注射用右丙亚胺无菌检查方法学研究

Methodology of Sterility Test of Dexrazoxane for Injection

目的:建立注射用右丙亚胺的无菌检查方法。方法:按2005年版《中国药典》无菌检查法中薄膜过滤法进行相关操作,试验菌株为金黄色葡萄球菌、铜绿假单胞菌、枯草芽孢杆菌、生孢梭菌、白色念珠菌、黑曲霉,分别用150、250、350mL氯化钠-蛋白胨缓冲液(pH7.0)冲洗,比较3种冲洗量对检查结果的影响。结果:冲洗量为150mL时,除枯草芽孢杆菌外其它各菌在24～72h内均未见生长,冲洗量为250、350mL时各试验菌株生长良好。结论:所建立的注射用右丙亚胺无菌检查方法准确、可靠。

OBJECTIVE： To establish the method for sterility test of dexrazoxane for injection. METHODS： The relative procedures were conducted in accordance with the membrane- filter procedure included in sterility test specified in Chinese Pharmacopoeia （2005 edition）, with Staphylococcus aureus, Pseudomonas aeruginosa, Bacillus subtilis, Clostridium sporogenes, Candida albicans and Aspergillus niger as test organisms, which were flushed with sodium chloride- peptone buffer solution （150 mL, 250 mL, and 350 mL, respectively, pH 7.0） to evaluate the impact of three flushing doses on the results of sterility test. RESULTS： At a flushing dose of 150 mL, there was no growth of bacteria except Bacillus subtilis at 24--72 h; however, at a flushing dose of 250 mL or 350 mL, all bacteria strains had a good growth. CONCLUSION： The established method for sterility test of dexrazoxane for injection is accurate and reliable.