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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 use the chromatographic fingerprinting of pattern recognition based on the whole composition as a new method for the consistency study of other related substances (hereinafter referred to as “sub-components”) outside of the main components in the preparation of midecamycin. Methods The national standard method was used to determine the antibiotic potency and the content of midecamycin A1 in the raw materials and tablets of mintomycin. At the same time, the fingerprints of different groups of midecamycin raw materials and preparations were calculated by the concept and algorithm of Chinese traditional medicine fingerprinting Similarity between the spectra. Results The test results showed that the quality of the raw materials and preparations of midecamycin in our company were much higher than the statutory standards, and the HPLC fingerprints of the sub-components among the samples were highly similar (all above 0.95), demonstrating that the quality of products from raw materials to finished products was stable and Inter-batch product quality is the same. Conclusion Chromatographic fingerprinting combined with chemometric analysis for the consistency of chemicals related substances, through the practical application of our mydicine quality control proved to have good applicability. It is expected to be applied to multi-component antibiotics such as ferulicillin, daptomycin and other fermented products to improve quality control.