草酸萘呋胺酯包衣微丸的稳定性研究

Study on the stability of naftidrofuryl oxalate coated pellets

目的考察草酸萘呋胺酯包衣微丸的稳定性。方法以外观性状、含量、有关物质、溶散时限为考察项目,对草酸萘呋胺酯包衣微丸进行影响因素试验、加速试验、长期试验。结果在考察期内,各项指标均稳定。结论样品包装能保证草酸萘呋胺酯包衣微丸的稳定性,暂定室温自然条件下有效期为2年。

Objective To investigate the stability of naftidrofuryl oxalate coated pellets.Methods The factors influencing test accelerate test and long-term test were carried on the naftidrofuryl oxalate coated pellets,the appearance,content,related substance and dissolution time were investigated.Results During the period,the appearance,content,related substance and dissolution time of naftidrofuryl oxalate coated pellets were stable.Conclusion The package could ensure the stability of naftidrofuryl oxalate coated pellets,and the shelf life of the product is defined as two years at room temperature temporarily.