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止痛顺气胶囊稳定性试验研究
文黛薇,邝俊健,孙玉霞
0
(梧州市中医医院,广西 梧州,543002)
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:
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

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