摘要
目的:研究鲜鹿茸全成分口腔崩解片的稳定性并测定其临界相对湿度。方法:考察该制剂在高温、高湿、光照和加速实验及长期实验条件下的外观性状、崩解时限、含水量和生物活性等变化,并采用减重法测定其临界相对湿度。结果:影响因素实验结果表明,本制剂在光照条件下性质稳定;高湿显著影响本制剂的外观性状、含水量和崩解时限;高温显著降低其生物活性(P<0.01);加速长期实验条件下制剂的外观性状、含水量和崩解时限与0月相比均发生显著变化,超出了质量标准的要求;减重法测得其临界相对湿度为72.59%。结论:湿度和高温是影响鲜鹿茸全成分口腔崩解片稳定性的关键因素,该制剂应采用防潮包装材料,密封置于相对湿度低于72.59%的阴凉干燥环境下储存,以保证制剂的稳定性和有效性。
This article was aimed to study the stability of fresh antler orally disintegrating tablets with all ingredients and determine its critical relative humidity. The changes in appearance,moisture,disintegration time and the biological activity of fresh antler orally disintegrating tablets with all ingredients under high humidity,high temperature and strong light,accelerated test and long term test were investigated. And its critical relative humidity was tested by the reducing heavy law. The results under influence factors indicated the tablets were stable under strong light while the appearance,moisture,disintegration time under high humidity and the biological activity under high temperature changed obviously（ P 〈0. 01）. To compare with 0 month,the appearance,moisture,disintegration time changed under accelerated test and long term test were not fitted the requirements of orally disintegrating tablets. Its CRH was 72. 59%. The major factors affecting its stability were temperature and humidity. In order to ensure its stability and effectiveness,the fresh antler orally disintegrating tablets with all ingredients should be packaged with moisture proof,stored sealed in a cool dry place with the relative humidity under 72. 59%.
出处
《中华中医药学刊》
CAS
北大核心
2015年第11期2643-2646,I0002,共5页
Chinese Archives of Traditional Chinese Medicine
基金
国家自然科学基金项目(81073056/H2806)
北京中医药大学研究生自主课题(2014-JYBZZ-XS-120
500102/0100605092)
关键词
鲜鹿茸
口腔崩解片
稳定性
临界相对湿度
fresh antler
orally disintegrating tablets
stability
critical relative humidity
