注射用穿琥宁的相关物质研究

Study on the related substances of Potassium dehydroandrograpolide succinate for injection

目的以注射用穿琥宁（0．2g）为例，探讨影响注射用穿琥宁质量的因素，优化注射用穿琥宁的生产工艺。方法以注射用穿琥宁有关物质为指标，采用正交试验法优选制备工艺参数，确定最佳生产工艺。结果配药用水温度、pH值对注射用穿琥宁相关物质有显著影响，该制剂的最佳生产工艺为配药用水温度40℃、pH值6．4和灌装时间2h。结论优化后的注射用穿琥宁生产工艺合理可行、质量可控，在保证该产品有关物质合格稳定的基础上适用于工业化生产。

Objective To discuss the influence factors on the quality of Potassium dehydroandrograpolide succinate for injection, and to optimize its production process. Methods The related substances were taken as the estimated standards and the orthogonal experimental method for determining the best production process was adopted. Results The water temperature and pH value had a significant effect on the related substances. The best production process was： dispensing water temperature at 40~C, pH at 6.4 and filling time being 2 h. Conclusion The optimized production process was quality control and reasonable, which can be used in industrial production.