| 摘要: |
| 摘 要: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。 |
| 关键词: 关键词:亚叶酸钙注射液 工艺优化 正交试验 |
| DOI： |
| 分类号: |
| 基金项目: |
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| Technological research on calcium folinate injection |
|
L IU Cheng2sheng
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| Abstract: |
| Abstract: To resolve the p roblems existing in the manufacturing p rocess, in this study, we op timized the tech2
nology of injection based on the results from orthogonal experiment, and we also determine the influence of tempera2
ture of samp les, p ressure 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 op timized in our experiments based
on the analysis of relative substances and visible particles. The results showed that the p roducts based on the op ti2
mizing p rograms are stable and reliable. |
| Key words: Key words: calcium folinate injection op timization ofmanufacture orthogonal experiment |
