十味盆安颗粒中9种成分的测定及指纹图谱研究  

Nine components in Shiwei Penan Granule and their fingerprint chromatography

作　　者：孙仙玲[1,2] 秦建平[3,2] 钱俊[3,2] 吴云[3,2] 王振中[3,2] 萧伟[1,3,2] 

机构地区：[1]南京中医药大学药学院,江苏南京210000 [2]中药制药过程新技术国家重点实验室,江苏连云港222001 [3]江苏康缘药业股份有限公司,江苏连云港222001

出　　处：《中草药》2015年第18期2727-2732,共6页Chinese Traditional and Herbal Drugs

基　　金：科学技术部国家重大新药创制项目:现代中药创新集群与数字制药技术平台(2013ZX09402203)

摘　　要：目的建立十味盆安颗粒中9种成分（没食子酸、丹参素钠、绿原酸、芍药苷、虎杖苷、苯甲酸、丹酚酸B、大黄素、大黄素甲醚）的定量测定及指纹图谱研究方法,为十味盆安颗粒的质量控制提供依据。方法采用HPLC法,色谱柱为Thermo C18柱（250 mm×4.6 mm,5μm）;以乙腈-0.1%磷酸水溶液为流动相,梯度洗脱：0～16 min,5%～14%乙腈;16～20 min,14%～17%乙腈,20～35 min,17%～19%乙腈;35～60 min,19%～35%乙腈;60～62 min,35%～75%乙腈;62～78 min,75%乙腈;体积流量1.0 m L/min;检测波长230 nm（定量测定与指纹图谱用）。结果没食子酸、丹参素钠、绿原酸、芍药苷、虎杖苷、苯甲酸、丹酚酸B、大黄素、大黄素甲醚9种成分均达到基线分离,在线性范围内线性关系良好,r均〉0.999 9,加样回收率分别为100.15%（RSD为1.39%）、99.89%（RSD为1.71%）、99.92%（RSD为0.67%）、99.28%（RSD为0.60%）、99.89%（RSD为0.80%）、99.72%（RSD为1.83%）、99.91%（RSD为0.79%）、100.06%（RSD为0.94%）、99.97%（RSD为1.36%）;利用中药指纹图谱相似度评价系统（2012版）对15批十味盆安颗粒指纹图谱进行分析,15批样品指纹图谱与对照指纹图谱相似度达0.976以上。结论该方法简便可行、快速准确,可以作为评价十味盆安颗粒质量的有效方法。Objective To determine the nine components in Shiwei Penan Granule and establish the fingerprnt analysis for the quality control of Shiwei Penan Granule. Methods The method was performed on a Thermo C18 column（250 mm × 4.6 mm, 5 μm）; The gradient mobile phase consisted of acetonitrile（A）-0.1% phosphoric acid（B） with a flow rate of 1.0 m L/min（0—16 min, 5%—14% A; 16—20 min, 14%—17% A, 20—35 min, 17%—19% A; 35—60 min, 19%—35% A; 60—62 min, 35%—75% A; 62—78 min, 75% A）; The detection wavelength was set at 230 nm（for quantitative analysis and fingerprint）. Results Gallic acid, sodium danshensu, chlorogenic acid, paeoniflorin, polydatin, benzoic acid, salvianolic acid B, emodin, and physcion were baseline seperated with good linearity relationships（r 〉0.999 9） between concentration and peak areas over the linear ranges. The average recoveries of the compounds were 100.15%（RSD = 1.39%）, 99.89%（RSD = 1.71%）, 99.92%（RSD = 0.67%）, 99.28%（RSD = 0.60%）, 99.89%（RSD = 0.80%）, 99.72%（RSD = 1.83%）, 99.91%（RSD = 0.79%）, 100.06%（RSD = 0.94%）, and 99.97%（RSD = 1.36%）. Using Traditional Chinese Medicine Fingerprint Similarity Evaluation System（2012 Edition） to analyze the fingerprint of 15 batches of Shiwei Penan Granule, the similarity values between the reference fingerprint and the 15 batches were higher than 0.977. Conclusion The method is simple, rapid, and accurate, and can be used as an effective method to evaluate the quality of Shiwei Penan Granule.

关 键 词：十味盆安颗粒 指纹图谱 质量控制 没食子酸 丹参素钠 绿原酸 芍药苷 虎杖苷 苯甲酸 丹酚酸B 大黄素 大黄素甲醚 

分 类 号：R286.02[医药卫生—中药学]