盐酸奈福泮药物树脂制备的研究

Studies on the preparation technology of nefopan hydrochloridere-sion complexes

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 factors that influence the preparation of the nefopan hydrochloride-resin complex. Method The drug resinates complex were prepared by the batch method and column method. The preparation of resinates complex by the batch method was optimized based on the orthogonal test. Results The resinates complex was prepared by column method with low drug concentration and low flow rate, at high temperature and small particle size of resin. The resinates complex was prepared by bath method with high temperature and small particle size of resin. Conclusion When the drug resinates complex were prepared by column method, loading and availability were influenced by the resin particle size, temperature, drug concentration and flow rate. Whereas the temperature and drug concentration were main influencing factors in bath method.