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目的建立痹可通散的HPLC指纹图谱,为质量标准研究提供依据。方法色谱柱为Inertsil ODS-3柱(250 mm×4.6 mm,5μm);以甲醇-乙腈(体积比为2∶1)-质量分数为0.1%的磷酸水溶液为流动相,梯度洗脱;检测波长为300 nm;柱温为30℃;流速为1.0 m L·min-1,应用“中药色谱指纹谱图相似度评价软件(2009版)”评价10批制剂的相似度。结果痹可通散的HPLC指纹图谱方法专属性、稳定性、重复性和精密度良好;10批供试品的相似度符合要求。结论该方法能够为痹可通散的质量标准研究提供实验依据。
OBJECTIVE To establish the HPLC fingerprint of BiKetong San, which can provide the basis for quality standard research. Methods The column was Inertsil ODS-3 column (250 mm × 4.6 mm, 5 μm). The mobile phase consisted of methanol-acetonitrile (2: 1 by volume) Was 300 nm. The column temperature was 30 ℃. The flow rate was 1.0 mL · min-1. The similarity of 10 batches of preparations was evaluated using “Chinese medicine chromatographic fingerprint similarity evaluation software (2009 version)”. Results Bike Tong San HPLC fingerprinting method specificity, stability, repeatability and good precision; 10 batches of the test sample to meet the requirements of similarity. Conclusion This method can provide an experimental basis for the research of Bi Tong Tong San quality standard.