配件

除了单位剂量取样仪(DUSA)和多级撞击器外,Copley还提供一系列必备辅助产品,从而形成完整的试验操作系统,用于确定经口吸入制剂及鼻用制剂(OINDP)的递送剂量均一性(DDU)和空气动力学粒径分布(APSD)。

吸入制剂试验附件

请从以下选项中选择,以获取更多信息。

流量控制器
流量控制器
Copley的临界流量控制TPK系列和呼吸致动控制BAC系列的设计充分考虑了欧洲药典和美国药典针对MDI , DPI , 雾化器 , ADI和鼻用产品试验规定的要求。
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流量计
流量计
如果在测试过程中使用的入口流量(人工喉或DUSA入口的流量)不正确和/或不一致,DDU和APSD数据的准确性会急剧降低,并在对多级撞击器与试验用吸入器影响效果方面产生偏差。
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真空泵
真空泵
泵是所有吸入制剂试验仪的核心。药典特别指出:“必须选择具有超大流量的真空泵,才能以指定的体积流量让吸入空气”通过试验仪,对于干粉吸入器,则要产生声波流。根据相关设置和所需流量,Copley供应三款泵。
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NGI散热器
NGI散热器

Exacerbated evaporation caused by the thermal mass of the NGI may be an issue for devices such as nebulisers that deliver the drug as an aerolised solution. Loss of solvent reduces droplet size, producing artificially low particle size measurements and compromises the integrity of APSD data.

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呼吸模拟器
呼吸模拟器

进行吸入制剂试验时,应采用有代表性的呼吸方式,以表征治疗患者的年龄和状况(儿科至老年病 , 肺部轻症至严重损伤)。

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吸入器测试工作站 (ITW)
吸入器测试工作站 (ITW)

The hub of an inhaler testing system, the ITW is a modular workstation designed to aid handling and manipulation of the various pieces of test apparatus and accessories, improving workflow. The ITW offers analysts the flexibility to pick and choose the attachments necessary for their test set-up needs. Simply connect the required attachments and start testing with greater ease.

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玻璃膨胀室
玻璃膨胀室

The majority of nasal products are designed to generate droplets/particles with a mass median aerodynamic diameter (MMAD) of greater than 10 to 20 microns. This is to increase nasal deposition and minimise deposition in the lungs. However, most sprays deliver a proportion (typically <5%) of fine droplets in the <10 micron range. It is important to quantify this Fine Particle Dose (FPD) since it can penetrate beyond the nasal tract and into the lower respiratory tract or lungs, which may be undesirable. Cascade impactors are designed to capture particles in the range 0 to 10 microns and are widely used for this application.

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喉舌和鼻托适配器
喉舌和鼻托适配器

Copley吸嘴适配器由优质硅橡胶模制而成,可确保吸入器与试验仪器之间的气密性,从而获得最准确的结果。

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