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目的建立肺泰胶囊的质量控制方法。方法采用TLC法对处方中黄芪、肿节风、土鳖虫、仙鹤草定性鉴别;采用HPLC法测定肺泰胶囊中异嗪皮啶的含量。色谱柱:依利特Hypersil ODS柱(4.6 mm×200 mm,5μm);流动相:乙腈-0.1%磷酸,梯度洗脱;检测波长:342 nm;流速:1.0 ml·min-1;柱温:30℃。结果 TLC斑点清晰,阴性样品无干扰;异嗪皮啶含量在2.07~41.40μg·ml-1范围内具有良好的线性关系。回归方程为Y=61.9617 X-4.8349,r=0.9999(n=6)。平均加样回收率为98.77%,RSD为1.37%(n=9)。结论该方法简便、准确,专属性强,重复性好,阴性无干扰,可用于肺泰胶囊的质量控制。
Objective To establish the quality control method of lungtai capsule. Methods The TLC method was used to qualitatively identify Astragalus membranaceus, Arthrobacter sp., Eupolyphaga sinensis and Agrimonia indica. HPLC was used to determine the content of isoindoline in the lung capsule. Column: Elite Hypersil ODS column (4.6 mm × 200 mm, 5 μm); mobile phase: acetonitrile-0.1% phosphoric acid, gradient elution; detection wavelength: 342 nm; flow rate: 1.0 ml · min-1; ℃. Results TLC spots clear, negative samples without interference; Isozine pyridine content in the range of 2.07 ~ 41.40μg · ml-1 has a good linear relationship. The regression equation was Y = 61.9617 X-4.8349, r = 0.9999 (n = 6). The average recovery was 98.77% with a RSD of 1.37% (n = 9). Conclusion The method is simple, accurate, specific, reproducible, negative non-interference, can be used for the quality control of the lung capsule.