湿毒清胶囊高效液相色谱指纹图谱  

Fingerprints of Shiduqing Capsule by High Performance Liquid Chromatography

作　　者：郑华[1] 蔡雨[1] 苏志恒[1] 梁永红[1] 宋慧[1] 

机构地区：[1]广西医科大学医学科学实验中心,药学院,南宁530021

出　　处：《中国实验方剂学杂志》2016年第2期59-62,共4页Chinese Journal of Experimental Traditional Medical Formulae

摘　　要：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 a measurement method for HPLC fingerprints of Shiduqing capsule,to evaluate the quality stability of Shiduqing capsule,and provide a more scientific and effective method for the quality control of Shiduqing capsule. Method： The fingerprint of Shiduqing capsule was performed on Agilent XDB-C18 column（4. 6 mm × 250 mm,5 μm） with acetonitrile-0. 1% phosphoric acid as gradient mobile phase.The flow rate was set at 1. 0 m L·min^-1. The detection wavelength was set at 220 nm and the column temperature was maintained at 30 ℃. Traditional Chinese medicine（TCM） chromatographic fingerprint similarity evaluation system（2004AEdition） by State Pharmacopeia Committee of China was used to evaluate the similarity of 10 batches of Shiduqing capsules. Result： The HPLC fingerprint of the Shiduqing capsules was established. Taking baicalin as the reference peak,21 common peaks were found from the compounds. RSD of the relative retention time for each common chromatographic peak was less than 1% and the RSD of relative peak area was less than 4%. The method has good precision,repeatability and stability. With this method to determine the HPLC fingerprints of 10 batches of Shiduqing capsules,the similarity value was more than 0. 95 for all of them. Conclusion： The quality of10 batches of Shiduqing capsules is stable. This method is simple and easy to apply,with good precision,reproducibility and stability,which could manifest the overall quality characteristics of the Shiduqing capsules,and provide a scientific basis for the production and quality control of Shiduqing capsules.

关 键 词：湿毒清胶囊 高效液相色谱 指纹图谱 质量控制 

分 类 号：R284.1[医药卫生—中药学]