文章摘要
胡亮,陈征,李瑞莲,周明.连知解毒胶囊质量标准研究[J].中国药事,2020,34(11):1308-1313
连知解毒胶囊质量标准研究
Study on Quality Standard of Lianzhi Detoxication Capsules
  
DOI：10.16153/j.1002-7777.2020.11.009
中文关键词: 连知解毒胶囊  连翘酯苷A  质量控制  薄层色谱法  高效液相色谱法
英文关键词: Lianzhi Detoxication Capsules  Forsythoside A  quality control  TLC  HPLC
基金项目:国家药品标准提高工作(中药)(编号 131)
作者单位
胡亮 湖南省药品检验研究院(湖南药用辅料检验检测中心),长沙 410001 ；湖南省药品质量评价工程技术研究中心,长沙 410001 
陈征 湖南省药品检验研究院(湖南药用辅料检验检测中心),长沙 410001 ；湖南省药品质量评价工程技术研究中心,长沙 410001 
李瑞莲 湖南省药品检验研究院(湖南药用辅料检验检测中心),长沙 410001 ；湖南省药品质量评价工程技术研究中心,长沙 410001 
周明 湖南省药品检验研究院(湖南药用辅料检验检测中心),长沙 410001 ；湖南省药品质量评价工程技术研究中心,长沙 410001 
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中文摘要:
      目的：完善连知解毒胶囊的质量标准。方法：采用薄层色谱法对方中连翘、知母、广藿香进行定性鉴别；采用高效液相色谱法测定连翘中连翘酯苷A的含量，使用Hypersil BDS色谱柱(250 mm×4.6 mm，5 µm)，以乙腈-0.1%磷酸溶液(14∶86)为流动相，流速1.0 mL·min-1，检测波长330 nm，柱温35 ℃。结果：薄层色谱法中均检出连翘、知母和广藿香，阴性对照无干扰，斑点清晰，分离度较好； 连翘酯苷A进样量在0.0209~3.141 μg范围内具有良好的线性关系(r=0.9994)，平均回收率为100.5%， RSD为1.42%。15批次样品中连翘酯苷A含量范围为5.4~12.6 mg·粒-1。结论：该拟定的质量标准专属性强，重复性好，检测指标合理，可用于连知解毒胶囊的质量控制。
英文摘要:
      Objective: To improve the quality standard of Lianzhi Detoxication Capsules. Methods: TLC method was used for the qualitative identification of the Forsythiae Fructus, Anemarrhenae Rhizoma and Pogostemonis Herba. HPLC method was used for the content determination of Forsythia Fructus. Hypersil BDS C18 column (250 mm × 4.6 mm, 5 μm) was adopted for the content determination of Forsythoside A in Forsythia Fructus, the mobile phase was acetonitrile-0.1% phosphoric acid solution(14∶86), the flow rate was 1.0 mL·min-1, the detection wavelength was set at 330 nm, and the column temperature was 35℃. Results: Forsythiae Fructus, Anemarrhenae Rhizoma and Pogostemonis Herba were detected by TLC. The negative control showed no interference, the spots were clear and the separation degree was good. Forsythoside A (injection volume 5 μL) had considerable linear relationship (r=0.9994) in the range of 0.0209-3.141 μg. The average recovery rate was 100.5% and RSD was 1.42%. The content of Forsythoside A in 15 batches of samples ranged from 5.4 to 12.6 mg·capsule-1. Conclusion: The proposed quality standard has strong specificity, good repeatability and reasonable detection indexes, so it could be used to be the quality control of Lianzhi Detoxication Capsules.
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