温度和相对湿度对穿心莲内酯-泊洛沙姆188-固体分散体稳定性的影响  

Effects of temperature and relative humidity on the stability of andrographolide-Poloxamer 188-solid dispersions

作　　者：张俊芳 张守德 赵国巍 欧丽泉 蔡萍 曾庆云 ZHANG Jun-fang;ZHANG Shou-de;ZHAO Guo-wei;OU Li-quan;CAI Ping;ZENG Qing-yun(Ministry of Education Key Laboratory for Modern Chinese Medicine Preparations,Jiangxi University of Chinese Medicine,Nanchang 330004,China)

机构地区：[1]江西中医药大学现代中药制剂教育部重点实验室,江西南昌330004

出　　处：《中成药》2022年第7期2077-2081,共5页Chinese Traditional Patent Medicine

基　　金：江西省教育厅科学技术研究项目(GJJ201233);江西中医药大学博士科研启动基金(2019WBZR001)。

摘　　要：目的 探讨温度和相对湿度对穿心莲内酯-泊洛沙姆188-固体分散体稳定性的影响。方法 在温度(40±2)、(60±2)℃,相对湿度(55±5)%、(75±5)%、(95±5)%下,测定固体分散体吸湿性、相对结晶度、溶出度。结果 在相对湿度≤(55±5)%下贮存30 d后,固体分散体分子间相互作用、相对结晶度发生变化,保持溶出稳定性;在相对湿度≥(75±5)%下贮存30 d后,即使温度≤(40±2)℃,固体分散体吸湿稳定性、重结晶稳定性、溶出稳定性被破坏。结论 相对湿度对穿心莲内酯-泊洛沙姆188-固体分散体稳定性的影响更明显。该制剂应在相对湿度≤(55±5)%下贮存。AIM To explore the effects of temperature and relative humidity on the stability of andrographolide-Poloxamer 188-solid dispersions.METHODS At the temperatures of(40±2),(60±2)℃and relative humidities of(55±5)%,(75±5)%,(95±5)%,the hygroscopicity,relative crystallinity and dissolution rate of solid dispersions were determined.RESULTS After storage for 30 d at the relative humidity of not more than(55±5)%,the solid dispersions demonstrated changed molecular interaction and relative crystallinity,along with maintained dissolution stability.After storage for 30 d at the relative humidity of not less than(75±5)%,the solid dispersions exhibited destroyed hygroscopic stability,recrystallization stability and dissolution stability even at the temperature of not more than(40±2)℃.CONCLUSION Relative humidity shows a more obvious influence on the stability of andrographolide-Poloxamer 188-solid dispersions.This preparation should be stored at the relative humidity of not more than(55±5)%.

关 键 词：穿心莲内酯 泊洛沙姆188 固体分散体 稳定性 温度 相对湿度 

分 类 号：R944[医药卫生—药剂学]