藏药十味乳香散HPLC特征图谱及5个成分的含量测定  

HPLC Specific Chromatogram of Tibetan Medicine Shiwei Ruxiang Powder and Content Determination of Five Components

作　　者：吴明慧 江德恩 杨俊峰 王佩 袁志兵 谢和兵 WU Ming-hui;JIANG De-en;YANG Jun-feng;WANG Pei;YUAN Zhi-bing;XIE He-bing(School of Pharmacy,Anhui University of Chinese Medicine,Hefei 230012,China;Nantong Haimen Yangtze Delta Drug Advanced Research Institute,Nantong 226133,China;Jiangsu Shenhou Pharmaceutical Research Co.,Ltd.,Nantong 226133,China;Xizang Shenhou Pharmaceutical Co.,Ltd.,Rikaze 857000,China)

机构地区：[1]安徽中医药大学药学院,安徽合肥230012 [2]南通市海门长三角药物高等研究院,江苏南通226133 [3]江苏神猴医药研究有限公司,江苏南通226133 [4]西藏神猴药业有限责任公司,西藏日喀则857000

出　　处：《中国现代中药》2024年第11期1980-1988,共9页Modern Chinese Medicine

基　　金：国家自然科学基金项目(81470247);西藏自治区科技厅区域科技协同创新专项(QYXTZX-RKZ2022-07)。

摘　　要：目的:建立藏族药十味乳香散高效液相色谱法(HPLC)特征图谱,以及指标成分没食子酸、诃子联苯酸、鞣花酸、诃子酸、11-羰基-β-乙酰乳香酸含量测定方法。方法:采用Ultimate XB-C_(18)色谱柱,以0.1%磷酸水溶液(A)-乙腈(B)为流动相,梯度洗脱,流速为1.0 mL·min^(–1),检测波长为250 nm,柱温为30℃,进样量为10μL。结果:建立的15批十味乳香散特征图谱中标识出25个共有峰,相似度均大于0.992;指标成分没食子酸、诃子联苯酸、鞣花酸、诃子酸和11-羰基-β-乙酰乳香酸的线性范围分别为2.86~57.20(r=1.0000)、8.18~163.54(r=0.9999)、3.61~72.21(r=0.9997)、9.96~199.23(r=0.9997)、0.53~10.69μg·mL^(–1)(r=0.9999)。稳定性、精密度、重复性均较好,平均加样回收率分别为100.6%(RSD=0.90%)、100.5%(RSD=2.14%)、103.6%(RSD=1.19%)、101.0%(RSD=1.22%)、102.2%(RSD=2.54%)。结论:建立的特征图谱和指标成分含量测定方法准确、简便、灵敏度高,可为提升十味乳香散的质量标准提供参考。Objective:To establish high performance liquid chromatography(HPLC)specific chromatogram for the Tibetan medicine Shiwei Ruxiang Powder and a method for determining the content of index components:gallic acid,chebulagic acid,ellagic acid,chebulinic acid,and acetyl-11-keto-β-boswellic acid.Methods:Gradient elution was carried out in the Ultimate XB-C_(18)column with 0.1%phosphoric acid aqueous solution(A)-acetonitrile(B)as the mobile phase at a flow rate of 1.0 mL·min^(–1).The detection wavelength was 250 nm,and the column temperature was 30℃.The sample injection volume was 10μL.Results:Twenty-five common peaks were identified in the specific chromatograms of 15 batches of Shiwei Ruxiang Powder,with the similarities more than 0.992.The linear ranges of gallic acid,chebulagic acid,ellagic acid,chebulinic acid,and acetyl-11-keto-β-boswellic acid were 2.86-57.20(r=1.0000),8.18-163.54(r=0.9999),3.61-72.21(r=0.9997),9.96-199.23(r=0.9997),and 0.53-10.69μg·mL-1(r=0.9999),respectively.The relative standard deviations(RSD)of stability,precision.The average recovery of the index components was 100.6%(RSD=0.90%),100.5%(RSD=2.14%),103.6%(RSD=1.19%),101.0%(RSD=1.22%),and 102.2%(RSD=2.54%),respectively.Conclusion:The established specific chromatogram and index component content determination method are precise,simple,and sensitive,which can provide a reference for improving the quality standard of Shiwei Ruxiang Powder.

关 键 词：十味乳香散 高效液相色谱法 含量测定 特征图谱 

分 类 号：R286[医药卫生—中药学]