通脉灵片质量标准研究

Study on quality standard of Tongmailing Tablets

目的:建立通脉灵片的质量标准.方法:采用薄层色谱法对样品中的郁金、地黄、降香、川芎进行定性鉴别,并采用高效液相色谱法对主药丹参中有效成分丹酚酸B的含量进行测定.结果:样品中均能检出郁金、地黄、降香、川芎的特征斑点;丹酚酸B在61.6～985.6ng范围内呈良好的线性关系(r=0.9999).加样回收率为98.8%,相对标准偏差(RSD)为1.70%(n=5).结论:所建立的方法可准确的进行定性、定量检测,能够用于该制剂的质量控制.

Objective: To establish the quality standards for Tongmailing Tablets.Methods:Radix curcumae,radix rehmanniae,lignum dalbergiae odoriferae,rhizoma chuanxiong are identified by TLC.The content of salvianolic acid B is assayed by HPLC.Result: Radix curcumae,radix rehmanniae,lignum dalbergiae odoriferae,rhizoma chuanxiong can be identified by TLC.The caliberation curve of salvianolic acid B is linear within 61.6~985.6ng(r =0.9999).The average recovery is 98.8%,and RSD is 1.70%(n=5).Conclusion: The methods are accurate and can be used for the quality control of the preparations.