低温法配制盐酸川芎嗪氯化钠注射液

Preparation of Ligustrazine Hydrochloride and Sodium Chloride Injection at Low Temperature

目的:探讨盐酸川芎嗪氯化钠注射液的配制条件。方法:改造现有蒸汽夹层锅,将注射用水快速降温到40℃～50℃,用此低温水配制盐酸川芎嗪氯化钠注射液,并与高温法配制的注射液进行对比研究。结果:高温配制法配制的注射液盐酸川芎嗪含量均<90.0%,达不到质量标准,而低温法配制的注射液盐酸川芎嗪含量均>99.0%,完全符合质量要求;两种方法配制的注射液氯化钠含量符合质量要求。高温法配制的注射液中有关物质含量较高,且20040506批号样品含量超标,而低温法配制的注射液中,有关物质含量均符合质量要求。低温法制备的注射液室温条件下放置半年,有效成分含量均>99.0%,有关物质含量均<1.0%。结论:在低温条件下(40℃～50℃)配制盐酸川芎嗪氯化钠注射液,盐酸川芎嗪及有关物质含量符合要求;通过改造现有设备快速大量制备低温注射用水,以实现制剂的低温配制。

Objective： To explore preparation conditions of Ligustrazine Hydrochloride and Sodium Chloride Injection.Methods： The existing Steam jacket pan was improved,by which injection water was rapidly cooled to 40℃～50℃ to prepare for ligustrazine sodium chloride injection,which compared with the injection prepared at high temperature.Results： Ligustrazine hydrochloride content in injec-tion prepared at high temperature less than 90.0%,lower than the quality standards,and content in injection prepared at low temperature more than 99.0%,in full compliance with the quality requirements.Sodium chloride content in two injection qualified.High content of related substances in injection prepared at high temperature was detceted,especially sample with lot 20040506 exceeded the standard,and the related substances in injection prepared at low temperature was in full compliance with the quality requirements.To keep the injection prepared at low temperature at room temperature for six months,the active ingredient content greater than 99.0% and the related substances less than 1.0%.Conclusion： Ligustrazine hydrochloride and related substances content in Ligustrazine Hydrochloride and Sodium Chloride Injection prepared at low temperature（40℃～50℃）meet the quality requirements.By improving existing equipment,large scale injection water at low temperature was prepared rapidly and preparation of injection at low-temperature achieved.