摘要
目的:制备布洛芬注射液,建立其质量控制方法,并考察其稳定性和安全性。方法:优化处方组成与制备工艺,并进行性状、鉴别、检查等质量研究,采用高效液相色谱法测定有关物质和含量,稳定性试验考察其稳定性,血管刺激性试验、溶血性试验以及过敏性试验评价其用药的安全性。结果:药品经酸、碱、氧化、高温、光照破坏后所产生的杂质峰均能与主峰有效分离,最低检测限0.03ng。布洛芬在0.26～1.24mg/ml的浓度范围内与峰面积成良好的线性关系,平均回收率为99.5%,RSD为0.64%。加速试验6个月和长期试验12个月,其性状、pH值、有关物质、含量等均未见明显改变。结论:该制剂处方合理,制备工艺简单可行,质量可控,稳定性良好。
Objective： To prepare Ibuprofen injection, establish its quality control and determine its stability and safety. Methods： Some work was done to optimize the prescription and preparation technology. The character, identification and examination were tested. The content and the related materials of Ibuprofen injection were determined by HPLC. Stress testing, accelerated testing and long-term testing were done to study its stability. The safety was evaluated by testing the vessel stimulation, haemolyticus and hypersensitivity. Results： The method had an effective separation of the main component from impurities which produced after a series of destruction test, such as acid, alkalization, oxidation, light and thermal destruction. The detective limit was 0. 03 ng. The linear relation of Ibuprofen was excellent within the range of 0.26-1.24 mg/ml, and the average recovery rate was 99.5%, with RSD was 0.64%. No obvious changes were observed at 6 month of an accelerated test or 12 month of long-term storage test. Conclusion： The preparation is reasonable in formulation, simple and convenient in preparation technique, accurate in quality control, good in stability, and safe in application.
出处
《华夏医学》
CAS
2011年第3期276-279,共4页
Acta Medicinae Sinica
关键词
布洛芬注射液
研制
质量控制
稳定性
Ibuprofen injection
preparation
quality control
stability
