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目的:研究硫酸阿米卡星注射液的变色问题,找到解决硫酸阿米卡星注射液变色的方法。方法:通过调整抗氧剂用量、pH范围、充氮量,确定最佳用量及使用范围。结果:通过实验研究确定了抗氧剂用量、pH范围、充氮量。结论:按实验研究确定的抗氧剂用量、pH范围、充氮量生产硫酸阿米卡星注射液,能保证注射液在有效期内稳定。
Objective: To study the discoloration of amikacin sulfate injection and to find a solution to the discoloration of amikacin sulfate injection. Methods: By adjusting the amount of antioxidants, pH range, nitrogen content, to determine the best dosage and scope of use. Results: The amount of antioxidants, pH range and nitrogen uptake were determined through experimental studies. Conclusion: According to the experimental study to determine the amount of antioxidants, pH range, nitrogen production of amikacin sulfate injection, to ensure that the injection is stable in the effective period.