冻干蜂王浆软胶囊的制备及稳定性影响因素研究

目的:制备冻干蜂王浆软胶囊并对其稳定性及影响因素进行实验研究。方法:以内容物沉降体积比为考察指标,筛选出适宜的助悬剂和工艺,轧制软胶囊,并考察其在冷藏、室温和高温高湿下的稳定性。HPLC法测定稳定性及不同影响因素下10-HAD含量的变化。结果:中试生产成品率90以上,软胶囊成品冷藏质量稳定,室温及高温高湿条件下产品质量明显下降,软胶囊壳中的水分对10-HAD的含量有明显影响。结论:冻干蜂王浆软胶囊的制剂成型工艺可行,产品贮存以冷藏为宜。

Preparation and stability test of Lyophiled Royal Jelly Soft Capsule

AIM:To prepare the Lyophiled Royal Jelly Soft Capsule and study its stability and Influential factors.METHODS:The suspending agent and processing method were optimized using sedimentation volume rate as the index.Soft capsules were prepared and product stability under high temperature and high humidity environment was studied according to the determination of the content of 10-HAD by HPLC.RESULTS:The finished product yield in pilot test was more than 90%,the soft capsule products stored in cold were stable,while those stored under room temperature or high temperature and high humidity were unstable with a noticeable decrease in quality.Water content in capsule shell affects the 10-HDA content of the finished product.CONCLUSION:The preparative process is feasible and the products should be storaged in cold enviroment.