复方氨基酸注射液生产工艺研究

目的对复方氨基酸注射液的制备工艺进行研究,制定切实可行的生产工艺。方法分析影响复方氨基酸注射液成品质量的因素,采用正交试验方法,选择最佳溶解温度、药液pH值、活性炭用量及灭菌条件,以确定最佳生产工艺。结果复方氨基酸注射液成品的含量、可见异物合格率高,成品率得到提高。结论用该工艺生产的复方氨基酸注射液质量稳定,工艺设计合理,切实可行。

Study on the preparation of Compound Amino Acid Injection

OBJECTIVE Intensive efforts had been made to establish a practical preparation technique suitable for the preparation of Compound Amino Acid Injection.METHODS After analyzing the injection quality influencing factors,we optimized the solution temperature,the solution PH,activated charcoal consumption and sterilization conditions by orthogonal experiment.RESULTS The passing rate of Compound Amino Acid Injection was increased.CONCLUSION With regard to Compound Amino Acid Injection,the developed production technique was reasonable and realistic.