恩他卡朋片微生物限度检查方法的建立及验证  

Establishment and Validation of Microbial Limit Test Method for Entacapone Tablets

作　　者：赵同申 秦桂霞 于洪华 季智飞 徐伟娜 ZHAO Tong-shen;QIN Gui-xia;YU Hong-hua;JI Zhi-fei;XU Wei-na(Shandong Hualu Pharmaceutical Co.,Ltd.,Liaocheng 252100,China;Shandong Academy of PharmaceuticalSciences,Jinan 250101,China)

机构地区：[1]山东华鲁制药有限公司,山东聊城252100 [2]山东省药学科学院,山东济南250101

出　　处：《食品与药品》2022年第4期362-365,共4页Food and Drug

摘　　要：目的建立恩他卡朋片微生物限度检验方法。方法按《中国药典》2020版四部要求,以含1%聚山梨酯80的pH 7.0无菌氯化钠-蛋白胨缓冲液为稀释剂,采用增加稀释法消除可能存在的抑菌性,进行微生物计数;采用用常规方法进行控制菌检验。结果增加稀释倍数至1:50后,微生物计数试验组回收比值均在0.5~2.0之间。控制菌试验组检出大肠埃希菌。结论当前方法适用于恩他卡朋片微生物限度检验。Objective To establish a microbial limit test method for Entacapone Tablets.Methods According to the requirements listed in Part IV of Chinese Pharmacopoeia(2020 Edition),with pH 7.0 sterile sodium chloride peptone buffer containing 1%polysorbate 80 as diluent,possible bacteriostasis was eliminated by increasing dilution method in microbial count,and the control bacteria were tested by conventional method.Results After increasing the dilution ratio to 1:50,the recovery ratio of microbial count test group was between 0.5-2.0.Escherichia coli was detected in the control bacteria test group.Conclusion The current method is suitable for microbial limit test of Entacapone Tablets.

关 键 词：恩他卡朋片 微生物检验 聚山梨酯80 稀释法 

分 类 号：R446.5[医药卫生—诊断学]