摘要
目的:研究建立尼莫地平微乳注射液的质量控制方法。方法:参考《中国药典》中的相关规定,选择尼莫地平微乳注射液的质量控制指标及相关的测定方法。结果:制定了有关制剂的外观、pH、形态、粒径、包封率及含量等指标,并选择冰冻蚀刻法测定微乳形态、凝胶柱层析法测定包封率、高效液相色谱法测定含量和检查有关物质。结论:所制定的质控指标和采用的测定方法能较好地控制该制剂的质量。
Objective： To establish a suitable method for controlling the quality of the Nimodipine microemulsion injection. Methods： According to the related regulations in CP 2005, a method for controlling the quality of the nimodipine microemulsion injection was selected. Results： The appearance, pH, morphology, size distribution, encapsulated efficiency and content of nimodipine microemulsion were determined. Microemulsion morphology was determined by freeze-etching methods and encapsulated efficiency was determined by gel column chromatography. The content and related compounds were determined by HPLC. Conclusion： The quality standards established could ensure the quality of the product.
出处
《药学进展》
CAS
2008年第4期176-181,共6页
Progress in Pharmaceutical Sciences
基金
国家自然科学基金资助项目(No.30500666)
清华大学裕元基金项目(No.20240000529)
关键词
尼莫地平
微乳注射液
质量控制
Nimodipine
Microemulsion injection
Quality control
