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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
【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.
【Key words】 Ornidazole; β-cyclodextrin; Inclusion compound; Preparation; Quality control;
- 【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