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目的:建立炎可宁片薄层鉴别、含量测定标准,更有效地控制该产品质量。方法:采用薄层色谱法对处方小檗碱、黄连、大黄、黄芩进行定性鉴别研究;含量采用高效液相色谱(HPLC)测定制剂中的黄芩苷。高效液相色谱条件:色谱柱:Dikma C18(5μm,250×4.6mm);流动相:甲醇-水-磷酸(47:53:0.2);流速:1.0ml/min;柱温:35℃;检测波长:280nm。结果:TLC、HPLC准确、可靠,HPLC回收率为99%~101%,RSD为1.02%。结论:建立的薄层色谱法和高效液相色谱法专属性强、准确度高、重复性好,可用于炎可宁片的质量控制。
OBJECTIVE: To establish a thin layer identification and determination standard of Yan Ke Ning tablets to control the quality of the product more effectively. Methods: TLC, berberine, berberine, rhubarb and Scutellaria baicalensis were identified qualitatively. The content of baicalin in the preparation was determined by high performance liquid chromatography (HPLC). High performance liquid chromatography conditions: Column: Dikma C18 (5 μm, 250 × 4.6 mm); mobile phase: methanol-water-phosphoric acid Wavelength: 280nm. Results: TLC and HPLC were accurate and reliable. The HPLC recovery was 99% ~ 101% with RSD 1.02%. Conclusion: The established TLC and HPLC have the advantages of high specificity, high accuracy and good repeatability, and can be used for the quality control of Yan Ke Ning tablets.