亚叶酸钙注射液工艺研究

Technological research on calcium folinate injection

针对亚叶酸钙注射液生产过程中存在的问题,以亚叶酸钙含量、有关物质为考察指标,以配液温度、氮气压力、搅拌时间为考察因素,选用L4(23)正交表进行试验,优选出药液配制工艺;以样品中有关物质、可见异物为考察指标,对不同的灭菌工艺进行试验,优选出最佳灭菌工艺条件,从而优化了亚叶酸钙注射液的生产工艺条件;经留样观察表明,用优化后的工艺生产的亚叶酸钙注射液,产品质量稳定。

To resolve the problems existing in the manufacturing process, in this study, we optimized the technology of injection based on the results from orthogonal experiment, and we also determine the influence of temperature of samples, pressure of nitrogen and time of agitation on the content of calcium folinate and relative substances in the mixture of injection. Furthermore, the condition of sterilization was also optimized in our experiments based on the analysis of relative substances and visible particles. The results showed that the products based on the optimizing programs are stable and reliable.