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目的研究丁酸氯维地平亚微乳注射液的制备并考察其理化性质。方法通过高压均质法制备乳剂,以制剂的外观、粒径、粒度分布及含量等为考察指标,采用单因素考察法对丁酸氯维地平亚微乳注射液处方中的磷脂种类和其用量、油酸用量、初乳p H值及制备过程中初乳温度、高压均质压力、次数和灭菌条件等因素进行了优化,确定最优处方及制备工艺。同时对制备的3批样品进行了理化性质研究。结果采用单因素考察法优化丁酸氯维地平亚微乳注射液的处方及制备工艺,在最优处方下制得的丁酸氯维地平亚微乳注射液样品外观均为白色或类白色均匀乳状液体,粒径为(225.3±55.5)nm,Zeta电位为-26.89 m V,p H值为7.01,包封率为98.1%,含量为99.2%。结论制备的丁酸氯维地平亚微乳注射液灭菌稳定性良好,有望开发成为临床用药的新制剂。
Objective To study the preparation of micro-emulsion injection of clevidipine butyrate and study its physico-chemical properties. Methods The emulsion was prepared by high pressure homogenization. The appearance, particle size, particle size distribution and content of the preparation were used as indexes to investigate the phospholipid types and their dosage in the formulation of clevidipine butyrate microemulsion injection by single factor method , The amount of oleic acid, the p H value of colostrum, the temperature of colostrum during preparation, the homogenization pressure under high pressure, the number of times and the sterilization conditions were optimized to determine the optimal formulation and preparation process. At the same time, three batches of samples were studied for physicochemical properties. Results The single factor method was used to optimize the formulation and preparation process of the micro-emulsion injection of clevidipine butyrate. The appearances of the sample of clevidipine butyrate micro-emulsion prepared under the optimal prescription were white or almost white-like The emulsion has a particle size of (225.3 ± 55.5) nm, a zeta potential of -26.89 mV, a p H value of 7.01, an encapsulation efficiency of 98.1% and a content of 99.2%. Conclusion The preparation of clevidipine butyrate microemulsion injection stability and good stability, is expected to develop into a new drug for clinical use.