摘要
为建立氟罗沙星胶囊的微生物限度检查方法,本文根据《中国药典》2015年版四部通则1105非无菌产品微生物限度检查：微生物计数法,通则1106非无菌产品微生物限度检查：控制菌检查法和通则1107非无菌药品微生物限度标准,利用硫酸镁与氟喹诺酮类抗生素的络合作用、聚山梨酯80和卵磷脂的中和作用,采用薄膜过滤法测定氟罗沙星胶囊对5种试验菌株的回收率,并对控制菌检查方法进行适用性试验.在对3个批次的样品进行需氧菌总数、霉菌和酵母菌计数方法适用性试验中,稀释剂对照组菌落数与菌液对照组菌落数的比值均在0.5～2之间,试验组菌落数减去供试品对照组菌落数与菌液对照组菌落数的比值均在0.5～2之间;在进行控制菌检查方法适用性试验中,试验组检出阳性试验菌.因此该方法可消除氟罗沙星胶囊的抑菌作用,可用于氟罗沙星胶囊的微生物限度检查.
According to 1105 microbiological examination of non-sterile products： microbial enumeration tests, 1106 microbiological examination of non-sterile products： tests for specified microorganisms and 1107 microbiological examination standards of non-sterile products in the appendices volume 1V of Chinese Pharmacopeia（edition 2015）, this article provides a method for microbial limit test of fieroxacin capsules. The complexation of magnesium sulfate, fluoroquinolone, neutralization of polysorbate-80 and lecithin, membrane-filter method were used to remove the antimicrobial activity in suitability of microbial limit test method. The ratio between diluent group and microorganism solution group in 3 preparations were between 0.5 and 2.The ratio between test group minus sample solution group and microorganism solution group were between 0.5 and 2. In the 3 control bacteria tests the control bacteria was found in the test group. In a result the established method can eliminate the antimicrobial activity in fleroxacin capsules and can be used for microbial limit test of fleroxacin capsules.
出处
《中国抗生素杂志》
CAS
CSCD
北大核心
2016年第6期445-447,共3页
Chinese Journal of Antibiotics
