硫酸妥布霉素注射液工艺研究

Study on Process of Tobramycin Sulfate Injection

目的:保证硫酸妥布霉素注射液成品质量符合2010版中国药典。方法:通过对硫酸妥布霉素注射液pH值的稳定性考察,确定硫酸妥布霉素注射液半成品pH范围。结果:硫酸妥布霉素注射液半成品pH应控制在5.5-6.0之间,方可保证硫酸妥布霉素注射液的质量符合药典标准。

Objective ：To ensure Tobramycin Sulfate Injection according with Chinese Pharmacopoeia. Methods：To Stability inspection of Tobramycin Sulfate Injection pH, determined pH limits of semi - finished products from Tobramycin Sulfate Injection. Results： of pH limits of semi - finished products from Tobramycin Sulfate Injection was controled from 5.5 to 6. 0, and Quality of Tobramycin Sulfate Injection can be ensured.