氯雷他定糖浆微生物限度方法学验证

Validation of Microbial Limit Methodology for Loratadine Syrup

目的:建立氯雷他定糖浆的微生物限度检查方法。方法:采用《中国药典》2015年版四部“非无菌产品微生物限度检验方法”规定的平皿法、培养基稀释法,验证确认所采用的方法是否适合该药品的微生物限度检查。结果:细菌、霉菌及酵母菌数测定采用平皿法;控制菌采用培养基稀释法,5种试验菌的回收率均在0.5~2范围内。结论:该方法可用于氯雷他定糖浆的微生物限度检查。

Objective:Establishment of microbial limit test method for loratadine syrup.Methods:The plate method and culture medium dilution method specified in four“microbial limit test method for non sterile products”of Chinese Pharmacopoeia(2015 Edition)were used to verify whether the method adopted is suitable for the microbial limit test of the drug.Results:The total bacterial count and the total molds and yeasts count adopted the conventional plate-count method.The recoveries of the five strains were all in the range of 0.5~2.Conclusion:This method can be used for the microbial limit test of Loratadine Syrup.