吉非罗齐原料药及制剂的有关物质研究  

Study on the related substances of the raw materials and preparations of Gemfibrozil

作　　者：李文莉 程智 傅萍 LI Wenli;CHENG Zhi;FU Ping(Sichuan Institute for Food and Drug Control,Chengdu,Sichuan,610097 P.R.China)

机构地区：[1]四川省药品检验检测院,四川成都610097

出　　处：《华西药学杂志》2024年第1期84-88,共5页West China Journal of Pharmaceutical Sciences

摘　　要：目的控制吉非罗齐胶囊中的有关物质。方法结合国内外标准研究吉非罗齐原料药及制剂中的有关物质,对抽验样品进行检验并分析结果。结果共抽取6家企业共计样品143批次,按法定标准检验,合格率为100%。但现行法定标准无法完全检出吉非罗齐的已知和未知杂质,现建立了专属性更高的杂质检查方法,并通过质谱图,推测出2个未见报道的杂质(吉非罗齐三聚物和吉非罗齐异丁酯)。并进一步发现了从胶囊壳中迁移至药品中的杂质山梨酸。结论进一步提高了吉非罗齐原料药的有关物质标准,控制了杂质A和杂质I,参照国外药典建议收紧单个杂质与总杂限度、增订吉非罗齐胶囊的有关物质检查项。OBJECTIVE To control the related substances in Gemfibrozil capsules.METHODS According to domestic and foreign standards,the related substances of Gemfibrozil API and preparations,were testd,and make statistical analysis of the results was performed.RESULTS A total of 143 batches of samples were taken from 6 manufacturers and the qualified rate was 100%according to the legal testing.However,the current regulatory standards cannot fully detect known and unknown impurities of Gemfibrozil.This study established a more specific impurity detection method and inferred two unreported impurities of Gemfibrozil trimer and isobutyl Gemfibrozil through mass spectrometry.Furthermore,the impurity sorbic acid was discovered migrating from the capsule shell to the drug.CONCLUSION This study further improves the related substances standards of Gemfibrozil API,controlls impurity A and impurity I,tightens the limit of single impurity and total impurity according to foreign pharmacopoeia,and increases the inspection items of related substances of Gemfibrozil capsules.

关 键 词：吉非罗齐 吉非罗齐胶囊 国家评价性抽验 杂质 有关物质 胶囊壳 抑菌剂 山梨酸钾 

分 类 号：R917[医药卫生—药物分析学]