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目的:优选提高复方乳酸钠注射液澄明度的最佳工艺。方法:采用正交试验法,选择可能影响药液澄明度的4个因素:浓溶液脱炭温度(A),浓溶液pH(B),浓溶液脱炭时间(C),注射液灌装温度(D),每个因素取3个水平,以复方乳酸钠注射液澄明度合格率为指标,优选最佳工艺条件。结果:最佳工艺条件为浓溶液脱炭温度80℃,浓溶液pH 6.5,浓溶液脱炭时间20 min,注射液灌装温度50℃。结论:该优选工艺能提高复方乳酸钠注射液的澄明度。
Objective: To optimize the best technology of compound sodium lactate injection clarity. Methods: The orthogonal test was used to select four factors that may affect the clarity of the drug solution: decarburization temperature of concentrated solution (A), pH of concentrated solution (B), time of decarbonization of concentrated solution (C), injection filling temperature (D), each factor take 3 levels, the compound sodium lactate injection clarity pass rate as an indicator, the optimal process conditions. Results: The optimal conditions were as follows: the decarbonization temperature of the concentrated solution was 80 ℃, the concentration of the concentrated solution was 6.5, the time for decarbonization of the concentrated solution was 20 min, and the filling temperature of the injection solution was 50 ℃. Conclusion: The optimized process can improve the clarity of compound sodium lactate injection.