国产醋酸麦迪霉素颗粒剂的质量评价

国产醋酸麦迪霉素颗粒剂的质量评价
姚尚辰;张夏;胡昌勤
【期刊名称】《中国抗生素杂志》
【年(卷),期】2017(42)6
【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.%Objective To evaluate the quality of domestic midecamycin acetate granules.Methods According to the current specification of midecamycin acetate granules combining with exploratory researches,and the general requirements of national drug assessment program in 2015,a comprehensive assessment to the quality of 15 batches of listed products of midecamycin acetate granules was carried out.The specification was also evaluated.Results The qualified rate of the test products was 93.3％.The potency of the products may be reduced due to the degradation during storage.According to the quality control
concepts of Chinese Pharmacopoeia 2015 of multi-componentantibiotics,a component/impurity control method for midecamycin acetate was established.Eighteen major components in the product were found and their structures were determined.Among them,9,3"-diacetylmidecamycin A1 (the main component),9-acetyl midecamycin A1,9,3"-diacetylatedkitamycin A6 and 9,3"-diacetylmidecamycin A2 were the active components,and the others were the impurities.The potency assay of the cylinder plate method was unified to solve the problems that the inhibition zone was not clear in some tests and it was difficult to be measured by instruments,in which Bacillus subtilis [CMCC(B)63501] served as the test organism and Ⅷ medium with 0.3％ yeast extract powder were
used.Conclusion The quality of domestic midecamycin acetate granules is generally under good control.However,the quality control specification needs to be further improved.
【总页数】7页(P496-502)
【作者】姚尚辰;张夏;胡昌勤
【作者单位】中国食品药品检定研究院,北京100050;中国食品药品检定研究院,北京100050;中国食品药品检定研究院,北京100050
【正文语种】中文
【中图分类】R917;R978.1
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