葡萄糖酸依诺沙星注射液无菌检查方法的建立及验证

发布时间：2018-09-11 08:13

【摘要】：目的:建立和验证葡萄糖酸依诺沙星注射液的无菌检查方法。方法:根据2010年版《中国药典》,采用薄膜过滤法,以0.1%蛋白胨水溶液为冲洗液,考察在不同冲洗液量和在培养基中加入中和剂时,6种阳性对照菌的生长情况。结果:在冲洗液量为每管300 ml、每次冲洗100 ml,使用含0.2 mol/L Mg2+的培养基时,所有阳性对照菌均生长良好。结论:最终确立的葡萄糖酸依诺沙星注射液的无菌检查方法为以大肠埃希菌为阳性对照菌,采用0.1%蛋白胨水溶液冲洗3次(每次100 ml),经薄膜过滤后加入含Mg2+培养基。本法简便、冲洗量相对较少,是葡萄糖酸依诺沙星注射液一种较为理想的无菌检查方法。
[Abstract]:Objective: to establish and verify the aseptic test method of enoxacin gluconate injection. Methods: according to the Chinese Pharmacopoeia of 2010, the growth of 6 positive control bacteria was investigated with 0.1% peptone solution as flushing solution and neutralizer added in the medium by membrane filtration method. Results: all the positive control bacteria grew well when the volume of washing solution was 300 ml, / tube and the culture medium containing 0.2 mol/L Mg2 was used. Conclusion: the final aseptic test method of enoxacin gluconate injection is to use Escherichia coli as positive control bacteria and rinse with 0.1% peptone solution for 3 times (100 ml), each time after membrane filtration and add Mg2 medium). This method is simple and relatively few. It is an ideal method for aseptic examination of enoxacin gluconate injection.
【作者单位】：解放军第153中心医院药械科;
【分类号】：R927.1

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