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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 verify the sterility test method of tromycin sulfate injection. Methods: According to the “Chinese Pharmacopoeia” 2010 edition two appendix sterility test method, the membrane filtration method, with 0.1% sterile peptone solution of sodium chloride as the rinse solution, investigate flushing volume were 100 and 200 mL per barrel, gold Streptomyces, Bacillus subtilis, Escherichia coli, Clostridium sporogenes, Candida albicans and Aspergillus niger growth. Results: The growth of Escherichia coli was poor when the volume of rinsing was 100 mL per barrel. When the volume of rinsing was 200 mL per barrel, all the bacteria grew well. CONCLUSION: The antimicrobial activity of trichostatin sulfate can be eliminated when the flush volume is 200 mL per barrel. Escherichia coli can be used as a sensitive strain of trichloretin sulfate. After verification, the law applies to the sterile test microtomycin sulfate injection.