水分对阿莫西林克拉维酸钾颗粒稳定性的影响

发布时间：2018-07-20 11:18

【摘要】：目的根据颗粒剂的制剂特点,探讨水分(包括水分含量和水分活度)对阿莫西林克拉维酸钾颗粒稳定性的影响;并以稳定性为指针,揭示阿莫西林克拉维酸钾颗粒在制剂过程中的关键质量控制属性。方法通过高湿加速稳定性实验[实验温度(25±2)℃;相对湿度(75±5)%],考察阿莫西林克拉维酸钾颗粒的水分、含量、有关物质、晶型特征等。结果阿莫西林克拉维酸钾颗粒的稳定性与样品的水分活度呈正相关,与样品的水分含量关系不大,水分活度低的样品的稳定性高。结论阿莫西林克拉维酸钾颗粒的关键质控属性是水分,关键工艺参数是水分活度。
[Abstract]:Objective to study the effect of water (including water content and water activity) on the stability of amoxicillin clavulanate potassium granules according to the characteristics of granules. The key quality control properties of amoxicillin clavulanate potassium granules in preparation process were revealed. Methods the moisture, content, related substances and crystal form of amoxicillin clavulanate potassium granules were investigated by high humidity accelerated stability experiment [temperature (25 卤2) 鈩，

本文编号：2133346