复方甲磺酸帕珠沙星滴鼻液的制备与质量控制  

Preparation and quality control of compound pazufloxacin mesylate nasal drops

作　　者：邓行文 吴建英[1] 张涛[1] 

机构地区：[1]广东省南雄市人民医院,南雄512400

出　　处：《海峡药学》2009年第5期49-51,共3页Strait Pharmaceutical Journal

摘　　要：目的制备复方甲磺酸帕珠沙星滴鼻液并建立质量标准。方法以甲磺酸帕珠沙星、奥硝唑为原料制备滴鼻液,采用紫外分光光度法在λ=247nm处测定甲磺酸帕珠沙星的含量;在λ=319.7nm处测定奥硝唑的含量。结果复方甲磺酸帕珠沙星滴鼻液的pH值4.5～6.0;甲磺酸帕珠沙星和奥硝唑的线性范围均为2～10mg.L-1,其平均回收率分别为100.18%,99.52%;RSD为0.51%,0.61%(n=9)。结论本制剂制备工艺简单,质量控制易行,稳定性好,有良好的临床使用价值。OBJECTIVE To study preparation and qualitycontrol of compound pazufloxacin mesylate nasal drops. METHODS Pazufloxacin mesylate and Ornidazole were used to perpare nasal drops, The content of pazufloxacin mesylate was detected by UV at the wavelength of 247 nm, The content of Ornidazole was detected by UV at the wavelength of 319.7nm. RESULTS The pH value of compound pazufloxacin mesylate nasal drops was 4.5--6.0;In the concentration range of 2--10mg· L^-1, the pazufloxacin mesylate and Ornidazole had a good linear relationship, the average recovery rate was 100.18 % and 99.52 %, RSD was 0.51% and 0.61% （n = 9） .CONCLUSION The present formula is rational, and the preparation technology is simple and the method for quality control is feasible and stable.

关 键 词：甲磺酸帕珠沙星 奥硝唑 滴鼻液 制备 质量控制 

分 类 号：R927.2[医药卫生—药学]