摘要
目的研究阿魏酸钠氯化钠注射液的制备工艺。方法对抗氧剂用量、pH值、活性炭用量和灭菌条件进行了筛选。用紫外分光光度法测定阿魏酸钠的含量,用HPLC法检测有关物质。结果加入0.1%甲硫氨酸,调pH值在4.0～6.0,加入0.1%的活性炭,100℃流通蒸汽灭菌30 min。制剂质量符合药典有关注射剂的质量标准。结论本品制备工艺可靠,适于工业化生产,质量可控。
Aim To study the preparative process of sodium ferulate and sodium chloride injection.Methods In the experiment,the ratio of antioxidant,pH,the ratio of activated charcoal to preparative solution in volume and sterlization condition experiment were selected respectively.Sodium ferulate content were determined by UV,and related substances were determined by HPLC.Results The optimal conditions were established as follows：antioxidant 0.1%,pH 4.0～6.0,activated charcoal 0.1%,mobile steam heat sterlization 100℃ for 30 min.The quality of the injection thus prepared conformed to the standard for injection in Chinese pharmacopoeia.Conclusion The preparation of sodium ferulate and sodium chloride injection is reliable and suitable for industrial manufacture.Its quality can be controlled.
出处
《安徽医药》
CAS
2007年第11期973-974,共2页
Anhui Medical and Pharmaceutical Journal
关键词
阿魏酸钠
制备工艺
注射剂
sodium ferulate
preparative process
injection
