伏立康唑原料药微生物限度方法学研究  

Methodological Study on Microbial Limits of Voriconazole API

作　　者：黄春娥 林鹏 常宁宁 吴宏伟 HUANG Chun-e;LIN Peng;CHANG Ning-ning;WU Hong-wei(Xiamen Food and Drug Quality Inspection and Research Institute,Xiamen 361012,China)

机构地区：[1]厦门市食品药品质量检验研究院,福建厦门361012

出　　处：《海峡药学》2024年第11期33-36,共4页Strait Pharmaceutical Journal

摘　　要：目的 通过对伏立康唑原料药(API)微生物检验方法学适用性研究,提示难溶性药物建立微生物检验方法学应重点关注的问题。方法 依据《中国药典》2020年版四部通则1105对检验方法进行适用性研究,建立伏立康唑原料药微生物限度检查方法。结果 采用加中和剂的薄膜过滤法,取1∶2000的供试品溶液200 mL全量过滤,稀释液和冲洗液均为0.1%吐温80的pH 7.0无菌氯化钠-蛋白胨缓冲液,冲洗量500 mL,每次冲洗100 mL,可以避免伏立康唑抗真菌的抑菌性作用对检验的影响。结论 该方法可以作为难溶性抗真菌药物的前期方法学适用性研究。OBJECTIVE Through the study of the applicability of the microbiological testing methodology for Voriconazole API,it is suggested that the establishment of microbiological testing methodology for insoluble drugs should focus on key issues.METHODS According to General Rule 1105 of the 2020 edition of the Chinese Pharmacopoeia,the applicability of the testing method was studied,and a microbial limit test method for Voriconazole API was established.RESULTS Using a membrane filtration method with a neutralizing agent,200 mL of the 1∶2000 test solution was fully filtered.The diluent and rinse were both 0.1% Tween 80(pH 7.0) sterile sodium chloride peptone buffer,with a rinse volume of 500 mL,and 100 mL each time.This could avoid the impact of the antifungal inhibitory effect of Voriconazole on the test.CONCLUSION This method can serve as a preliminary methodological applicability study for insoluble antifungal drugs.

关 键 词：伏立康唑 溶解度 微生物限度研究 

分 类 号：R927[医药卫生—药学]