氯化钾溶液配制方法的改进
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摘要
目的探讨氯化钾溶液配制和存放过程中羟苯乙酯析出的问题,改进配制方法,提升氯化钾溶液的质量。方法采用HPLC法和紫外分光光度法鉴别析出物为羟苯乙酯,并测定羟苯乙酯的含量。优化配制流程、温度和溶剂的参数,结合羟苯乙酯抑菌效力的测定结果,改进羟苯乙酯的含量,并进行长期稳定性考察。结果采用水溶解法替代醇溶液,配制温度控制在60℃以上,羟苯乙酯的含量为0.030%,留样观察12个月,各项检查结果均符合规定。结论改进后的配制方法简单方便,可以提高氯化钾溶液的质量和稳定性。
Objective To solve ethylparaben precipitation during the preparation and storage of potassium chloride solution in order to improve the preparation method and the quality of potassium chloride solution.Methods The precipitates were identified as ethylparaben by high performance liquid chromatography and ultraviolet spectrophotometry.The content of ethylparaben in potassium chloride solution was determined.The preparation process,temperature and solvent parameters were optimized,the content of ethylparaben was improved by combining the results of bacteriostasis tests,and the long-term stability was investigated.Results Water solution was used instead of alcohol solution.The temperature of preparation was controlled above 60 C.0.030% was the best content for ethylparaben.After 12 months of observation,all the results were up to the standard.Conclusion The improved method is simple and user-friendly,and can improve the quality and stability of potassium chloride solution.
Objective To solve ethylparaben precipitation during the preparation and storage of potassium chloride solution in order to improve the preparation method and the quality of potassium chloride solution.Methods The precipitates were identified as ethylparaben by high performance liquid chromatography and ultraviolet spectrophotometry.The content of ethylparaben in potassium chloride solution was determined.The preparation process,temperature and solvent parameters were optimized,the content of ethylparaben was improved by combining the results of bacteriostasis tests,and the long-term stability was investigated.Results Water solution was used instead of alcohol solution.The temperature of preparation was controlled above 60 C.0.030% was the best content for ethylparaben.After 12 months of observation,all the results were up to the standard.Conclusion The improved method is simple and user-friendly,and can improve the quality and stability of potassium chloride solution.
引文
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[2]国家药典委员会.中华人民共和国药典(四部)[S].北京,中国科技医药出版社,2015:569-570
[3]陆小儿.氯化钾溶液中羟苯乙酯的质量控制[J].医药导报,2008,27(8):994-995
[4]李志胜,李佳鹏.氯化钾溶液配制方法的探讨[J].齐鲁药事,2007,26(6):350
[5]寇培艳,张丽华,郭新玲,等.氯化钾溶液配制方法的改进[J].包头医学,1998,22(1):22