甲磺酸罗哌卡因注射液制备工艺研究

Study on preparation technology of Ropivacaine Mesilate Injection

目的:获得优化的甲磺酸罗哌卡因注射液的处方和制备工艺。方法:通过对注射液性状、pH值范围、活性炭用量、灭菌条件等筛选得到优选处方。结果:按照本工艺制备的产品,稳定性良好,达到了质量标准的要求。结论:处方和制备工艺合理,利于生产操作,适于工业化生产。

Objective： To determine the prescription and preparation technology of Ropivacaine Mesilate Injection. Methods：The formulation of Ropivacaine Mesilate Injectionn was optimized with appearance, pH, activated carbon dosage and sterilization condition. Results ： The prepared product have good stability and have met the requirements of the quality standards. Conclusion ： The prescription and preparation technology are reasonable, and conducive to the production operation and ensure product quality, high production efficiency.