心脉舒一号口服液质量标准提升研究
Improvement of Quality Standard of Xinmaishu Yihao Oral Liquid
唐勇琛 1张洪平 1毛桂福 1樊玲凤 2杨玉竹 2张亚洲2
作者信息
- 1. 广西壮族自治区柳州市中医医院·广西壮族自治区柳州市壮医医院,广西 柳州 545000;广西壮族自治区柳州市中药<壮瑶药>制剂开发工程技术研究中心,广西 柳州 545000
- 2. 贵州中医药大学,贵州 贵阳 550025
- 折叠
摘要
目的 提升心脉舒一号口服液的质量标准.方法 采用薄层色谱(TLC)法定性鉴别制剂中的麦冬、五味子;以芦丁、D(+)-无水葡萄糖为对照品,采用紫外-可见分光光度(UV-Vis)法,分别在 504,490 nm波长处测定制剂中总黄酮、总多糖的含量.结果 麦冬、五味子的TLC图斑点清晰,分离度好,阴性对照无干扰.芦丁、D(+)-无水葡萄糖质量浓度分别在 0.016 7～0.058 5 mg/mL(R2=0.999 3,n=6)和 0.002 7～0.016 2 mg/mL(R2=0.987 9,n=6)范围内与吸光度线性关系良好.精密度、稳定性、重复性试验结果的RSD均小于 1.0%;平均加样回收率分别为 99.85%和 99.80%,RSD分别为 0.04%和 0.22%(n=6);19 批制剂中总黄酮、总多糖的平均含量分别为 0.695,22.30 mg/mL.结论 该方法操作简便,灵敏度高,精密度、稳定性、重复性均较好,可用于心脉舒一号口服液的质量控制.
Abstract
Objective To improve the quality standard of Xinmaishu Yihao Oral Liquid.Methods Ophiopogonis Radix and Schisandrae Chinensis Fructus in the preparation were qualitatively identified by the thin layer chromatography(TLC)method.With rutin and D(+)-anhydrous glucose as the reference,the contents of total flavonoids and total polysaccharides in the preparation were determined by the ultraviolet-visible spectroscopy(UV-Vis)at wavelengths of 504,490 nm,respectively.Results The TLC chromatograms of Ophiopogonis Radix and Schisandrae Chinensis Fructus showed clear spots,good resolution,and there was no interference from the negative reference.The linear ranges of rutin and D(+)-anhydrous glucose were 0.016 7-0.058 5 mg/mL(R2=0.999 3,n=6),0.002 7-0.016 2 mg/mL(R2=0.987 9,n=6)respectively.The RSDs of precision,stability and repeatability tests were all lower than 1.0% .The average recovery rates of total flavonoids and total polysaccharides were 99.85% and 99.80%,with the RSDs of 0.04% and 0.22% (n=6)respectively.The average contents of total flavonoids and total polysaccharides in 19 batches of preparation were 0.695,22.30 mg/mL respectively.Conclusion This method is easy,sensitive,precise,stable and repeatable,which can be used for the quality control of Xinmaishu Yihao Oral Liquid.
关键词
心脉舒一号口服液/薄层色谱法/紫外-可见分光光度法/总黄酮/总多糖/质量控制Key words
Xinmaishu Yihao Oral Liquid/TLC/UV-Vis/total flavonoids/total polysaccharides/quality control引用本文复制引用
基金项目
广西壮族自治区柳州市科技计划项目(2020NBAA0807)
出版年
2024
国家科技期刊平台
NSTL
万方数据