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中国药物评价 ›› 2025, Vol. 42 ›› Issue (1): 49-53.

• 评价技术与方法 • 上一篇    下一篇

清肺抑火片中6种植物生长调节剂的检测研究

范秀春, 罗廷顺, 徐维二, 缪明锦, 董坤*   

  1. 大理白族自治州药品检验所, 云南 大理 671000
  • 收稿日期:2024-08-16 修回日期:2025-02-05 出版日期:2025-02-28 发布日期:2025-02-28
  • 基金资助:
    2022年云南省药品评价抽检计划项目(云药监办2022-07)

Study on the Detection of 6 Plant Growth Regulators in Qingfei Yihuo Tablet

  1. Dali Bai Autonomous Prefecture Drug Control Institute, Yunnan Dali 671600, China
  • Received:2024-08-16 Revised:2025-02-05 Online:2025-02-28 Published:2025-02-28

摘要: 目的:建立清肺抑火片中6种植物生长调节剂的检测方法,从安全性方面评价清肺抑火片的质量。方法: 采用超高效液相色谱-三重四级杆串联质谱法同时检测清肺抑火片中矮壮素,缩节胺,丁酰肼,吡啶醇,多效唑及烯效唑6种植物生长调节剂。结果: 34批清肺抑火片样品中:3个厂家生产的10批样品检出矮壮素的量为7.3~238.9 g·kg-1,其余成分未检出。各组分线性关系良好(r=0.991 2~0.999 9),各组分的加标回收率均为60%~80%,RSD%为6.4%~11.2%。结论:本研究建立的以超高效液相色谱-串联质谱法检测清肺抑火片中矮壮素,缩节胺,丁酰肼,吡啶醇,多效唑及烯效唑6种植物生长调节剂的方法,准确度高、专属性强,具有实用性,可为药品质量控制和监管提供技术支撑。

关键词: font-size:medium, ">清肺抑火片;植物生长调节剂;超高液相色谱串联质谱;检测

Abstract: Objective: To establish a method for the detection of 6 plant growth regulators in Qingfei Yihuo tablet, and to evaluate the quality of Qingfei Yihuo tablet from the aspect of safety. Methods: Ultra high performance liquid chromatography-triple quadrupole tandem mass spectrometry was used to detect six plant growth regulators in Qingfeiyihuo tablet, including butyrin, acetamide, butyrhydrazine, pyridinol, polybutyrazole and tenbutyrazole. Results: Among the 34 batches of Qingfei Yihuo tablet samples, the content of nebulocin in 10 batches of samples produced by 3 manufacturers ranged from 7.3 μg·kg-1 to 238.9 μg·kg-1, and the other components were not detected. The linear relationship of each component was good (r=0.991 2-0.999 9), and the recoveries of each component were 60%-80%, RSD was 6.4%-11.2%. Conclusion: The UPLC/MS method for the simultaneous detection of six plant growth regulators in Qingfeiyihuo tablets, including butanylhydrazine, pyridinol, polybutenazole and tenbutenazole, has high accuracy, strong specificity and practicability, and can provide technical support for drug regulation.

Key words: font-size:medium, ">Qingfei yihuo tablet; Plant growth regulator; Ultra high performance liquid chromatography-tandem mass spectrometry; Detection

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