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舒糖络颗粒质量标准研究 被引量:5

Quality control of Shutangluo Granules
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摘要 目的建立舒糖络颗粒(葛根、黄连、鬼箭羽、生地、凌霄花)的质量标准。方法采用薄层色谱法对该复方制剂中葛根、黄连、生地、凌霄花进行定性鉴别,并采用高效液相色谱法对主要成分葛根素、盐酸小檗碱进行定量测定。结果薄层色谱斑点清晰,在与对照品或对照药材相应的位置上显相同颜色的斑点,阴性对照无干扰;葛根素和盐酸小檗碱分别在0.053-0.210 mg/m L(r=0.999 7)、0.011-0.192 mg/m L(r=0.999 5)范围内线性关系良好;加样回收率(n=6)均值分别为99.2%、101.6%,RSD分别为2.6%、1.1%。结论所建立的方法操作简便,准确度高,重复性好,能全面、有效地控制该制剂的质量。 AIM To establish the quality control of Shutangluo Granules( Puerariae lobatae Radix,Coptidis Rhizoma,Euonymus alarus,Rehmanniae glutinosa,Campsis Flos). METHODS TLC was used to identify Puerariae lobatae Radix,Coptidis Rhizoma,Rehmanniae glutinosa,and Campsis Flos. The quantitative determination of puerarin and berberine hydrochloride was completed by HPLC. RESULTS The spots in TLC were clear without interference. And the same color spots appeared in the corresponding position of references and reference drugs.The linear ranges of puerarin and berberine hydrochloride were 0. 053- 0. 210 mg / m L( r = 0. 999 7),and 0. 011- 0. 192 mg / m L( r = 0. 999 5),respectively. The average sample recoveries of puerarin,berberine hydrochloride were 99. 2%( RSD = 2. 6%),and 101. 6%( RSD = 1. 1%),respectively. CONCLUSION The quality control established is simple,accurate,reproducible and specific,which can be used for the quality control of Shutangluo Granules.
出处 《中成药》 CAS CSCD 北大核心 2015年第4期785-792,共8页 Chinese Traditional Patent Medicine
基金 江苏省社会发展科技计划 医药高技术计划项目(BS2007091)
关键词 舒糖络颗粒 葛根素 盐酸小檗碱 薄层鉴别 高效液相 质量标准 Shutangluo Granules puerarin berberine hydrochloride TLC HPLC quality standard
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