国产注射用头孢孟多酯钠的质量现状与处方合理性评价

Evaluation on rationality of the existing quality and formulation of domestic sodium cefamandole nafate for injection

目的对国产注射用头孢孟多酯钠的质量现状和处方合理性进行了评价。方法依据现行药品质量标准对市场上的产品进行检验;对不同处方制剂的关键检测数据、稳定性和不良反应等指标进行对比分析。结果含碳酸钠注射用头孢孟多酯钠制剂较不含碳酸钠产品固体稳定性没有明显差异;制成溶液后,虽然含碳酸钠的产品溶液起始pH略高,水解速率相对较快,杂质的增加速率也相对较快,但这种差异并不明显;且含碳酸钠的制剂溶液澄清度更不易变化。结论注射用头孢孟多酯钠处方中应加入一定比例的碳酸钠以确保产品安全性,但目前国内市场上多为头孢孟多酯钠直接分装的产品,其处方不合理。

Objective To evaluate the quality situation and formulation rationality of domestic cefamandole nafate for injection. Methods The products on the domestic market were inspected by the current statutory standard. The key test data, stability, clinical adverse events and other index of different formulated preparations were comparatively analyzed. Results The solid stability of different formulated preparations of cefamandole nafate for injection had no significant differences. After the solution was made, the initial pH of the solution containing sodium carbonate was slightly higher, the hydrolysis rate was relatively fast, and the rate of impurity increase was relatively fast, but the difference was not very obvious. The clarity of preparation contained sodium carbonate is not easy to change. Conclusion Cefamandole nafate for injection should be added a certain proportion of sodium carbonate to ensure the safety of products, but the most domestic products are direct packaging of cefamandole nafate. This formulation is not reasonable.