摘要
目的基于国家药品抽检工作,系统性评价风湿定胶囊的质量,分析存在的问题,为该品种的质量控制和监管提供参考。方法抽检风湿定胶囊样品136批次,进行标准检验,并开展探索性研究:采用高效液相色素(HPLC)法建立制剂中白芷、徐长卿、甘草的含量测定和毒藜碱的限量测定,采用超高效液相色谱法建立风湿定胶囊特征图谱,建立人工色素的筛查方法,采用超高效液相色谱-质谱联用筛查风湿定胶囊中非法添加化学药品的情况。结果136批次样品根据现行质量标准检验均合格,依据探索性研究结果进行评估,徐长卿、白芷、甘草含量测定存在低于拟定限度的情况,毒藜碱限量检查未超出拟定限度,特征图谱有部分企业的样品出现缺失峰情况,部分样品检出人工色素及对乙酰氨基酚残留。结论该次风湿定胶囊国家药品抽检的质量状况总体评价为“一般”。建议进一步完善质量标准,重视原药材质量,加强生产企业自身管理,加强监督检查。
Objective To systematically evaluate the quality of Fengshiding capsules,to analyze existing problems based on national drug sampling and testing,and to offer references and suggestions for improving quality control and regulatory supervision of this product.Methods A total of 136 batches of Fengshiding capsules were subjected to standard quality tests and exploratory analyses.HPLC was used to establish the content determination of Angelica dahurica,Cynanchum paniculatum,and Glycyrrhizae Radix,as well as the limit test for anabasine in the preparation.Additionally,an UPLC method was also employed to establish the characteristic chromatogram of Fengshiding capsules.A screening method for artificial pigments was developed,and UPLC-MS/MS was used to detect the illegal addition of chemical drugs in Fengshiding capsules.Results All 136 batches of samples passed inspection according to the current quality standards.However,based on exploratory study evaluations,the content determination results of Cynanchum paniculatum,Angelica dahurica,and Glycyrrhiza Radix were below the proposed limits.The limit test for anabasine did not exceed the proposed threshold.Furthermore,the characteristic chromatograms revealed missing peaks in several samples,and some batches contained artificial pigments and residues of acetaminophen.Conclusions The overall quality of Fengshiding capsules is rated as“average”based on national drug sampling and testing.To enhance product quality,it is recommended to improve quality standards,ensure the use of high-quality raw herbal materials,promote stronger internal oversight by manufacturers,and intensify regulatory supervision.
作者
郭璐玫
程韬
刘冬兰
刘兴鹏
杨洺
司芳芳
邹敏
朱嘉亮
GUO Lumei;CHENG Tao;LIU Donglan;LIU Xingpeng;YANG Ming;SI Fangfang;ZOU Min;ZHU Jialiang(Department of Traditional Chinese Medicine,Guizhou Institute for Food and Drug Control,Guiyang 550018,China;Chemical Laboratory,Yipin(Guiyang)Quality Technology Co.,Ltd.,Guiyang 550016,China;Technical Supervision Center,National Institutes for Food and Drug Control,Beijing 100050,China)
出处
《医药导报》
北大核心
2025年第9期1423-1430,共8页
Herald of Medicine
基金
国家药品抽检计划项目。
关键词
风湿定胶囊
国药药品抽检
质量评价
Fengshiding capsules
National drug sampling and testing
Quality evaluation
