复方酪萨维口腔速崩片的制备及质量控制

Preparation and quality control of compound Laosawei rapidly disintegrating oral tablets

目的:制备复方酪萨维口腔速崩片并建立其质量控制方法。方法:采用微晶纤维素、低取代-羟丙纤维素、交联聚维酮等为辅料,直接压片法制备复方酪萨维口腔速崩片;采用高效液相色谱法测定红景天苷和酪萨维的含量;采用气相色谱法测定冰片含量。结果:复方酪萨维口腔速崩片崩解时限符合要求,红景天苷、酪萨维、冰片中龙脑的平均回收率分别为100.46%(RSD=1.03%)、100.87%(RSD=1.68%)、97.59%(RSD=1.96%)。结论:该制剂处方组成合理,制备方法可行,质量可控。

OBJECTIVE To prepare orally disintegrating tablets of compound Laosawei rapidly disintegrating oral tablets and to establish its quality control method. METHODS The tablets were prepared with the technique of direct powder compres- sion, the testing method of dissolution was established, and the content of salidroside and rosavin was determined by HPLC, and the content of borneolum was determined by GC. RESULTS The disintegrating time of the orally disintegrating tablets com- plied with requirements, the average recoveries of salidroside and rosavin and borneolum were 100. 46% （RSD = 1.03%）, 10（1. 87 %（RSD = 1.68 % ） and 97. 59 % （RSD = 1.96% ）, respectively. CONCLUSION This recipe component was reasonable, the prepared procedure was practicable,and the quality control was able to control the aualitv of this Droduet.