复方碳酸钙泡腾颗粒剂处方筛选及吸湿性考察

Selection and hygroscopicity examination of prescription of compound calcium carboate effervescent granule

目的 优化复方碳酸钙泡腾颗粒剂处方组成 ,并对优化处方制备的泡腾颗粒剂进行吸湿性考察。方法 以干燥失重 %为指标 ,均匀试验设计筛选复方碳酸钙泡腾颗粒剂处方中乳糖、山梨醇、PVP等辅料的用量 ,建立吸湿性曲线方程 ,考察泡腾颗粒剂不同湿度下放置的吸湿性。结果 本品在相对湿度 75 %以下放置吸湿性小于 5 %。

AIM The component of compound calcium carbonate effervescent granule was optimized, meanwhile, the optimized prescriptions hygroscopicity was examined. METHODS According to the index of loss on drving of chemicals, even design of experiments used, the doses of lactose,sorbitol, PVP and other auxiliary materials were chosen from the compound calcium carbonate granule. The hygroscopicity of the effervescent granule at the different humidity conditions was examined by the established curve formula. RESULTS This drugs hygroscopicity was less than 5% when layed down at down 75% relative humidity condition. CONCLUSION The effervescent granule made of optimized prescription have good stability.