灯盏花素凝胶剂的制备及质量控制  

Preparation and Quality Control of Breviscapine Gel

作　　者：方睿[1] 王成芳[1] 刘子沐[1] 费超[1] 杜树山[1] 

机构地区：[1]北京师范大学中药资源保护与利用北京市重点实验室,北京100875

出　　处：《中国实验方剂学杂志》2011年第24期52-55,共4页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：北京教育委员会共建项目建设计划(SYS100270430);北京市新医药学科群重点支持项目(xk100270569)

摘　　要：目的:制备灯盏花素凝胶剂,并以野黄芩苷含量、凝胶pH等为质量控制指标,建立质量控制方法。方法:以灯盏花素为主药,卡波姆940等为基质,制备灯盏花素凝胶剂。对其性状进行评价,测量pH,建立高效液相色谱法测定野黄芩苷含量的方法,并进行初步稳定性研究。结果:灯盏花素凝胶剂性状稳定、pH在6.00～7.00,符合2010年版《中国药典》规定,凝胶中野黄芩苷含量不少于8 mg.g-1,且初步稳定性良好,可长期存放。结论:灯盏花素凝胶剂的质量稳定,控制方法简便可行,结果准确可靠,重复性好,可作为本制剂的质控标准。Objective： To prepare breviscapine gel and use scutellarin content and pH as the major effective index to establish an accurate method for its quality control.Method： The gel was prepared by taking breviscapine as main component and carbopol as materia1.Valuation the gel with appearance and pH.The content of the component in the gel was determined by HPLC.Result： The properties is stabilization,pH between 6.00-7.00 all in line with the rules of The Pharmacopoeia of PRC（2010）,content of scutellarin in breviscapine gel is above 8 mg·g-1.Moreover,the gel was uniformity and stability.Conclusion： The method is simple,reliable and accurate,and can be used for the quality control of breviscapine gel.

关 键 词：灯盏花素凝胶剂 野黄芩苷 高效液相色谱 质量控制 稳定性 

分 类 号：R284.1[医药卫生—中药学]