参归益血合剂质量标准研究
Study on Quality Standard of Shengui Yixue Mixture
李小伟 1张松 1牛倩 2吴鸿飞3
作者信息
- 1. 安徽省亳州市蒙城县中医院,安徽 亳州 233500
- 2. 安徽省亳州职业技术学院,安徽 亳州 236800
- 3. 安徽中医药大学药学院,安徽 合肥 230031
- 折叠
摘要
目的 建立参归益血合剂的质量标准.方法 采用薄层色谱(TLC)法对制剂中的虎杖、当归、白芍进行定性鉴别;采用高效液相色谱法测定芍药苷的含量,色谱柱为Hypersil GOLD C18 柱(250 mm×4.6 mm,5 μm),流动相为乙腈-0.1%磷酸水溶液(梯度洗脱),流速为 1.0 mL/min,检测波长为 230 nm,柱温为 30℃,进样量 5 μL.结果 3 种药材TLC图斑点清晰,分离度好,且阴性对照无干扰.芍药苷的质量浓度在 0.00732～0.1464 mg/mL范围内与峰面积线性关系良好(R2=0.9998,n=5);精密度、稳定性、重复性试验结果的RSD均小于 1.0%;平均加样回收率为 101.92%,RSD为 0.66%(n=6).3 批样品中芍药苷含量分别为 0.2640,0.2819,0.2716 mg/mL.结论 本研究中所建方法操作简便、结果准确可靠,可用于参归益血合剂的质量控制.
Abstract
Objective To establish the quality standard of Shengui Yixue Mixture.Methods Polygoni Cuspidati Rhizoma et Radix,Angelicae Sinensis Radix and Paeoniae Radix Alba in the preparation were qualitatively identified by the thin-layer chromatography(TLC)method.The content of paeoniflorin was determined by the high-performance liquid chromatography(HPLC)method;the chromatographic column was the Hypersil GOLD C18 column(250 mm×4.6 mm,5 μm),the mobile phase was acetonitrile-0.1%phosphoric acid aqueous solution(gradient elution),the flow rate was 1.0 mL/min,the detection wavelength was 230 nm,the column temperature was 30℃,and the injection volume was 5 μL.Results The TLC chromatograms of the three medicinal herbs showed clear characteristic spots,good resolution,and there was no interference from the negative reference.The linear range of paeoniflorin was 0.00732-0.1464 mg/mL(R2=0.9998,n=5).The RSDs of precision,stability and repeatability tests were all lower than 1.0%.The average recovery rate of paeoniflorin was 101.92%with an RSD of 0.66%(n=6).The contents of paeoniflorin in three batches of samples were 0.2640,0.2819,0.2716 mg/mL,respectively.Conclusion The established method is easy,accurate and reliable,which can be used for quality control of Shengui Yixue Mixture.
关键词
参归益血合剂/质量标准/薄层色谱法/高效液相色谱法/芍药苷/含量测定Key words
Shengui Yixue Mixture/quality standard/TLC/HPLC/paeoniflorin/content determination引用本文复制引用
基金项目
安徽省高校自然科学研究项目(KJ2021A1432)
出版年
2024
国家科技期刊平台
NSTL
万方数据