羟乙基淀粉(200/0.5)乳酸钠林格注射液无菌检查方法学研究

Method study on the asepsis inspection of hydroxyethyl (200/0.5) starch lactic acid ringer's injection

目的建立羟乙基淀粉(200/0.5)乳酸钠林格注射液的无菌检查方法。方法该试验取羟乙基淀粉(200/0.5)乳酸钠林格注射液,按《中国药典》2010年版二部收载的"无菌检查法"项下进行试验,通过对阳性对照菌,冲洗量等条件的选择,建立了无菌检查方法。结果该药对金黄色葡萄球菌有抑制作用,采用直接法达不到检验要求,但通过薄膜过滤冲洗法可达到满意的检验结果。结论该方法灵敏,结果可靠,可作为羟乙基淀粉(200/0.5)乳酸钠林格注射液的无菌检查方法。

Objective To establish the sterility test methods for Hydroxyethyl（200/0.5） starch sodium lactate ringer＇s injection.Methods Sterility test methods were adopted to do the test,according to Chinese Pharmacopoeia（2010 and edition）.By selecting the positive control bacteria and irrigation conditions,we established the method of sterility test.Results The sample had strong inhabilitory activity for stuplylococcus aureus.Membrane filtrating method had higher antimicrobial effect.Conclusion The method is sensitive and reliable.It can be used as a method for sterility test of sodium lactate ringer＇s injection.