中国药房2012，Vol.23Issue(1)：56-58,3.DOI:10.6039/j.issn.1001-0408.2012.01.20
异丙托溴铵雾化吸入液的制备与质量控制
Preparation and Quality Control of Ipratropium Bromide Solution for Inhalation
路伟 1李玉珍 1李成 1罗意文 1王蔓琳1
作者信息
- 1. 深圳市第四人民医院药剂科,广东深圳518033
- 折叠
摘要
Abstract
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 ace-tonitrile-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.关键词
异丙托溴铵雾化吸入液/制备/质量控制/高效液相色谱法/稳定性Key words
Ipratropium bromide solution for inhalation/ Preparation/ Quality control/HPLC/ Stability分类
医药卫生引用本文复制引用
路伟,李玉珍,李成,罗意文,王蔓琳..异丙托溴铵雾化吸入液的制备与质量控制[J].中国药房,2012,23(1):56-58,3.
