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目的优化盐酸普萘洛尔微囊的制备工艺。方法采用流化床制备普萘洛尔微囊,以平均粒径,包封率、载药量及总评归一值为评价指标,并运用星点设计考察囊材液流速、喷雾压力对制备工艺的影响,对结果进行多元线性和二项式拟合,效应面法选取最佳工艺条件进行预测分析。结果从复相关系数上看,各指标二项式拟合方程均优于多元线性回归方程,最佳工艺参数:囊材液流速1.00 mL·min-1,喷雾压力0.65 bar,在此工艺条件下得到微囊粒径为300μm,载药量为20.54%,包封率达89.63%。结论优选普萘洛尔微囊的流化床制备工艺稳定可行,包封率高,有利于工业化生产。
Objective To optimize the preparation process of propranolol hydrochloride microcapsules. Methods The fluidized bed was used to prepare propranolol microcapsules. The average particle size, entrapment efficiency, drug loading and the total value were used as evaluation indexes. The star point design was used to investigate the flow rate of the capsule material and the spray pressure on the preparation process The results were multivariate linear and binomial fit, effect surface method to select the best process conditions for predictive analysis. Results From the complex correlation coefficient, the binomial fitting equation of each index was better than multivariate linear regression equation. The optimum process parameters were as follows: the flow rate of the capsule material was 1.00 mL · min-1 and the spray pressure was 0.65 bar. Under this condition, The microcapsule particle size of 300μm, drug loading of 20.54%, encapsulation efficiency of 89.63%. Conclusion The preparation process of propranolol microcapsules is stable and feasible, and the entrapment efficiency is high, which is benefit to industrialized production.