| 基于指纹图谱与化学计量学的藿香正气软胶囊质量控制方法研究 |
| 投稿时间：2023-06-28 点此下载全文
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| 引用本文：马宿杉,苏建,李舒琪,苏紫藤,王常顺,刘永利.基于指纹图谱与化学计量学的藿香正气软胶囊质量控制方法研究[J].中国现代中药,2024,26(2):378-386 |
| DOI：10.13313/j.issn.1673-4890.20230628002 |
| 摘要点击次数: 152 |
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| 作者中文名 | 作者英文名 | 单位中文名 | 单位英文名 | E-Mail |
| 马宿杉 |
MA Su-shan |
河北科技大学，河北 石家庄 050000
河北省药品医疗器械检验研究院/河北省中药质量评价与标准研究重点实验室，河北 石家庄 050000 |
Hebei University of Science and Technology, Shijiazhuang 050000, China
Hebei Institute for Drug and Medical Device Control/Hebei Provincial Key Laboratory of Quality Evaluation and Standard Research of Chinese Medicine, Shijiazhuang 050000, China |
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| 苏建 |
SU Jian |
河北省药品医疗器械检验研究院/河北省中药质量评价与标准研究重点实验室，河北 石家庄 050000 |
Hebei Institute for Drug and Medical Device Control/Hebei Provincial Key Laboratory of Quality Evaluation and Standard Research of Chinese Medicine, Shijiazhuang 050000, China |
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| 李舒琪 |
LI Shu-qi |
河北中医学院，河北 石家庄 050000 |
Hebei University of Chinese Medicine, Shijiazhuang 050000, China |
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| 苏紫藤 |
SU Zi-teng |
河北科技大学，河北 石家庄 050000 |
Hebei University of Science and Technology, Shijiazhuang 050000, China |
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| 王常顺* |
WANG Chang-shun |
河北省药品医疗器械检验研究院/河北省中药质量评价与标准研究重点实验室，河北 石家庄 050000 |
Hebei Institute for Drug and Medical Device Control/Hebei Provincial Key Laboratory of Quality Evaluation and Standard Research of Chinese Medicine, Shijiazhuang 050000, China |
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| 刘永利* |
LIU Yong-li |
河北省药品医疗器械检验研究院/河北省中药质量评价与标准研究重点实验室，河北 石家庄 050000 |
Hebei Institute for Drug and Medical Device Control/Hebei Provincial Key Laboratory of Quality Evaluation and Standard Research of Chinese Medicine, Shijiazhuang 050000, China |
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| 基金项目:河北省重点研发计划项目（21372502D） |
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| 中文摘要:目的 建立藿香正气软胶囊的高效液相色谱法（HPLC）指纹图谱及多指标成分测定方法，结合化学计量学方法评价藿香正气软胶囊的质量。方法 采用HPLC，SHIMADZU VP-ODSC18色谱柱（250 mm×4.6 mm，5 μm），以乙腈-0.1%磷酸水溶液为流动相，梯度洗脱，流速为1.0 mL·min–1，梯度波长为254、283 nm，柱温为30 ℃，进样量为10 μL，建立指纹图谱及多指标成分测定方法，结合化学计量学方法对不同批次藿香正气软胶囊质量进行分析和评价。结果 建立了藿香正气软胶囊的HPLC指纹图谱，共标定了22个共有峰，15批藿香正气软胶囊指纹图谱的相似度均在0.8以上；对甘草苷、柚皮芸香苷、橙皮苷、水合氧化前胡素、白当归脑、欧前胡素、和厚朴酚、珊瑚菜素、异欧前胡素、厚朴酚10个成分进行了含量测定；化学计量学分析表明，不同企业生产的藿香正气软胶囊质量存在一定差异，区分各样品的质量差异标志物为水合氧化前胡素、和厚朴酚、异欧前胡素、珊瑚菜素、厚朴酚和甘草苷。结论 建立的HPLC指纹图谱及多指标成分测定方法准确、简便，结合化学计量学方法可用于评价藿香正气软胶囊的质量。 |
| 中文关键词:藿香正气软胶囊 指纹图谱 化学计量学 聚类分析 主成分分析 正交偏最小二乘法-判别分析 质量评价 |
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| Quality Control Method of Huoxiang Zhengqi Soft Capsules Based on Fingerprint and Chemometrics |
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| Abstract:Objective To establish a high performance liquid chromatography (HPLC) fingerprint and multi-index component determination method for Huoxiang Zhengqi Soft Capsules, and to evaluate the quality of the prescription by chemometrics.Methods HPLC was performed using a SHIMADZU VP-ODS C18 column (250 mm×4.6 mm, 5 μm) with acetonitrile-0.1% phosphoric acid aqueous solution as mobile phase in gradient elution. The flow rate was 1.0 mL·min–1, and the gradient wavelength was 254 nm and 283 nm. The column temperature was 30 °C and the injection volume was 10 μL. Then the fingerprint and multi-index component determination method were established for analyzing and evaluating the quality of different batches of Huoxiang Zhengqi Soft Capsules in combination with chemometrics.Results The HPLC fingerprint of Huoxiang Zhengqi Soft Capsules was established, and 22 common peaks were calibrated. The similarity of the fingerprints of 15 batches of samples was above 0.8. Liquiritin, narirutin, hesperidin, oxypeucedanin hydrate, byakangelicol, imperatorin, honokiol, phellopterin, isoimperatorin and magnolol were determined. Chemometrics showed that there were some differences in the quality of Huoxiang Zhengqi Soft Capsules produced by different enterprises, and the quality markers were oxypeucedanin hydrate, honokiol, isoimperatorin, phellopterin, magnolol and liquiritin.Conclusion The established HPLC fingerprint and multi-index component determination method were accurate and simple, and could be used to evaluate the quality of Huoxiang Zhengqi Soft Capsules in combination with chemometrics. |
| keywords:Huoxiang Zhengqi Soft Capsules fingerprint chemometrics cluster analysis principal component analysis orthogonal partial least squares-discriminant analysis quality evaluation |
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