复方银杏通脉口服液的质量标准提高研究

Study on Improving the Quality Standard of Compound Yinxing Tongmai Oral Liquid

目的:进一步优化提高复方银杏通脉口服液质量标准,以提升产品质量的可控性,保障药品的有效性。方法:采用薄层色谱(TLC)法定性鉴别复方银杏通脉口服液中女贞子和钩藤药材;丹酚酸B和二苯乙烯苷用HPLC法测定含量。结果:薄层色谱斑点清晰,比移值较适合,阴性对照无干扰。主要特征成分丹酚酸B和二苯乙烯苷在各自线性范围内线性关系良好,平均加样回收率分别为95.49%和94.84%,RSD分别为2.12%和1.91%(n=6)。结论:多味药材定性鉴别和特征成分含量测定相结合建立的复方银杏通脉口服液质量控制方法科学合理,保证质量的可控,可为该制剂后续质量提升提供依据。

Objective To further optimize and improve the standard of Compound Yinxing Tongmai Oral Liquid,so as to improve the controllability of product quality and ensure the effectiveness of drugs.Methods TLC was used to qualitatively identify Ligustrum lucidum and Uncaria hook in Compound Yinxingtongmai Oral Liquid;salvianolic acid B and stilbene glycosides were determined by HPLC.Results The spots of TLC were clear,the ratio shift was suitable,and the negative control had no interference.The main characteristic components salvianolic acid B and stilbene glycosides had good linear relationship in their respective linear ranges,the average sample recovery rates were 95.49%and 94.84%,and the RSDs were 2.12%and 1.91%,respectively(n=6).Conclusion The quality control method of compound Yinxing Tongmai oral liquid established by the combination of qualitative identification of multi-flavor medicinal materials and content determination of characteristic components is scientific and reasonable,which can ensure the controllability of quality,and can provide a basis for the subsequent quality improvement of the preparation.