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目的:建立复方磺胺嘧啶分散片中冰片的体外溶出度测定方法。方法:依据《中国药典》2005年版溶出度测定法,以水为溶出介质,转速75 r·min~(-1),45 min取样测定溶出度。结果:冰片在0.42～4.20μg浓度范围内与峰面积呈良好的线性关系(r=0.999 7),回收率98.8%(RSD=0.8%);3批样品在45 min的平均溶出量均在88.6%以上。结论:该法稳定、简便、准确,可用于复方磺胺嘧啶分散片中冰片的体外溶出度测定。
Objective: To establish a method for the in vitro dissolution test of borneol in compound sulfadiazine dispersible tablets. Methods: According to the dissolution test of Chinese Pharmacopoeia 2005 edition, the dissolution rate was determined by taking water as dissolution medium, rotating speed 75 r · min ~ (-1) for 45 min. RESULTS: The results showed that the linear relationship between the concentration of borneol and the peak area was 0.42 ~ 4.20μg (r = 0.999 7) and the recovery rate was 98.8% (RSD = 0.8%). The average dissolution of borneol was 88.6 %the above. Conclusion: The method is stable, simple and accurate. It can be used to determine the in vitro dissolution of borneol in the compound sulfadiazine dispersible tablets.