注射用盐酸甲氯芬酯在输液中的配伍稳定性考察
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[摘 要] 目的：考察注射用盐酸甲氯芬酯在输液中的配伍稳定性，为临床用药安全、有效提供可靠依据。方法：根据本品临床使用情况，将注射用盐酸甲氯芬酯用5%葡萄糖注射液溶解成0.5mg/ml、1mg/ml、2.5mg/ml、100mg/ml的浓度，于0、0.5、1、2、4h，分别观察其外观性状、溶液澄清度、pH值、有关物质和含量的变化。结果：本品在输液中有关物质增长较快，高浓度溶液较低浓度溶液稳定，0.5mg/ml2h、1mg/ml2h、2.5mg/ml4h有关物质超出了质量标准范围，100mg/ml4h内有关物质稳定。外观性状、溶液澄清度、pH值均无明显变化。结论：出于用药安全性考虑，建议本品溶解和稀释后在60分钟内用完。
[关键词] 注射用盐酸甲氯芬酯；5%葡萄糖注射液；配伍稳定性
[Abstract] Purpose：Investigation with Meclofenoxate Hydrochloride for Injection in the infusion for clinical drug compatibility stability, and provide reliable basis for safe and effective. Method: According to the clinical use of this product will be Meclofenoxate Hydrochloride for Injection in 5% glucose solution dissolved into 0.5mg/ml, 1mg/ml, 2.5mg/ml, 100mg/ml concentration, and 0,0.5,1, 2,4 h, observe the appearance of a shape, clarify of solution ,ph value, and the related substance and assay of changes. Result: The product on a drip of the related substance grew rapidly, a strong solution is stabilizer than a low concentration of solution, 3 5mg/ml 2h, 1mg/ml 2h, 2 ......
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