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红霉素软膏微生物限度方法学的验证

Validation of the microbial limit methodology of erythromycin ointment

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目的 验证红霉素软膏微生物限度实验方法.方法 选取三个批号的红霉素软膏(S1~S3),分别采用三种冲洗方式分为试验组和阳性、阴性对照组(供试品对照组和菌液对照组),通过试验分析红霉素软膏的微生物限度检测方法.结果 试验的不同批次红霉素软膏所需的氧菌、酵母菌、霉菌以及加菌回收比值在0.5~2 区间内,红霉素软膏试验微生物菌株的抑制可以采取薄膜过滤法.因此,所有方法均能有效消除红霉素软膏的抑菌成分,实验结果能真实反映出红霉素软膏的微生物污染情况.结论 离心集菌薄膜过滤法在红霉素软膏抑菌清除中的应用具有较高价值存在,且该方式不会对红霉素软膏的微生物限度试验造成影响.
Objective To verify the experimental method of erythromycin ointment.Methods Three batch numbers of erythromycin ointment(S1~S3)were selected and divided into three washing methods:test group and positive and negative control group(test article control group and bacterial solution control group).The microbial limit detection method of erythromycin ointment was analyzed by test.Results The recovery ratio of oxygen bacteria,yeast,mold and added bacteria required for different batches of erythromycin ointment in the test is between 0.5 and 2,and the inhibition of microbial strains of erythromycin ointment test can be adopted by membrane filtration method.Therefore,all the methods can effectively eliminate the antibacterial components of erythromycin ointment,and the experimental results can truly reflect the microbial contamination of erythromycin dye ointment.Conclusion The application of centrifugal method in antibacterial removal will not affect the microbial limit test of erythromycin ointment.

erythromycin ointmentmicrobial limitsbacteriostasic activityrecovery rate

金健、陈昱、崔永学、金桂花

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吉林省延边朝鲜族自治州食品药品检验所,延吉 133000

红霉素软膏 微生物限度 抑菌作用 回收率

2024

实验室检验
中国检验检测学会

实验室检验

ISSN:2097-261X
年,卷(期):2024.2(6)