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目的建立昆明山海棠片HPLC指纹图谱。方法采用HPLC法,用中药色谱指纹图谱相似度评价系统2004A(国家药典委员会)对20批昆明山海棠片制剂的数据进行分析、建立其指纹图谱,并对该方法进行方法学验证。结果不同批次样品图谱相似度均在0.9以上,色谱方法可靠。结论建立的指纹图谱能较全面地反映了制剂的质量,其方法可靠且简单易行,具有较好的重复性、适应性,为昆明山海棠片的整体质量评价提供科学依据。
Objective To establish HPLC fingerprinting of Begonia Tablets in Kunming. Methods The HPLC method was used to analyze the data of 20 batches of Begonia amulet from Kunming Begonia using the similarity evaluation system of chromatographic fingerprints of traditional Chinese medicine 2004A (National Pharmacopoeia Committee). The fingerprints were established and the method was validated by the method. Results The similarity of different batches of samples was above 0.9, and the chromatographic method was reliable. Conclusion The established fingerprint can reflect the quality of the preparation more completely. The method is reliable and easy to operate, has good repeatability and adaptability, and provides a scientific basis for the overall quality evaluation of Begonia.