脑康通泰分散片的制备及溶出度测定

目的]确定脑康通泰分散片的处方工艺,并建立其溶出度测定方法。并与自制普通剂型进行溶出度比较。方法]以休止角、硬度、崩解时限、颗粒流动性等为指标考察处方,优化后确定终处方。采用2010年版中国药典二部附录溶出度测定法,以900 mL水为溶出介质,转速为100 r/min,并于270 nm波长处测定吸收度。结果]优选出最佳处方:24%磷酸氢钙和20%微晶纤维素为填充剂,10%交联聚维酮与2%二氧化硅为混合崩解剂,1%硬脂酸镁为润滑剂,分散片的崩解时限小于3 min。30 min内溶出度不低于75%。结论]湿法制粒压片制备脑康通泰分散片处方合理,工艺简单,溶出度测定方法结果准确,质量可控,开发脑康通泰分散片具有临床意义。

Determination of preparation and dissolution with Naokangtongtai dispersible tablet

Objective] To prepare Naokangtongtai dispersible tablets and establish the dissolution method.To compare with the dissolution of other common products.Methods] The formulation of the tablets was optimized through the indices: slope of repose,hardness,disintegration time and corpuscular liquidity.Dissolution was determined by the solvent according to the method in Chinese Pharmacopoeia(2010,Appendix Ⅱ) with 900 mL water as the solvent at a rotation speed of 100 r/min.And the detection wavelength was 270 nm.Results] The proportion of each adjuvant in the optimal formulation consisted of 20% microcrystalline cellulose and 24% brushite as a filler,and 10% crospovidone mixed with 2% silicon dioxide as disintegrating agent,1% magnesium stearate as lubricants.The dispersible tablets could disintegrate completely within 3 minutes and its dissolution rate could reach beyond 75% in 30 min.Conclusion] The preparative method of Naokangtongtai dispersible tablets by wet granulation is simple.The method is accurate and suitable for the dissolution determination of Naokangtongtai dispersible tables.