复方中药提取物栓剂的稳定性

Stability of Suppository Extracted From Chinese Herbal Prescription

目的:研究复方中药提取物栓剂的稳定性并建立其临床使用有效期.方法:采用加速试验及室温留样考查试验等方法.结果:高湿是影响本品原料稳定性的主要因素,本品于室温条件下保存质量稳定.结论:本品于室温条件下保存,有效期可达2年.

Objective： To study the stability of suppository of extractant from Chinese herbal prescription and to predict its efficacy term tbr clinical application. Methods： The test of determining the factors that influence the stability of extractant, the test of reserving it under the condition of （30±2） ℃ and RH 60%±5%, and under the condition of room temperature were used. Results： High humidity is the main factor that influence the extractant stability and it is stable under the condition of room temperature. Conclusion： Its efficacy term for clinical application is 2 years if it is reserved under the condition of room temperature.