| 引用本文: | 陆静娴,陈勇,黄琴伟,马临科,祝明.银翘解毒颗粒中金银花的投料规范性研究[J].中国现代应用药学,2019,36(13):1669-1672. |
| LU Jingxian,CHEN Yong,HUANG Qinwei,MA Linke,ZHU Ming.Research on Normalization Feeding of Lonicerae Japonicae Flos in Yinqiao Jiedu Granules[J].Chin J Mod Appl Pharm(中国现代应用药学),2019,36(13):1669-1672. |
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| 摘要: |
| 目的 采用HPLC-ELSD建立银翘解毒颗粒中山银花检查方法，对制剂中金银花的投料规范性进行研究。方法 采用Ecosil C18（250 mm×4.6 mm，5 μm）色谱柱，甲醇-0.1%甲酸（63：37）为流动相，蒸发光散射检测器。结果 以灰毡毛忍冬皂苷乙为指标，对不同省份的11批金银花进行测定，结果均未检出。同时在189批次银翘解毒颗粒样品中，116批次样品检出灰毡毛忍冬皂苷乙，其中94批次超上限，存在违规投料的情况。结论 本法专属性好，灵敏度高，可为更好地控制银翘解毒颗粒的制剂质量提供科学依据，进而促使企业规范生产。 |
| 关键词: 银翘解毒颗粒 投料规范性 山银花 金银花 灰毡毛忍冬皂苷乙 |
| DOI：10.13748/j.cnki.issn1007-7693.2019.13.014 |
| 分类号:R917.101 |
| 基金项目: |
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| Research on Normalization Feeding of Lonicerae Japonicae Flos in Yinqiao Jiedu Granules |
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LU Jingxian, CHEN Yong, HUANG Qinwei, MA Linke, ZHU Ming
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Zhejiang Institute for Food and Drug Control, Hangzhou 310053, China
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| Abstract: |
| Objective To establish an HPLC-ELSD method for the determination of Lonicerae Japonicae Flos in examination of Yinqiao Jiedu granules, to investigate the phenomenon of illegal feeding. Methods Ecosil C18(250 mm×4.6 mm, 5 μm) column was adopted; mobile phase was methanol-0.1% formic acid solution (63:37); ELSD detector was used. Results Maranthoidin B was used as a marker. Among 11 batches from different provinces, no batch was detected with maranthoidin B. Among 189 batches of Yinqiao Jiedu granules, maranthoidin B was detected in 116 batches, and 94 batches were above the limit. There were cases of illegal feeding. Conclusion the established method is simple and sensitive; it provides a scientific basis for better quality control of Yinqiao Jiedu granules and standardize the production behavior. |
| Key words: Yinqiao Jiedu granules normalization feeding Lonicerae Flos Lonicerae Japonicae Flos maranthoidin B |
