基于国家药品抽检的小建中制剂质量评价与研究
Quality Evaluation and Research on Xiaojianzhong Preparations Based on National Drug Sampling
刘敏敏 1胡佳哲 1何嘉雯 1陈俏 1温家欣 1李华 1吴群悦1
作者信息
摘要
目的 基于国家药品抽检工作,系统性评价小建中制剂的质量以及分析存在的问题,为该品种的质量控制提供参考和建议.方法 对抽样的160批次样品进行标准检验,探索性研究采用液相色谱-串联质谱法检测赭曲霉毒素A和玉米赤霉烯酮残留量;采用超高效液相色谱-串联高分辨质谱法检测小建中制剂中芍药苷亚硫酸酯;建立高效液相色谱法测定桂皮醛含量;建立指纹图谱分析法评价小建中制剂的整体质量;对合剂的pH值进行考察.结果 160批次样品依标检验合格率为100％.探索性研究表明,33.1％样品检出赭曲霉毒素A或玉米赤霉烯酮,83.5％样品检出芍药苷亚硫酸酯,9％合剂pH值超出苯甲酸抑菌效力范围,95.4％样品桂皮醛低于拟定限度,14.6％样品指纹图谱分析相似度低于拟定限度.结论 建议统一4种剂型质量标准质控项目,增加合剂pH限度,对小建中制剂中原辅料炙甘草及糊精进行质量监测,规范饴糖使用问题,加强古代经典名方开发的制度规范.
Abstract
OBJECTIVE To provide reference and suggestions for the quality control of this variety,evaluate the quality of xiao-jianzhong preparations and preparations analyze the existing problems based on the national drug sampling.METHODS A total of 160 batches of samples were tested according to the statutory standard.In the exploratory study,ochratoxin A and zearalenone residues were detected by liquid chromatography-tandem mass spectrometry;paeoniflorin sulfite in xiaojianzhong preparation was detected by ultra performance liquid chromatography-tandem high resolution mass spectrometry;cinnamaldehyde was determined by high perform-ance liquid chromatography;the overall quality of Xiaojianzhong preparation was evaluated by fingerprint analysis.The pH value of the mixture was investigated.RESULTS The qualified rate of 160 batches of samples was 100％according to statutory standard.Explor-atory studies showed that ochratoxin A or zearalenone was detected in 33.1％of the samples,and paeoniflorin sulfite was detected in 83.5％of the samples.The pH value of 9％mixture was beyond the range of benzoic acid inhibitory effect.Cinnamaldehyde in 95.4％of the samples was below the proposed limit.Fingerprint analysis showed that the similarity of 14.6％of samples was lower than the proposed limit.CONCLUSION It is suggested to unify the quality control items of the four dosage forms,increase the pH limit,monitor the quality of the raw materials of licorice and dextrin,standardize the use of cerealose,and strengthen the system specification for the development of ancient classic prescriptions.
关键词
国家药品抽检/小建中制剂/中药/质量评价Key words
national evaluation sampling/xiaojianzhong preparation/traditional Chinese medicine/quality evaluation引用本文复制引用
出版年
2024
NETL
NSTL
万方数据