指纹图谱在麦迪霉素原料及制剂质量控制中的新尝试  

A New Strategy to Analyze Quality of Raw Materials and Preparations of Midecamycin by Using Chromatographic Fingerprint Analysis

作　　者：王锐 王祥红[2] 郭国领 谢培山 李高照[2] 赵娜[2] 梁秋华[2] 杨景娣 

机构地区：[1]丽珠医药集团股份有限公司,广东珠海519020 [2]丽珠集团丽珠制药厂,广东珠海519020 [3]广州万正药业有限公司,广东广州510663

出　　处：《今日药学》2016年第3期175-178,共4页Pharmacy Today

摘　　要：目的利用以整体组分的模式识别的色谱指纹图谱作为建立麦迪霉素原料及制剂中主成分外的其他相关物质小组分(以下简称"小组分")一致性考察的新方法。方法利用国家标准的方法,测定麦迪霉素原料及片剂的抗生素效价及麦迪霉素A1的含量,同时借助中药指纹图谱的概念与算法,计算不同批次麦迪霉素原料与制剂小组分指纹图谱间的相似度。结果检测结果显示本公司麦迪霉素原料、制剂的质量均远高于法定标准,样品间小组分HPLC指纹图谱具有高度的相似性(均在0.95以上),证明产品从原料到成品质量的稳定与批间产品质量的一致。结论色谱指纹图谱技术结合化学计量分析用于化学药品相关物质一致性的考察,通过在本厂麦迪霉素质量控制的实际应用证明具有良好的适用性。可望应用于类似产品如麦白霉素、达托霉素等发酵的多组分抗生素以提高质量控制水平。OBJECTIVE To establish a new strategy of the chromatographic fingerprint analysis aided by chemometric calculation for assessment of the stability and consistency of the raw materials and the preparation of Midecamycin. METHODS In addition to the official standard of Midecamyci A1 by HPLC determination of the principal component stipulated in Chinese Pharmacopoeia,a new strategy of Chromatographic fingerprinting was also applied to evaluate the similarity and batch-to-batch consistency of the composition of minor other related substances in the raw material and the preparation of Medecamycin aided by chemometric calculation. RESULTS The tested samples of starting material medemycin,and the preparation showed high similarity were above 0.95. CONCLUSION It is known that the minor substances related to the principal compound of the medicine could be a possible factor for reliable clinical efficacy. As in-house determination of the raw material and the preparation of Medecamycin,the composition of the minor related substances region in the HPLC profile revealed batch-to-batch high similarity and composition consistency. That means the chromatographic fingerprint strategy is suitable and meaningful tool when applied to the intrinsic quality assessment of medicine. Therefor it is presumed that chromatographic fingerprinting can also applied to the other similar medicines,such as multicomponent antibiotics which come from fermented Meleumycin and Daptomycin.

关 键 词：麦迪霉素 麦迪霉素A1 指纹图谱 相似度 

分 类 号：R927[医药卫生—药学]