左旋卡尼汀氯化钠注射液制备工艺研究  

Study on the preparative process of levocarnitine and sodium chloride injection

作　　者：赵刚[1] 凌林[2] 

机构地区：[1]中国人民解放军第105医院制剂室,安徽合肥230001 [2]安徽省医药科技实业公司,安徽合肥230001

出　　处：《安徽医药》2005年第5期331-332,共2页Anhui Medical and Pharmaceutical Journal

摘　　要：目的研究左旋卡尼汀氯化钠注射液的制备工艺。方法对活性炭用量、pH值、灭菌条件进行了筛选,并考察制剂稳定性。用HPLC法检测含量及有关物质。结果制备工艺采用浓配法,加入0.1%的活性炭,调pH值在5.5～6.5,115℃热压灭菌30min。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,适于工业生产。质量可控。Aim To study the preparative process of levocarnitine and sodium chloride injection. Methods In the experiment,the ratio of activated charcoal to preparative solution in volume,pH and sterlization condition were selected respectively,and the stability of the injection was investigated.Related substances and levocarnitine content were determined by HPLC.Results A dense solution of levocarnitine and NaCl was adjusted to the method of preparation.The optimal conditions were established as follows: activated charcoal 0.1%,pH 5.5～6.5, moist heat sterlization 115℃ for 30 min. The quality of the injection thus prepared conformed to the standard for injection in Chinese pharmacopoeia. Conclusion The preparation of levocarnitine and sodium chloride injection is reliable and suitable for industrial manufacture.Its quality can be controlled.

关 键 词：左旋卡尼汀氯化钠注射液 工艺研究 制备工艺 HPLC法 灭菌条件 有关物质 热压灭菌 质量标准 制剂质量 工业生产 活性炭 PH值 稳定性 浓配法 注射剂 

分 类 号：TQ463[化学工程—制药化工]