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目的:建立重参消炎胶囊的质量标准。方法:采用薄层色谱法对重参消炎胶囊中的重楼、当归、苦参进行定性鉴别;采用高效液相色谱法测定制剂中苦参碱的含量,色谱柱:NUCLEOSIL-NH2(4.6 mm×250 mm,5μm)柱;流动相:乙腈-无水乙醇-3%磷酸溶液(80∶10∶10);流速:1.0 mL/min;柱温:25℃;检测波长为220 nm。结果:重楼、当归、苦参特征斑点清晰,分离度好,阴性无干扰。苦参碱在0.433 2~2.166 0μg范围内呈良好的线性关系,r=0.999 45,平均回收率为100.54%,RSD=1.85%。结论:所建立的方法简便准确,专属性、重复性好,可作为重参消炎胶囊的质量控制标准。
Objective: To establish the quality standard of Chong Shen Xiao Yan Capsule. Methods: TLC was used to qualitatively identify Zhonglou Xiaoqin, Angelica sinensis and Sophora flavescens Ait. The content of matrine in the preparation was determined by high performance liquid chromatography. Column: NUCLEOSIL-NH2 (4.6 mm × 250 mm, 5 μm) column; mobile phase: acetonitrile-anhydrous ethanol-3% phosphoric acid solution (80:10:10); flow rate: 1.0 mL/min; column temperature: 25°C; detection wavelength at 220 nm. Results: The characteristics of heavy building, Chinese angelica and Sophora flavescens were clear, the degree of separation was good, and the negative had no interference. Matrine has a good linear relationship in the range of 0.433 2 to 2.166 0 μg, r=0.999 45, with an average recovery of 100.54% and RSD=1.85%. Conclusion: The established method is simple and accurate, with good specificity and reproducibility. It can be used as a quality control standard for CQS anti-inflammatory capsules.