论文部分内容阅读
目的:建立甲磺酸培氟沙星注射液的无菌检查方法。方法:按2005年版《中国药典》附录无菌检查法项下薄膜过滤法。结果与结论:经方法学验证,甲磺酸培氟沙星注射液对细菌有明显的抑制作用。采用0.1%蛋白胨冲洗液(每900 ml冲洗液中加入5 ml 0.1 mol·L~(-1)无菌硫酸锰溶液)作为冲洗液,可完全消除药品的抑菌性。从而对建立甲磺酸培氟沙星注射液的无菌检查法提供了依据。
Objective: To establish a sterile test method of pefloxacin mesylate injection. Methods: According to the 2005 edition of “Chinese Pharmacopoeia” appendix sterile examination under the membrane filtration method. RESULTS AND CONCLUSION: Pefloxacin mesylate injection has obvious inhibitory effect on bacteria by methodological verification. Using 0.1% peptone rinse (adding 5 ml of 0.1 mol·L -1 aseptic manganese sulfate solution per 900 ml rinse) as the rinse solution can completely eliminate the antibacterial activity of the drug. Thus providing a basis for establishing a sterile test of pefloxacin mesylate injection.