于铎, 孙影, 申欣, 张欣, 毛世瑞*. 鼻喷剂喷雾模式与羽流几何测量方法及其与鼻腔沉积的相关性J. 药学学报, 2022,57(7): 2032-2040. doi: 10.16438/j.0513-4870.2021-1766
引用本文: 于铎, 孙影, 申欣, 张欣, 毛世瑞*. 鼻喷剂喷雾模式与羽流几何测量方法及其与鼻腔沉积的相关性J. 药学学报, 2022,57(7): 2032-2040. doi: 10.16438/j.0513-4870.2021-1766
YU Duo, SUN Ying, SHEN Xin, ZHANG Xin, MAO Shi-rui*. Spray pattern and plume geometry measurement method of nasal spray and its correlation with nasal depositionJ. Acta Pharmaceutica Sinica, 2022,57(7): 2032-2040. doi: 10.16438/j.0513-4870.2021-1766
Citation: YU Duo, SUN Ying, SHEN Xin, ZHANG Xin, MAO Shi-rui*. Spray pattern and plume geometry measurement method of nasal spray and its correlation with nasal depositionJ. Acta Pharmaceutica Sinica, 2022,57(7): 2032-2040. doi: 10.16438/j.0513-4870.2021-1766

鼻喷剂喷雾模式与羽流几何测量方法及其与鼻腔沉积的相关性

Spray pattern and plume geometry measurement method of nasal spray and its correlation with nasal deposition

  • 摘要: 鼻喷剂可治疗鼻炎等局部疾病,在包括疫苗免疫在内的全身疾病治疗中也发挥了重要作用。鼻喷剂作为药械组合产品,为确保质量,常使用喷雾模式作为鼻喷剂的质量表征指标。羽流几何不仅可与喷雾模式相结合评估鼻喷剂性能,同时也可预测鼻喷剂的鼻腔沉积。本文对鼻喷剂的喷雾模式与羽流几何的定义、测量方法及其与鼻腔沉积的相关性进行了系统综述。对喷雾模式与羽流几何的测量参数进行了界定。明确了处方、装置与触发参数等因素对于喷雾模式与羽流几何的影响,并分析了各项参数与鼻腔沉积的相关性。同时,根据喷雾羽流的尺度与形状对测量参数进行了分类。羽流角度与药物在鼻腔内的沉积相关性较大。羽流角度较小的射流状羽流可增加鼻喷剂在鼻腔弯曲解剖结构中的导航能力,有利于鼻腔沉积。这使得通过适当增加鼻喷剂黏度与触变性以增加鼻喷剂在鼻腔中的沉积成为可能。本综述旨在为我国高质量鼻喷剂的研发提供理论基础。

     

    Abstract: Nasal spray can treat local diseases such as rhinitis, it also plays an important role in the treatment of systemic diseases including vaccine immunity. As a drug-device combination product, spray pattern is often used as the quality indicator of nasal spray to ensure its quality, plume geometry can not only be combined with the spray pattern to evaluate the performance of the nasal spray, but also can predict the deposition of the nasal spray in the nasal cavity. This article systematically reviews the definition and measurement methods of the spray pattern and plume geometry of nasal spray and their correlation with nasal deposition behavior. The measurement parameters of spray pattern and plume geometry are defined. The influence of formulation, device and trigger parameters on spray pattern and plume geometry is clarified. The correlation between various parameters and nasal deposition is analyzed. The measurement parameters are classified according to the size and shape of the spray. Plume angle is closely related to the deposition of drugs in the nasal cavity. Jet-like plume with a smaller plume angle can increase the navigation ability of the nasal spray in the curved anatomical structure of the nasal cavity, which is conducive to increase drug deposition. This makes it possible to increase deposition of the nasal spray in the nasal cavity via appropriately increasing viscosity and thixotropy of the nasal spray formulation. This review provides the theoretical basis for the high quality nasal spray product development.

     

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