【摘要】 目的制订适合中药新药申报要求的灯盏生脉软胶囊质量标准。方法应用高效液相色谱法测定了本品君药灯盏细辛主要有效成分野黄芩苷的含量,应用薄层色谱法对方中3味药材进行定性鉴别研究。结果制定了野黄芩苷含量测定方法并提出了含量限度为每粒不少于15.0mg,制定了灯盏细辛、人参、五味子的定性鉴别方法,阴性样品无干扰。结论本文制定的灯盏生脉软胶囊的质量标准合理可行,较灯盏生脉胶囊质量标准有所提高,可保证本品的质量合格、稳定。更多还原

【Abstract】 AIM Through research on entire quality standard of Dengzhan Shengmai soft capsule, to establish the quality standard which will meet the criteria of the application requirement for new Chinese patent medicine. METHODS Quantity of scutellarin was determined by HPLC through measuring the main effective ingredients of Dengzhan and quality identifying methods for three meteria medica was established by TLC. RESULTS Method of quantity determination of scutellarin was set up, outcoming with the minimum content of each capsule had not to be less than 15.0 mg; and thus also established the identification method for Herba erigerontis, Ginseng, Fructus Schisandrae Chinensis, and there was no interference with the negative references. CONCLUSION The establishment of quality standard of Dengzhan Shengmai soft capsule is scientificial and practical, which is superior than quality standard of Dengzhan Shengmai capsule, and further ensures the quality and stability of Dengzhan Shengmai soft capsule.更多还原