左奥硝唑分散片的研制及溶出度测定方法的研究

Study on preparation and dissolution determination method of levornidazole dispersible tablets

目的对左奥硝唑分散片进行处方分析,并建立溶出度测定方法。方法以崩解时限为指标,优选左奥硝唑分散片的处方;采用紫外分光光度法测定溶出度。结果确定了左奥硝唑分散片的处方,分散片于3 min时均已溶出90%以上。建立了溶出度测定方法,在5.329～26.645μg/mL浓度范围内,其吸收度值与浓度呈良好的线性关系(r=1.0),方法回收率为99.8%,精密度好(RSD=0.2%)。结论筛选的处方合理,制得的左奥硝唑分散片分散快、溶出快。用紫外分光光度法测定左奥硝唑分散片溶出度,方法简单、可靠。

Objective To prepare levornidazole dispersible tablets, and establish a dissolution determination method for levornidazole dispersible tablets in pharmacy research. Methods The prescription of levomidazole dispers- ible tablets was optimized with indicator of disintegration. Dissolution of levornidazole dispersible tablet was determined by Ultraviolet spectrophotometry. Results The rational prescription was selected. The dissolution rate of levornidazole dispersible tablets in 3 rain was more than 80%. The dissolution determination method was established, levomidazole concentration presented a good linear correlation within the range of 5. 329 - 26. 645 μg/mL with the average recovery of 99. 8% and a good precision （RSD = 0. 2% ）. Conclusion The prescription was reasonable, levornidazole dispers- ible tablets were characteristic of rapid dispersion, fast in dissolution. The method was suitable for the dissolution test of levornidazole dispersible tablets with simple operation and accurate consequence.