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作 者:林新文 唐闪光 朱光冕 陈娜[3] LIN Xin-wen;TANG Shan-guang;ZHU Guang-mian;CHEN Na(Hunan Drug Examination and Inspection Center,Changsha 410001;Hunan Yige Pharmaceutical Co.,Ltd,Xiangtan Hunan 411100;The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine,Changsha 410021)
机构地区:[1]湖南省药品审核查验中心,长沙410001 [2]湖南一格制药有限公司,湖南湘潭411100 [3]湖南中医药大学第一附属医院,长沙410021
出 处:《中南药学》2022年第8期1844-1849,共6页Central South Pharmacy
摘 要:目的优化过氧化碳酰胺的处方及其制备工艺,提高其稳定性。方法采用单因素试验法,以过氧化碳酰胺pH、含量和收率为指标,以pH调节剂种类和添加量、依地酸二钠添加量为因素,对其处方进行优化;以溶解水浴温度、析晶温度、真空干燥温度为因素,对其制备工艺进行优化。采用长期试验和加速试验考察过氧化碳酰胺原料的稳定性。结果最优处方及制备工艺为浓过氧化氢溶液126 g、枸橼酸0.82 g、依地酸二钠0.12 g、尿素60.06 g、溶解水浴温度30~40℃、析晶温度0~-7℃、真空干燥温度30~40℃。经3次试验验证,所得过氧化碳酰胺的平均pH为3.6,平均含量为35.6%,平均收率为78.4%。长期试验和加速试验表明,过氧化碳酰胺在低温下放置6个月,性状、溶液澄清度、pH、干燥失重和含量均无明显变化。结论所得最优处方及制备工艺稳定、可行,可用于过氧化碳酰胺原料的制备。Objective To optimize the formulation and preparation technology of urea peroxide and improve its stability.Methods The single factor experiment was used.The pH,content and yield were used as indexes,and the formulation was optimized by taking the pH regulator,addition amount and EDTA-2Na addition amount as factors.The preparation technology was optimized by taking the reaction temperature,crystallization temperature,and drying temperature as factors.The stability of urea peroxide was determined by the acceleration test and the long-term test.Results The optimal formulation and preparation technology were as follows:hydrogen peroxide 126 g,citric acid 0.82 g,EDTA-2Na 0.12 g,urea 60.06 g,reaction temperature 30~40℃,crystallization temperature 0~-7℃,and vacuum drying temperature 30~40℃.After three experiments,the average pH of urea peroxide was 3.6,the average content was 35.6%,and the average yield was 78.4%.The acceleration test and long-term test showed no significant change in the properties,solution clarity,pH,drying weight loss and the content when urea peroxide was placed at low temperature for 6 months.Conclusion The formulation and preparation technology are stable and feasible,and can be used for the preparation of urea peroxide.
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