枸橼酸莫沙必利自微乳中空栓剂的制备及质量标准研究

Study on preparation and quality standard of self-microemulsion-hollow suppository of mosapride citrate

目的制备枸橼酸莫沙必利自微乳中空栓剂,并建立其质量标准。方法将枸橼酸莫沙必利自微乳填充于混合脂肪酸甘油酯为基质的中空栓剂中制备栓剂;按2005年版《中国药典》建立质量标准。结果枸橼酸莫沙必利自微乳中空栓剂各项指标均达到《中国药典》有关规定。结论本研究为开发枸橼酸莫沙必利新产品奠定了基础。

Objective To prepare self-microemulsion-hollow suppository of mosapride citrate,and establish its quality standard.Methods The self-microemulsion of mosapride citrate was filled into the suppository cavity with mixed fatty acid ester as base and the quality standard was set up according to CHP 2005.Results The self-microemulsion of mosapride citrate can match the requirement of CHP.Conclusion This study has settled good foundation for developing new product of mosapride citrate.