中国处方药2024,Vol.22Issue(9) :27-30.

不同厂家及批次的硝苯地平片质量分析与评价

Quality analysis and evaluation of nifedipine tablets from different manufacturers and batches

黄英栋 姜丽君 刘旺培 朱燕 陈洁敏 罗蔚 陈华龙
中国处方药2024,Vol.22Issue(9) :27-30.

不同厂家及批次的硝苯地平片质量分析与评价

Quality analysis and evaluation of nifedipine tablets from different manufacturers and batches

黄英栋 1姜丽君 1刘旺培 1朱燕 1陈洁敏 1罗蔚 1陈华龙1
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作者信息

  • 1. 韶关市食品药品检验所,广东韶关 512000
  • 折叠

摘要

目的 对收集的 25 批次硝苯地平片进行多项目测定,对不同厂家产品的质量进行分析与评价.方法 参照《中国药典》,比较不同厂家产品的性状、有关物质、含量均匀度、溶出度、含量测定等项目,对检验结果进行统计分析和评价.结果 25 批次检验结果均符合《中国药典》标准,合格率为 100%,但存在较大差异.结论 不同厂家硝苯地平片质量存在差异,部分厂家有关物质杂质Ⅱ的控制有待提高.

Abstract

Objective 25 batches of nifedipine tablets were collected for multi-item determination,and the quality of products from different manufacturers was analyzed and evaluated.Methods According to Chinese Pharmacopoeia,the properties,related substances,content uniformity,dissolution and content determination of products from different manufacturers were compared,and the results were statistically analyzed and evaluated.Results The test results of 25 batches were all in line with the standard of Chinese Pharmacopoeia,and the qualified rate was 100%,but there were great differences.Conclusion The quality of nifedipine tablets from different manufacturers is different,some manufacturers need to improve their control of related substance Impurity Ⅱ.

关键词

硝苯地平片/不同厂家/质量/高效液相色谱法

Key words

Nifedipine tablets/Different manufacturers/Quality/High performance liquid chromatography

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出版年

2024
中国处方药
南方医药经济研究所

中国处方药

影响因子:0.649
ISSN:1671-945X
参考文献量4
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