高温高湿联合作用对银参胶囊稳定性的影响

目的探讨高温高湿联合作用对银参胶囊稳定性的影响,为该产品产、储、运和有效期的确定提供参考。方法取3批样品,置高温[(37±1)℃]、高湿(相对湿度75%)条件下,分别于0,30,60,90 d时取样,参照2015年版《中国药典》检测外观性状、功效成分、理化指标、微生物指标。结果模拟上市的这3批样品在高温高湿环境放置30,60,90 d后,各项检测指标与0 d时比较无显著变化,且均符合质量标准要求。结论银参胶囊在(37±1)℃、相对湿度75%条件下放置90 d内稳定。

Synergistic Effect of High-Temperature and High-Humidity on the Stability of Yinshen Capsules

Objective To investigate the synergistic effect of high-temperature and high-humidity on the stability of Yinshen Capsules,and to provide a scientific basis for determination of the production,storage,transportation and effective period of Yinshen Capsules.Methods The three batches of samples were placed in the high-temperature test[(37±1)℃]and the high-humidity test(75%of relative humidity),the samples were tested at 0,30,60,90 d.The indicators,including the appearance properties,functional components,physical and chemical indexes and microbial indexes were examined according to the Chinese Pharmacopeia(2015 Edition).Results Compared with the results of 0 d,all the other results of the three batches of samples simulated to be on the market met the requirements of quality standards after placing in the high-temperature and the high-humidity environment for 30,60,90 d,with no significant changes.Conclusion Yinshen Capsules are stable within 90 d at(37±1)℃and 75%of relative humidity.