奥硝唑中空栓的制备及质量控制

Preparation and Quality Control of Ornidazole Hollow Suppository

目的：制备奥硝唑中空栓并建立其质量控制方法。方法：以半合成脂肪酸甘油酯为基质制成中空栓；采用紫外分光光度法测定主药奥硝唑含量，测定波长为316nm。结果：奥硝唑检测浓度在6．0～18．0μg／ml范围内线性关系良好（r=0.9997），平均回收率为99．80％（RSD=0．75％，n=5）。结论：本方法简便、准确、重现性好，可用于奥硝唑中空栓的质量控制。

OBJECTIVE： To prepare ornidazole hollow suppository and to establish its quality control. METHODS： The compound metronidazole hollow suppository was prepared with semisynthesis fatty acid glyceride as ground sudstance. The content of ornidazole was determined by ultraviolet spectrophotometry at a detection wavelength of 316 nm, RESULTS： The linear concentration range of ornidazole was 6.0～18.0μg/ml（ r = 0,9 997）and the average recovery was 99,80% （RSD = 0.75%, n = 5） . CONCLUSIONS： This method is simple, accurate and reproducible, and suitable for the quality control of ornidazole hollow suppository.