枸橼酸钾凝胶骨架缓释丸体外释放的影响因素研究

Factors Influencing the Release of Potassium Citrate Gel Matrix Sustained-release Pill in Vitro

目的自制枸橼酸钾凝胶骨架缓释丸,考察影响其体外释放度的处方和工艺因素。方法实验采用硫酸铜比色法测定枸橼酸钾含量,研究不同型号、不同黏度的HPMC、丸剂大小及压力大小对药物释放的影响。结果该缓释微丸的体外释放度与美国药典对枸橼酸钾缓释片体外释放度的相关要求相符。结论该剂型可以作为缓释片的替代剂型用于相关疾病的治疗。

OBJECTIVE To investigate the formulated and technological factors that influence the release of potassium citrate gel matrix sustained-release pill. METHODS The factors which include different models and different viscosity of HPMC, the size of pills and production pressure were investigated by determining the content of postassium citrate in potassium citrate solution using the UV spectrophortometry. RESULTS The release of sustained-release pills in vitro was in line with of the requirements of USP for the potassium citrate extended-release tablets. CONCLUSION The formulations can be used as alternative formulations for the treatment of related diseases.