【摘 要】
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目的研制甲磺酸帕珠沙星泡腾片并建立该制剂的质量控制标准。方法用酸、碱分开制法制备甲磺酸帕珠沙星泡腾片,并对其性状、重量差异、崩解时限、酸度、鉴别、含量测定、稳定
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目的研制甲磺酸帕珠沙星泡腾片并建立该制剂的质量控制标准。方法用酸、碱分开制法制备甲磺酸帕珠沙星泡腾片,并对其性状、重量差异、崩解时限、酸度、鉴别、含量测定、稳定性等进行了检测。结果甲磺酸帕珠沙星检测浓度在20.0～80.0μg/ml范围内,线性关系良好(r=0.9999),平均回收率为98.2%(RSD=1.86%,n=6)。结论本品处方、制备工艺简单、质量稳定,本品可作为甲磺酸帕珠沙星制剂新品种的开发。
Objective To develop pazufloxacin mesylate effervescent tablets and establish the quality control standard of the preparation. Methods Pazufloxacin mesylate effervescent tablets were prepared separately by acid and alkali. The properties, weight difference, disintegration time, acidity, identification, content determination, stability and so on were tested. Results The pazufloxacin mesylate concentration was in the range of 20.0-80.0 μg / ml with a good linear relationship (r = 0.9999). The average recovery was paratocryptin 98.2% (RSD = 1.86%, n = 6). Conclusion This product prescription, preparation process is simple, stable quality, the product can be used as a new species of pazufloxacin mesylate development.
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