糠酸氟替卡松鼻用喷雾剂流变学特性考察  

Investigation on the Rheological Properties of Fluticasone Furoate Nasal Spray

作　　者：李祥梅 罗华菲[1] 邵奇 LI Xiangmei;LUO Huafei;SHAO Qi(National Advanced Medical Engineering Research Center,China State Institute of Pharmaceutical Industry,Shanghai 201203;SPH Sine Pharmaceutical Laboratories Co.,Ltd.,Shanghai 201206)

机构地区：[1]中国医药工业研究总院医药先进制造国家工程研究中心,上海201203 [2]上海上药信谊药厂有限公司,上海201206

出　　处：《中国医药工业杂志》2025年第3期285-292,共8页Chinese Journal of Pharmaceuticals

摘　　要：糠酸氟替卡松鼻用喷雾剂用于治疗变应性鼻炎,其疗效和使用体验在很大程度上取决于药物的流变学特性,包括屈服值、触变性、线性黏弹区和最大模量值。这些特性不仅影响药物在鼻腔内的分布和滞留时间,还影响生物利用度和治疗效果。该研究旨在深入分析糠酸氟替卡松鼻用喷雾剂的流变学特性,并使用流变仪评估了自制制剂与市售制剂在这些特性上的差异。结果显示,自制制剂的线性黏弹区较市售制剂更宽,表明其具有更好的均匀性和稳定性;自制制剂的最大模量值低于市售制剂,表明自制制剂在鼻腔内更容易形变和分布,并且市售制剂贮存时间越长,最大模量值越大。总体而言,自制制剂与市售制剂在流变学行为上具有一致性,且自制制剂在线性黏弹区范围和均匀性方面表现更优,同时具备更强的抗形变能力。Fluticasone furoate nasal spray is used to treat allergic rhinitis,and its efficacy and patient experience are significantly influenced by the rheological properties,including yield value,thixotropy,linear viscoelastic region,and maximum modulus.These characteristics not only affect the distribution and retention time of the drug within the nasal cavity,but also impact bioavailability and overall therapeutic effectiveness of the product.This study aimed to conduct an in-depth analysis of the rheological properties of fluticasone furoate nasal spray.Then,the differences in these characteristics between the self-prepared formulation and the commercially available preparation were determined and assessed using a rheometer.The self-prepared formulation exhibited a broader linear viscoelastic region compared with the commercial product,suggesting superior uniformity and stability.The maximum modulus value of the self-prepared formulation was lower than that of the commercial product,indicating that the self-prepared formulation was more easily deformed and better distributed in the nasal cavity.Moreover,the longer the storage time for the commercial product,the greater the maximum modulus value.In summary,the self-prepared formulation was consistent with the commercial product in terms of rheological behavior,and performed better in the linear viscoelastic region and uniformity,as well as possessing stronger resistance to deformation.

关 键 词：糠酸氟替卡松 鼻用喷雾剂 变应性鼻炎 屈服值 流变学 

分 类 号：R943[医药卫生—药剂学] R944.9[医药卫生—药学] R976