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亚甲蓝原料药的稳定性考察
引用本文:李莉,汤磊,张敏,黄家宇,张毅.亚甲蓝原料药的稳定性考察[J].贵阳医学院学报,2009,34(3):308-310.
作者姓名:李莉  汤磊  张敏  黄家宇  张毅
作者单位:贵阳医学院,药学院,贵州,贵阳,550004
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。

关 键 词:亚甲蓝  药物  稳定性    温度  湿度

Study on the Stability of Methylene Blue
LI Li,TANG Lei,ZHANG Min,HUANG Jiayu,ZHANG Yi.Study on the Stability of Methylene Blue[J].Journal of Guiyang Medical College,2009,34(3):308-310.
Authors:LI Li  TANG Lei  ZHANG Min  HUANG Jiayu  ZHANG Yi
Institution:(School of Pharmacology, Guiyang Medical College, Guiyang 550004, Guizhou, China)
Abstract: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.
Keywords:methylene blue  drug stability  light  temperature  humidity
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