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.
关键词
丁酸氯维地平注射用乳剂/工艺优化/商业化生产
Key words
clevidipine butyrate emulsion for injection/process optimization/commercial production
维普
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