香元消痔巴布贴的稳定性考察

The Investigation on the Stability of Xiangyuan Xiaozhi Cataplasm

目的：考察香元消痔巴布贴的稳定性。方法：采用HPLC法测定香元消痔巴布贴中没食子酸的含量，并考察性状、鉴别、含膏量、赋形性、黏附性、微生物限度等指标。结果：香元消痔巴布贴在进行加速试验及长期试验考察时，各项检查指标均无明显变化。结论：香元消痔巴布贴稳定性较好，本品的制备工艺及包装设计合理，符合制剂稳定的要求。

Objective：To investigate the stability of Xiangyuan Xiaozhi cataplasm. Methods：HPLC was used in content determination of gallic acid in Xiangyuan Xiaozhi cataplasm, and reviewed the indexes of characters, differentiation, ointment content, forming property, adhesiveness and micro-bial limit. Results：Each inspection index of Xiangyuan Xiaozhi cataplasm had no significant changes under the accelerated test and long-term test. Conclusion：The stability of Xiangyuan Xiaozhi cataplasm is good, the preparation technology and package design are reasonable, which fits the re-quirements of preparation stability.