五福饮口服液的质量控制方法研究

Study on Quality Control of Wufuyin Oral Liquid

目的:建立五福饮口服液的质量控制方法,以提高该制剂的质量标准。方法:采用薄层色谱法对五福饮口服液中熟地黄、当归进行定性分析;采用高效液相色谱法对当归中阿魏酸、人参中人参皂苷Re进行定量分析。结果:薄层色谱中熟地黄和当归的特征斑点清晰,专属性强,分离度好。含量测定中阿魏酸、人参皂苷Re分别在浓度0.0 138-0.0 690 mg/mL、0.0 104-0.0 520 mg/mL的范围内呈良好线性关系,平均加样回收率分别为99.13%,RSD为0.3%及98.30%,RSD为0.86%。结论:该定性定量分析方法可操作性强、分析结果准确,可用于五福饮口服液质量标准的检验。

Objective: To raise quality standard of Wufuyin oral liquid by establishing quality control methods of the preparations. Methods: TLC was adopted to analyze Shudihuang(rehmanniae radix praeparata) and Dangui[Angelica sinensis(Oliv.)Diels] in Wufuyin oral liquid qualitatively;HPLC was used to perform the quantitative analysis for ferulic acid contained in Danggui and ginsenoside Re in ginseng. Results: TLC of Shudihuang and Danggui were featured in clear spots, strong specificity and good separation. Content determination of ferulic acid and ginsenoside Re demonstrated good linear relationship in the ranges between 0.0 138 and 0.0 690 mg/mL, 0.0 104 and 0.0 520 mg/mL, average sample recovery rates and RSD of erulic acid and ginsenoside Re were 99.13%, 0.3% 98.30% and 0.86%. Conclusion: The qualitative and quantitative method is easy to operate and accurate in the analysis, and it could be used for the detection of quality standard of Wufuyin oral liquid.