Objective:To ensure that products with good quality and stability can be prepared on commercial production lines by optimizing the preparation process of clevidipine butyrate emulsion for injection.Methods:The preparation process of clevidipine butyrate emulsion for injection suitable for commercial production was screened out by the optimization of method for the addition of egg yolk lecithin,the investigation of the crude emulsion feeding sequence,homogenization parameters and pH adjustment steps.Results:A better quality clevidipine butyrate emulsion for injection could be obtained by adding egg yolk lecithin to the oil phase,mixing oil and water in a fixed proportion,setting the homogenization pressure at 50-70 MPa,maintaining the temperature of the liquid at 40-60℃,homogenizing the liquid for 5-12 times and adjusting the pH to 7.0-8.0.Conclusion:It is possible to prepare a good quality and stable clevidipine butyrate emulsion for injection using the optimized process parameters on a commercial production line.
clevidipine butyrate emulsion for injectionprocess optimizationcommercial production
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