无糖型养胃颗粒的稳定性考察

The Observation of the Stability to the Sugar-free Yangwei Granular Preparation

目的 有糖型养胃颗粒改制成无糖型养胃颗粒后 ,对改制后的制剂在高温干热、恒温恒湿、留样考察 3个方面进行了质量稳定性考察。方法 用HPLC法测定养胃颗粒的芍药甙含量 ,按《2 0 0 2年版中国药典》对其他各项考察指标进行测定。 结果 该产品的含量、吸湿性 ,软化 ,粒度 ,溶化性 ,pH值和卫生学在考察期内基本无变化。

OBJECTIVE To observe the stability in the conditions of the high temperature and dry heat,constant temperature and constant heat,and observation of remained sample after sugar Yangwei granular preparation be changed into the sugar free one.METHODS To apply the method of HPLC to determine the paeonidin's content of Yangwei granular preparation;at the same time,to determine other referential indexes according to the Chinese Pharmacopoeia 2000.RESULTS The content,hygroscopic property,softness,granularity,solution,pH value and hygienics of the Yangwei granular preparation kept stability during the observing period.CONCLUSION The experiment proved that the quality is stabile for the sugar free Yangwei granular preparation in one and half year.