清肺抑火片中6种植物生长调节剂的检测研究  

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

作　　者：范秀春 罗廷顺 徐维二 缪明锦 董坤 FAN Xiuchun;LUO Tingshun;XU Weier;MIAO Mingjin;DONG Kun(Dali Bai Autonomous Prefecture Drug Control Institute,Yunnan Dali 671600,China)

机构地区：[1]大理白族自治州药品检验所,云南大理671000

出　　处：《中国药物评价》2025年第1期49-53,共5页Chinese Journal of Drug Evaluation

基　　金：2022年云南省药品评价抽检计划项目(云药监办2022-07)。

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=0.9912~0.9999),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。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 7.3μg·kg^(-1) to 238.9μg·kg^(-1),and the other components were not detected.The linear relationship of each component was good(r=0.9912-0.9999),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.

关 键 词：清肺抑火片 植物生长调节剂 超高液相色谱串联质谱 检测 

分 类 号：R284.2[医药卫生—中药学] R927.1[医药卫生—中医学]