| 刘艳丽,周永妍,李菲,李龙龙,孙胜斌,姜国志,李振江.丹灯通脑软胶囊质量标准的提高[J].中国药品标准,2017,18(4):245-251 |
| 丹灯通脑软胶囊质量标准的提高 |
| Improvement of quality standard of Dandeng Tongnao Soft Capsules |
| 投稿时间：2017-05-11 修订日期：2017-08-02 |
| DOI： |
| 中文关键词: 丹灯通脑软胶囊 质量标准 薄层色谱 高效液相色谱 |
| 英文关键词: Dandeng Tongnao Soft Capsules quality standard TLC HPLC |
| 基金项目: |
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| 摘要点击次数: 835 |
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| 中文摘要: |
| 目的：提升丹灯通脑软胶囊的质量标准。方法：采用薄层色谱法(TLC)对丹灯通脑软胶囊中丹参、灯盏细辛、川芎及粉葛药材进行定性鉴别；采用高效液相色谱法(HPLC),以葛根素、野黄芩苷、丹酚酸作为指标成分进行定量测定。结果：薄层色谱法能清晰地鉴别丹灯通脑软胶囊中的丹参、灯盏细辛、川芎及粉葛,阴性无干扰；葛根素、野黄芩苷、丹酚酸B分别在3.85~115.5μg/mL(r2=0.9998)、5.81～174.3μg/mL(r2=0.9998)和12.28～368.4μg/mL(r2=0.9998)质量浓度范围内与峰面积具有良好的线性关系；平均回收率(n=9)分别为99.8%、100.2%和99.7%。结论：所建立的方法准确、可靠、专属性强, 可作为丹灯通脑软胶囊的质量控制方法。 |
| 英文摘要: |
| Objective: To improve quality standard for Dandeng Tongnao Soft Capsules. Methods: Salviae Miltiorrhizae Radix et Rhizoma, Erigerontic Herba, Chuanxiong Rhizoma, Puerariae Lobatae Radix in Dandeng Tongnao Soft Capsules were identified by TLC, and puerarin, scutellarin and salvianolic acid B as index components were simultaneously determined by HPLC．Results: Dandeng Tongnao Soft Capsules could be detected by TLC, The linearity ranges obtained from the calibration curves of puerarin, scutellarin and salvianolic acid B were 3.85~115.5μg/mL(r2=0.9998), 5.81~174.3μg/mL(r2=0.9998), 12.28~368.4μg/mL(r2=0.9998), respectively. The average recoveries and RSD(n = 9) were 99.8%, 100.2%, and 99.7%, respestively．. Conclusion: This method is simple, accurate, selective and highly reproducible. It can be used for the quality control of Dandeng Tongnao Soft Capsules. |
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