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大青叶配方颗粒质量标准研究

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目的：：建立大青叶配方颗粒的质量标准。方法：采用薄层色谱法鉴别配方颗粒中的靛蓝、靛玉红,采用醇溶性浸出物测定法中的热浸法测定浸出物的含量,采用高效液相色谱法测定靛玉红的含量。结果：薄层色谱斑点清晰,分离度好；浸出物的含量限度初步拟定为应不少于12.0%；含量测定中,靛玉红在0.50~8.04μg·ml-1质量浓度范围内线性关系良好( r=0.9999),平均回收率为99.41%,RSD为1.21%(n=9),并初步确定靛玉红的含量应不得少于50.0μg/袋。结论：建立的定性定量方法操作方便、结果准确、专属性强,可用于大青叶配方颗粒的质量控制。
Study on Quality Standard for Isatidis Folium Dispensing Granules
Objective:To establish the quality standard for Isatidis folium dispensing granules. Methods:Indigo and indirubin in the granules were identified by TLC. The extract content was determined by a hot dipping method for the determination of alcohol-solu-ble extract. The content of indirubin was determined by HPLC. Results:The spots in TLC were clear and well-separated. The extrac-tion limit no less than 12. 0% was preliminarily drawn up. Indirubin showed a good linear relationship within the range of 0. 50-8. 04μg·ml-1(r=0. 999 9) with the average recovery of 99. 41%(RSD=1. 21%, n=9). The content limit no less than 50. 0 μg per pack was preliminarily drawn up for indirubin. Conclusion: The method is easy-operated and accurate with good specificity for the quality control of Isatidis folium dispensing granules.

Isatidis folium dispensing granulesQuality standardTLCExtractHPLCIndirubin

巩伟、赵庆华、赵梅、孙旭、刘忠良、李兴东、张欣欣、张琨

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济南军区联勤部药品仪器检验所 济南250022

大青叶配方颗粒 质量标准 薄层色谱法 浸出物 高效液相色谱法 靛玉红

军队医疗机构制剂标准提高专项课题

13ZJZ21-2

2014

中国药师
国家药品监督管理局高级研修学院,武汉医药（集团）股份有限公司

中国药师

CSTPCD
影响因子：0.944
ISSN：1008-049X
年,卷(期)：2014.(12)
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