摘要
为了保持注射用前列腺素E1在常温储存条件下质量稳定 ,对不同工艺配方的产品进行破坏性试验研究 ,优选出合理的工艺配方 :产品在 40± 1℃ ,相对湿度 75 %的条件下存放 3个月后观察其鉴别项中的特异吸收峰为 2 78nm ,通过试验得出 ,加β 环糊精对主成分进行包合工艺能够使产品在常温储存条件下有效期内保证质量。
The aim is to optimize the technological prescriptions and increase the sta bility of Alprastadil for jection in normal temperature,proving by destructive experime nt.Conditions of storage:temperature is 40±1℃,relative humidity is 75%, maintain three mont hs,and then determining its absorbable peak at 278nm and the variations of content and so to optimize th e best technology.The experiment can proved that the technological prescrip tion of inclusion compound of β cyclodextrin is the only one′s that ensure the quality stability in nor mal temperature and in its expiry date.
出处
《南阳师范学院学报》
CAS
2002年第4期61-63,共3页
Journal of Nanyang Normal University
关键词
前列腺素E1
质量稳定性
破坏性试验
Β-环糊精
包合
Alprastadil for Injection
quality stability
destructive experiment
β cyclodextrin
inclusion
