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湿滞片质量控制标准研究

Quality Standard for Shizhi Tablets
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摘要 目的建立湿滞片质量控制标准。方法采用TLC法对香附、黄芩进行鉴别;采用HPLC法测定黄芩苷的含量,流动相为0.1%磷酸溶液-甲醇(60:40);色谱柱为SHIMADZU(岛津)shim—packVP—ODS(4.6mm×250mm,5μm);流速为1.0ml·min-1;波长为2801nm。结果供试品色谱中,在与香附、黄芩对照药材色谱相应的位置上,显相同颜色的斑点,阴性样品无干扰,黄芩苷在10.6784~213.568μg·L-1范围内与峰面积呈良好的线性关系,回收率为99.8%,RSD为0.5%。结论该方法操作简便、快捷,可为该制剂提供严格可控的质量标准。 Objective To establish a standard for quality control of Shizhi tablets. Methods TLC was used for the identification of Rhizoma Cyperi and Radix Scutellariae. The content of baicalin was determined by HPLC. The mobile phase consisted of 0.1% phosphoric acid-methanol (60: 40). The column was SHIMADZU shim-pack VP-ODS (4.6 mm× 250 mm ,5 μm) at a flow rate of 1.0 ml ·min-1 and a detection wavelength of 280 nm. Results TLC indi- cated that Rhizoma Cyperi and Radix Scutellarie showed spots of the same color with the control herbs in the same po- sition. Negative samples were free of interference. Baicalin had a good linear relationship in the range of 10.6784 - 213.568 μg·L-1. The rate of recovery was 99.8%, and RSD was 0.5%. Conclusion This method is simple, quick, and can provide a strictly controlled quality standard.
出处 《解放军药学学报》 CAS 2014年第3期253-255,共3页 Pharmaceutical Journal of Chinese People's Liberation Army
基金 梅州市科技计划项目 No.2013B51
关键词 湿滞片 TCL法 HPLC法 黄芩苷 Shizhi tablets TLC HPLC baicalin
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