甲磺酸培氟沙星凝胶的研制与质量控制
Practical Pharmacy and Clinical Remedies（2007）
Abstract
目的 研制甲磺酸培氟沙星凝胶.方法 用CMC-Na作凝胶基质制奋甲磺酸培氟沙星凝胶,采用紫外分光光度法直接进行含量测定,检测波长277 nm,线性范围2～14 μg/mL,r=0.999 9,建立性状、鉴别、酸碱度、含量测定等质控方法,并对制剂进行质量控制.结果 含量测定回收率为99.54%-100.41%,RSD=1.98%(n=6),pH值6.0～8.0.凝胶稳定无变化.结论 该凝腔制备工艺简单,稳定性好,质量可控,适于临床应用.
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Key words
Gel,Quality control,Preparation,Pefloxacin mesylate
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