摘要
目的:考察亚甲蓝原料药的稳定性。方法:亚甲蓝原料药经强光照射(4500 lx)10 d、高温存放(40℃)10 d、高湿存放[25℃,RH(75±5)%]10 d、加速试验[(40±2)℃,RH(75±5)%]6个月、长期试验1年,考察亚甲蓝原料药经不同条件存放后的性状、含量及有关物质的变化。结果:亚甲蓝原料药经光照试验、高湿试验、高温试验、加速试验和长期试验后,所考察指标均符合质量标准要求。结论:亚甲蓝原料药稳定性较好,但具有吸湿性。
Objective： To investigate the stability of methylene blue crude materials. Methods： The raw material of methylene blue was treated respectively with highlight （4500Lx, 10d） for 10 days, high temperature （ 40℃ ） for 10 days, high wet （25℃, RH75% ± 5% ）for 10 days, accelerating testing （40℃ ±2℃ RH75% ±5% ）for six months, and a long-term testing of one year, and then the changes of characters, contents of active components and related substances under different storage conditions were observed. Results： All of the tested indexes of the sample were consistent with the quality standards after the series tests. Conclusions： The tested material is stable but is hygroscopicity.
出处
《贵阳医学院学报》
CAS
2009年第3期308-310,共3页
Journal of Guiyang Medical College
关键词
亚甲蓝
药物
稳定性
光
温度
湿度
methylene blue
drug stability
light
temperature
humidity
