鼻腔喷雾剂给药装置的性能考察

目的:考察所选鼻腔喷雾剂给药装置的性能,建立评价该类装置性能的方法。方法:参考2010年版《中国药典》喷雾剂项下有关要求,分别以失重率和增重率为指标考察高温(60℃)和高湿(95%)条件下装置的密闭性,以及室温、40℃、60℃条件下的每喷喷量。结果:该装置在高温和高湿条件下失重率和增重率均<1%,3种条件下以60℃时的每喷喷量不准确、差异较大。结论:该装置的密闭性良好,在40℃及以下温度环境中放置时的每喷喷量准确、精密度好,符合鼻腔给药装置的要求。本文建立的方法可用于该类装置的性能考察。

Investigation on Performance of Delivery Devices of Nasal Spray

OBJECTIVE： To investigate the performance of delivery device of nasal spray, and to establish the method for the performance evaluation of the device. METHODS： Referring to the requirements of nasal spray stated in Chinese Pharmacopeia （2010 edition）, the airtight performance of the devices was investigated under the condition of high temperature（60 ℃ ） and high humidity （95%） using proportion of weight loss and growth as index. The spray volume per spray of the selected devices was inves- tigated under room temperature, 40 ℃ and 60 ℃, respectively. RESULTS： The proportion of weight loss and growth both were smaller than 1% under high temperature and high humidity. The spray volume per spray of the selected devices was not accurate and precise under 60 ℃. CONCLUSIONS： The devices of nasal spray are in good airtight condition; the spray volume per spray is accurate and precise at 40 ℃ or below, which confirms to the requirements for the devices of nasal administration. Established method is suitable for the performance evaluation of delivery device of nasal spray.