摘要
目的:建立盐酸特比奈芬凝胶微生物限度检查方法。方法:利用氯化钙能与凝胶中的卡波姆结合形成钙盐沉淀达到破胶目的的原理,用10%氯化钙溶液10 mL 与盐酸特比奈芬凝胶10 g 混匀,加0.9%无菌氯化钠溶液至200 mL,得1:20破胶供试液,取1 mL,加0.9%无菌氯化钠溶液100 mL 稀释后过膜,用900 mL pH 7.0的无菌氯化钠-蛋白胨缓冲液分11次冲洗滤膜,前4次每次50 mL,以后每次100 mL,边冲洗边振摇,泵速为160 r·min^(-1)。结果:可以有效地去除盐酸特比奈芬凝胶抗(抑)真菌成分,使加菌回收达到满意的效果。结论:该方法准确、可靠。
Objective：To establish and validate a method for the microbial limit tests of terbinafine hydrochloride Gel. Methods：Added CaCl2 into terbinafine hydrochloride Gel to produce the precipitate and destroy the Gel. 100 mL of the solution （1 mL upper solution diluted with sterile 0. 9% NaCl solution）can be filtered by membrane and then wash the filter membrane 11 times with 900 mL washing solution. Results：The method eliminate antifungal effect of terbinafine hydrochloride Gel effectively. Conclusion：The method is suitable for the microbial limit test of terbinafine hydrochloride Gel.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2008年第12期2135-2139,共5页
Chinese Journal of Pharmaceutical Analysis
关键词
盐酸特比奈芬凝胶
微生物限度
方法验证
氯化钙
破胶
薄膜过滤
terbinafine hydrochloride Gel
microbial limit tests
validation
CaC12
destruction of the Gel
membrane filtration
