盐酸氯哌丁微生物限度检查方法的研究

Investigation of microbial limit test of cloperastine hydrochloride

目的 建立盐酸氯哌丁的微生物限度检查方法。方法 采用《中国药典》2020年版四部通则“1105”、“1106”项下的方法对本品进行微生物限度检查方法适用性试验。结果 本品对药典规定的5种微生物均有强烈的抑制作用,用含表面活性剂的稀释液溶解稀释到适宜浓度后,需氧菌总数、霉菌和酵母菌总数测定,大肠埃希菌检查均可采用薄膜过滤法。结论 此方法可以有效地检查盐酸氯哌丁的微生物限度。

Objective To establish the microbial limit test method of cloperastine hydrochloride.Methods The test was performed according to the general chapters 1105 and 1106 of the Chinese Pharmacopoeia 2020 Vol Ⅳ.Results This product had a strong antimicrobial activity on all 5 microorganisms specified in the pharmacopoeia.After being dissolved and diluted to the appropriate concentration,total aerobic bacteria count,total combined yeasts and molds count,and the examination of Escherichia coli were determined with membrane filtration method.Conclusion The established method can effectively control the microbial limit of cloperastine hydrochloride.