枸橼酸西地那非原料微生物限度检查方法研究

Study on Microbial Limit Test of Sildenafil Citrate

目的建立枸橼酸西地那非微生物限度检查方法。方法本品采用pH 7.6无菌磷酸盐缓冲液制备供试液,需氧菌总数计数用1∶100供试液和薄膜过滤法、霉菌和酵母菌总数计数用平皿法,依法检查;控制菌大肠埃希菌用直接接种法,依法检查。结果采用微生物计数方法适用性试验中各菌回收比值均在0.5~2.0之间;控制菌检查方法适用性试验检出阳性试验菌。结论所建立的方法可作为枸橼酸西地那非微生物限度检查方法。

OBJECTIVE To establish a microbiological limit test method for sildenafil citrate.METHODS Theproduct was prepared with pH 7.6 sterile phosphate buffer solution,the total number of aerobic bacteria was counted by 1:100 test solution and membrane filtration method,the total number of mold and yeast was counted by plate method,and checked according to the method.Controlled bacteria escherichia coli by direct inoculation the method,inspection according to the method.RESULTS In the applicability test of microbial counting method,the recovery ratio of all bacteria was between 0.5 to 2.0.Positive test bacteria were detected in applicability test of control bacteria examination method.CONCLUSION The established method can be used as a microbiological limit test for sildenafil citrate.