泽泻滴丸的加速稳定性试验

Accelerated Stability Test of Rhizoma Alismatis Dripping Pills

目的对泽泻滴丸进行加速稳定性试验。方法按"新药稳定性试验"对滴丸剂质量稳定性考察的要求,对3批中试泽泻滴丸样品,在温度(40±2)℃、相对湿度(75±5)%的条件下,进行6个月的加速试验,考察其性状、鉴别、检查、含量、微生物限度的变化。结果各项指标符合新药加速试验的要求。结论泽泻滴丸的稳定性良好。

Objective To study the stability of rhizoma alismatis dripping pills by accelerated stability test. Methods According to the quality and stability requests of dripping pill in 'new drugs stability test', three batches of dripping pills samples received accelerated test for 6 months under the conditions of(40±2)℃, relative humidity of(75±5)%, and the changes of characteristics, identification, inspection, content and microbial limit were investigated. Results All indicators conformed to the requirements in 'new drugs stability test'. Conclusion The stability of rhizoma alismatis dripping pills is well.