抗妇炎胶囊的指纹图谱建立、化学模式识别分析及含量测定 点击下载
| 论文标题： | 抗妇炎胶囊的指纹图谱建立、化学模式识别分析及含量测定 |
| 英文标题： | |
| 中文摘要： | 目的 建立抗妇炎胶囊指纹图谱并进行化学模式识别分析，同时测定其中5种成分的含量，以促进该药质量标准的提升。方法采用《中药色谱指纹图谱相似度评价系统（2012版）》建立11批抗妇炎胶囊（S1～S11）的高效液相色谱（HPLC）指纹图谱并进行相似度评价，分别通过与对照品、单味饮片图谱比对进行色谱峰的指认和归属分析，分别采用SPSS26.0、SIMCA14.1软件进行聚类分析和主成分分析。采用HPLC法测定样品中苦参碱、盐酸黄柏碱、芦丁、连翘脂苷A、盐酸小檗碱的含量。结果11批样品的指纹图谱中共有29个共有峰，相似度均大于0.99；共指认出5个色谱峰，分别为苦参碱（峰3）、盐酸黄柏碱（峰14）、芦丁（峰20）、连翘脂苷A（峰22）、盐酸小檗碱（峰28）。聚类分析和主成分分析结果均显示，S1～S9聚为一类，S10、S11聚为另一类。上述5种成分的含量分别为29.3205～60.1443、0.6216～1.0766、1.0259～2.8305、2.8993～6.2127、4.4251～8.5816mg/g。结论所建立的指纹图谱和含量测定方法稳定、可靠，再结合化学模式识别分析，可为该制剂的质量控制提供参考依据。 |
| 英文摘要： | OBJECTIVE To establish the fingerprints of Kangfuyan capsules and carry out chemical pattern recognition analysis，and simultaneously determine the contents of five components so as to promote the quality standard of the drug. METHODS High performance liquid chromatography （HPLC）fingerprints of 11 batches of Kangfuyan capsules （S1-S11）were established by Similarity Evaluation System of TCM Chromatographic Fingerprint （2012 edition）；identification and attribution analysis of chromatographic peaks were carried out by comparison with the chromatograms of the reference substance and the decoction pieces of single ingredient. SPSS 26.0 and SIMCA 14.1 software were used for cluster analysis and principal component analysis. HPLC method was used to determine the contents of matrine ，phellodendrine chloride ，rutin，forsythoside A and berberine hydrochloride. RESULTS There were 29 common peaks in the fingerprints for 11 batches of samples ，and the similarity was higher than 0.99. A total of 5 chromatographic peaks were identified ，which are matrine （peak 3），phellodendron chloride （peak 14），rutin （peak 20），forsythiaside A （peak 22） and berberine hydrochloride （peak 28）. The results of cluster analysis and principal component analysis showed that S 1-S9 were clustered into one category ，and S 10 and S 11 were clustered into another category. The contents of above 5 components were 29.320 5-60.144 3，0.621 6-1.076 6，1.025 9-2.830 5，2.899 3-6.212 7 and 4.425 1-8.581 6 mg/g， respectively. CONCLUSIONS The established fingerprint and content determination method are stable and reliable ，and can provide reference for the quality control of the preparation in combination with chemical pattern recognition analysis. |
| 期刊： | 2022年第33卷第17期 |
| 作者： | 王铭菊，黄家宇，杜秋莹，张会，严学辉，王福勇，李莉 |
| 英文作者： | WANG Mingju ，HUANG Jiayu，DU Qiuying ，ZHANG Hui，YAN Xuehui ，WANG Fuyong ，LI Li |
| 关键字： | 抗妇炎胶囊；高效液相色谱法；指纹图谱；化学模式识别；含量测定 |
| KEYWORDS： | Kangfuyan capsules ；high performance liquid chromatography ；fingerprint；chemical pattern recognition ；content |
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