基于指纹图谱和成分定量的丹参化瘀颗粒质量评价研究  

Study on quality evaluation of Danshen Huayu Granules based on fingerprint analysis and multi-component simultaneous quantification

作　　者：朱静静[1] 闫勇 翟亮 李京旻 吴曙辉[1] 苟小军[2] 高珊珊 左琦 ZHU Jing-jing;YAN Yong;ZHAI Liang;LI Jing-min;WU Shu-hui;GOU Xiao-jun;GAO Shan-shan;ZUo Qi(Department of Otolaryngology,Baoshan Branch,Shuguang Hospital Affiliated with Shanghai University of Traditional Chinese Medicine»Shanghai 201999,China;Central Laboratory,Baoshan Branch,Shuguang Hospital Affiliated with Shanghai University of Traditional Chinese Medicine»Shanghai 201999,China)

机构地区：[1]上海中医药大学附属曙光医院宝山分院耳鼻喉科,上海201999 [2]上海中医药大学附属曙光医院宝山分院中心实验室,上海201999

出　　处：《中国医院药学杂志》2022年第10期986-992,共7页Chinese Journal of Hospital Pharmacy

基　　金：国家自然科学基金青年项目(编号:82004429);上海市卫生健康委员会科研课题(编号:201940498);上海市宝山区科学技术委员会科技创新专项资金项目(编号:20-E-20)。

摘　　要：目的:建立丹参化瘀颗粒的HPLC指纹图谱及多成分定量分析方法,为其质量评价提供依据。方法:采用Agilent 5TC-C_(18)(2)色谱柱(250 mm×4.6 mm, 5.0μm),以0.05%磷酸水溶液(A)-乙腈(B)作为流动相进行梯度洗脱,体积流量1.0 mL·min^(-1),柱温30℃,进样量20μL,检测波长403 nm、230 nm及302 nm,测定12批次丹参化瘀颗粒指纹图谱,标定共有峰并进行归属分析及相似度评价,对采用对照品比对确认的成分进行含量测定。结果:12批丹参化瘀颗粒指纹图谱标定共有峰29个,其中8个来源于丹参、1个来源于天麻、2个来源于当归川芎药对、1个来源于红花、1个来源于芍药。通过对照品比对确认其中7个成分,分别为天麻素、羟基红花黄色素A、芍药苷、阿魏酸、丹酚酸B、隐丹参酮、丹参酮ⅡA。各批样品相似度均在0.99以上。结论:所建立的方法灵敏度高,专属性强,HPLC指纹图谱结合多成分定量测定能全面反映丹参化瘀颗粒内在质量,可用于其质量控制。OBJECTIVE To establish the HPLC fingerprint of Danshen Huayu Granules, so as to provide a basis for its quality evaluation.METHODS Agilent 5 TC-C_(18)(2)(250 mm×4.6 mm, 5.0 μm) chromatographic column was used, and 0.05% phosphoric acid aqueous solution(A)-acetonitrile(B) was used as the mobile phase for gradient elution, and the volume flow rate was 1.0 mL·min^(-1),column temperature was 30 ℃,injection volume was 20 μL,detection wavelength was 403 nm, 230 nm and 302 nm. The fingerprints of 12 batches of Danshen Huayu Granules were determined, the common peaks were calibrated, the attribution analysis and similarity evaluation were carried out, and the contents of the components confirmed by comparison with the reference substance were determined.RESULTS A total of 29 peaks were calibrated in the fingerprint of 12 batches of Danshen Huayu Granules, including 8 from Danshen, 1 from Gastrodia elata, 2 from Angelica and Ligusticum Chuanxiong, 1 from safflower and 1 from peony. Seven of them were confirmed by comparison of the reference substances, which were named gastrodin, hydroxy safflower yellow A,paeoniflorin, ferulic acid, salvianolic acid B,cryptotanshinone and tanshinone ⅡA. The similarity of each batch of samples was above 0.99.CONCLUSION The established method has high sensitivity and strong specificity. The HPLC fingerprint combined with multi-component quantitative determination can fully reflect its inherent quality and can be used for the quality control of Danshen Huayu Granules.

关 键 词：丹参化瘀颗粒 高效液相色谱法 指纹图谱 相似度分析 

分 类 号：R283.6[医药卫生—中药学]