首页|辅酶Q10氯化钠注射液的稳定性研究

辅酶Q10氯化钠注射液的稳定性研究

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目的 考察辅酶Q10 氯化钠注射液对光线、温度的稳定性。方法 以辅酶Q10 含量、吸光度、pH值及溶液外观变化为指标,采用紫外分光光度计、pH计以及观察溶液的澄清度等方法,考察光线、温度对辅酶Q10 氯化钠注射液稳定性的影响。结果 强光照射下 2 h后溶液颜色变黄并随着时间推移颜色加深,出现黄色沉淀,pH值升高(但在正常范围内)吸光度下降,含量降低;日光照射下 4 h后溶液颜色变黄,出现黄色沉淀,pH值升高(但在正常范围内)吸光度下降,含量降低;室内不避光下放置 6 h后溶液颜色微黄,出现黄色絮状沉淀,pH值升高(但在正常范围内),吸光度下降,含量略下降。低温 48 h内各项指标无明显变化;高温对注射液略有影响,80℃时溶液外观澄清,pH值下降(但在正常范围内),吸光度及含量下降,40℃、60℃时注射液各项指标无明显变化。结论 辅酶Q10 氯化钠注射液对光不稳定,对温度较稳定,高温使pH值降低。因此,在储存过程中应严格避光室温保存。
Stability study of coenzyme Q10 sodium chloride injection
Objective To investigate the stability of coenzyme Q10 sodium chloride injection to light and temperature.Methods The effects of light and temperature on the stability of coenzyme Q10 sodium chloride injection were investigated by UV spectrophotometer,pH meter and clarification of the solution with the content,absorbance,pH value and appearance of the solution as indexes.Results After 2 h of exposure to strong light,the color of the solution turned yellow and deepened with time,yellow precipitation appeared,pH value increased,but within the normal range,and the absorbance decreased and the content decreased.After 4 h of sunlight,the color of the solution turned yellow,yellow precipitation appeared,the pH value increased,but within the normal range,the absorbance decreased and the content decreased.After 6 h in the room without light,the color of the solution was yellowish,yellow flocculent precipitation appeared,pH value increased,but within the normal range,the absorbance decreased,and the content decreased slightly.There was no significant change in all indexes within 48 h of low temperature.High temperature has a slight effect on the injection.At 80℃,the appearance of the solution was clarified and the pH value was decreased,but within the normal range,the absorbance and content of the solution were decreased,and the indicators of the injection had no significant change at 40℃and 60℃.Conclusion Coenzyme Q10 sodium chloride injection is unstable to light,stable to temperature,high temperature reduces pH value.Therefore,during the storage process should be strictly kept away from light at room temperature.

Coenzyme Q10LightTemperatureStabilityUltraviolet spectrophotometry

罗敏、赵方允、李文莲、余大领、易晓燕、唐无忌、李燕

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昭通市第一人民医院药剂科,云南昭通 657000

昆明医科大学附属延安医院药学部,昆明 650051

辅酶Q10 光照 温度 稳定性 紫外分光光度法

2024

中国处方药
南方医药经济研究所

中国处方药

影响因子:0.649
ISSN:1671-945X
年,卷(期):2024.22(2)
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