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目的:建立湿毒清胶囊高效液相色谱指纹图谱,对湿毒清胶囊产品的质量稳定性进行评价,为湿毒清胶囊的质量控制提供更为科学有效的方法。方法:采用Agilent XDB-C_(18)色谱柱(4.6 mm×250 mm,5μm),流动相乙腈-0.1%磷酸水溶液,梯度洗脱,流速1.0 m L·min~(-1),检测波长220 nm,柱温30℃,对10批不同批次的湿毒清胶囊复方制剂进行分析,使用国家药典委员会颁布的“中药色谱指纹图谱相似度评价系统”2004 A版,对产品的相似度进行评价。结果:建立了湿毒清胶囊指纹图谱,以黄芩苷为参照峰,确立了复方中21个共有峰,各共有峰的相对保留时间的RSD<1%,相对峰面积的RSD<4%,方法精密度、稳定性、重复性良好。采用该方法测定了10个批次湿毒清胶囊指纹图谱,相似度均>0.95。结论:10批湿毒清胶囊复方制剂质量稳定。该方法简便易行,稳定可靠,重复性好,能够表征湿毒清胶囊的整体质量,可为其生产和质量控制提供科学的依据。
OBJECTIVE: To establish the HPLC fingerprint of Shunduqing Capsules and evaluate the quality and stability of Shuxuqing Capsules, and provide a more scientific and effective method for the quality control of Shudun Capsules. METHODS: The mobile phase consisted of acetonitrile-0.1% phosphoric acid aqueous solution with gradient elution at a flow rate of 1.0 m L · min -1 using an Agilent XDB-C 18 column (4.6 mm × 250 mm, 5 μm) nm, the column temperature was 30 ℃. Ten batches of different batches of SD capsules were analyzed. Using the similarity evaluation system of TCM chromatographic fingerprint promulgated by National Pharmacopoeia Committee, the similarity of the products Evaluation. Results: The fingerprint of Shuxuqing Capsule was established. The baicalin was taken as the reference peak and 21 common peaks were established. The relative retention time of all the common peaks was less than 1%, and the RSD of relative peak area was less than 4% Precision, stability, reproducibility is good. The fingerprints of 10 batches of Shuxuqing Capsules were determined by this method, and the similarity was> 0.95. Conclusion: The quality of 10 batches of SD capsules is stable. The method is simple and convenient, stable and reliable, and has good repeatability, and can be used to characterize the overall quality of the SD capsule and provide a scientific basis for its production and quality control.