| 磷酸氯喹片微生物限度检查方法适用性研究 |
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| 引用本文： | 李文靖,张帆,凌晓敏. 磷酸氯喹片微生物限度检查方法适用性研究[J]. 药品评价, 2021, 0(3): 148-151 |
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| 作者姓名： | 李文靖 张帆 凌晓敏 |
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| 作者单位： | 广东省药品检验所 |
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| 摘 要： | 目的:建立磷酸氯喹片微生物限度的限度检查方法.方法:按照《中国药典》2015年版通则1105、1106和1107,采用平皿法及培养基稀释法建立磷酸氯喹片的微生限度检查方法.结果:对4个厂家7批产品行常规平皿法检查,B、D厂家3次试验各菌株的回收均在0.5～2范围内;而A、C厂家检查,不能消除本品对铜绿假单胞菌或枯草芽孢...
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| 关 键 词： | 盐酸氯喹片 需氧菌 真菌 微生物限度 方法学 |
Applicability of Microbial Limit Test Method for Chloroquine Phosphate Tablets |
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| LI Wenjing,ZHANG Fan,LING Xiaomin. Applicability of Microbial Limit Test Method for Chloroquine Phosphate Tablets[J]. Drug Evaluation, 2021, 0(3): 148-151 |
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| Authors: | LI Wenjing ZHANG Fan LING Xiaomin |
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| Affiliation: | (Guangdong Instrute for Drug Control,Guangzhou Guangdong 510000,China) |
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| Abstract: | Objective:Toestablish miicrobial limit test method for chloroquine phosphate tablets.Methods:According to the generalguidelines of 1105,1106,and 1107 in Chinese Pharmacopoeia 2015,plate methodand medium dilution method were used for the development of microbial limit detection method for chloroquine phosphate tablets.Results:The total aerobic microbialcountwere determined byconventional plate method,or need to further dilute the test solution for determine,the total molds and yeast countwere determined by conventional plate method,the control of bacteria were determined by medium dilution method.Conclusion:Themethod is accurate,reliable,and suitable for detection of the microbial limit of chloroquine phosphate tablets. |
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| Keywords: | Chloroquine phosphate tablets Aerobic bacteria Fungi Microbial limit detection Methodology |
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