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新生发丸的制剂工艺和质量标准研究

Study on Preparation Technique and Quality Standard for New Shengfa Pills

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【作者】 杨阳于文惠杨静赵长琦

【Author】 Yang Yang;Yu Wenhui;Yang Jing;Zhao Changqi;School of Pharmaceutical Sciences,Xi’an Medical University;College of Life Science,Beijing Normal University;

【机构】 西安医学院药学院北京师范大学生命科学学院

【摘要】 目的:考察新生发丸的制剂工艺及制定质量控制方法。方法:应用正交试验法,选择二苯乙烯苷的含量和干浸膏得率两项指标,优选新生发丸中水提部分药材的最佳提取工艺;二苯乙烯苷的含量通过HPLC测定;采用薄层色谱法对制剂中的当归和牛膝进行了鉴别。结果:最佳提取工艺为,熟地黄等五味药材用12倍水量提取3次,每次1h。薄层鉴别的色谱斑点分离好,阴性无干扰。结论:该制剂工艺合理、可行、质量可控。

【Abstract】 Objective: To study the preparation technique and quality standard for new Shengfa pills. Methods: The best water extraction process of the medicinal herbs was optimized by orthogonal test using stilbene glucoside content and dry extract percent as the indices. The content of stilbene glucoside was determined by HPLC,and Hyssop and Chinese angelica in the preparation were identified by TLC. Results: The optimized preparation conditions were as follows: 12-fold water was used in the 3-time extraction with 1 h for each time. The spots in TLC were clear without interference from the negative control. Conclusion: The preparation process is reasonable and feasible in techniques with controllable quality.

【基金】 十二五“重大新药创制”科技重大专项(编号:2013ZX09103001-019-001)
  • 【分类号】R283.6
  • 【下载频次】139
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