水分对氨苄西林胶囊稳定性的影响

The water content and quality stability of ampicillin capsules

目的探讨氨苄西林胶囊水分含量中非结晶水含量的影响因素,研究非结晶水含量对本品制剂稳定性的影响。方法通过高湿试验[试验温度(25±2)℃,相对湿度90%±5%RH]和加速试验[试验温度(40±2)℃,相对湿度75%±2%],对本品性状、水分、有关物质和含量进行考察。结果非结晶水含量的变化与氨苄西林胶囊的稳定性呈负相关,辅料的引湿性、生产工艺及药品的包装材料对氨苄西林胶囊的非结晶水含量有显著影响。结论国产氨苄西林胶囊现有的包装形式可满足对本品水分控制的需求,水分检查可不列入质量标准中。

Objective To investigate the influencing factors of non-crystalline water content of ampicillin capsule, the effects of non-crystalline water content on the stability of ampicillin capsules were studied. Methods Through the high humidity stability test（25℃±2℃, 90%±5% RH） and the accelerated stability test （40℃±2℃, 75%±5% RH）, the properties, the moisture content, related substances, and active ingredient contents were investigated. Results The non-crystalline water content was negatively correlated with the stability of ampicillin capsules. The moisture absorption of auxiliary materials, the production process, and the drug packaging have significant influence on the non-crystalline water content of ampicillin capsules. Conclusion The existing packaging forms of ampicillin capsules can meet the requirements of moisture control in this product. It is acceptable that the water testing is not included in the quality standard.