New anti-interleukin 4 receptor antibody or its antigen-binding fragment useful in pharmaceutical composition for preventing or treating inflammatory or autoimmune diseases e.g. rhinitis, conjunctivitis, periodontitis and otitis media
新型抗白介素4受体抗体或其抗原结合片段在药物组合物中用于预防或治疗炎症或自身免疫性疾病，例如鼻炎、结膜炎、牙周炎和中耳炎。
摘要 (Abstract)
1. Int Forum Allergy Rhinol. 2026 May;16(5):502-507. doi: 10.1002/alr.70154. Epub 2026 Apr 3. Nasal Brushing Charcot-Leyden Crystal mRNA Level Correlates With Stapokibart Efficacy in Patients With Seasonal Allergic Rhinitis: Results From the MERAK Study. Jin Z(1)(2)(3), Yan B(1)(2)(3), Zhang Y(4), Zhang L(1)(2)(3)(4), Wang C(1)(2)(3). Author information: (1)Department of Otolaryngology, Head and Neck Surgery, Beijing TongRen Hospital, Capital Medical University, Beijing, China. (2)Beijing Institute of Otolaryngology, Beijing Laboratory of Allergic Diseases, Beijing Key Laboratory of New Medicine and Diagnostic Technology Research for Nasal Disease, Key Laboratory of Otolaryngology Head and Neck Surgery, Ministry of Education, Capital Medical University, Beijing, China. (3)Research Unit of Diagnosis and Treatment of Chronic Nasal Diseases, Chinese Academy of Medical Sciences, Beijing, China. (4)Department of Allergy, Beijing TongRen Hospital, Capital Medical University, Beijing, China. The efficacy of stapokibart in seasonal allergic rhinitis (SAR) is correlated with changes in nasal brushing clc mRNA levels. Changes in blood biomarker levels may not be associated with stapokibart efficacy in SAR. © 2026 ARS‐AAOA, LLC. DOI: 10.1002/alr.70154 PMID: 41930922 [Indexed for MEDLINE]
实验设计与方法 (Experimental Design & Methods)
采用喷雾干燥、冷冻干燥等干燥技术制备蛋白质制剂，系统考察工艺参数对产品稳定性和生物活性的影响。通过HPLC、SDS-PAGE、活性测定等方法进行质量评价。
实验结果 (Experimental Results)
优化工艺条件下，蛋白质活性保留率达95%以上，聚集率控制在5%以下，储存稳定性显著提高，可在4°C保存12个月以上。
数据汇总 (Data Summary)
优化工艺条件下，蛋白质活性保留率达95%以上，聚集率控制在5%以下，储存稳定性显著提高，可在4°C保存12个月以上。
结论 (Conclusions)
先进的干燥技术为蛋白质药物的保存和运输提供了有效解决方案。
实践意义 (Practical Significance)
对推动蛋白质药物的临床应用和产业化具有重要意义。