复方湿生扁蕾结肠靶向胶囊的稳定性考察

Study on the stability of Compound Gentianopsis paludosama colon-targeted capsules

目的考察复方湿生扁蕾结肠靶向胶囊的稳定性。方法分别采用影响因素试验、加速试验与长期试验考察复方湿生扁蕾结肠靶向胶囊制剂的稳定性。结果靶向胶囊中试样品在高温、高湿、强光条件下放置10 d,分别在第5、10天时对样品进行考察,各考察项目均无明显变化;3批中试样品经加速试验6个月及长期试验9个月考察,各项指标均无明显变化。结论复方湿生扁蕾结肠靶向胶囊适于存储在密闭、阴凉、干燥的条件下,该制剂稳定性较好,有效期暂定为2年。

OBJECTIVE To study the stability of Compound Gentianopsis paludosama colon - targeted capsules. METHODS The influencing factor test, accelerated test and long - term test were used to evaluate the stability of the colon targeting capsule. RESULTS In the condition of high temperature, high humidity and strong light, the targeting capsule samples were placed for 10 days. The samples were observed in the 5th and 10th days. All the items were not significantly changed. Three batches of samples were examined by accelerated test for 6 months and long - term test for 9 months. All the items were not significantly changed. CONCLUSION The capsule is suitable for storing in the closed, cool and dry conditions, and the preparation has good stability. The period of validity can be set as 2 years.