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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 investigate the preparation conditions of ligustrazine hydrochloride and sodium chloride injection. Methods: The existing steam sandwich pot was modified and the water for injection was rapidly cooled to 40 ℃ ~ 50 ℃. The ligustrazine hydrochloride and sodium chloride injection was prepared with this low temperature water and compared with the injection prepared by high temperature method. Results: The contents of tetramethylpyrazine hydrochloride in injection prepared by high-temperature preparation method were less than 90.0%, which failed to meet the quality standards. The contents of ligustrazine hydrochloride in injection prepared by low-temperature method were all more than 99.0%, which fully met the quality requirements. Injection sodium chloride content in line with quality requirements. The high-temperature injection of the preparation of the relevant substance content is high, and 20040506 batch samples exceed the standard, and the injection of low-temperature preparation of the formula, the relevant substance content are in line with the quality requirements. The cryogenic preparation was placed in room temperature for six months at room temperature, the active ingredient content were> 99.0%, the relevant substance content <1.0%. CONCLUSION: Ligustrazine hydrochloride and sodium chloride injection and tetramethylpyrazine hydrochloride were prepared at low temperature (40 ℃ ~ 50 ℃) and the content of the related substances met the requirements. The low temperature injection water was rapidly and massively prepared by reforming the existing equipment Preparation.