注射用米卡芬净钠无菌检查方法研究

Study on the sterility test method for Micafungin Sodium for Injection

根据《中华人民共和国药典》2015年版四部通则1101无菌检查法,采用薄膜过滤法,以含1%吐温80和不含1%吐温80的p H7.0无菌氯化钠-蛋白胨缓冲液为冲洗液,当冲洗量分别为每膜300,700和1 000 m L时,以硫乙醇酸盐流体培养基作为厌氧菌和需氧菌检查培养基,以含1.2%酵母浸粉或不含1.2%酵母浸粉的胰酪大豆胨液体培养基作为真菌和需氧菌检查培养基,考察金黄色葡萄球菌、枯草芽孢杆菌、大肠埃希菌、生孢梭菌、白色念珠菌和黑曲霉的生长情况。文章研究结果以含1%吐温80的p H7.0无菌氯化钠-蛋白胨缓冲液为冲洗液,冲洗量为每筒300 m L,以硫乙醇酸盐流体培养基作为厌氧菌和需氧菌检查培养基,以胰酪大豆胨液体培养基作为真菌和需氧菌培养基,所有菌均生长良好。该方法可消除注射用米卡芬净钠的抗菌作用,白色念珠菌或黑曲霉菌可作为注射用米卡芬净钠的敏感菌株。

The 1101 Sterility Test Method in the Chinese Pharmacopoeia 2015 edition was applied to study the growth of Staphylococcus aureus, Bacillus subtilis, Escherichia coli, Clostridium sporogenes, Candida albicans and Aspergillus niger. Sodium chloride pepton containing 1% Tween 80, or excluding 1% Tween 80-sterile with pH7.0 was used as buffer. When washing with 300 or 700 or 1 000 mL per membrane, fluid thioglvcollate medium was used as anaerobic and aerobic inspection medium; tryptose soya broth containing 1.2% yeast extract or excluding 1.2% yeast extract. The results showed that with the use of 300 mL sodium chloride peptone buffer containing 1% Tween 80-sterile and pH7.0, fluid thioglycollate medium is the option for anaerobic and aerobic bacteria checking medium; tryptose soy broth medium is the option for fungi and aerobic bacteria checking medium. This proposed methods eliminate antibacterial effect for Micafungin Sodium injection. Candida albicans or Aspergillus can be used as the sensitive strains for Micafungin Sodium.