摘要
目的为了解蜂胶胶囊在温度、湿度、光照条件随时间变化下质量的变化规律,为该药品的研、产、储、运和有效期的确定提供依据。方法本试验对蜂胶胶囊在不同温度、湿度和光线的条件下进行加速稳定性试验和长期稳定性试验稳定性的研究。结果蜂胶胶囊模拟上市的3批包装,经加速试验0月试验结果,与6个月相比较,各项指标符合质量标准要求,未见显著变化。经长期12个月试验考察,与0月相比较,各项指标均无显著变化。结论经过对比试验,各项结果均未显明显变化趋势,有效期暂定12个月。
Objective In order to understand the changing rule of quality of propolis capsule under temperature,humidity and light conditions with time,to provide a basis for determining the research,production,storage,transportation and effective period of propolis capsule. Methods The experiment was carried out to study the stability of propolis capsule under the conditions of different temperature,humidity and light,and the stability of long-term stability test. Results Simulation of the 3 batches of propolis listed packaging,by the accelerated test test 0 month,compared with 6 months,the indicators meet the quality standards,and there is no significant change. After a long 12 months test,compared with the 0 month,there are no significant changes in the indicators. Conclusion After test comparison,there is no obvious change trend in all results. The period of validity is tentatively fixed for 12 months.
作者
张玮
韩颂
ZHANG Wei;HAN Song(Heilongjiang Food and Drug Information Center/ Heilongjiang Food and Drug Inspection Center, Harbin, Heilongjiang, 150001, China)
出处
《黑龙江医学》
2018年第5期408-409,共2页
Heilongjiang Medical Journal
关键词
蜂胶胶囊
稳定性
有效期
Propolis capsule
Stability
Validity period
