基于全程质量控制理念的杜仲颗粒特征图谱研究  

Characteristic chromatogram of Duzhong granules on whole process quality control concept

作　　者：马永青 王璐 刘颖 刘永利 MA Yongqing;WANG Lu;LIU Ying;LIU Yongli(Hebei Institute for Drug Control,Shijiazhuang,Hebei 050011,China;Hebei Province for Food and Drug Evaluation Certification Center,Shijiazhuang,Hebei 050011,China)

机构地区：[1]河北省药品检验研究院,河北石家庄050011 [2]河北省食品药品审评认证中心,河北石家庄050011

出　　处：《河北工业科技》2020年第1期54-58,共5页Hebei Journal of Industrial Science and Technology

基　　金：河北省科技计划项目(16272511)。

摘　　要：为明确杜仲颗粒生产过程中水溶性成分的转移情况,提供更为全面的质量控制方法,采用HPLC法对杜仲饮片、杜仲叶饮片、标准煎液与杜仲颗粒的特征图谱进行了相关性评价。使用Phenomenex(4.6mm×250mm,5μm)色谱柱,以乙腈-0.1%磷酸溶液为流动相进行梯度洗脱,检测波长为227nm,柱温为30℃,流速为1.0mL/min,考察提取方式、提取溶剂及时间的影响。结果表明,选用超声提取方式,以甲醇作为提取溶剂,反应时间为20min时获得的效果较好;在此优化条件下建立特征图谱分析方法,能够使得杜仲颗粒的药效物质基础与药材保持一致,样品质量稳定,制备工艺规范,几个特征峰可全部在饮片中得到追溯,各共有峰的相对保留时间小于0.5%。所建立的特征图谱专属性强,重复性好,可有效鉴别和评价杜仲颗粒的质量,为制定系列品种的全面质量控制方法提供参考。In order to clarify the transfer of water-soluble components in the production process of Duzhong granules and provide a more comprehensive quality control method,HPLC method is used to evaluate the correlation between the characteristic maps of Eucommiae Cortex,Eucommiae Folium,standard decoction and Duzhong granules.The analysis is performed on Phenomenex C18 column(4.6 mm×250 mm,5μm),with acetonitrile-0.1%phosphoric acid aqueous solution as the mobile phase for gradient elution.The detection wavelength is set at 227 nm,the column temperature is maintained at 30℃and flow rate is 1.0 mL/min.The effects of extraction method,extraction solvent and reaction time are investigated.The results show that the ultrasonic extraction method is selected,methanol is used as the extraction solvent,and the reaction time is 20 minutes.The analysis method of Duzhong granules characteristic map is established under the optimized conditions.The effective substance basis of Duzhong granules is consistent with that of medicinal materials,the sample quality is stable,the preparation process is standard,several characteristic peaks could be traced all in the decoction pieces,and the relative retention time of each common peak is small at 0.5%.The established characteristic map has strong specificity and good repeatability,which can effectively identify and evaluate the quality of Duzhong granules,and provide a certain reference for the quality detection methods of a series of varieties.

关 键 词：中药化学 高效液相色谱法 杜仲饮片 杜仲叶饮片 杜仲颗粒 特征图谱 

分 类 号：R917[医药卫生—药物分析学]