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目的考察盐酸奈福泮药物树脂复合物制备工艺中各因素的影响。方法分别采用静态法和动态法制备盐酸奈福泮药物树脂复合物,并对其制备工艺进行考察,同时采用正交设计法,对静态制备条件进行优化。结果采用动态法制备盐酸奈福泮药物树脂复合物时宜选用低质量浓度药液与小粒径树脂,并以低流速在高温条件下制备。静态法制备时宜选用小粒径的树脂在高温条件下制备,而浓度的选择要考虑药物利用率和载药量两方面因素而定。结论采用动态法制备药物树脂时,载药量及药物利用率受树脂粒径、体系温度、药物质量浓度和流速的影响,而采用静态法制备时,两者主要受体系温度和初始质量浓度的影响。
Objective To investigate the influence of various factors on the preparation process of nembophor hydrochloride resin composite. Methods Static and dynamic methods were used to prepare the drug resin complex of nefopam hydrochloride and the preparation process was investigated. At the same time, the orthogonal design method was used to optimize the static preparation conditions. Results When using the dynamic method to prepare the drug resin complex of Nefopam hydrochloride, the low concentration liquid and small particle size resin should be selected and prepared at low flow rate under high temperature. Static method should be used when preparing small particle size resin prepared at high temperature conditions, and the concentration of the choice of drug utilization and drug loading to consider both the two factors. Conclusions When using dynamic method to prepare drug resin, drug loading and drug utilization rate are affected by resin particle size, system temperature, drug concentration and flow rate. However, when prepared by static method, both of them are mainly affected by temperature and initial mass concentration influences.