痛风宁分散片的制备及溶出度测定

Preparation and Dissolution of Tongfengning Dispersible Tablets

目的:制备痛风宁分散片,并考察其体外溶出度。方法:以分散均匀性为考察指标,考察崩解剂的种类及用量、润滑剂的用量及加入方式;通过吸湿性试验测定临界相对湿度;以别嘌醇及苯溴马隆为指标比较痛风宁分散片与通益风宁片的溶出度。结果:优选的崩解剂为8.8%CMS-Na,41.6%MCC,润滑剂为1.6%微粉硅胶。临界相对湿度为73.5%。痛风宁分散片较普通片溶出快。结论:痛风宁分散片处方处方合理,工艺可行。

Objective： To prepare the Tongfengning dispersible tablets and investigate the dissolution rate in vitro. Method： The dispersion uniformity was used as the index to study the type and amount of disintegrants, and the amount and addition method of the lubricant. Through the moisture absorption test, the critical relative humidity was determined. The allopurinol and benzbromarone was employed as the indicators to compare the release rates of Tongfengning tablets and Tongyi Fengning tablets. Result： The optimal disintegrants were CMS-Na（ 8. 8% ） and MCC （41.6%） ,and the optimal lubricant was colloidal silicon dioxide （1.6%）. The critical relative humidity was about 73.5%. The dissolution rate of the dispersible tablets was more rapid than that of Tongyi Fengning tablets. Conclusion： The prepared Tongfengning dispersible tablets are reasonable in formula and feasible in technology.