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国产厂家与原研厂家卡托普利片的质量比较研究
引用本文:马平. 国产厂家与原研厂家卡托普利片的质量比较研究[J]. 现代药物与临床, 2016, 39(6): 999-1002
作者姓名:马平
作者单位:南京市食品药品监督检验院, 江苏 南京 210038
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。

关 键 词:质量比对  卡托普利片  卡托普利二硫化物  溶出曲线
收稿时间:2016-03-21

Quality ananlysis between domestic manufacturers and original manufacturer for Captopril Tablets
MA Ping. Quality ananlysis between domestic manufacturers and original manufacturer for Captopril Tablets[J]. Drugs & Clinic, 2016, 39(6): 999-1002
Authors:MA Ping
Affiliation:Nanjing Institute for the Food and Drug Control, Nanjing 210038, China
Abstract: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.
Keywords:comprison of the quality  Captopril Tablets  captopril-disuphide  dissolution curve
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