| 陈安珍,袁航,王亮,卢京光,马双成.治带片质量标准的提高及质量评价研究[J].中国药品标准,2019,20(2):128-132 |
| 治带片质量标准的提高及质量评价研究 |
| Study on Quality Standards and Quality Evaluation of Zhidai Tablets |
| 投稿时间：2018-10-09 修订日期：2019-04-03 |
| DOI： |
| 中文关键词: 治带片 薄层色谱法 高效液相色谱法 质量标准 苍术素 |
| 英文关键词: Zhidai Tablets TLC HPLC Quality standard Atractylodin |
| 基金项目:国家药典委员会《中国药典》药品标准提高任务(198号),中国食品药品检定研究院中青年基金(No. 2013WA8) |
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| 中文摘要: |
| 目的：对治带片的质量标准进行完善提高，对其质量进行整体评价。方法：采用薄层色谱法（TLC）对治带片中金樱子、苍术和知母药材进行定性鉴别；采用高效液相色谱（HPLC），以苍术素作为检测指标，进行定量测定。结果：薄层色谱法能清晰、有效的鉴别治带片中金樱子、苍术和知母药材，阴性无干扰；苍术素在1.0~104.7 μg/?mLmL-1浓度范围内线性关系良好, 回归方程为Y=131.9X+29.8，相关系数为0.99998；最低检测限为0.79 μg/??g-1，最低定量限为2.63μg? g-1μg/g；加标回收率为98.86%，RSD为0.91% （(n=6）。)。结论：提高后的质量标准新建立的方法质量标准增加了可控检测药味更多，可控性、系统性更强；建立的实验方法简便快捷，准确可靠，适应性好，可用于该制剂的质量控制和质量评价。 |
| 英文摘要: |
| Objective: To improve the quality standards and realize overall quality evaluation for Zhidai Tablets. Methods: The TLC identification methods of Rosae Laevigatae Fructus, Atractylodis Rhizoma and Anemarrhenae Rhizoma in Zhidai Tablets were studied. The content of atractylodin was determined by HPLC. Results: Rosae Laevigatae Fructus, Atractylodis Rhizoma and Anemarrhenae Rhizoma in Zhidai Tablets could be identified by TLC without the blank interference. The linearity equation between the concentrations and peak areas of atractylodin were Y=131.9X+29.8 in the ranges of 1.0-~104.7 μg?mL-1μg/mLmL ( r2 = 0.99998) with the average recoveries as 98.86%( n = 6). The limit of detection and quantification was 0.79 μg?g-1μg/g and 2.63 μg?g-1μg/g respectively. Conclusion: The improved quality standard is more systematic and controllable; the established experimental method is simple, fast, accurate, reliable, and adaptable, and can be used for quality control and quality evaluation of Zhidai Tablets. |
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