基于国家药品抽检的参梅养胃颗粒安全性质量评价OA

Objective Based on the national drug sampling and testing,this study conducted a safety and quality evaluation of Shenmei Yangwei granules in accordance with the variety characteristics of the preparation,sorted out the key points of safety research in sampling inspection,and put forward regulatory and enterprise quality control suggestions combined with the evaluation results,to provide support for ensuring the safety of public medication.Methods Ultra-performance liquid chroma-tography(UPLC)was adopted to determine the paeoniflorin sulfite as the indicator for the sulfur-fumigation inspection of Radix Paeoniae Alba in Shenmei Yangwei granules,and a reasonable limit was formulated.High-performance liquid chromatography-mass spectrometry(HPLC-MS)was used to inspect 36 prohibited colorants,screen other exogenous harmful substances,heavy metal and harmful element residues,47 prohibited pesticide residues,10 mycotoxins,and plant growth regulator residues.Thus,the quality and safety of 148 batches of Shenmei Yangwei granules.Results Exploratory studies showed that:the paeoniflorin sulfite content in samples from some enterprises exceeded the proposed limit,indicating that the sulfur dioxide residue in the in-put Radix Paeoniae Alba exceeded the standard;prohibited colorants were detected in samples from some enterprises,suggesting that the input Flos Carthami had been illegally dyed,which posed potential safety risks to medication.Conclusions The safe-ty-related issues found in this random inspection should be taken seriously and rectified.It is suggested that enterprises should pay attention to supplementary testing methods raw and auxiliary materials,establish reasonable internal quality control standards,and strictly control the quality of incoming raw materials during acceptance to ensure the quality of the input medicinal materials.