硫酸小诺霉素注射液无菌检查方法的建立及验证

Establishment of the Methods of Sterility Test for Micronomicin Sulfate Injection and Its Validation

目的:验证硫酸小诺霉素注射液的无菌检查方法。方法:根据《中国药典》2010年版二部附录无菌检查法,采用薄膜过滤法,以0.1%无菌蛋白胨氯化钠水溶液为冲洗液,考察冲洗量分别为每筒100和200 mL时,金葡菌、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。结果:冲洗量为每筒100 mL时,大肠埃希菌生长情况不佳;冲洗量为每筒200 mL时,所有菌均生长良好。结论:冲洗量为每筒200 mL时,可消除硫酸小诺霉素的抗菌作用,大肠埃希菌可作为硫酸小诺霉素的敏感菌株。经过验证,该法适用于硫酸小诺霉素注射液的无菌检查。

Objective： To validate the method of sterility test for micronomicin sulfate injection. Methods： According to the Appendix of Chinese Pharmacopoeia（ 2010 edition）, membrane filtration method was used, and 0. 1% sterile peptone solution with sodium chloride was used as flushing liquid. The growth conditions of Staphylococcus aureus, Bacillus subtilis, Escherichia coli, Clostridium sporogenes, Candida albicans and Aspergillus niger were observed and investigated when the volume of flushing liquid were 100 and 200 mL, respectively. Results： Escherichia coli grew poorly when the volume of flushing liquid was 100 mL, while all the strains grew normally when 200 mL flushing liquid in each barrel were used. Conclusion： The antibacterial effect of micronomicin sulfate can be eliminated by using 200 mL flushing liquid in each barrel. It indicates that Escherichia coli is sensitive to micronomicin sulfate. It is shown that this method is suitable for the sterility test of micronomicin sulfate injection.