磷酸苯丙哌林胶囊微生物限度检查方法适用性试验

Applicability Test of the Method for Microbe Limit of Benproperine Phosphate Capsules

目的建立磷酸苯丙哌林胶囊的微生物限度检查方法。方法按《中国药典》2015年版四部具体规定:微生物计数检查采用平皿法、稀释法、薄膜过滤法,控制菌检查采用常规法、培养基稀释法、薄膜过滤法进行适用性试验。结果本品需氧菌总数计数、霉菌和酵母菌总数计数检查用薄膜过滤法,各试验菌回收率均达到50%~200%的要求;控制菌大肠埃希菌检查用薄膜过滤法,检出大肠埃希菌。结论磷酸苯丙哌林胶囊对各试验菌均有不同程度的抑菌作用,使用薄膜过滤法可消除其抑菌性,客观地反映药物中微生物的污染状况,以达到检测目的,保证检验结果的准确性。

OBJECTIVE To establish a method for microbe limit test of benproperine phosphate capsules. METHODS According to the specific provisions in the forth part of the ChP 2015, pan method, dilution method, and membrane filtration method were used to examine microbial count. Routine method, medium dilution method, and membrane filtration method were used to examine control bacteria for applicability test. RESULTS Membrane filtration method was used for aerobic bacteria count, mold and yeast total count, with recovery rate of the test bacteria from 50% to 200% ; membrane filtration method was used for control bacteria escherichia coli to detect escherichia coli. CONCLUSION Benproperine phosphate capsules have bacteriostasis effect with varying degrees on the test bacteria, while the use of membrane filtration method can eliminate bacteriostasis and objectively reflects the microbe contamination of drugs.