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奥硝唑-β-环糊精包合物的制备及其质量控制

Preparation and Quality Control of Ornidazole-β-Cyclodextrin Inclusion Compound

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【作者】 朱海涛陈吉炎黄良永王章元涂自良

【Author】 ZHU Haitao,CHEN Jiyan,HUANG Liangyong,TU Ziliang(Taihe Affiliated Hospital,Hubei Yunyang Medical College,Shiyan442000,China) WANG Zhangyuan(College of Pharmacy,Tongji Medical College,Central China Science and Technology University,Wuhan430030,China)

【机构】 湖北郧阳医学院附属太和医院华中科技大学同济医学院药学院湖北郧阳医学院附属太和医院 十堰市442000十堰市442000武汉市430030十堰市442000

【摘要】 目的:制备奥硝唑-β-环糊精包合物并建立其质量控制方法。方法:采用饱和水溶液法制备奥硝唑-β-环糊精包合物,并用紫外分光光度法进行含量测定。结果:经显微观察证实,所得成品为奥硝唑-β-环糊精包合物;奥硝唑检测浓度线性范围为5.1~20.5μg/ml(r=0.9999),平均回收率为101.52%,RSD=1.4%。结论:该制剂制备方法可行,所得成品稳定性好,且所建立的质量控制方法简便、可靠。

【Abstract】 OBJECTIVE:To prepare ornidazole-β-cyclodextrin inclusion compound and establish its quality control method.METHODS:The ornidazole-β-cyclodextrin inclusion compound was prepared by saturated water solution method and the content was determined by ultraviolet spectrophotometry.RESULTS:The finished preparation was confirmed to be ornidazole-β-cyclodextrin inclusion compound under the microscope.The detection concentration range of ornidazole was5.1~20.5μg/ml(r=0.9999);the average recovery rate was101.52%,RSD=1.4%.CONCLUSION:This preparation method is practicable;the finished preparation is stable in quality and the established quality control method is simple,reliable.

  • 【文献出处】 中国药房 ,China Pharmacy , 编辑部邮箱 ,2005年17期
  • 【分类号】R943
  • 【被引频次】19
  • 【下载频次】271
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