目的 利用高效液相色谱建立肺结核丸的指纹图谱,为肺结核丸的质量控制和评价提供可靠的方法。方法 采用HPLC梯度洗脱技术进行分离分析,采用Diamonsil C18色谱柱(4.6 mm×250 mm,5 μm),流动相为乙腈-0.01%磷酸溶液,检测波长270 nm,体积流量0.8 mL·min-1,柱温25 ℃。结果 10个批次的肺结核丸有10个共有峰,鉴别了其中4个共有峰,初步确定了8个共有峰的归属,10批样品相似度均大于0.90。结论 本实验所建立的方法简便快速,准确可靠,可以作为肺结核丸质量控制的有效方法。
Abstract
OBJECTIVE To establish the HPLC fingerprints of Feijiehe pills and provide a foundation for its quality control and evaluation. METHODS A gradient elution method was applied. Ten batches of samples were analyzed by HPLC on a Diamonsil C18 (4.6 mm×250 mm,5 μm) column with mobile phase composed of acetonitrile-0.01% phosphoric acid solution at a flow rate of 0.8 mL·min-1, the detection was carried out at 270 nm, and the column temperature was maintained at 25 ℃. RESULTS There were 10 common peaks in the HPLC fingerprints. The similarity between peaks was more than 0.90. CONCLUSION The method is simple, accurate, reliable, and suitable to be applied to the quality control of Feijiehe pills.
关键词
肺结核丸 /
质量控制 /
高效液相色谱法 /
指纹图谱
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Key words
Feijiehe Pills /
quality control /
HPLC /
fingerprint
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中图分类号：
R284
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