| 引用本文: | 朱敏汇,彭潇,刘理燕,马雪,陆苑,李勇军,林昌虎.基于HPLC-ELSD指纹图谱与化学计量学相结合的舒眠胶囊质量评价[J].中国现代应用药学,2021,38(17):2088-2092. |
| ZHU Minhui,PENG Xiao,LIU Liyan,MA Xue,LU Yuan,LI Yongjun,LIN Changhu.Quality Evaluation of Shumian Capsules Based on HPLC-ELSD Fingerprint and Stoichiometry[J].Chin J Mod Appl Pharm(中国现代应用药学),2021,38(17):2088-2092. |
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| 基于HPLC-ELSD指纹图谱与化学计量学相结合的舒眠胶囊质量评价 |
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朱敏汇1,2, 彭潇1,2, 刘理燕1,2, 马雪1, 陆苑3, 李勇军1,3, 林昌虎1
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1.贵州医科大学民族药与中药开发应用教育部工程研究中心/省部共建药用植物功效与利用国家重点实验室, 贵阳 550004;2.贵州医科大学药学院, 贵阳 550004;3.贵州医科大学贵州省药物制剂重点实验室, 贵阳 550004
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| 摘要: |
| 目的 建立舒眠胶囊HPLC-ELSD指纹图谱与化学计量学相结合，全面、系统评价舒眠胶囊质量的方法。方法 采用ACE Excel AR C18色谱柱（4.6 mm×250 mm，5.0 μm），流动相为乙腈-水，梯度洗脱，柱温30℃，流速为1.0 mL·min-1，ELSD漂移管温度50℃，N2流速为3.0 mL·min-1。用HPLC-ELSD对15批次舒眠胶囊进行分析，建立指纹图谱共有模式，采用聚类分析（cluster analysis，CA）、主成分分析（principal component analysis，PCA）等化学计量学方法进行区分与比较，寻找导致不同批次间差异的主要标志性成分。结果 共确定了16个共有峰，归属了10个共有峰的药材来源，通过对照品比对指认了4个共有峰归属，分别为柴胡皂苷a、芍药内酯苷、芍药苷、槲皮苷，样品相似度均>0.90，CA将样品分为3类，PCA筛选出不同批次间差异的主要标记物，分别为3（芍药苷），14，15号峰。结论 本研究建立的HPLC-ELSD指纹图谱与HPLC-DAD指纹图谱相结合能对舒眠胶囊产品一致性、稳定性进行全面有效评价，可用于舒眠胶囊的质量综合评价。 |
| 关键词: 舒眠胶囊 HPLC-ELSD 指纹图谱 化学计量学 质量评价 |
| DOI：10.13748/j.cnki.issn1007-7693.2021.17.006 |
| 分类号:R917 |
| 基金项目:贵州省科技计划项目（黔科合〔2016〕支撑2820号，黔科合平台人才〔2016〕5613，黔科合平台人才〔2016〕5677）；贵州省创新人才团队项目（20165613/20165677）；中央引导地方科技发展专项项目（黔科中引地〔2018〕4006） |
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| Quality Evaluation of Shumian Capsules Based on HPLC-ELSD Fingerprint and Stoichiometry |
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ZHU Minhui1,2, PENG Xiao1,2, LIU Liyan1,2, MA Xue1, LU Yuan3, LI Yongjun1,3, LIN Changhu1
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1.Engineering Research Center for the Development and Application of Ethnic Medicine and TCM/State Key Laboratory of Functions and Applications of Medicinal Plants, Guizhou Medical University, Guiyang 550004, China;2.School of Pharmacy, Guizhou Medical University, Guiyang 550004, China;3.Guizhou Provincial Key Laboratory of Pharmaceutics, Guizhou Medical University, Guiyang 550004, China
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| Abstract: |
| OBJECTIVE To establish the HPLC-ELSD fingerprint of Shumian capsules and combine it with stoichiometry to comprehensively and systematically evaluate the quality of Shumian capsules. METHODS The chromatographic column was ACE Excel AR C18(4.6 mm×250 mm, 5.0 μm), the mobile phase was acetonitrile-water for gradient elution at a flow rate of 1.0 mL·min-1, the columm temperature was 30℃, ELSD evaporator tube temperature was 50℃ and the flow of N2 was 3.0 mL·min-1. Fifteen batches of samples were determined by HPLC-ELSD and a common mode of fingerprint was established. Based on the results, stoichiometry methods such as cluster analysis(CA), principal component analysis(PCA) were used to find main marker that caused the difference of the preparation. RESULTS There were 16 common peaks, then 10 peaks were tracked assigned and four peaks were identified as saikosaponin a, albiflorin, paeoniflorin and quercitrin. Similarities of samples were > 0.90. The CA divided the samples into three categories, and three main markers for differences between different batches, peake 3(paeoniflorin), 14 and 15 were screen out by PCA. CONCLUSION The established HPLC-ELSD fingerprint combine with HPLC-DAD fingerprint in this study can comprehensively and effectively evaluate the consistency and stability of Shumian capsules, and can provide a quality evaluation reference of Shumian capsules in the future. |
| Key words: Shumian capsules HPLC-ELSD fingerprint stoichiometry quality evaluation |
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