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| 连知解毒胶囊质量标准研究 |
| Study on Quality Standard of Lianzhi Jiedu Capsules |
| 投稿时间：2020-04-10 修订日期：2020-07-16 |
| DOI： |
| 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 Jiedu Capsules Forsythoside A quality control TLC HPLC |
| 基金项目:国家药品标准提高工作(中药)[项目编号131] |
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| 中文摘要: |
| 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5.4～12.6mg?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: |
| Abstract Objective: To improve the quality standard of Lianzhi Jiedu 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，and the detection wavelength was set at 330 nm，the column temperature was 35 ℃．Results: Forsythoside A（injection volume 5 μL） had considerable linear relationship in the range of 0.0209-3.141 μg（R=0.9994）．The average recovery was 100.5%，RSD was 1.42%．，The content of forsythiaside 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，it can be used for the quality control of Lianzhi Jiedu Capsules． |
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