Analysis of Residue and Transfer Status and Risk Assessment of Plant Growth Regulator Paclobutrazol in Shenmai Granules
10.3870/j.issn.1004-0781.2024.03.019
- VernacularTitle:参麦颗粒中多效唑残留转移状况分析及风险评估
- Author:
Xiaolei WANG
1
,
2
;
Huizhu SUN
;
Rong LEI
;
Qi AN
;
Yongli LIU
Author Information
1. 河北省药品医疗器械检验研究院,石家庄 050227
2. 国家药品监督管理局中药材质量监测评价重点实验室,石家庄 050227
- Keywords:
Shenmai granules;
Ophiopogonis Radix;
Polylobuzole;
Gas chromatography-mass spectrometry/mass spec-trometry;
Transfer rate;
Risk assessment
- From:
Herald of Medicine
2024;43(3):435-440
- CountryChina
- Language:Chinese
-
Abstract:
Objective To analyze the residual status,transfer behavior,and risk of paclobutrazole in the national mar-ket of Shenmai granules.Methods GC-MS/MS determined the residual amount of paclobutrazol in Shenmai granules,and ANOVA analyzed the distribution characteristics of sample residuals.The transfer rule of paclobutrazol from Ophiopogonis Radix to Shenmai granules was investigated by simulating the production process,and chronic exposure assessment was performed using the point evaluation model.Results The established method can accurately determine the residual amount of paclobutrazol in Shenmai granules.The residual amount of paclobutrazol in 85 batches of Shenmai granules ranged from 0.001 3 to 0.015 8 mg·kg-1,and there was a statistical difference in the residual amount among different enterprise samples.The transfer rate of paclobutrazol from decoction pieces to preparations was 29.8%.The chronic risk quotient(HQc)of paclobutrazol residues in Shenmai granules was 0.000 7%,far lower than 1.Conclusion There is a general presence of paclobutrazol residues in Shenmai granules.The risk assessment results show that the normal dosage of Shenmai granules does not pose an unacceptable risk to the general population.The residual distribution characteristics and process transfer rules can provide a reference for safety risk control in production enterprises.
