| 摘要: |
| 目的：通过建立不同贮存时间草麻黄的高效液相色谱（High Performance Liquid Chromatography，HPLC）指纹图谱，对比研究其质量随贮存时间的变化规律，为其临床应用提供参考依据。方法：以提取时间、甲醇浓度、提取溶剂体积为考察因素，以盐酸麻黄碱、盐酸伪麻黄碱的综合评分作为考察指标，采用L9(43)正交实验设计对草麻黄供试品溶液制备方法进行优选，确定供试品溶液制备方法并进行验证。采用HPLC建立各批次草麻黄HPLC指纹图谱，并对不同贮存时间草麻黄的指纹图谱进行比较。结果：建立不同贮存时间的草麻黄HPLC指纹图谱，共标定17个色谱峰，指认了其中4个色谱峰，分别为盐酸麻黄碱、盐酸伪麻黄碱、儿茶素和绿原酸。15批草麻黄指纹图谱与对照图谱进行相似度评价结果显示，相似度为0.872~0.998。结论：不同贮存年份的草麻黄中儿茶素、绿原酸含量较为稳定，而盐酸麻黄碱、盐酸伪麻黄碱含量随年份增长有所降低，可为草麻黄的贮存与临床用药提供参考。 |
| 关键词: 草麻黄 HPLC指纹图谱 贮存时间 正交试验 质量评价 |
| DOI： |
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| Change in the quality of Ephedra sinica after different periods of storage：A study based on high-performance liquid chromatography fingerprint |
| FENG Suifen,LI Bizhu,LI Shaoqiang |
| (Guangdong Second Provincial Traditional Chinese Medicine Hospital/Guangdong Research Institute of Traditional Chinese Medicine Manufacturing Technology，Guangzhou 510095，Guangdong，China) |
| Abstract: |
| Objective：To establish the high-performance liquid chromatography (HPLC) fingerprint of Ephedra sinica after different periods of storage，to investigate the change in quality over the time of storage，and to provide a basis for clinical application.Methods：With extraction time，methanol concentration，and volume of extraction solvent as the observation factors，as well as the comprehensive scores of ephedrine hydrochloride and pseudoephedrine hydrochloride as the observation indicators，the L9(43) orthogonal experimental design was used to optimize the method for preparing the test solution of Ephedra sinica and determine and validate the preparation method for the test solution.HPLC was used to establish the HPLC fingerprints of each batch of Ephedra sinica，and the fingerprints of different batches of Ephedra sinica were compared.Results：The HPLC fingerprints of different batches of Ephedra sinica were established，and a total of 17 chromatographic peaks were labeled，among which 4 chromatographic peaks were identified as ephedrine hydrochloride，pseudoephedrine hydrochloride，catechin，and chlorogenic acid.A similarity assessment was performed between the fingerprints of 15 batches of Ephedra sinica and the control fingerprints，and the results showed a similarity of 0.872-0.998.Conclusion：The contents of catechin and chlorogenic acid remain relatively stable in Ephedra sinica after different periods of storage，while the contents of ephedrine hydrochloride and pseudoephedrine hydrochloride tend to decrease over the time of storage，which provides a reference for the storage and clinical application of Ephedra sinica. |
| Key words: Ephedra sinica high-performance liquid chromatography fingerprint period of storage orthogonal test quality assessment |
