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目的:建立加替沙星注射液无菌检查方法。方法:根据《中国药典》2010年版二部附录XIH无菌检查法验证试验指导原则,采用薄膜过滤法和添加硫酸锰中和剂去除加替沙星抑菌活性的实验方法和条件进行了验证,建立了加替沙星注射液无菌检查的方法。结果:采用薄膜过滤法用pH7.0无菌氯化钠-蛋白胨缓冲液进行冲洗,每桶5×100mL的冲洗量,每桶(100mL)培养基中加入硫酸锰溶液可去除加替沙星对各菌株的抑菌作用。结论:加替沙星注射液的无菌检查可采用上述方法。
Objective: To establish a gatifloxacin injection sterility test. Methods: According to the principles of the sterility test method of XIH in Appendix II of Chinese Pharmacopoeia (2010 edition), the experimental methods and conditions for removing antibacterial activity of gatifloxacin by membrane filtration and addition of manganese sulfate neutralizer were validated. A method of sterilizing gatifloxacin injection was established. RESULTS: Films were filtered and washed with pH 7.0 sterile sodium chloride-peptone buffer at a volume of 5 × 100 mL per barrel. Manganese sulfate solution was added to 100 mL of medium to remove gatifloxacin Antibacterial effect of each strain. Conclusion: Gatifloxacin injection can be sterilized by the above method.