业化的全流程放大生产提供坚实保障
增强患者用药安全性：通过先进的杂质去除工艺，最大程度降低刺激性、过敏反应及有毒杂质的风险
提高患者用药依从性：通过降低杂质含量，使辅料色泽更浅、气味更淡、口感更佳，从而改善患者用药体验
法规合规优势：严格的杂质控制有助于简化注册申报流程，加快 FDA 审批，缩短产品上市周期
额外的分析报告（CoA）检测：部分 Super Refined™ 辅料提供的（CoA）检测报告中包含详尽的杂质谱分析，有助于增强对产品质量与法规和理性的信心

高纯度药用辅料产品目录

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高纯度药用辅料在眼科药物制剂中的应用

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高纯度药用辅料在肠外给药中的应用

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Super Refined™超级精制辅料的应用

我们的 Super Refined™ 超级精制药用辅料，专为满足高纯度要求的敏感型药物制剂而设计，能够坦然应对最严苛的质量标准。目前，众多产品已被收录于美国 FDA药用辅料数据库FDA’s Inactive Ingredient Database (IID)，为药物研发人员在法规合规和药物申报准备方面提供了更强保障。主要应用领域包括：

肠外或注射剂型（包括静脉注射、肌肉注射或皮下注射）

Super Refined™ 超级精制药用辅料，非常适用于对纯度要求极高的注射用药物制剂，包括静脉、肌肉或皮下注射等给药途径。

生物制剂与生物类似药

Super Refined™ 超级精制药用辅料，可通过减少复杂蛋白质（如单克隆抗体、双特异性抗体）或病毒载体的聚集，帮助维持敏感生物分子的稳定性。

眼科制剂

Super Refined™ 超级精制药用辅料，非常适用于对纯度要求极高的眼科制剂，有效降低杂质引起眼部刺激或不良反应的风险。

口服与外用制剂

Super Refined™ 超级精制药用辅料，可改善患者使用体验，可提升口感和气味体验，还能降低过敏风险以及对皮肤的刺激性。

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常见问答

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Super Refined™ 超级精制药用辅料

Super Refined™ 超级精制药用辅料的核心优势？

Super Refined™ 辅料在药物配方中的作用

在制剂配方中使用Super Refined™ 超级精制辅料的优势

高纯度药用辅料 产品目录

高纯度药用辅料在眼科药物制剂中的应用

高纯度药用辅料在肠外给药中的应用

Super Refined™超级精制辅料的应用

肠外或注射剂型（包括静脉注射、肌肉注射或皮下注射）

生物制剂与生物类似药

眼科制剂

口服与外用制剂

查看我们的超级精制产品系列

常见问答

哪些因素会影响药物的稳定性，而Super Refined™又是如何改善这一情况的呢？

Super Refined™ 超级精制辅料是如何实现减少细胞刺激效果的呢？

Super Refined™ 超级精制辅料，适用于哪些应用领域？

Super Refined™ 药用辅料与常规药典级药用辅料有何不同？

为什么在生物制剂配方中去除氧化性杂质至关重要？

为什么辅料的纯度对于注射剂或外用制剂而言十分重要？

Super Refined™超级精制辅料，是否经过细菌内毒素检测？

Super Refined™ 超级精制辅料，能延长我的药品保质期吗？

Super Refined™ 超级精制辅料，是否支持全球法规申报？

Super Refined™ 超级精制辅料，适用于小分子药物和生物制剂吗？

与常规辅料相比，Super Refined™ 超级精制辅料提供了哪些额外优势或技术支持？

联系禾大医药健康

高纯度药用辅料产品目录