| 林吉恒,彭志兰,吴纤愫.蒲地蓝消炎片微生物限度检查方法的建立及检验结果分析[J].中国药品标准,2020,21(1):48-55 |
| 蒲地蓝消炎片微生物限度检查方法的建立及检验结果分析 |
| Establishment of microbial limit test for Pudilan Xiaoyan tablets and the analysis of the test results LIN Ji-heng, PENG Zhilan, WU Qiansu(Zhoushan Institute for Food and Drug Control, Zhejiang 316021, China) |
| 投稿时间：2019-04-25 修订日期：2020-02-06 |
| DOI： |
| 中文关键词: 蒲地蓝消炎片 微生物限度检查 方法适用性 |
| 英文关键词: Pudilan Xiaoyan tablets microbial limit test validation of method |
| 基金项目:浙江省食品药品监管系统科技计划项目 BH201704 |
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| 中文摘要: |
| 目的 建立蒲地蓝消炎片微生物限度检查法,并对14个生产企业59批次产品的微生物限度检查结果进行分析。方法 按照《中国药典》2015年版对14家生产企业59批次的蒲地蓝消炎片进行微生物限度检查,细菌鉴定采用MALDI-TOF MS及VITEK 2全自动细菌鉴定试验系统。结果 需氧菌、霉菌和酵母菌计数方法适用性试验中各试验菌的回收率均为0.5~2.0；在控制菌检查方法适用性试验中, 大肠埃希菌检查阳性对照组和供试品对照组检出大肠埃希菌；耐胆盐革兰阴性菌检查阳性对照组和供试品对照组检出大肠埃希菌和铜绿假单胞菌；沙门菌检查阳性对照组和供试品对照组检出沙门菌。样品主要污染的微生物是阴沟肠杆菌和其他环境常见污染菌。结论 建立蒲地蓝消炎片的微生物限度检查方法, 14个生产企业59批次的微生物限度检查结果均符合规定。 |
| 英文摘要: |
| ABSTRACT: OBJECTIVE To establish the method of microbial limit test of Pudilan Xiaoyan tablets, and analyze the test results of 59 batches from 14 manufacturers. METHODS The method validation of the 59 batches of Pudilan Xiaoyan tablets from 14 manufacturers was conducted by microbial limit test from appendixes in ChP 2015. The bacterial strains were identified using MALDI－TOF MS and VITEK2 COMPACT 30. RESULTS The recoveries of all kinds of strains in the tests of total aerobic microbial count, total yeast and mold count were 0.5~2.0. In the method validations of Escherichia coli, bile-tolerant gram-negative bacteria and Salmonella enterica subsp., all kinds of strains were respectively detected．The main contaminant bacteria were Enterobacter cloacae and the bacteria related to the environment. |
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