| 摘要: |
| 目的：观察止痛顺气胶囊在恒温恒湿加速试验及长期试验中稳定性的变化。方法：取符合质量标准的3个批号止痛顺气胶囊，置于恒温恒湿培养箱，在温度维持在（40±2）℃和相对湿度（75±5）%的条件下放置6个月，进行加速稳定性试验。取符合质量标准的止痛顺气胶囊置于恒温恒湿培养箱，于箱内温度维持在（25±2）℃和相对湿度（60±10）%的条件下放置24个月，进行长期稳定性试验。结果：3个批号的止痛顺气胶囊在恒温、恒湿加速留样以及长期留样观察条件下，性状、鉴别、水分、崩解时限、含量测定、微生物限度检查等均符合各项规定。结论：止痛顺气胶囊质量稳定可靠，该稳定性试验为制定其有效期提供了充足依据。 |
| 关键词: 止痛顺气胶囊 加速试验 长期试验 稳定性 |
| DOI： |
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| An experimental study of the stability of Zhitong Shunqi capsules |
| WEN Daiwei,KUANG Junjian,SUN Yuxia |
| (Wuzhou Hospital of Traditional Chinese Medicine，Wuzhou 543000，Guangxi，China) |
| Abstract: |
| Objective：To investigate the change in the stability of Zhitong Shunqi capsules in accelerated stability test and long-term stability test with constant temperature and humidity.Methods：For the accelerated stability test，three batches of Zhitong Shunqi capsules which met the quality standard were selected and placed in an incubator with constant temperature and humidity for 6 months，with a temperature maintained at 40℃±2℃ and a relative humidity maintained at 75%±5%.For the long-term stability test，Zhitong Shunqi capsules which met the quality standard were selected and placed in an incubator with constant temperature and humidity for 24 months，with a temperature maintained at 25℃±2℃ and a relative humidity maintained at 60%±10%.Results：In the accelerated stability test and the long-term stability test with constant temperature and humidity，the properties，identification，water content，disintegration time，content determination，and microbial limit results of the three batches of Zhitong Shunqi capsules all met related criteria.Conclusion：Zhitong Shunqi capsules have stable and reliable quality，and such stability tests provide a sufficient basis for determining its expiry date. |
| Key words: Zhitong Shunqi capsules accelerated stability test long-term stability test stability |
