异丙托溴铵雾化吸入液的制备与主药含量测定

Preparation of Ipratropium bromide solution for Inhalation and Determination of Ipratropium bromide content

目的制备异丙托溴铵雾化吸入液并建立主药含量测定方法。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。结果制备的雾化吸入液为几乎无色的澄清液体;异丙托溴铵检测浓度在50~250μg.mL-1范围内,线性关系良好,平均回收率为100.6%（RSD=0.58%,n=9）。结论该制剂制备工艺简单,主药含量测定方法准确、可靠。

OBJECTIVE To prepare Ipratropium Bromide Solution for Inhalation and establish the method of determining Ipratropium Bromide Content. METHODS Ipratropium Bromide Solution for Inhalation was prepared by dissolution method, HPLC method was used to determine the Ipratropium Bromide. RESULTS The prepared Solution for Inhalation was almost colorless and clear. The linear range was 50- 250μg·mL^- l and the average recoveries were 100.6% （RSD = 0.58%, n = 9） .CONCLUSION The Preparation technology is simple and the Determination method is accurate and reproducible.