国产醋酸麦迪霉素颗粒剂的质量评价

发布时间：2018-03-20 16:39

本文选题：醋酸麦迪霉素　切入点：药品标准　出处：《中国抗生素杂志》2017年06期 　论文类型：期刊论文

【摘要】：目的对国产醋酸麦迪霉素颗粒的质量进行评价。方法现行质量标准检验结合探索性研究,综合评价上市产品的质量及现行质量标准对产品质量的可控性。结果 15批国产醋酸麦迪霉素颗粒合格率为93.3%,产品在贮存期可能因降解导致效价降低。按《中国药典》2015年版对多组分抗生素的质控理念,建立了醋酸麦迪霉素组分/杂质控制方法,对产品中18个主要小组分的结构进行了推测,其中9,3''-二乙酰麦迪霉素A1(主组分)、9-乙酰麦迪霉素A1、9,3''-二乙酰吉他霉素A6和9,3''-二乙酰麦迪霉素A2为活性组分,其他组分为杂质;统一了效价测定方法,采用枯草芽孢杆菌[CMCC(B)63501]为检定菌,采用加入0.3%酵母浸出粉的抗Ⅷ号培养基,解决了抑菌圈不清晰,无法采用抑菌圈测量仪测量的难题。结论国内醋酸麦迪霉素颗粒质量总体良好,质控标准需进一步完善。
[Abstract]:Objective to evaluate the quality of domestic Midecamycin Acetate Granules. The current quality standard test method combined with exploratory research, the controllability of the comprehensive evaluation of listed product quality and the current quality standard on the quality of the products. The results of 15 batches of domestic Midecamycin Acetate Granules 93.3% pass rate, product may result in degradation due to less effective storage period. Press < China Pharmacopoeia >2015 quality control concept in the version of multicomponent antibiotics, established the acetic acid Maddie zymoid component / impurity control method, the structure of the 18 major groups in the products were proposed, including two 9,3''- acetyl Maddie mycomycin A1 (principal component), 9- acetyl Maddie bleomycin A1,9,3''- two acetylkitasamycin and A6 9,3''- two Maddie acetyl mycomycin A2 as active component and other components for impurities; unified method for determination of titer by Bacillus subtilis [CMCC (B) 63501] as the test strain, by adding 0.3% yeast Anti No. VIII medium parent leaching powder, solve the bacteriostatic ring is not clear, not by bacteriostatic ring measuring instrument for measuring the problem. Conclusion the domestic Midecamycin Acetate Granules quality is generally good, quality standards need to be further improved.

【作者单位】：中国食品药品检定研究院;
【分类号】：R927.1

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