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作 者:董欣昱 张生杰 庞文娟 王丽 田志梅 曹雪芹 刘小华 DONG Xinyu;ZHANG Shengjie;PANG Wenjuan;WANG Li;TIAN Zhimei;CAO Xueqin;LIU Xiaohua(Wuwei Institute for Durg Control,Wuwei Gansu 733000,China)
机构地区:[1]武威市药品检验检测中心,甘肃武威733000
出 处:《中医药导报》2024年第2期42-47,共6页Guiding Journal of Traditional Chinese Medicine and Pharmacy
基 金:武威市2023年度市级科技计划自筹经费项目(WW23B02SF039)。
摘 要:目的:采用高效液相色谱(HPLC)指纹图谱结合近红外光谱模型评价祖师麻膏药质量。方法:采用HPLC法测定了祖师麻甲素含量,建立了25批祖师麻膏药HPLC指纹图谱;用近红外光谱仪采集25批祖师麻膏药近红外光谱图,应用分析软件OPUS5.5建立相关系数模型和一致性评价模型。结果:祖师麻甲素含量均符合药品质量标准,平均值为122μg/g;祖师麻膏药HPLC指纹图谱和近红外图谱的平均相似度分别为98.52%和99.90%,25批祖师麻膏药全部通过一致性评价模型验证,两种方法均证明了祖师麻膏药质量稳定、可控。结论:近红外光谱模型具有快速、无损伤、无污染的优点,可用于评价祖师麻膏药的质量。Objective:To evaluate the quality of Zushima plaster by HPLC fingerprint and near infrared spectroscopy model.Methods:The content of daphnetin was determined by high performance liquid chromatography(HPLC),and the HPLC fingerprint of 25 batches of Zushima plaster was established.The near infrared spectra of 25 batches of Zushima plaster were collected by near infrared spectrometer.The correlation coefficient model and the uniformity evaluation model were established by OPUS5.5 analysis software.Results:The content of daphnetin was in line with the drug quality standard,and the average value was 122μg/g.The similarity of HPLC fingerprint and near infrared fingerprint of Zushima plaster was 98.52%and 99.90%respectively.The 25 batches of Zushima plaster were verified by consistency evaluation model.The two methods proved that the quality of Zushima plaster was stable and controllable.Conclusion:Near infrared spectroscopy model can be used to evaluate the quality of Zushima plaster quickly,without damage and pollution-free.
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