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目的:建立骨刺片制剂的指纹图谱测定方法和骨刺片指纹图谱的共有模式,比较、评价不同企业产品之间、相同企业不同批次产品之间的稳定性。方法:以乙腈-0.1%醋酸溶液为流动相,按照一定的梯度进行洗脱,柱温30℃,流速0.8 ml·min-1,检测波长283 nm,使用中药色谱指纹图谱相似度评价软件对结果进行评价。结果:本次抽检的6个厂家共100批骨刺片样品中只有一批样品的相似度<0.8,其余批次的产品制剂质量稳定,相似度>0.9。结论:HPLC指纹图谱技术快捷方便、稳定可靠,能有效的监测中药制剂的质量,值得在中药制剂质量控制方面推广应用。
OBJECTIVE: To establish a method for the determination of fingerprints of Bonethorn preparations and the common mode of Bonestones fingerprinting, and to compare and evaluate the stability of different batches of products among different enterprises and between different batches of the same enterprise. Methods: Acetonitrile-0.1% acetic acid solution was used as the mobile phase and eluted according to a certain gradient. The column temperature was 30 ℃, the flow rate was 0.8 ml · min-1 and the detection wavelength was 283 nm. Using the similarity evaluation software Evaluation. Results: The similarity of only one batch of samples in 100 batches of bone spiked samples was less than 0.8. The quality of other batches was stable and the similarity was> 0.9. Conclusion: HPLC fingerprinting technique is fast and convenient, stable and reliable, and can effectively monitor the quality of Chinese medicine preparations. It is worth to promote the application of traditional Chinese medicine preparation in quality control.