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

作　　者：刘敏敏[1] 胡佳哲 何嘉雯 陈俏[1] 温家欣[1] 李华[1] 吴群悦 LIU Minmin;HU Jiazhe;HE Jiawen;CHEN Qiao;WEN Jiaxin;LI Hua;WU Qunyue(Guangdong institute for Drug Control,Guangzhou 510525,China)

机构地区：[1]广东省药品检验所,广州510525

出　　处：《中国药学杂志》2024年第23期2266-2271,共6页Chinese Pharmaceutical Journal

基　　金：国家药品抽检计划项目资助(国药监药管[2023]2号)。

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。OBJECTIVE To provide reference and suggestions for the quality control of this variety,evaluate the quality of xiaojianzhong 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 performance 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.Exploratory 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 

分 类 号：R284[医药卫生—中药学] R917[医药卫生—中医学]