摘要
对保存于综合药品稳定性试验箱的保健食品崩解时限的变化进行研究。发现样品剂型及内容物成分是影响崩解时限稳定性的主要原因,样品在不同介质条件下的测定对崩解时限也有较大的影响。结果表明,保健食品在温度(25±2)℃、相对湿度(60±10)%条件下放置0~12个月,片剂、硬胶囊剂崩解时间均无明显改变,而软胶囊剂部分品种崩解时间变化显著。
The change of the disintegration time of health food stored in the comprehensive drug stability test chamber was studied.It was found that the main factors affecting the stability of disintegration time were the dosage form and content,and the determination of samples under different media conditions also had a great influence on disintegration time.The results showed that the disintegrating time of the tablets and hard capsules did not change significantly when the health food was placed at temperature(25±2)℃and relative humidity(60±10)%for 0~12 months,while the disintegrating time of some varieties of soft capsules changed significantly.
作者
叶姣姣
胡雁来
杨子忠
李亚军
冯雪萍
YE Jiao-jiao;HU Yan-lai;YANG Zi-zhong;LI Ya-jun;FENG Xue-ping(Hubei Provincial Key Laboratory of Yeast Function,Hubei Yichang 443003;Angel Nutritech Co.,Ltd,Hubei Yichang 443003,China)
出处
《广州化工》
CAS
2023年第17期54-55,58,共3页
GuangZhou Chemical Industry
关键词
保健食品
崩解时限
中国药典
长期稳定性
health food
disintegration time limit
Chinese pharmacopoeia
long term stabilit
