| 姜军华,陈建兰,许妍,吴良发.HPLC多波长切换法同时测定小儿咽扁颗粒中11种成分的含量[J].中国药事,2023,(2):199-204 |
| HPLC多波长切换法同时测定小儿咽扁颗粒中11种成分的含量 |
| Simultaneous Determination of Eleven Compositions in Xiaoer Yanbian Granule by HPLC Multiwavelength Switching Method |
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| DOI：10.16153/j.1002-7777.2023.02.011 |
| 中文关键词: 小儿咽扁颗粒 波长切换法 高效液相色谱法 含量测定 质量控制 |
| 英文关键词: Xiaoer Yanbian Granule wavelength switching method HPLC content determination quality control |
| 基金项目:江西省药品监督管理局科研项目(编号 2019JS05) |
| 作者 | 单位 | | 姜军华 | 江西省药品检验检测研究院,国家药品监督管理局 中成药质量评价重点实验室,江西省药品与医疗器械质量工程技术研究中心,南昌 330029 | | 陈建兰 | 南昌县中 医医院,南昌 330200 | | 许妍 | 江西省药品检验检测研究院,国家药品监督管理局 中成药质量评价重点实验室,江西省药品与医疗器械质量工程技术研究中心,南昌 330029 | | 吴良发 | 江西省药品检验检测研究院,国家药品监督管理局 中成药质量评价重点实验室,江西省药品与医疗器械质量工程技术研究中心,南昌 330029 |
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| 中文摘要: |
| 目的：为更好地控制小儿咽扁颗粒的质量，建立HPLC法同时测定小儿咽扁颗粒中新绿原酸、 绿原酸、隐绿原酸、异绿原酸B、3,5-二-O-咖啡酰奎宁酸、野鸢尾苷、4,5-二-O-咖啡酰奎宁酸、哈巴俄苷、肉桂酸、野鸢尾苷元和次野鸢尾黄素11种成分的含量。方法：基于波长切换技术的HPLC法， 色谱柱为Agilent 5T-C18(2)(250 mm×4.6 mm，5 μm)，以乙腈-0.1%磷酸溶液为流动相梯度洗脱， 流速为1.0 mL·min-1，柱温为30 ℃，进样量10 μL，检测波长分别为327、280 nm。结果：新绿原酸、 绿原酸、隐绿原酸、异绿原酸B、3,5-二-O-咖啡酰奎宁酸、野鸢尾苷、4,5-二-O-咖啡酰奎宁酸、 哈巴俄苷、肉桂酸、野鸢尾苷元和次野鸢尾黄素线性范围分别为0.029~0.43、0.12~1.82、0.020~0.30、 0.031~0.47、0.030~0.45、0.058~0.87、0.038~0.57、0.0090~0.13、0.012~0.19、0.026~0.39、0.0031~0.047 μg，相关系数r≥0.9996；平均加样回收率分别为98.55%、98.58%、96.12%、93.22%、97.42%、 93.88%、95.63%、101.73%、97.37%、97.50%、95.69%，RSD分别为0.69%、1.45%、2.08%、1.88%、 1.75%、2.69%、1.46%、2.70%、1.26%、2.59%、1.62%。结论：该方法简单准确，重复性良好，可用于小儿咽扁颗粒质量控制。 |
| 英文摘要: |
| Objective: To perform the quality control of Xiaoer Yanbian Granules, a HPLC method was established for the simultaneous determination of 11 components, including neochlorogenic acid, chlorogenic acid, cryptochlorogenic acid, isochlorogenic acid B, 3,5-di-O-caff eoylquinic acid, iridin, 4,5-di-O-caff eoylquinic acid, harpagoside, cinnamic acid, Irigenin, irisflorentin in Xiaoer Yanbian Granules. Methods: Based on wavelength switching technology, HPLC method was used with Agilent 5T- C18(2) column (250 mm×4.6 mm, 5 μm), the mobile phase was acetonitrile and 0.1% phosphoric acid with gradient elution, and fl ow rate was 1.0 mL·min-1. The temperature was 30℃, and the sample volume was 10 μL, and the detection wavelength was 327, 280 nm respectively. Results: The linear ranges of neochlorogenic acid, chlorogenic acid, cryptochlorogenic acid, isochlorogenic acid B, 3,6-di-O-caff eoylquinic acid, iridin, 4,5-di-O-caff eoylquinic acid, harpagoside, cinnamic acid, irigeni, irisfl orentin were 0.029- 0.43, 0.12 -1.82, 0.020- 0.30, 0.031 -0.47, 0.030 -0.45, 0.058- 0.87, 0.038 -0.57, 0.0090 -0.13, 0.012 -0.19, 0.026- 0.39, 0.0031- 0.047 μg, respectively. The correlation coeffi cient r≥0.9996. The average recovery rates were 98.55%, 98.58%, 96.12%, 93.22%, 97.42%, 93.88%, 95.63%, 101.73%, 97.37%, 97.50%, 95.69% with RSD of 0.69%, 1.45%, 2.08%, 1.88%, 1.75%, 2.69%, 1.46%, 2.70%, 1.26%, 2.59%, 1.62%, respectively. Conclusion: This method is simple, accurate and reproducible and can be used for the quality evaluation of Xiaoer Yanbian Granules. |
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