异丙托溴铵雾化吸入液的制备与质量控制

目的:制备异丙托溴铵雾化吸入液并建立其质量控制方法。方法:采用溶解法制备异丙托溴铵雾化吸入液,以高效液相色谱法测定异丙托溴铵的含量。色谱条件:色谱柱:Hypersil ODS;流动相:乙腈-0.25%庚烷磺酸钠(含0.5%三乙胺,磷酸调pH=3.2)=22∶78,流速:1.0 mL·min-1;检测波长:210 nm。对制剂进行光照、高温和加速试验考察其稳定性。结果:制备的雾化吸入液为几乎无色的澄清液体,鉴别及检查符合《中国药典》2010年版(二部)相关规定;异丙托溴铵检测浓度线性范围为50～250 μg·mL-1(r=0.999 8),平均回收率为100.60%(RSD=0.58%,n=9);光照和高温试验表明样品主药含量略有下降、有关物质含量略有上升。结论:该制剂制备工艺简单、可行,质量可控,宜置于凉暗处保存。

Preparation and Quality Control of Ipratropium Bromide Solution for Inhalation

OBJECTIVE:To prepare Ipratropium bromide solution for inhalation,and to establish its quality control method.METHODS:Ipratropium bromide solution for inhalation was prepared by dissolution method.HPLC method was used to determine the content of ipratropium bromide.The determination was performed on Hypersil ODS column with mobile phase consisted of acetonitrile-0.25% sodium heptanesulfonate(containing 0.5% triethyamine,pH value adjusted to 3.2 by phosphoric acid)(22:78)at the flow rate of 1.0 mL·min-1.The detection wavelength was set at 210 nm.The stability of the solution was investigated by light test,high temperature test and accelerated test.RESULTS:The solution was almost colorless and clear.The identification and examination of solution were all in line with Chinese Pharmacopeia Ⅱ(2010 edition).The linear range of ipratropium bromide was 50～250 μg·mL-1(r=0.999 8) with an average recovery of 100.60%(RSD=0.58%,n=9).The stability test indicated that the content of ipratropium bromide decreased slightly and related substance increased under light and heat.CONCLUSION:The preparation technology is simple,practical and controllable in quality.It should be kept in cool and shady place.