文献类型：期刊文献

中文题名：七十味珍珠丸HPLC指纹图谱结合含量测定的质量评价方法研究

英文题名：Study on the Quality Evaluation Method of Seventy Flavored Pearl Pills Combined with HPLC Fingerprint and Content Determination

作者：杨世辉[1];宋承佳[1];王芸[1];俞树琴[1];周强[1];高建德[1];马文俊[2]

第一作者：杨世辉

机构：[1]甘肃中医药大学,甘肃兰州730000;[2]金诃藏药股份有限公司,甘肃西宁810003

第一机构：甘肃中医药大学

年份：2025

卷号：34

期号：14

起止页码：45

中文期刊名：中国民族民间医药

外文期刊名：Chinese Journal of Ethnomedicine and Ethnopharmacy

基金：青海省科学技术厅十大国家级科技创新平台培育建设项目-现代藏药创制全国重点实验室建设(2023-ZJ-J05):特色藏药炮制研究及绿色智能制造(ZYYSDPT-2023-04)。

语种：中文

中文关键词：七十味珍珠丸;HPLC指纹图谱;含量测定;浸出物含量

外文关键词：Seventy Flavored Pearl Pills;HPLC Fingerprint Spectrum;Content Determination;Extract Content

摘要：目的:建立七十味珍珠丸的HPLC指纹图谱及5种成分含量测定方法,测定浸出物含量,为七十味珍珠丸质量控制提供参考。方法:采用Agilent SB-C_(18)色谱柱(150 mm×4.6 mm,5μm),以0.2%磷酸(A)-乙腈(B)作为流动相,梯度洗脱,流速1.0 mL/min,检测波长254 nm,柱温30℃,进样量10μL;根据5批样品色谱图数据建立七十味珍珠丸指纹图谱;采用HPLC法建立指认成分(诃子酸、西红花苷Ⅰ、肉桂酸、西红花苷Ⅱ、芒柄花素)的含量测定方法;依据2020版《中国药典》通则2201项下冷浸法测定七十味珍珠丸中水溶性浸出物和醇溶性浸出物含量。结果:5批七十味珍珠丸HPLC色谱图共标定了23个共有峰,相似度在0.861~0.984,其精密度、重复性、稳定性的RSD值均小于3%;通过对照品指认了HPLC色谱图中5个色谱峰成分依次为诃子酸、西红花苷Ⅰ、肉桂酸、西红花苷Ⅱ、芒柄花素,5种成分分别在0.023~0.046 mg/mL、0.017~0.033 mg/mL、0.011~0.022 mg/mL、0.019~0.038 mg/mL、0.015~0.030 mg/mL的浓度范围内呈现良好的线性关系(r>0.9992),平均加样回收率分别为100.5%、99.96%、97.99%、100.1%、101.43%;测得两批七十味珍珠丸水溶性浸出物含量分别为24.01%、20.42%,醇溶性浸出物含量分别为26.07%、24.78%。结论:文章建立的方法操作简单、方便易行,可为七十味珍珠丸的质量标准研究提供理论依据。
Objective To establish the HPLC fingerprint of Qiqiwei Pearl Pill and five methods for the determination of the content of five components,and to determine the extract content,so as to provide a reference for the quality control of Qiwei Pearl Pill.Meth-ods Agilent SB-C_(18) column(150 mm×4.6 mm,5μm)was used as mobile phase with 0.2%phosphoric acid(A)-acetonitrile(B)as mobile phase,gradient elution,flow rate of 1.0 mL/min,detection wavelength of 254 nm,column temperature of 30℃,and injection volume of 10μL.According to the chromatogram data of 5 batches of samples,the fingerprint of 70 flavor pearl pills was es-tablished.HPLC was used to establish a method for the determination of the content of identified components(chebulic acid,saffronⅠ.,cinnamic acid,saffronⅡ.,and miscanthin).According to the cold soak method under the general principles 2201 of the 2020 edi-tion of the Chinese Pharmacopoeia,the content of water-soluble extract and alcohol-soluble extract in Qiwei pearl pill was deter-mined.Results A total of 23 common peaks were identified in the HPLC chromatograms of 5 batches of Qiwei pearls,with a similarity of 0.861-0.984,and the RSD values of precision,repeatability and stability were less than 3%.The five chromatographic peak components in the HPLC chromatogram were identified as chebulic acid,saffron glycosideⅠ.,cinnamic acid,safflower glycosideⅡ.,and miscanthin by reference substances,and the five components showed a good linear relationship(r>in the concentration range of 0.023-0.046mg/mL,0.017-0.033mg/mL,0.011-0.022mg/mL,0.019-0.038mg/mL,and 0.015-0.030 mg/mL,respec-tively0.9992),and the average recovery rates were 100.5%,99.96%,97.99%,100.1%,and 101.43%,respectively.The water-soluble extracts of the two batches of 70-flavor pearl pills were 24.01%and 20.42%,and the alcohol-soluble extracts were 26.07%and 24.78%,respectively.Conclusion The method established in this paper is simple and convenient to operate,which can provide a theoretical basis for the research on the quality standard of 70 flavor pearl pills.