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作 者:谢四芳 杨思成 唐佩莉 黄菊 段雪云 孙婉瑾 范恒[3] XIE Sifang;YANG Sicheng;TANG Peili;HUANG Ju;DUAN Xueyun;SUN Wanjin;FAN Heng(School of pharmacy,Hubei University of Chinese Medicine,Hubei Wuhan 430065,China;Pharmaceutical Division,Hubei Hospital of Chinese Medicine/Affiliated Hospital of Hubei University of Chinese Medicine,Hubei Wuhan 430061,China;Chinese and Western Combination Department,Union Hospital,Tongji Medical College,Huazhong University of Science and Technology,Hubei Wuhan 430022,China)
机构地区:[1]湖北中医药大学药学院,湖北武汉430065 [2]湖北省中医院/湖北中医药大学附属医院药事部,湖北武汉430061 [3]华中科技大学同济医学院附属协和医院中西结合科,湖北武汉430022
出 处:《中国医院药学杂志》2023年第13期1484-1488,共5页Chinese Journal of Hospital Pharmacy
摘 要:目的:建立养血利尿颗粒的高效液相色谱指纹图谱(HPLC),为其质量控制提供依据。方法:采用Agilent Eclipse Plus C_(18)(4.6 mm×150 mm,5μm)色谱柱,以0.4%磷酸-乙腈进行梯度洗脱,进样量10μL,柱温35℃,流速为0.3 mL·min^(-1),检测波长为254 nm。运用“中药色谱指纹图谱相似度评价系统”(2012版)分别对10批养血利尿颗粒和10批中间品的相似度进行评价,指认了颗粒对照指纹图谱中的部分色谱峰并确定每个共有峰的药材归属;通过比对单味饮片、中间品和颗粒色谱图中标志性成分群的转移评价其物质相关性;运用化学模式识别方法中的聚类分析(CA)、主成分分析(PCA)和正交偏最小二乘法-判别分析(OPLS-DA)寻找养血利尿颗粒批间差异的关键性成分。结果:10批颗粒和中间品的相似度分别都在0.9以上,颗粒对照指纹图谱标定出28个共有峰并指认出其中10个成分;成品颗粒与中间品对照指纹图谱基本一致,物质相关性良好;CA和PCA将10批养血利尿颗粒聚为3类,OPLS-DA寻找出10个差异性成分,这些成分可能是导致养血利尿颗粒批间差异的关键因素。结论:该方法能快速、准确地评价养血利尿颗粒的饮片、中间品、成品之间的相关性,可用于养血利尿颗粒的质量控制。OBJECTIVE To establish the high performance liquid chromatographic(HPLC) fingerprint of Yangxue Liniao granules,and provide the basis for its quality control.METHODS Agilent Eclipse Plus C18(4.6 mm×150 mm,5 μm,) column,gradient elution with 0.4% phosphoric acid-acetonitrile,sample volume 10 μL,column temperature 35 ℃,flow rate at 0.3 mL·min^(-1).The detecting wavelength was 254 nm.The Similarity Evaluation System for Chromatographic Fingerprint of Traditional Chinese Medicine(2012 edition)was used to evaluate the similarity of 10 batches of Yangxue Liniao Granules and 10 batches of intermediate products.Some chromatographic peaks in the control fingerprint were identified to determine the attribution of each common peak;The material correlation was evaluated by comparing the transfer of marker component groups in the chromatograms of single decoction pieces,intermediate products and finished granules.Cluster analysis(CA),principal component analysis(PCA) and orthogonal partial least squares discriminant analysis(OPLS-DA) were used to find the key components leading to the difference between batches of Yangxue Liniao Granules.RESULTS The similarity of 10 batches of granules and intermediate products were all above 0.9,and 28 common peaks were identified and 10 components were identified;The fingerprint of finished granules was basically consistent with that of intermediate control,and the correlation of substances was good;CA and PCA clustered 10 batches of Yangxue Liniao granules into three categories,and OPLS-DA found 10 differential components,which may be the key factors leading to the difference between batches of Yangxue Liniao granules.CONCLUSION This method can quickly and accurately evaluate the correlation between medicinal materials,intermediate products and finished products of Yangxue Liniao Granules,and can be used for the quality evaluation of Yangxue Liniao Granules.
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