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

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)%.