【摘要】 目的优化碳酸氢钠复方电解质注射液的制备工艺。方法对制剂处方进行分析,以pH值、钙离子浓度、可见异物为主要评价指标,比较不同制备工艺对产品质量的影响。结果优选的碳酸氢钠投料条件:配液温度为50±5℃,投料时需充入CO2并调节pH4.5~6.5,碳酸氢钠应最后投料。结论配液温度、药液pH值对注射液成品质量的影响显著,应进行严格控制;采用优化工艺制备的产品主要指标达到课题设计要求,解决了含碳酸氢钠电解质注射液的工业化大生产与稳定性问题。更多还原

【Abstract】 OBJECTIVE To optimize the preparation process of multiple electrolytes injection containing sodium bicarbonate. METHODS The formulation was investigated. The indexes including p H value,concentration of calcium and visible particles were used to compare the effect of different preparation process on the quality of final products. RESULTS The optimal preparation process was confirmed as follows: the temperature of solution preparation was set to be 50 ± 5 ℃; CO2 was filled into the solution and the p H was adjusted to 4. 5- 6. 5,and then sodium bicarbonate was added. CONCLUSION The quality of the final product was greatly affected by temperature and p H value of the solution,so these parameter conditions should be under strictly control during the preparation. The product prepared by the optimal preparation process met the expected quality standards. The stability problem was solved and large scale manufacture was realized in the case of the multiple electrolytes injection containing sodium bicarbonate.更多还原