固本养血口服液质量标准研究

Quality Criteria of Guben Yangxue Oral Liquid

目的:建立固本养血口服液的质量标准。方法:用薄层色谱(TLC)法对方中女贞子、山茱萸、黄芪、熟地黄、当归进行定性鉴别;用紫外分光光度法对制剂中多糖进行含量测定。结果:TLC斑点清晰、分离度好、专属性强,阴性对照无干扰。多糖检测浓度在0.0206～0.0721mg·mL-1范围内与吸光度呈良好线性关系(r=0.9992);平均回收率为98.64%,RSD=0.56%(n=9)。结论:所建标准可用于固本养血口服液的质量控制。

OBJECTIVE： To establish the quality criteria of Guben yangxue oral liquid. METHODS： TLC was employed to identify prepared Ligustrum lucidum, Comus officinalis, Radix Astragali, Radix Rehmanniae Praeparata, and Angelica sinensis, and the content of polysaccharide was determined by ultraviolet spectrophotometry. RESULTS： The TLC spots were clear, well- separated and specific yet without interference from negative control. The linear range of polysaccharide was 0.020 6-0.072 1 mg · mL^- 1（ r =0. 999 2） with an average recovery of 98.64% （RSD = 0.56%, n = 9）. CONCLUSION： The established quality criteria is suitable for the quality control of Guben yangxue oral liquid.