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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 prepare potassium citrate gel matrix sustained-release pellets and investigate the prescriptions and process factors that affect its in vitro release. Methods The content of potassium citrate was determined by copper sulfate colorimetry. The effects of different types and different viscosities of HPMC, pill size and pressure on drug release were studied. Results The in vitro release of the sustained release pellets was in accordance with the requirements of the United States Pharmacopeia for the in vitro release of potassium citrate sustained release tablets. Conclusion This dosage form can be used as an alternative dosage form for the treatment of related diseases.