摘要
目的对国产厂家与原研厂家生产的卡托普利片的质量进行比对研究。方法按照《中国药典》第一增补本的方法对不同厂家的卡托普利片进行实验,测定二硫化物、溶出曲线、含量测定等项目,综合评定产品质量。结果各厂家质量均符合标准规定。国产厂家在二硫化物、溶出曲线等项目与原研厂家存在差异性。结论国内部分厂家与原研厂家质量存在差异,建议提高工艺水平,提高药品质量。
Objective To research the quality of Captopril Tablets of domestic manufacturers and the original manufacturer. Methods Captopril-disuphide, dissolution cures and content was determined according to CP 2010 the first enlarged edition of different manufacturers, for comprehensive evaluation of the quality of the products. Results The quality of each manufacturer was promising. There are differences in Captopril-disuphide and dissolution cures projects between the original manufacturer and domestic manufacturers. Conclusion Part of domestic manufacturers＇ quality was different with the original manufacturer, suggest to raise the level of technology improve the quality of medicines.
出处
《药物评价研究》
CAS
2016年第6期999-1002,共4页
Drug Evaluation Research
关键词
质量比对
卡托普利片
卡托普利二硫化物
溶出曲线
comprison of the quality
Captopril Tablets
captopril-disuphide
dissolution curve
