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产复欣糖浆的制备及质量控制 被引量:2

Preparation and Quality Control of Chanfuxin Syrup
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摘要 目的:建立产复欣糖浆的制备方法及质量控制标准。方法:确定产复欣糖浆的制备工艺,并依照《中华人民共和国药典》(2005年版)中薄层色谱法对产复欣糖浆中的枸杞子、当归主药进行定性鉴别;依照高效液相色谱法对产复欣糖浆中的白芍主药的主成分芍药苷进行含量测定,拟订其质量标准,考核该制剂的稳定性。结果:采用本法制备的制剂质量稳定,鉴别方法有专属性,含量测定方法准确可靠。结论:制备工艺合理,质量控制方法可行。 OBJECTIVE: To establish the preparative method and quality control method of Chanfuxin Syrup. METHODS: The preparation process of Chanfuxin Syrup was established. The barbary wolfberry fruit and angelica were qualitatively identified by TLC in accordance with Chinese pharmacopoeia (2005 edition) ; and the content of peoniflorin in the Syrup was determined by HLC in accordance with Chinese pharmacopoeia (2005 edition). The quality standard was established and the stability of the syrup was investigated. RESULTS: The syrup was stable in quality, specific in identification and accurate and reliable in content determination. CONCLUSION: The preparation process is reasonable and the quality control method is feasible.
作者 刘茜
出处 《中国医院用药评价与分析》 2008年第7期518-521,共4页 Evaluation and Analysis of Drug-use in Hospitals of China
关键词 产复欣糖浆 制备 质量控制 Chanfuxin syrup Preparation Quality control
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参考文献3

  • 1国家药品监督管理局.国家中成药标准汇编(外科、妇科分册)[S].2005:643.
  • 2国家药品监督管理局.药品注册管理办法(附件1)[S].局令第28号,2007.
  • 3国家药品监督管理局.中药新药研究的技术要求[S].国药管注[1999]363号,1999.

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