贵州医科大学学报

2009, v.34;No.138(03) 308-310

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亚甲蓝原料药的稳定性考察
Study on the Stability of Methylene Blue

李莉;汤磊;张敏;黄家宇;张毅;
LI Li,TANG Lei,ZHANG Min,HUANG Jiayu,ZHANG Yi (School of Pharmacology,Guiyang Medical College,Guiyang 550004,Guizhou,China)

摘要(Abstract):

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.

关键词(KeyWords): 亚甲蓝;药物;稳定性;光;温度;湿度
methylene blue;drug stability;light;temperature;humidity

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作者(Author): 李莉;汤磊;张敏;黄家宇;张毅;
LI Li,TANG Lei,ZHANG Min,HUANG Jiayu,ZHANG Yi (School of Pharmacology,Guiyang Medical College,Guiyang 550004,Guizhou,China)

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DOI: 10.19367/j.cnki.1000-2707.2009.03.020

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